Abstract
Aims:
The primary aim of this current study was to investigate the impact of the clinical pharmacist interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes in Egypt.
Methods:
A prospective trial was conducted on 100 patients with uncontrolled type 2 diabetes admitted in the diabetes outpatient’s clinics. Patients were randomly allocated into the clinical pharmacist intervention group and usual care group. In the intervention group, the clinical pharmacist, in collaboration with the physician had their patients receive pharmaceutical care interventions. In contrast, the usual care group patients received routine care without clinical pharmacist’s interference.
Results:
After 6-month of follow-up, of the average HbA1c and FBG values of the patients in the clinical pharmacist intervention group (HbA1c % from 8.6 to 7.0; FBG (mg/dL) from 167.5 to 121.5) decreased significantly compared to the usual care group patients (HbA1c % from 8.1 to 7.8; FBG (mg/dL) from 157.3 to 155.9) (P < .05). Additionally, the results indicated that mean scores of patients ‘diabetes knowledge, medication adherence, and diabetes self-care activities of the patients in the clinical pharmacist group increased significantly compared to the control group (P < .05).
Conclusions:
The study demonstrated an improvement in HbA1c, FBG, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The study outcomes support the benefits and the need to integrate clinical pharmacist interventions in the multidisciplinary healthcare team in Egypt.
Keywords: pharmacists, education, HbA1c, diabetes mellitus
Introduction
It is important to recognize that Diabetes mellitus (DM) is a chronic disease that requires continuous monitoring, ongoing patient education, and counseling to prevent acute complications and reduce the risk of chronic complications. 1 All diabetic patients are at risk of complications, but specifically Type 2 Diabetes Mellitus (T2DM) may present with complications. It is known that inadequate glycemic control is associated with increased risks of CD, microvascular complications and hospitalizations. The intervention of the clinical pharmacist utilizing pharmaceutical care interventions and educational programs can be used to mitigate the aforementioned complications by optimizing pharmaceutical treatment, 2 and contribute to patient care by providing individual guidance which consider one of the most significance arm in Diabetes mellitus management. 3
Globally it is estimated that 382 million patients suffer from diabetes for a prevalence of 8.3% among adults, and this number is expected to rise beyond 592 million by 2035. 4 Moreover, from the view of pharmacoeconomics, the International Diabetes Federation (IDF) estimated that global healthcare expenditures for diabetes management totaled at least US dollars (USD) 465 billion in 2011, and by the year 2030 burden of disease is projected to exceed USD 595 billion. 5 Urbanization, fast food, and decreased exercise are the most important factors of the increased numbers of DM all over the world. 6 In 2015, the IDF estimated that globally, 415 million adults 20 to 79 years of age or 8.8% of the adult population have diabetes. 7
Egypt is 8th of the top 10 countries for the number of adults with diabetes, with a number of 8.2 million DM patients in 2018. That number was predicted to be doubled by 2045, and Egypt will climb to number 6th rank in the top 10 list.8,9 There are no formal referral systems in the ministry of Health of Egypt in a delivery system, and most patients with diabetes are either treated in the private clinics through out-of-pocket fee for service, in the limited number of academic hospitals, or in the scarce dedicated diabetes centers in Cairo and some other major hospitals. According to the IDF, the current spending on diabetes in Egypt is among the lowest in the Middle-East and North Africa (MENA) at $116 per patient per year. 7 This is far lower than the spending in other developed countries, which usually ranges from $2000 to $7000 per patient per year and even lower than the general spending in the MENA region, which ranges from $160 to $3000 per patient per year. 7
Currently, DM is a leading cause of vision loss in Egypt. It is estimated that 42% of diabetic patients in Egypt have retinopathy, 5% of them are legally blind, and 22% had peripheral neuropathy. Diabetes is also the major cause of end-stage renal disease (ESRD) and leg amputation in Egypt. 9 Therefore DM progression and complication control are some of the important components for DM management in healthcare programs. 10
Glycosylated hemoglobin (HbA1c) is considered the main test for glycemic control and fundamental to the management of diabetes, and it is an important predictor of chronic complications of diabetes. 1 American Diabetes Association (ADA) 1 and the American Association of Clinical Endocrinologists 11 guidelines emphasized the importance of achieving and maintaining glycemic levels as near to the normal non-diabetic range as possible to prevent or delay diabetes-related complications. Several randomized clinical trials have reported that clinical pharmacist diabetes care programs improved glycemic control and other clinical outcomes in patients with diabetes.12-19
