Development and Validation of USM-Insulin Adherence Module for Patients with Type 2 Diabetes Mellitus.

Background: Many patients with type 2 diabetes mellitus (T2DM) do not achieve the desired glycaemic control despite being treated with insulin. Studies found this due to an improper understanding of insulin function, its intensification process and patients' negative perspective on insulin. We developed an education module to enhance adherence to insulin therapy. Methods: This study applied a mixed design. It was conducted in three phases: i) Phase I: literature search and focus group discussions (FGDs), ii) Phase II: module development and iii) Phase III: content and face validation of Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM). FGDs were used to gather patients' opinions. All researchers repeatedly discussed about the module content and arrangement, the words and images used, and the grammar in producing the final draft. Specialists and target audience performed content and face validation of the module. Results: Thirty-six participants were involved in the FGDs. Data saturation was achieved at the 4th FGD. Three themes emerged from qualitative data analysis and were incorporated into the module. USM-IAM was finalised with five units. The content validity index (CVI) was 0.92, while face validity agreements were between 86% and 97%. Conclusion: The CVI and face agreement for USM-IAM exceed the cut-off point for a sound module. It has good potential to be used as a resource for educating patients in enhancing insulin adherence.

Insulin Adherence and Associated Factors in Patients with Type 2 Diabetes Mellitus Treated in Klang Primary Health Care Centres.

BACKGROUND: Insulin therapy is necessary for patients with type 2 diabetes mellitus (T2DM) to reach the targeted glycaemic level and prevent complications. This study aimed to determine the proportion of adherence to insulin therapy and the associated factors in patients with T2DM. METHODS: A cross-sectional study was conducted among 249 patients with T2DM who had been on insulin therapy for at least 2 months in primary care centres of the Ministry of Health in Klang, Malaysia. A validated insulin adherence questionnaire for diabetes mellitus (DM) was used to assess insulin adherence. Data on the sociodemographic characteristics, disease-related factors, treatment-related factors and clinical parameters were extracted from medical records and interviews with patients. RESULTS: The adherence to insulin therapy was 8.43%. The factors associated with insulin adherence were self-monitoring of blood glucose (SMBG) (adjusted odds ratio [AOR]: 5.39; 95% confidence interval (CI): 1.20, 24.13; P = 0.028), exercise (AOR: 3.38; 95% CI: 1.37, 10.03; P = 0.029) and the number of daily insulin injections (AOR: 1.63; 95% CI: 1.09, 2.44; P = 0.017). CONCLUSION: The adherence to insulin therapy in primary health care centres in Malaysia was very poor. Patients who practiced SMBG, exercised and frequent daily insulin injections were significantly more adherent to insulin therapy.

Achievement of LDL Cholesterol Goal and Adherence to Statin by Diabetes Patients in Kelantan.

BACKGROUND: Statins are a class of potent drugs that can be used to reduce cholesterol, especially low-density lipoprotein cholesterol (LDL-C). However, their effectiveness is limited if adherence to treatment is poor. The objectives of the study are to estimate the proportion of diabetic patient who has achieved LDL-C goal and to determine the association of LDL-C achievement with socio demographic factors and statin therapy adherence. METHODS: This is a cross-sectional study involving 234 patients with type 2 diabetes mellitus (T2DM) and dyslipidaemia attending an outpatient clinic in a hospital in Kelantan. Interviews and self-administered questionnaires were used to determine their sociodemographic and clinical characteristics. Adherence to therapy was assessed using the Medication Compliance Questionnaire (MCQ). The associations between the achievement of LDL targets and sociodemographic/clinical factors, including adherence, were analysed with simple logistic regression. RESULTS: About 37.6% of patients achieved their LDL-C target. The percentage of patients who adhered to statin use was 98.3%, and 20.5% of these patients reported full adherence. There was no significant association between achievement of LDL-C targets with adherence or any other sociodemographic factors, such as age, gender and educational or economic status (all P-value < 0.05). CONCLUSION: Despite a high level of adherence, the majority of patients failed to achieve LDL-C targets. More concerted efforts are needed to improve this.

Population pharmacokinetics of nevirapine in Malaysian HIV patients: a non-parametric approach.

