INTRODUCTION
Diabetes mellitus (DM] is a chronic disease associated with a major economic burden on persons, health care systems, and countries.[ 1 ] Globalhealth care expenditures on the management of DM were estimated at $760 billion in 2019, and this expenditure is anticipated to further increase and become $845 billion by 2045.[ 2 ] In Iraq , the average diabetes-related expenditure per DM person increased from just 96$ in 2010[ 3 ] to $544 in 2017.[ 4 ] Diabetes-related expenditure involves both direct costs for treating DM and its complications, besides indirect costs that result from disability and loss of productivity.[ 5 ] Effective management of DM can play an important role in reducing both DM-related direct and indirect costs.[ 6 ] Diabetes self-management education and support (DSME(S)) is considered an essential approach for the effective management of T2DM patients.[ 7 ] Additionally, it was found that the DSME(S) program is a highly cost-effective method in the management of T2DM patients compared to the usual care.[ 8 ] Unfortunately, such information about the cost-effectiveness of DSME(S) programs was mainly obtained from studies conducted in developed countries.[ 9 ] Furthermore, cost-effectiveness analyses (CEA) for DSME(S) programs in Iraq were also lacking. Therefore, this study aimed to determine the cost-effectiveness of a recently developed culturally-specific DSME(S) program regarding glycemic control, lipid profile, and body weight.
METHODOLOGY
Study design and selection of participants
A randomized controlled clinical trial design was used to assess the cost-effectiveness of the developed DSME(S) program[ 10 ] from the perspective of healthcare providers [based on results of an unpublished study]. Participants were included only if their archives were available for the retrospective recognition of their management in the last 6 months.
Participants were divided between the intervention [DSME(S)] and control groups in a 1:1 ratio and followed up for 6 months.
In the CEA, cost per participant (patient) and clinical outcomes over 6 months were compared between the intervention and control groups. Incremental cost-effectiveness ratios (ICERs) were expressed as cost-per-unit improvement in HbA1c, FBG, TC, LDL-C, HDL-C, SBP, DBP, and body weight.
The current study was ethically approved by the ethical committee at the National Diabetes Center, Baghdad, Iraq .
Costing issue
The current CEA was conducted based on the perspective of Iraqi healthcare providers, so only direct medical costs were taken into account.[ 11 ] However, direct medical costs of clinical examination and laboratory tests were not included in the analysis because they did not differ between the trial groups.[ 12 ] Meanwhile, direct medical costs of the prescribed medications and of the DSME(S) program were different between the trial groups and thus included in the CEA. All of the included direct medical costs in the CEA were calculated for all enrolled participants even if they did not complete the whole study.[ 13 ]
Target item costs were expressed in “Iraqi Dinar (ID)” and based on the average prices at the study time (2018 and 2019) (USD1 = ID 1220). Costs were calculated at the end of the 6-months period of the DSME(S) program. The costs and outcomes of the intervention program were not discounted as the current study was conducted over 6 months.[ 14 ] Cost resources include:
Dispensed medications: The cost of medications prescribed by the physicians of the National Diabetes Center (NDC) to manage DM and its complications (anti-diabetic, antihypertensive, lipid-lowering, and neuropathic agents) was calculated. Whereas medications to manage other conditions and/or supplies (e.g., insulin syringes and glucose testing strips) that are purchased by patients from private pharmacies were not calculated.[ 15 ] Medications cost was based on their average cost in private Iraqi drug stores during 2018 and 2019, since no information about drugs cost in the governmental institutions is available. The cost of medications at each visit to the NDC was calculated based on individual daily doses, therapy duration, and the cost of a single dose. The only exception in the calculation of medication cost was reported for patients using very low insulin doses (less than 24 units of insulin per day), the cost of one insulin dose may be higher than the actual cost because part of the vial must be disposed of as a result of shelf-life of the opened insulin vials. In such cases, a fixed price (28757 ID/3 months) of insulin was used. On the other hand, the total medication cost during the 6 months period was calculated by summation of medication costs at two visits (baseline and the first follow-up assessment visit) to the NDC. Note: Because baseline variations (even small variations) in the cost of prescribed medications between participants in the intervention and control group can influence the accuracy of CEA [ 12 ] ; therefore, the change in medications’ cost was used for CEA calculations. The change in medication cost was calculated by measuring the changes in the cost of prescribed medications during the study period compared to the 6-month before the study for participants in each study group (the intervention and control group). The cost of resources consumed during the study period providing the participants with DSME(S) was accounted for as follows:
The capital costs: The cost of the used facilities (furniture and equipment) needed for the conduction of the DSME(S) program was calculated according to their average cost in the Iraqi market in 2018 and 2019. The used equipment included an electronic sphygmomanometer, electronic balance, glucometer, and an air conditioner. The furniture included two chairs (chairs with handles), a table, and a wooden locker. Equivalent annual cost (EACs) of these facilities (equipment and furniture) was adopted to measure the annual depreciation in the asset value. Equipment’s useful life was estimated to be 5 years at a 5% discount rate.[ 16 ] The estimated EAC was measured according to the equation in Figure 1 . Despite that the room used for educating participants during the current study was donated for free by the NDC, its cost was calculated based on the average monthly rental cost of houses in Baghdad in 2018 and 2019.[ 17 ]
The cost of the DSME(S) program provided by a pharmacist (diabetes educator) to participants during the current study. The average monthly salary of a pharmacist with 5-10 experience years was converted into a salary per minute, and then this salary was multiplied by the mean time spent by the educator (ID/min) to measure the cost of each educational session.
