Quality of Care in Patients with Type 2 Diabetes in Iran: A 5-year retrospective study

Background The object of this study was to evaluate the quality of care indicators (process- and outcome-related) in patients with type 2 diabetes using patient-level data during the last 5 years in Iran, in private and public diabetes centers in five provinces (Tehran, Isfahan, Yazd, Mazandaran, and Kurdistan). Method Our study was a cross-sectional study carried out on patients with type 2 diabetes at 13 diabetes centers (private and public). Annual tests for hemoglobin A1C, serum lipid (LDL) and screening for nephropathy (urine protein or urine albumin quantitative test) were used to evaluate process-related and hemoglobin A1C, blood pressure and lipids levels were used to assess outcome-related outcomes.Findings Among 1976 patients, 54% were women with an average of 15 years of diabetes duration and approximately 83% of patients were obese or overweight. About 9% of patients had a hemoglobin A1C test every three months. The values obtained were favorable for controlling lipid profile but less than standard for screening for nephropathy and only about 30% of patients were within the optimal range for simultaneous control of process-related indicators. Findings for outcome- related indicators show that the achievement of blood glucose, blood pressure, and low-density lipoprotein targets were 31, 49 and 70%, respectively and concurrent achievement was 13.8% in the last year.


Abstract
Background The object of this study was to evaluate the quality of care indicators (process-and outcome-related) in patients with type 2 diabetes using patient-level data during the last 5 years in Iran, in private and public diabetes centers in five provinces (Tehran, Isfahan, Yazd, Mazandaran, and Kurdistan).
Method Our study was a cross-sectional study carried out on patients with type 2 diabetes at 13 diabetes centers (private and public). Annual tests for hemoglobin A1C, serum lipid (LDL) and screening for nephropathy (urine protein or urine albumin quantitative test) were used to evaluate process-related and hemoglobin A1C, blood pressure and lipids levels were used to assess outcome-related outcomes.Findings Among 1976 patients, 54% were women with an average of 15 years of diabetes duration and approximately 83% of patients were obese or overweight. About 9% of patients had a hemoglobin A1C test every three months.
The values obtained were favorable for controlling lipid profile but less than standard for screening for nephropathy and only about 30% of patients were within the optimal range for simultaneous control of process-related indicators. Findings for outcome-related indicators show that the achievement of blood glucose, blood pressure, and low-density lipoprotein targets were 31, 49 and 70%, respectively and concurrent achievement was 13.8% in the last year.
Conclusion The performance of the health system has much room for improvement and diabetes control programs have not been favorable in any of the provinces studied and have not led to optimal control. Background 4 Studies show that the Middle East will experience the largest increase in diabetes burden among the rest of the world in the coming years. Most of this increase in diabetes will occur in the age group of 45-64 years, which are economically active population in the community. However, the situation is different in Western countries and most people with diabetes are over 65 years of age who are economically less active or inactive (1).
The prevalence of type 2 diabetes continues to increase in Iran due to population growth, aging, urbanization, obesity, and inactivity (2,3). The prevalence of diabetes in Iran is estimated at 11.4% in 2011 and is still increasing (35% increase between 2005 and 2011) (4). About 40% of these patients have not yet been diagnosed (5).
Literature in this point of view is dichotomous, while some studies have shown improvement in care outcomes in type 2 diabetic patients in Iran (6), a precise literature review shows that the performance of the health care system is still far from the optimal point Only 6.4% of respondents had a hemoglobin A1C test last year and 25.7% stated they had a blood lipid profile test at the same time. 39.8% and 20.5% of diabetic patients had eye and foot examinations, respectively in the year leading up to the study (2009) and about 25% of patients needed to improvement in low-density lipoprotein levels and 45% of them had high blood pressure (7). Previous findings have also shown that only about 50% of diabetic patients have good blood glucose control and blood pressure and dyslipidemia control were even lower (39.9 and 46.8%) (4).
Studies have shown that high quality of care, as well as regular consultation with a physician, may reduce the risk of mortality and the occurrence of micro-and macro-vascular complications (8)(9)(10). Therefore, it is vital to improving the quality of care, including maintaining optimal blood glucose and regular control of complications (11).
Indicators for measuring quality of care include two general categories: a) Processrelated indicators (The extent of the use of a specific evidence-based care process), for example, the number of annual A1C tests and b) outcome-related indicators (reports change in the patient's condition), for instance, the percentage of patients achieving A1c-related goals (12,13).
Unfortunately, only a few limited studies have been conducted to determine control goals in Iran, but the findings have not been sufficiently comprehensive and generalizable at the national level. On the other hand, these studies have mostly been conducted for a short period and do not reflect an understanding of the quality of care in a long time (7,14).
This study aimed to evaluate the quality of care indicators (process and outcome) in patients with type 2 diabetes using patient-level data during the last 5 years in Iran, in private and public diabetes centers in five provinces (Tehran, Isfahan, Yazd, Mazandaran, and Kurdistan).