In Egypt, the clinical pharmacy program became a part of the pharmaceutical curriculum in 2008, and many schools of pharmacy began to prepare pharmacy students for clinical pharmacy practice in hospitals. In recent years the promising developments in pharmacy practice, several issues must be evaluated and solved, including the implementation of clinical pharmacy units in hospitals for continuing education, recognition of clinical pharmacists tasks as an important part in health care system, and the removal of physicians’ resistance to the pharmacist’s role in patient care. 20 The primary aim of the present study was 1. To investigate through a randomized controlled clinical trial, the impact of the clinical pharmacist interventions on glycemic control which evaluated by HbA1c, Fasting blood glucose (FBG) levels, and other health-related outcome like lipid profile, and body mass index (BMI) at 6 months’ follow-up period .2. To demonstrate the role of clinical pharmacist interventions on adherence to prescribed diabetes medications, diabetes knowledge, and diabetes self-care activities at 6 months’ follow-up period.
Subjects, Materials, and Methods
Study Design, Setting, and Sample
The study was a prospective clinical trial with a 6-month follow-up period. This study was approved by the Ethical Committee of the Faculty of Pharmacy, Helwan University. The study site was the outpatient diabetes clinic at Ahmed Maher Teaching Hospital, in Cairo, Egypt. The outpatient clinic provides usual care services daily with regular follow-up clinic visits every 1 to 3 months, according to the results of a glycemic lab at each visit. Patients were included in the study if they were previously diagnosed with T2DM, adult ≥ 18 years old, managed with diet and exercise only, and/or use oral hypoglycemic agents. Patients were excluded if they were diagnosed with renal impairment (eGFR < 30 mL/minute/m2) or hepatic diseases, patients on insulin treatment, pregnant women or breastfeeding, patients with dementia or cognitive impairment, severe/unstable congestive heart failure that required hospitalization, patients with endocrine disorders that affects glucose metabolism such as thyroid dysfunctions and patients who were unable to provide a consent form.
Patient recruitment and randomization
During the process of obtaining the informed consent, all participants were informed that they would be assigned to either the intervention group (clinical pharmacist–physician model) or the control group (usual care, physician model-only). At the time of recruitment, patients were equally randomized into the clinical pharmacist intervention group (n = 50) and the usual care group (n = 50). In order to minimize the selection and randomization bias, Samples are chosen randomly and strictly randomized by chance (simple random sampling).
Outcome measurements
According to ADA guidelines, 1 HbA1c is considered the primary indicator for glycemic control and disease progression; therefore, HbA1c was set as the primary outcome in this study. A blood sample of HbA1c was taken 3 times and was performed on the same day of the interviews. The first was the baseline reading at the initial visit, and the second was after 3 months, and the third was after 6 months of follow up. Current guidelines for glycemic control recommend HbA1c <7% as a treatment goal for most patients and Less stringent control (HbA1c up to 8% may be recommended if the risks and burdens outweigh the potential benefits. 1 Other Health-related clinical outcomes that were obtained during the time of the study were FBG, serum low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), serum triglycerides, total serum cholesterol, and body mass index (BMI). Patients’ adherence to prescribed medications, patient’s knowledge about their disease and diabetes self-care activities were also measured for both groups using validated scores.
Description of clinical pharmacist intervention model versus usual care model
Patients who were not controlled by their diabetes treatment and were on a diet only were initiated on Metformin therapy. Those who were already on Metformin monotherapy were initiated on a second hypoglycemic agent. Oral hypoglycemic agent doses were titrated according to the results of HbA1c and FBG levels. The drug therapy initiation or drug dose titration was done according to the most current clinical guideline for type 2 diabetes management. 1
Group 1: Clinical pharmacist intervention model
We assessed and managed patient condition collaboratively with physicians, also gave recommendations with respect to drug therapy including initiation, dose titration, adding or changing of oral hypoglycemic agents. All these recommendations and patient care plans were discussed with the physicians, who had the final decision to accept or reject them. Physician accepted almost all recommendation after requesting literature evidence for each item. Participants in this intervention group met with the clinical pharmacist in outpatient pharmacy clinic for 30 minutes after seeing the physician. Patient education and counseling along printed material was provided by the clinical pharmacist about T2DM.Topics discussed included types, doses, and side effects of medications, diabetic complications, importance of medication adherence and self-management of blood glucose testing at each visit.
