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  1. Mikhael EM, Hassali MA, Hussain SA
    Diabetes Metab Syndr Obes, 2020;13:117-138.
    PMID: 32021358 DOI: 10.2147/DMSO.S232958
    Aim: This review study aimed to determine the effectiveness and factors affecting the success of DSME programs in T2DM patients living in ME countries.

    Methods: An extensive manual literature search was conducted using PubMed and Google Scholar for clinical trials assessing the effect of diabetes self-management education (DSME) for type 2 diabetes mellitus patients in Middle East countries. Information from the included studies was summarized in relation to study population, sample size, duration of follow-up, characteristics of DSME program, and follow-up time, besides in addition to parameters used in assessment, results, and conclusions. The risk of bias in the included studies was assessed using the Cochrane risk of bias tool. The effect of DSME on clinical and patient-reported outcomes was measured by calculation of the percentage of DSME studies that produce a significant improvement in these outcomes for patients in intervention group as compared to those in control group. Additionally, the effect of DSME on each clinical outcome was assessed by calculating the mean for the absolute effect of DSME on that outcome.

    Results: Twelve studies were included in this review. Heterogeneity was found among included studies in terms of DSME program characteristics, the enrolled patients, duration of follow-up, assessment methods, and obtained outcomes. All clinical glycemic outcomes (glycosylated hemoglobin, fasting, and non-fasting blood glucose), lipid profile (total cholesterol and triglycerides), and body mass index were significantly improved for patients in intervention group as compared to those in control group in at least 60% of the included studies. All patients' reported outcomes (medication adherence, self-management behavior, knowledge, self-efficacy, health belief and quality of life) were significantly improved by the DSME program.

    Conclusion: DSME programs are highly effective in improving glycemic control, lipid profile and BMI, and modestly effective in improving BP. Thus, they can reduce the risks of developing diabetes complications. Patient diabetes knowledge, DSM behaviors, adherence to medications, self-efficacy, and quality of life can also be significantly improved by DSME.
  2. Mikhael EM, Ong SC, Hussain SA
    J Pharm Bioallied Sci, 2023;15(1):49-56.
    PMID: 37313544 DOI: 10.4103/jpbs.jpbs_767_21
    BACKGROUND: Diabetes mellitus (DM) is a chronic disease associated with a major economic burden on persons, health care systems, and countries. Diabetes self-management education and support (DSME(S)) programs are highly effective method in the management of T2DM patients. Therefore, this study aimed to determine the cost-effectiveness of the developed culturally-specific DSME(S) program regarding glycemic control, lipid profile, and body weight for Iraqi type 2 DM patients.

    METHODS: A randomized controlled clinical trial design was used to assess the cost-effectiveness of the culturally-specific DSME(S) program from the perspective of health care providers. In the cost-effectiveness analysis (CEA), cost per patient and clinical outcomes over 6 months were compared between the intervention and control group. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per unit improvement in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high density lipoprotein- cholesterol (HDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and body weight.

    RESULTS: The effectiveness of most outcomes was better in the intervention group compared with the control group. The ICER per unit improvement in HbA1c, SBP, DBP, serum TC, and TG levels was <1 of the minimum CET compared with the control group, thus meeting the definition of being highly cost-effective.

    CONCLUSION: The currently developed DSME(S) was cost effective method to improve glycemic control, blood pressure, TC, and TG for T2DM patients in Iraq.

  3. Mikhael EM, Hassali MA, Hussain SA, Shawky N
    J Pharm Bioallied Sci, 2020 07 18;12(3):262-268.
    PMID: 33100785 DOI: 10.4103/jpbs.JPBS_190_19
    Background and Aim: The current trend for determining the effectiveness of new treatment or services provided for diabetes mellitus (DM) patients is based on assessing the improvement in both glycemic control and the patient quality of life. Many scales have been developed to assess quality of life among DM patients, but unfortunately, no one can be considered as gold standard. Therefore, this study aimed to develop and validate a brief and specific scale to assess quality of life among Iraqi type 2 DM patients.

    Methods: An extensive literature review was done using Google-Scholar and PubMed to find out scales that utilized to assess quality of life among DM patients. Four relevant scales, three diabetes specific and one general, were selected. The selected scales were carefully evaluated to find out domains that are commonly used to assess quality of life and then the items within the selected domains were reviewed to choose relevant and comprehensive items for Iraqi type 2 DM patients. Ten items were selected to formulate the quality of life scale for Iraqi DM patients (QOLSID). The content validity of QOLSID was established via an expert panel. For concurrent validity QOLSID was compared to glycosylated hemoglobin (HbA1C). For psychometric evaluation, a cross sectional study for 103 type 2 DM patients was conducted at the National Diabetes Center, Iraq. Test-retest reliability was measured by re-administering QOLSID to 20 patients 2-4 weeks later.

    Results: The internal consistency of the QOLSID was 0.727. All items had a corrected total-item correlation above 0.2. There was a negative significant correlation between QOLSID score and the HbA1C level (-0.518, P = 0.000). A significant positive correlation was obtained after re-testing (0.967, P = 0.000).