Educational materials for participants of the intervention group include plastic divided plates (Idaho plate), an educational book (diabetes self-management guide), and blank papers to write educational notes to the participant.
Phone calls to contact each participant in the intervention group to assess, and reinforce the achieved goals. Each participant was called twice during the study period.
Overhead costs: cost of using electricity to light room, and cool/warm the room.
Figure 1: The equation for the estimation of the equivalent annual cost
Health outcome measures
The effectiveness of any clinical parameter (outcome) was measured by calculating the difference between the values of a clinical parameter at the end of the study from that at the start of the study. Meanwhile, the effectiveness to improve any clinical parameter was assumed to be zero for participants who did not complete the study (an intention-to-treat approach).[ 13 ] The outcome measures of the economic evaluation study include a unit improvement in HbA1c (%), fasting blood glucose (FBG) (mg/dl), total cholesterol (TC) (mg/dl), serum triglycerides (TG) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl), systolic blood pressure (SBP) (mmHg), diastolic blood pressure (DBP) (mmHg), and body weight (Kg).
Statistical analysis
The incremental cost-effectiveness ratio (ICER) per average improvement in the achieved outcomes was measured for each outcome variable in the local currency (ID).
Although many studies assess the cost-effectiveness of educational interventions according to the WHO recommendations in 2001 that based on the threshold of 1-3 times the gross domestic product (GDP) per capita; however, this method is not accurately reflecting cost-effectiveness in Iraq and many middle-income countries because it does not reflect the healthcare budget and thus may lead to falsely adoption of intervention that is not locally affordable.[ 17 ] Therefore, the more conservative cost-effectiveness threshold (CET) based on recent empirical estimates of opportunity cost in Iraq (USD$1,504-4,679 (1834880-5708380 ID))[ 18 ] was used to assess the economic benefits of the currently developed DSME(S) program. Cost-effectiveness was categorized as follows: highly cost-effective, if the incremental cost per incremental improvement in each variable was <1 of the minimum CET; cost-effective if the cost was <1 of the maximum CET, and dominant (i.e., cost-saving) if the cost per outcome improvement was <0.0.
Shapiro Wilk test was used to test the normality of the distribution of continuous variables. Independent T-test was used to test the significance of the difference between normally distributed continuous variables. Mann Whitney U test was used to test the significance of the difference between abnormally distributed continuous variables. Chi-square test was used to test the significance of difference for categorical variables. P values less than 0.05 was considered significant.
Sensitivity analysis
One-way sensitivity analysis with one parameter changed each time was performed to examine the effect of varying costs and outcomes of the education program on the findings of the base-case analysis. The sensitivity analysis was performed by varying two key parameters. First, the effectiveness of changes in HbA1c and serum TC among the participants in the intervention group was lowered by 50%.[ 19 ] Second, DSME(S) program costs during the study period were arbitrarily changed by ± 50% for both intervention and control groups. The minimum and maximum costs were used as plausible costs for the sensitivity analysis.
RESULTS
Socio-demographic characteristics and descriptive analysis of baseline clinical variables
A total of 78 participants were divided equally into the intervention and the control group (n = 39). However, only 60 participants (30 in each group) completed the study. Table 1 shows the distribution of the socio-demographic characteristics of the participants in the intervention and the control group. No significant differences in age, gender, educational level, or DM duration were observed between the participants in both groups. Descriptive analyses of the baseline clinical variables are shown in Table 2 . A non-significant difference was found in all clinical parameters between the two groups.