Group 2: Usual care model
Participants received the usual care provided by the physician and the dispensing pharmacist only. Including initiation, dose titration, adding or changing of oral hypoglycemic agents but all intervention provided by the clinical pharmacist about T2DM. included types, doses, and side effects of medications, diabetic complications, importance of medication adherence and self-management of blood glucose testing not performed in this group.
Study instruments
Self-reported measure of medication adherence (Morisky Green Levine Scale)
This scale assessed the probability that patients take their medications as prescribed. 21 The higher score indicating higher levels of adherence to prescribed medications. Five questions were asked of the patient to determine the score: how often during the last month they forgot to take their medications, skipped their medications, stopped their medications when they felt better, stopped their medications when they felt worse, or stopped their medications when they experienced side effects. This scale uses a 5-point Likert scale response format (never, rarely, sometimes, often, and always) that generates a total score up to 25.
The revised summary of diabetes self-care activities scale
The Revised Summary of Diabetes Self-Care Activities (SDSCA) scale 22 is probably the most widely used self-reporting instrument for measuring diabetes self-management in adults. That includes items assessing the following aspects of the diabetes regimen: diet (4 items), exercise (2 items), self-monitoring of blood glucose (2 questions), foot care (2 items), and smoking (1 item). Respondents report on the frequency with which they performed various activities over the previous 7 days. The mean number of days for each self-care activity was calculated, with a higher scores indicating a higher levels of diabetes self-care performance. 22
Diabetes knowledge test
Michigan Diabetes Research and Training Center developed a diabetes knowledge test. 23 The test is consists of 14 items, and was found to be a valid and reliable measure for estimating a patient general understanding of T2DM. The test answer was scored either 0 (wrong answer) or 1 (correct answer), so the higher the score, the better the patients knowledge about lifestyle modification and other non-pharmacological therapy for Type 2 DM. If the patients had scored 11 or less in the total knowledge were considered had inadequate knowledge.
Baseline and follow-up assessments
The baseline data included demographic data, HbA1c, FBG, total cholesterol, triglycerides, HDL-C, and LDL-C, BMI, and prescription medications information was collected for each patient through an interviews, lab reading, and hospital records. Also, the adherence scale, knowledge test, and self-care activities questionnaire were also completed for both groups. Laboratory results were obtained at each subsequent follow up visit including adherence, knowledge test, and self-care questionnaire at 6-month follow up.
Data analysis
Patients’ demographics were summarized using descriptive statistics. Continuous variables would be expressed as mean ± standard deviation (SD) and ranges, for continued variables, paired t-test was used to compare follow-up values with the baseline values, and independent samples t-test used to compare the data between 2 study groups. Comparisons between 2 parallel groups with continuous data were performed using an independent t-test, while similar non- parametric categorical data were performed using the chi-square test, and non-parametric continuous data were performed using the Mann–Whitney test. All analyses were performed based on intention to treat and at a significance level of P < .05. Statistical analyses were conducted using the Statistical Package for the Social Sciences (IBM SPSS® 25).
Results
A total of 125 T2DM patients attending the outpatient diabetes clinic were recruited into the study (63 clinical pharmacist intervention model group; 62 usual care group). During the study period, thirteen patients from the first group and twelve patients from the usual care group dropped out of the study. Therefore, a total of 100 patients (50 clinical pharmacist intervention model group 50 usual care group) completed the 6-month study period.