AIMS: Nevirapine is the first non-nucleoside reverse-transcriptase inhibitor approved and is widely used in combination therapy to treat HIV-1 infection. The pharmacokinetics of nevirapine was extensively studied in various populations with a parametric approach. Hence, this study was aimed to determine population pharmacokinetic parameters in Malaysian HIV-infected patients with a non-parametric approach which allows detection of outliers or non-normal distribution contrary to the parametric approach. METHODS: Nevirapine population pharmacokinetics was modelled with Pmetrics. A total of 708 observations from 112 patients were included in the model building and validation analysis. Evaluation of the model was based on a visual inspection of observed versus predicted (population and individual) concentrations and plots weighted residual error versus concentrations. Accuracy and robustness of the model were evaluated by visual predictive check (VPC). The median parameters' estimates obtained from the final model were used to predict individual nevirapine plasma area-under-curve (AUC) in the validation dataset. The Bland-Altman plot was used to compare the AUC predicted with trapezoidal AUC. RESULTS: The median nevirapine clearance was of 2.92 L/h, the median rate of absorption was 2.55/h and the volume of distribution was 78.23 L. Nevirapine pharmacokinetics were best described by one-compartmental with first-order absorption model and a lag-time. Weighted residuals for the model selected were homogenously distributed over the concentration and time range. The developed model adequately estimated AUC. CONCLUSIONS: In conclusion, a model to describe the pharmacokinetics of nevirapine was developed. The developed model adequately describes nevirapine population pharmacokinetics in HIV-infected patients in Malaysia.

Exploring CYP2B6 activity by measuring the presence ofnevirapine hydroxy metabolites in plasma.

BACKGROUND/AIM: Nevirapine is a reverse-transcriptase inhibitor widely used in combination therapy to treat HIV infection. Nevirapine is extensively metabolized in the liver and CYP2B6 is mainly responsible for oxidation of 3-hydroxynevirapine (3-OH NVP). This study aims to explore CYP2B6 activity by measuring 2-hydroxynevirapine (2-OH NVP) and 3-OH NVP in plasma and to identify factors associated with nevirapine pharmacokinetic parameters. MATERIALS AND METHODS: A total of 112 patients were recruited and treated with nevirapine-based antiretroviral therapy. Plasma nevirapine and metabolite concentrations were assayed using high-performance liquid chromatography via liquid-liquid extraction. RESULTS: Thirty-nine (34.8%) of the patients had no 3-OH NVP detected in their plasma while 2-OH NVP was detected in all patients. Metabolite concentrations were low compared to nevirapine. Positive correlations were observed between nevirapine and its metabolites, 2-OH NVP (P < 0.01) and 3-OH NVP (P = 0.012). Nevirapine concentration was decreased when concomitantly administered with methadone. Univariate analysis showed that ALT level, AST level, and detection of 3-OH NVP were associated with nevirapine pharmacokinetic parameters. CONCLUSION: The variability of nevirapine pharmacokinetic parameters was caused by liver enzymes and the presence of 3-OH NVP metabolites. The presence of 3-OH NVP can probably be used to distinguished CYP2B6 activity and efficacy of nevirapine in patients with HIV infection.

Validity and reliability of the Malay version of the Structured Migraine Interview (SMI) Questionnaire.

BACKGROUND: The Structured Migraine Interview (SMI) is a valid and reliable instrument for migraine diagnosis. However, a Malay version of the SMI is not available to be applied to the local Malaysian population. This study was designed to access the validity and reliability of a new Malay version of the SMI questionnaire. METHODS: Patients with headache attending the Neurology Clinic, Hospital Universiti Sains Malaysia, Kelantan, Malaysia, were screened against the inclusion/exclusion criteria before recruitment. A standard translation procedure was used to translate and adapt the questionnaire into the Malay language. The translated version was tested for face, content and construct validities. Subsequently, validity and reliability studies were conducted (1(st) compilation), followed by retesting seven days later (2(nd) compilation). RESULTS: A total of 157 patients between 15 and 60 years of age were enrolled in this study. The kappa value was 0.70 (p < 0.001) with high sensitivity (0.97) and specificity (0.63). The misclassification rate was 0.15, with a positive predictive value of 0.82 and a negative predictive value of 0.92. The positive likelihood ratio was 2.62, while the negative likelihood ratio was 0.05. The Cronbach's alpha was 0.93 (1(st) compilation) and 0.90 (2(nd) compilation), respectively. The Spearman's correlation coefficient ranged from 0.86 (Question 4) to 0.95 (Question 1). The overall concordance for item 1 was very high (97%), followed by item 4 (83%), item 2 (71%) and finally item 3 (64%). CONCLUSION: The Malay version of the SMI questionnaire is comparable to the English version in terms of validity and reliability. It was highly reliable with good internal consistency and can be used for the diagnosis of migraine in clinical settings in Malaysia.