Table 1: Demographic data of participants enrolled in this study
Table 2: Baseline clinical data of study participants
Medications costs
The average total cost of medications during the study period for each participant in the intervention and the control group (ID 230343 and ID 265539.2, respectively), was increased from that during the period before the study (ID 228680.07 and ID 252667.6, respectively); however, such increase was smaller among participants in the intervention group (0.73%) than that among the control subjects (5.09%).
For participants who missed the study follow-up visits, there was no change in the prescribed medications type or dose; thus, the cost of medications during the study period was similar to that in 6 months period before the study for participants in both the intervention and the control group.
The capital cost of facilities used in the DSME(S) program
The cost of the used equipment and furniture during the present 6-month study was estimated after dividing the estimated annual cost by two. The useful life span of the equipment and furniture was assumed to be five years with a 5% discount rate and with no resale value at the end of the life span. The annual cost of batteries required for operating electronic equipment was considered as the annual maintenance cost.
The average monthly rental cost of a 200 m2 house in Baghdad during 2018 was 1250000 ID. Since the area of the room that was used for educational purposes in the current study was (4 m * 4 m = 16 m2 ), hence the average monthly rental cost for this room was 100000 ID. The cost of electricity was set at 2500 ID per month after considering the average electricity consumption during 1 month of the study and the cost of 1 unit of electricity (10 ID per 1 unit) in 2018.
The estimated working hours per day were 6 hours with 5 working days per week, leading to 792 working hours and 47520 minutes per 6 months. Therefore, the cost of using any facilities (equipment, furniture, room, and electricity) per minute was measured after taking into account the number of working minutes during the study period (47520 min). The capital cost of all facilities and the total capital cost during the study period per participant in the intervention (2730.6 ID) and the control group (263.655 ID).
Health care education costs during the DSME(S) program
The cost of the DSME(S) during the current study was estimated based on the salary of the educator (a pharmacist). The average monthly salary of a pharmacist with 5-10 years of experience was 1250000 ID. The estimated working hours per day were 6 hours, with 5 working days per week, leading to 792 working hours (47520 min) per 6 months. This means that the salary per minute for the educator pharmacist was 26.3 ID. The average time consumed for educating each participant in the intervention group was 180 min, while the average time for additional education (through 2 phone calls) and reinforcement was 25 min. The average time consumed for educating each participant in the control group was 17.5 min. The total cost per participant in the intervention group who completed the study was ID 5391.5 and ID 4865.5 for those who did not complete the study. The total cost per participant in the control group was ID 460.25.
Costs of educational and consumable materials
The cost of the educational materials was 8710 ID after taking into account the cost of one educational book (8500 ID), one plastic plate (200 ID), and two white papers (10 ID). The cost of each five minutes phone call was 600 ID. Since participants who completed the study were called twice, so, the total cost per participant who completed the study was 9910 ID. On the other hand, participants who didn’t complete the study were called once and thus the total cost per those participants was 9310 ID.
Total cost of the diabetes self-management education and support program
By taking into account the (capital, manpower, and consumables) cost per participant, the total cost of the DSME(S) per participant in the intervention group who completed the study was ID 18032.1 and ID 16678.55 for a participant who did not complete the study. The total cost of the DSME(S) per participant in the control group was only ID 723.91.
The total cost per participant in the intervention and the control group
Table 3 shows the total cost incurred in the intervention & the control group during the study period. The actual cost incurred by a participant who completed the study follow-up visits was ID 19695.03 in the intervention group and ID 13595.51 in the control group. After taking into account the cost spent on participants who lost follow-up visits during the study period, the total cost per participant was measured by dividing the total cost per group over 30. The total cost per group was measured by the summation of the actual costs for participants who completed the study (actual costs per completer participant *30) with the actual costs for participants who didn’t complete the study (actual cost per non-completer participant*9). Thus the total cost per participant in the intervention group was 24698.595 ID and 13812.683 ID for those in the control group [Table 3 ].