Sampling Method
We using direct interview method to collect demographic information. Clinical information was also extracted from paper records available at diabetes centers in public hospitals and social security hospitals as well as private diabetes clinics.
We had a some reason's for choosing the cities, Tehran and Isfahan are two metropolises (23% of the total population of Iran lived in these two provinces in other provinces. Yazd has the highest prevalence of diabetes (16.3%) among all provinces (31 provinces), the family physician program is running in Mazandaran and Kurdistan was one of the deprived provinces in terms of access to the care.
Inclusion criteria for the patients included diagnosis of type 2 diabetes, the use of anti-diabetic medications for the past 5 years, the existence of clinical and pharmacological information for the patient over the period and ongoing referral to the relevant treatment center.
Initially, patients with type 2 diabetes who have regular visits to diabetes centers were identified and selected. The clinical information for these patients was recorded and available for at least 5 years. The subjects were selected and invited to cooperate using a random sampling method based on the patient file number (1984 Patients with type 2 diabetes). In centers where the statistical population was small, the entire statistical population was included in the study.
Required information including demographic information was collected and direct interviews were performed to evaluate the validity of the items such as the number of referrals, number of diagnostic tests ... in the patients' records to extract process-related indicators. Also, data related to ABC care goals (hemoglobin A1C, Blood pressure, and low-density lipoprotein) were used to extract outcome-related indicators in these patients. This information was collected for a period of 5 years.

Statistical analysis
All statistical analysis was performed using Stata-Corp 2014.
Descriptive analysis was performed for each year using mean and standard deviation, for continuous variables and percentage for binary variables. One-way ANOVA was used to compare changing the means during the study period were appraised through the absolute increase of each variable and 95% CI.

Process-related quality indicators:
To continuously improve the patients' clinical indicators, we extracted the following aspects: (1) Hemoglobin A1C test (2) Serum lipid test (LDL) (3) Nephropathy screening For blood glucose control, testing hemoglobin A1C every three months was considered a standard limit based on clinical guidelines (26,32).
For lipid profile control, serum lipids (low-density lipoprotein) testing performed at least once a year were considered appropriate.
For nephropathy screening, one or both of the following tests were considered appropriate: a urine protein test or a urine albumin test. Besides, the annual results of these tests were considered as a standard limit.
The percentage of patients with simultaneous measurement of all three variables was evaluated.

Outcome-related quality indicators
Randomized clinical trials in patients with type 2 diabetes have shown that controlling blood sugar, blood pressure and lipids are effective strategies to reduce the risk of complications of diabetes (8,(15)(16)(17)(18). Also, these strategies are very costeffective (19)(20)(21).
To measure the achievement of these indicators, we have used ABC [1] Care (12), which The American Diabetes Association (ADA) has put a lot of emphasis on the control and achievement of these triple goals.
For blood glucose control, HbA1c <7% was considered as the standard limit.
Blood pressure <130/80 mm Hg was considered as a standard limit to control blood pressure profile.
To control the lipid profile, low-density lipoprotein (LDL) <100 mg/dL was considered as the standard limit.
The percentage of patients with Simultaneous achievement of ABC care goals was evaluated.

Results
Analyses and results are based on data from 1984 patients with type 2 diabetes who were collected from private and public diabetes centers in five provincial capital cities (Tehran, Isfahan, Yazd, Mazandaran, and Kurdistan). We will continue with these analyses and results (Table 1).  Outcome-related quality indicators Achieving ABC Care Goals:  Based on the results (Table 4), about 56% of patients had a mean blood pressure lower than the target or optimal level (lower than 130/80) in the first year and this amount reaches 49% in the last year. The percentage decreased in optimal blood pressure over a 5-year interval was statistically significant in all populations. To control the lipid profile, about 70% of patients had a mean LDL below the target limit (below 100) and these values (increases) were statistically significant in all the provinces studied over 5 years (Table 5).   Discussion: Simultaneous goals of diabetes control include reduction of blood sugar to the recommended targets through lifestyle and pharmacotherapy; evaluation and decreasing of cardiovascular risk factors (overweight / obesity, hypertension, and dyslipidemia); regular screening for micro-and macro-vascular complications (22).
In this study, we attempted to investigate the levels of access to each. There are very limited studies on the quality of diabetes care in Iran and their findings are limited to specific areas.
We divided our analysis into two subtitles; process evaluation and outcome evaluation.