Patients in both groups were most often male (66% and 70%, in the clinical pharmacist intervention group and usual care group respectively), age ranged from 48 to 63 years old, diabetic duration range from 8.2 ± 2.4 to 8.7 ± 2.5 years. Other baseline demographic and clinical characteristics for the 2 groups are presented in Table 1. All differences between the 2 groups on the baseline variables except for the HDL-C (mg/dL) statistical analyses indicated non-significant. Types and frequency of most commonly used oral ant diabetic patient also presented in Table 1 as Biguanides (Metformin) were the main class of anti-diabetic agents used alone or in combination by patients in 2 groups (98% and 94% in clinical pharmacist intervention group and usual care group respectively).
Table 1.
Baseline Demographics and Clinical Characteristics of the Study Participants (N = 100).
| Variable | Clinical pharmacist intervention model (N = 50) |
Usual care model (N = 50) |
P-value |
|---|---|---|---|
| M (SD) a | M (SD) | ||
| Age (y) | 53.8 (5.6) | 55.7 (6.9) | .287 b |
| Male | 33 (66%) c | 35 (70%) | .668 |
| Female | 17 (34%) | 15 (30%) | |
| BMI (kg/m2) | 29.8 (4.1) | 29.1 (3.4) | .486 |
| DM duration (y) | 8.2 (2.4) | 8.7 (2.5) | .404 |
| HbA1c (%) | 8.6 (1.1) | 8.1 (0.91) | .066 |
| FBG (mg/dL) | 167.5 (39.9) | 157.3 (33.4) | .292 |
| Serum-cholesterol (mg/dL) | 174.2 (32.4) | 183.7 (26.6) | .091 |
| LDL-C (mg/dL) | 105.5 (27.4) | 107.8 (22.1) | .513 |
| HDL-C (mg/dL) | 38.6 (5.3) | 43.5 (7.9) | .001 d |
| Serum-Triglyceride (mg/dL) | 184.4 (82.8) | 152.7 (56.3) | .066 |
| Metformin n (%) | 49 (98) | 47 (94) | |
| DPP-IVinhibitors (Vildagliptin-sitagliptin) n (%) | 1 (2) | 3 (6) | |
| Sulphonylureas (Glibenclamide-Glimepride) n (%) | 40 (80) | 42 (84) |
Note. BMI = body mass index; kg/m2 = kilograms per squared meter; HbA1c = glycosylated hemoglobin; FBG = fasting blood glucose; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol.
Values presented as mean and standard deviation.
P values for indepentant samples calculated by independent t-test for continuous variables and Mann–Whitney test for categorical variables.
Percent within intervention group.
P value <.05 means statistically significant deference.
Diabetes Control and Other Related Parameters
As shown in Table 2, the change of HbA1c (%) from baseline was significantly greater in the Clinical pharmacist intervention model group than in the usual care group (−1.6 vs −0.3, P < .001). This result was also confirmed by FBG (mg/dL) at 6 months follow up, with a −46 decrease from baseline in the intervention group compared to a decrease of −1.4 in the control group (difference between groups: P < .05).
Table 2.
Comparison of Participant’s Scores in Glycemic Control and Other Health-Related Clinical Outcomes in Both Groups at Baseline and 6 Months Follow Up.
| Outcome | Clinical pharmacist intervention model (N = 50) |
Usual care model (N = 50) |
P value of difference | ||||
|---|---|---|---|---|---|---|---|
|
M (SD)
a
|
M (SD)
b
|
||||||
| Baseline | Follow up | Difference | Baseline | Follow up | Difference | ||
| HbA1c (%) | 8.6 (1.1) | 7.0 (0.6) | 1.6 (0.5) | 8.1 (0.91) | 7.8 (0.9) | 0.3 (0.01) | <.001 |
| FBG (mg/dL) | 167.5 (39.9) | 121.5 (16.9) | 46 (22.9) | 157.3 (33.4) | 155.9 (30.7) | 1.4 (2.7) | <.001 |
| Serum cholesterol (mg/dL) | 174.2 (32.4) | 158.1 (22.3) | 16.2 (10.2) | 183.7 (26.6) | 172.2 (20.6) | 11.5 (6.0) | .011 |
| LDL-C (mg/dL) | 105.5 (27.4) | 95.7 (16.3) | 9.8 (11.2) | 107.8 (22.1) | 104.1 (16.8) | 3.6 (5.3) | .002 |
| HDL-C (mg/dL) | 38.6 (5.3) | 42.1 (4.8) | 3.5 (0.5) | 43.5 (7.9) | 44.6 (7.3) | 1.1 (0.6) | <.001 |
| Serum Triglyceride (mg/dL) | 184.4 (82.8) | 153.9 (50.5) | 30.5 (32.4) | 152.7 (56.3) | 149.6 (42.8) | 3.1 (14.3) | <.001 |
| BMI (kg/m2) | 29.8 (4.1) | 29.3 (3.9) | 0.5 (0.1) | 29.1 (3.4) | 29.6 (3.3) | −0.5–(0.1) | <.001 |
| Knowledge test | 7.8 (1.4) | 11.6 (1.5) | 3.9 (0.1) | 8.1 (1.5) | 8.8 (1.5) | 0.7 (0.1) | <.001 |
| Medication adherence | 11.8 (2.9) | 15.1 (2.1) | 3.4 (0.8) | 13.4 (2.2) | 12.7 (2.3) | −0.7–(0.1) | <.001 |
Note. HbA1c = glycosylated hemoglobin; FBG = fasting blood glucose; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol; BMI = body mass index; kg/m2 = kilograms per squared meter.