    Conclusion: The QOLSID is a reliable and valid instrument that can be used for assessing quality of life among Iraqi type 2 DM patients.

  4. Mikhael EM, Hussain SA, Shawky N, Hassali MA
    BMJ Open Diabetes Res Care, 2019;7(1):e000658.
    PMID: 31354953 DOI: 10.1136/bmjdrc-2019-000658
    Background: Medication non-adherence is a common problem among patients with diabetes. Patient-reported medication adherence scales are the most commonly used method to assess patient medication adherence, but up to today there is no specific tool for assessing medication adherence among patients with diabetes in Arab countries. This study aimed to develop and validate a new tool for assessment of adherence to antidiabetic medications among Iraqi patients with diabetes.

    Methods: The Iraqi Anti-Diabetic Medication Adherence Scale (IADMAS) consists of eight items. The face and content validity of the IADMAS were established via an expert panel. For convergent validity, the IADMAS was compared with the Medication Adherence Questionnaire (MAQ). For concurrent validity, the IADMAS was compared with glycosylated hemoglobin. A total of 84 patients with types 2 diabetes were recruited from a diabetes center in Baghdad, Iraq. Test-retest reliability was measured by readministering the IADMAS to the same patients 4 weeks later.

    Results: Only 80 patients completed the study (response rate: 95%). Reliability analysis of the IADMAS showed a Cronbach's alpha value of 0.712, whereas that of the MAQ was 0.649. All items in the IADMAS showed no significant difference in the test-retest analysis, indicating that the IADMAS has stable reliability. There was no difference in the psychometric properties of the IADMAS and the MAQ. The sensitivity and specificity of the IADMAS were higher than that of the MAQ (100% vs 87.5% and 33.9% vs 29.7%, respectively).

    Conclusion: The IADMAS developed in this study is a reliable and valid instrument for assessing antidiabetic medication adherence among Iraqi patients.

  5. Mikhael EM, Hassali MA, Hussain SA, Shawky N
    PMID: 30588052 DOI: 10.2147/DMSO.S183776
    Background and aim: Diabetes self-management behaviors are necessary to ensure optimum glycemic control. However, limited data were available regarding the practice of self-management by the Iraqi diabetic patients. This study aims to understand the knowledge, behaviors, and barriers of diabetes self-management among Iraqi type 2 diabetes mellitus (T2DM) patients in addition to their opinions and views toward the diabetes self-management educational program.

    METHODS: A qualitative method approach was used to obtain the data from T2DM patients recruited from the National Diabetes Center, Baghdad, Iraq. Data were collected using a semi-structured interview guide, and a thematic analysis approach was used to process the data.

    RESULTS: Most participants agreed to the importance of self-management practices especially healthy eating, exercise, taking medications, and healthy coping with stress to control DM and prevent its complications. Healthy eating and physical activity recommendations were inadequately practiced by most of the participants. Most participants reported irregular self-monitoring of blood glucose. Most of the participants properly adhered to the anti-diabetic medications. They generally lack proper information/knowledge about the importance of self-management practices of foot care and managing diabetes during sick days and how such practices should be implemented. Most participants have positive attitudes toward diabetes self-management practices. Face-to-face educational sessions are preferred by most patients.

    CONCLUSION: The Iraqi diabetic patients have inadequate self-management behaviors. The main barrier to self-management practices was the lack of knowledge due to the absence of diabetes self-management educational programs in Iraq.

  6. Mikhael EM, Ong SC, Sheikh Ghadzi SM
    J Pharm Pract, 2023 Aug;36(4):980-987.
    PMID: 35581701 DOI: 10.1177/08971900221102119
    Background: Coronavirus disease 2019 (COVID-19) is associated with a high risk of mortality especially among diabetes mellitus (DM) patients. Effective treatments against COVID-19 can complement the vaccination effort worldwide. Many review articles studied the effects of the dipeptidyl peptidase 4 (DPP-4) inhibitors among COVID-19 patients and found conflicting results. This heterogeneity may be due to different systemic pleiotropic effects of different DPP-4 inhibitors. Sitagliptin appears to be one of the good DPP-4 inhibitors that have antiinflammatory and antithrombotic effect. Therefore, this review assessed the benefits and safety of sitagliptin in the treatment of COVID-19. Methods: A detailed literature review using the electronic databases of Pubmed and Google Scholar was conducted during July and August 2021 to find out studies that published in English language and discussed the role of sitagliptin for COVID-19 patients. Results: 14 articles were eligible and thus included in this narrative review. Nine of these articles agreed to the benefit of sitagliptin in the treatment of COVID-19, while 3 studies considered sitagliptin as non useful or even risky, and one study was neutral in its conclusion towards the usage of sitagliptin in COVID-19. Only one study focused on the safety of sitagliptin and found that it is safe. Conclusion: Sitagliptin has anti-inflammatory, antifibrotic and antiapoptotic properties; such effects may be beneficial in reducing risks of COVID-19. Sitagliptin has good safety and fair benefits to reduce mortality among DM patients with COVID-19. Further randomized clinical trials are needed to confirm these benefits especially among patients without DM.
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