Process evaluation:
While previous studies showed that only 6.4% of the patients had one or more tests per year for the HBA1c (7) Gradual changes in the treatment of hypertension in patients with type 2 diabetes, from the classic target blood pressure of less than 90/140 mmHg to more intensive blood pressure control (80/130 mmHg), have been affected by several major clinical trials. Evidence specifically indicates that a further reduction in blood pressure (to 130/80 mmHg) is possible in diabetic patients (29) and may lead to a significant reduction in cardiovascular complications in these groups of patients undergoing more intensive blood pressure treatment (29)(30)(31).
Various Iranian internal studies have shown that blood pressure is controlled by 40-50% (less than 130/80 mmHg) and these values for our study show that 55% of patients have achieved optimal goals on average. These values show a higher optimal level than most previous studies in Iran, but in our study patients with optimal blood pressure decreased during the study period, from 56% in 2012 to 49% in 2016 and these changes were statistically significant.
The findings of our study showed that about 14.2% of patients were able to achieve control goals simultaneously. This value was 13.6% at the beginning of the study, but the reported increase was not statistically significant (p-value > 0.05).
The Among process-related care, optimal control has only been performed on the number of paraclinical tests for blood lipid levels, and the results of the study also show optimal outcomes for blood LDL levels, but in other cares, the results for the processes and their outcomes were undesirable.
Control level was not optimal at both process and outcome levels (at the process level, 30% of patients and at the outcome level, 13.8% of patients were in a desirable condition).
Different factors can be involved in the optimal control of diabetes that lack of multi-factor control can lead to undesirable results: Overall, 83% of patients were overweight and obese, according to our study, and obesity alone or in combination with uncontrolled hemoglobin A1C, systolic and diastolic blood pressure, and LDL-cholesterol are a risk factor for microvascular and neuropathic complications in diabetic patients (33) In addition, today's clinical guidelines not only generally state that patients who cannot reach the goals set for hemoglobin A1c should be followed up every 2-3 times to regulate treatment but also indicate that clinical judgment should be performed individually for each individual (34-39 and in patients with undesirable conditions, urgent attention should be paid to prompt and consistent treatment (40).
Researches have shown that approximately 50% of patients with type 2 diabetes achieve A1c levels below 7% (appropriate control according to ADA) with oral monotherapy for 3 years (41)(42)(43)(44)(45)(46). This disappointing result is partly due to the delay in initiating the first drug treatment after reaching A1c levels above expected levels (47). This outcome may also be due to delayed timely diagnosis of pre-diabetic or diabetic patients, and also is largely due to the actions of specialist and primary care physicians who do not perform well early interventions, and thus, the critical window of treatment for effective disease management is often missed (44).
Despite a large number of guidelines for type 2 diabetes, studies have shown that many physicians do not have adequate information about existing clinical guidelines for type 2 diabetes. In one of these studies, only 39.8% of physicians participated in a continuous improvement program for diabetes management, and 52% of general practitioners were aware of the therapeutic targets for HbA1c (17). Another study showed that only 29% of physicians had adequate information about existing guidelines (41). A study of knowledge and attitudes in 8 countries found that 51% of patients had never heard of HgA1c before and more than 10% of physicians measured it once a year (44).
Before focusing on structured guidelines that emphasize more on the HgA1c recommended targets in different countries, diabetes management with Hypoglycemic Medications was often inadequate and appropriate changes in drug regimens were only made when A1C levels were above 9% (41,43,48). Poor blood glucose management and subsequent failure to achieve HbA1c target levels are often clinically related to physician inertia (failure to initiate therapy or to intensify or change therapy inpatients) and may inappropriately set personalized goals (49).
Although the efficacy of most insulins has been proven in several studies compared to most oral medications (50)(51)(52)(53) and most patients with type 2 diabetes require insulin to maintain HbA1c levels less than 7%, about nine years after diagnosis (46) the share of insulin use, in 2016, was only 25% of the total anti-diabetic medications use (insulin pens have been covered by insurance in Iran since 2012) The findings of the study also showed that, between 2012 and 2016, there was no significant change in the pattern of antidiabetic medications use (54) while the share of insulin in total anti-diabetic medications use was more than 40% in Sweden, Norway, Germany, Denmark and the UK (55).

Conclusion
The findings of the study showed that diabetes control programs were not favorable in any of the studied provinces and did not lead to optimal control. Findings showed that total HbA1c changes were not statistically significant in the whole population and the percentage of patients with optimal blood pressure was statistically significantly reduced in all studied provinces over a period of 5 years.