Values presented as mean and standard deviation.
P values for indepentant samples calculated by independent t-test for continuous variables and Mann–Whitney test for categorical variables.
Lipid profile in the clinical pharmacist intervention model group, as well as the usual care group at 6-month follow up, revealed significant improvement as there was a mean reduction in total cholesterol, LDL, and triglycerides, in addition to increasing mean HDL-C values in the clinical pharmacist intervention group compared to the usual care group. Results revealed that the clinical pharmacist intervention group statistically achieved a reduction in BMI in comparison to the usual care group which showed an increase in BMI values over the 6-month study (P < .05) (Table 2).
Diabetes knowledge test
Participants in both groups had inadequate diabetes knowledge in baseline results. However, at the 6-month follow-up period, he was significant improvement in the mean score of the clinical pharmacist group compared to the usual care group who still showed inadequate T2DM knowledge (P < 0.05) (Table 2).
Adherence to prescribed medications
Baseline results indicated that the usual care group had numerically higher scores than the clinical pharmacist group (13.4 vs 11.8). However at the 6-month follow-up, the clinical pharmacist group reported a higher medications adherence (P < .05) (Table 2).
Discussion
The mean HbA1c values at baseline was higher in the clinical pharmacist group versus the usual care group which provided a greater opportunity to assist the patients in lowering their values closer to the normal range. At the 6-month follow-up period however, this difference in HbA1c values between the 2 groups was lost (mean HbA1c % was 7.0 and 7.8 for the clinical pharmacist intervention group and the usual care group, respectively). A recent literature review 24 found that pharmacist intervention had significant impact on T2DM management, including HbA1c level. Also, this reduction is consistent with previous research findings over different follow-up periods.19,25,26 For example, Al Mazroui et al 19 reported mean HbA1c % was 7.1 and 8.4 for the intervention group and the usual care group, respectively, over a period of 8 months.
Farsaei et al 27 showed that significant difference in mean HbA1c were achieved down from 9.3 to 7.5 (P < .001) in the clinical pharmacist group after the 3-month follow-up. The present study findings and results of previous studies indicated that the clinical pharmacist model regard to medication optimization, individualized counseling on basic knowledge of the disease and its treatment by patients, how to improve medication adherence, and regular telephone follow-up could result in significant improvements in HbA1c which consider primary outcome measure in this study.
In contrast to Chan et al 28 where there is no significant improvements in HDL-C and triglyceride in the intervention group; our finding showed significant improvement in total cholesterol, LDL-C, HDL-C, and triglycerides levels in the clinical pharmacist group when compared to the changes in lipid profile in the usual care group. These results are consistent with findings from previous studies29-33 that reported a reduction in lipid profile in the intervention group patients when compared to the control group patients.