Table 3: Total costs per participant during the study period
Cost-effectiveness analysis of the DSME(S) programThe CER provides information about the cost required for one-unit improvement in a clinical outcome. The cost incurred by the intervention group was greater than the cost incurred by the control group; yet, the effectiveness of most outcomes including HbA1c, FBG, TC, TG, SBP, and DBP was better in the intervention group compared with the control group. Only LDL-c and HDL-c levels were improved to a greater extent in the control group. Hence, the control group in the present study was found to be dominant in terms of LDL-c and HDL-c levels. CERs and ICERs per one-unit improvements in HbA1c, TC, LDL-C, HDL-C, SBP, DBP, and body weight are summarized in Table 4 . The ICER per unit improvement in HbA1c, SBP, DBP, serum TC, and TG levels among participants in the intervention group was <1 of the minimum CET compared with the control group, thus meeting the definition of being highly cost-effective [Table 4 ].
Table 4: ICER of the developed DSME(S) program
Sensitivity analysis
Sensitivity analyses were performed to assess the robustness of the cost-effectiveness model. CER and ICER were calculated for each parameter included in the sensitivity analysis. Subsequently, CET fractions of ICER were calculated. Table 5 summarizes the variations in DSME(S) cost performed in the sensitivity analysis. The ICER of HbA1c and TC level remained within the highly cost-effective range (<1.0 min CET) after increasing DSME(S) cost by 50%. On the other hand, reducing DSME(S) cost by 50% resulted in a dominant effect in the intervention group. Table 5 also shows the results of the sensitivity analysis on ICER after assuming a 50% reduction in the effectiveness of the intervention (DSME(S) program) on HbA1c and TC levels. The ICER ratios for both HbA1c and TC levels were unaffected and remained within the highly cost-effective range.
Table 5: Sensitivity analysis for changing the diabetes self-management education cost and effectiveness by±50%
DISCUSSION
The current study showed that the cost incurred by DSME(S) program for participants in the intervention group was greater than that in the control group (ID 18032.1 ($14.78) vs. ID 723.91 ($0.59)). The cost of the current DSME(S) program for participants in the intervention group was much less than that incurred by educational programs for T2DM patients in the USA (3045$) and even less than that in South Africa (22$).[ 20 ] The high cost of the educational programs in the aforementioned studies compared to the current DSME(S) program may be related to the design of these studies that involve many (4-25) educational sessions, besides being delivered by a healthcare team.[ 20 ] The low salary of healthcare workers in Iraq compared to that in other countries, especially the USA, may be considered as an additional reason for the low cost of the DSME(S) program in the current study.
The present study also showed that the cost of the prescribed medications was increased for participants in both groups during the study period compared to 6 month period before the study. Such an increase was expected since T2DM patients, especially those with uncontrolled hyperglycemia, need the intensification of their medications and/or the addition of new medications to control DM and prevent its complications.[ 21 ] In this regard, the increase in the cost of the prescribed medications was greater in the control group as compared to that in the intervention group (ID 12871.6 ($10.55) vs. ID 1662.93 ($1.36)). Similarly, Alaboudi found that the cost of medications was lower in the intervention group as compared to than in the control group.[ 22 ]
On the other hand, the present study reported that the total cost incurred by the intervention group was greater than that incurred by the control group, with a differential cost of ID 10885.912 (8.92$) per participant over the 6-month study period. This cost difference between the intervention and the control group was in accordance with other studies that evaluated the cost benefits of a DSME program for T2DM patients in the South African public sector[ 23 ] and also in real-world community primary care settings.[ 19 ] This higher cost in the intervention group compared to the control group could be related to the current study design that involved individualized-based DSME(S) rather than group-based DSME(S). In this regard, it was found that the direct costs of DSME(S) programs may be reduced through group-based educational sessions.[ 24 ]
The present study found that the HbA1c value was improved to a greater extent among participants in the intervention group; yet, such improvement was at the expense of increasing costs. In this regard, the developed DSME(S) program was highly cost-effective in reducing the HbA1c level by 1 unit with an incremental cost of ID 18450.69 ($15.12). Close to this finding, three studies conducted in the USA showed that DSME programs were cost-effective to improve HbA1c levels; however, the incremental cost in these programs was much greater than that in the current study ($490-7723 vs. $15.12).[ 9 ] A low direct cost of the DSME(S) program [discussed earlier] and the greater HbA1c improvement in the current study as compared to that in the aforementioned studies (0.81% vs. 0.34-0.6%) may be the main reasons behind the very low incremental cost of HbA1c improvement in the current study. Additionally, enrollment of only T2DM patients with uncontrolled hyperglycemia may be another reason for the high cost-effectiveness of the currently-developed DSME(S) program to improve glycemic control.[ 25 ]