Lindenmeyer et al 34 in the review of 5 studies revealed a potential benefit of diabetes care interventions by pharmacists to improve medication adherence, especially when providing individualized patient counseling. These finding are considered with our results as both groups, at baseline were considered non-adherent due to the lack of T2DM knowledge. The patients also did not fully understand the risk of complications due to having this disease, and thus were not adherent to their medications. However, after the 6-month follow up the clinical pharmacist intervention group reported higher adherence score to medications than the usual care group due to regular telephone follow-up and improvement in patient knowledge after individualized patient education in private room. This significant improvement in mean score of patient diabetes knowledge in our study for clinical pharmacist group (7.8-11.6) versus (8.1-8.8) for usual care group is consistent with result of Al Mazroui et al. 19
Other studies have shown that the application of self-care management principles, adherence programs and the integration of the pharmacist in the education program are useful for glycemic control in patients with DM.11,35
The observed improvements in diabetes knowledge demonstrated by the improvement in the number of correct answers to the knowledge acquisition questionnaire, considered one of the most important positive outcomes reported in our study as may also be indirectly related to practice adherence in their daily life. Similarly, Chrvala et al, Heald et al and Kostoff et al,36-38 reported that patient knowledge also improved in intervention group.
As shown in Table 3, mean number of days for each self-care activity in the baseline results indicated that participants in both groups reported low levels especially self-monitoring of blood glucose test and exercise were the least performed activities. Our findings from real-practice do not support the ADA recommendations on the importance of regular exercise and self-monitoring, 1 and consistent with other previous studies.38-42 However, diabetes self-care activities regarding aspects of diet, exercise, foot care, and self-monitoring of blood glucose were improved significantly in the intervention group after 6-month follow up. Similarly, Mehuys et al. 42 reported that patient’s diabetes self-care activities for patients among intervention group were also improved. The significant improvement in these activities was likely due to the ongoing education given to patients by the clinical pharmacist focusing on the importance of regular physical activity and how exercise can optimize glycemic control and possibly prevent and manage diabetes complications, also when educational materials were provided patients remembered to perform these activities.
Table 3.
Comparison of Participant’s Scores in Diabetes Self-Care Activities Subscales in Both Groups at Baseline and 6 Months Follow Up.
| SDSCA scale a | Clinical pharmacist intervention model (N = 50) |
Usual care model (N = 50) |
P value of difference | ||||
|---|---|---|---|---|---|---|---|
|
M (SD)
b
|
M (SD) |
||||||
| Baseline | Follow up | Difference | Baseline | Follow up | Difference | ||
| Diet | 3.2 (0.9) | 4.6 (0.5) | 1.4 (0.3) | 3.4 (1.1) | 3.2 (0.98) | −0.19–(0.1) | <.001 c |
| Exercise | 2.5 (1.4) | 3.8 (1.1) | 1.3 (0.4) | 2.6 (1.1) | 2.6 (1.2) | −0.1–(0.1) | <.001 |
| Foot care | 3.1 (1.7) | 6.2 (0.8) | 3.2 (1.1) | 3.5 (1.7) | 3.8 (1.6) | 0.4 (0.3) | <.001 |
| Self-monitoring | 1.5 (1.2) | 3.2 (1.4) | 1.6 (0.6) | 1.9 (1.1) | 2.1 (1.2) | 0.2 (0.2) | .001 |
The revised summary of diabetes self-care activities.
Values presented as mean and standard deviation.
P values for indepentant samples calculated by Mann–Whitney test for categorical variables.
The limitations of this study include a relatively small sample size and participants from one hospital outpatient clinic, which limits the generalizability of our results. This study assessed outcomes after 6 months, and longer follow-up is needed to determine if the outcomes obtained after 6 months are sustained or changed. However, this being the first study in this field in Egypt could open the door for future studies in this important field. Therefore, our recommendation to repeat this study with a larger sample size from multiple hospitals and to extend time of follow-up longer than 6 months is recommended for future research. In conclusion, to our knowledge, this type of intervention is the first of its kind to be reported in Egypt and shows that clinical pharmacists could have added value in the health care team as the present study, in agreement with other studies, demonstrated the positive impact of clinical pharmacist intervention for patients with type 2 diabetes regarding health-related clinical outcomes, including HbA1c, FBG, and lipid profile, in addition to medication adherence, diabetes knowledge, and diabetes self-care activities.
Footnotes
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
ORCID iD: Mohamed A. Mobarez 
https://orcid.org/0000-0001-6148-7957
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