The results of this study also showed that the developed DSME(S) program was highly cost-effective in reducing FBG level by 1 unit with an incremental cost of ID1234.23 ($1.01). This result was expected since the current program was highly cost-effective to improve HbA1c value; however, the incremental cost of decreasing 1 unit (mg/dl) of FBG was much lower than that of reducing 1 unit of the HbA1c level. This low incremental cost of reducing 1 unit of FBG compared to that of the Hba1c is expected since the mean blood glucose (fasting and random blood glucose) level must be decreased by about 29 mg/dl to achieve a 1% reduction (from 8% to 7%) in the HbA1c level.[ 26 ]
The current study results showed that BP (SBP and DBP) decreased in both groups; however, the associated costs and reduction in BP were higher in the intervention group compared to the control group. In this regard, the developed DSME(S) program was highly cost-effective in reducing SBP and DBP by 1 unit (1 mmHg) with an incremental cost of ID 5039.773 ($ 4.13) and ID 19439.13 ($ 15.93), respectively. This finding was consistent with that of a previous study by Anchala and colleagues,[ 27 ] who found that $36.57 was needed for each 1 unit reduction in SBP by an intervention focusing on lifestyle education and clinical decision support system among hypertensive patients.[ 27 ]
The present study showed that TC and TG levels were decreased in the intervention group only. This improvement was associated with higher costs in the intervention group compared with that in the control group. In this regard, the developed DSME(S) program was highly cost-effective for reducing TC and TG levels by 1 unit (mg/dl) with an incremental cost of ID 5310.2 ($4.35) and ID 1245.527 ($1.02), respectively. This finding was close to that of Alaboudi, who reported that a DSME program was highly cost-effective to improve TC and cost-saving to improve TG levels for Saudi T2DM patients.[ 22 ]
On the other hand, the current study showed that HDL-c and LDL-c levels were improved in both groups; however, such improvement was better, and the associated costs were lower in the control group compared to the intervention group. Thus, the control group dominated the intervention group in terms of HDL-c and LDL-c improvements. Consequently, the current DSME(S) program was not found to be a cost-saving or cost-effective method to improve LDL-c and HDL-c levels. This finding was not expected since the currently developed DSME(S) program was highly cost-effective to improve glycemic control [HbA1c and FBG], BP, TC, and TG levels. This unexpected finding may be explained in that some new interventions were more cost-effective than usual care in improving some but not all clinical outcomes.[ 28 ]
The results of the current study showed that body weight was increased in both groups; however, this increase and the associated costs were higher in the intervention group as compared to the control group. This unexpected finding was nearly similar to that seen in many other educational studies for T2DM patients.[ 29 , 30 ] Despite the similarity between the aforementioned studies[ 29 , 30 ] and the current study regarding the effect on body weight, cost analysis was not reported in those studies. Close to the current finding, Crawford and colleagues reported a higher cost and worse outcome among participants in the intervention group (who received brief advice to reduce alcohol consumption) than those in the control group.[ 31 ]
Sensitivity analysis was performed to assess the effects of different assumptions of the economic model on the CER of the developed DSME(S) program. In the current study, a number of sensitivity analyses were performed: the first one examined the impact of reducing the improvement in HbA1c and TC levels by 50% among participants in the intervention group only. However, the cost-effectiveness of the current DSME(S) program was not found to be obviously affected by variations in any of the above assumptions and remained within the highly cost-effective range. The second sensitivity analysis involved varying DSME(S) program costs (for both groups) by ± 50%. In this regard, it was found that the DSME(S) program was still highly cost-effective by increasing its direct costs by 50%. Meanwhile, decreasing these costs by 50% allowed the intervention group to dominate the control group with regard to CER. All of the above sensitivity analysis findings will help decision-makers to determine whether the level of certainty in the results of the present study was adequate enough to justify the adoption of the developed program in clinical practice.
The current study was the first one to assess the cost-effectiveness of a DSME(S) program in Iraq . Furthermore, the results of the current study were highly reliable since CEA was not restricted to the participants who completed all study follow-up visits, besides its involvement in detailed sensitivity analysis.[ 32 ] Despite all of the above advantages of the current study, it has some limitations, such as the small sample size and being conducted in only one center of DM care.
CONCLUSION
The currently developed DSME(S) was cost-effective method to improve glycemic control, blood pressure, total cholesterol, and triglyceride for T2DM patients in Iraq .
Practice implications: The developed culturally specific DSME(S) program can be applied in daily practice for the management of type 2 DM patients in Iraq and other Arab countries.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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