Quality of life and migraine disability among female migraine patients in a tertiary hospital in Malaysia.

BACKGROUND: Disability caused by migraine may be one of the main causes of burden contributing to poor quality of life (QOL) among migraine patients. Thus, this study aimed to measure QOL among migraine sufferers in comparison with healthy controls. METHODS: Female diagnosed migraine patients (n= 100) and healthy controls (n=100) completed the Malay version of the World Health Organization QOL Brief (WHOQOL-BREF) questionnaire. Only migraine patients completed the Malay version of the Migraine Disability Assessment questionnaire. RESULTS: Females with migraines had significantly lower total WHOQOL-BREF scores (84.3) than did healthy controls (91.9, P<0.001). Similarly, physical health (23.4 versus 27.7, P<0.001) and psychological health scores (21.7 versus 23.2, P< 0.001) were significantly lower than those for healthy controls. Seventy-three percent of patients experienced severe disability, with significantly higher number of days with headaches (13.8 days/3 months, P< 0.001) and pain scores (7.4, P< 0.013). Furthermore, migraine patients with lower total QOL scores had 1.2 times higher odds of having disability than patients with higher total QOL scores. CONCLUSIONS: The present study showed that migraine sufferers experienced significantly lower QOL than the control group from a similar population. Disability was severe and frequent and was associated with lower QOL among the migraine patients.

Adherence to capecitabine treatment and contributing factors among cancer patients in Malaysia.

Ensuring adherence to chemotherapy is important to prevent disease progression, prolong survival and sustain good quality of life. Capecitabine is a complex chemotherapeutic agent with many side effects that might affect patient adherence to treatment. This cross sectional study aimed to determine adherence to capecitabine and its contributing factors among cancer outpatients in Malaysia. One hundred and thirteen patients on single regime capecitabine were recruited from Hospital Sultan Ismail and Hospital Kuala Lumpur from October 2013 to March 2014. Adherence was determined based on adherence score using validated Medication Compliance Questionnaire. Patient socio-demographics, disease, and treatment characteristics were obtained from medical records. Satisfaction score was measured using the validated Patient Satisfaction with Healthcare questionnaire. The mean adherence score was 96.1% (standard deviation: 3.29%). The significant contributing factors of adherence to capecitabine were Malay ethnicity [ß=1.3; 95% confidence interval (CI): 0.21, 2.43; p value=0.020], being female [ß=1.8; 95%CI: 0.61, 2.99; p value=0.003]), satisfaction score [ß=0.08; 95%CI: 0.06, 1.46; p value=0.035], presence of nausea or vomiting [ß=2.3; 95%CI: 1.12, 3.48; p value <0.001] and other side effects [ß=1.45; 95%CI: 0.24, 2.65; p value=0.019]. Adherence to capecitabine was generally high in our local population. Attention should be given to non-Malay males and patients having nausea, vomiting or other side effects. Sufficient information, proactive assessment and appropriate management of side effects would improve patient satisfaction and thus create motivation to adhere to treatment plans.

Validity and reliability of the Bahasa Melayu version of the Migraine Disability Assessment questionnaire.

BACKGROUND: The study was designed to determine the validity and reliability of the Bahasa Melayu version (MIDAS-M) of the Migraine Disability Assessment (MIDAS) questionnaire. METHODS: Patients having migraine for more than six months attending the Neurology Clinic, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, were recruited. Standard forward and back translation procedures were used to translate and adapt the MIDAS questionnaire to produce the Bahasa Melayu version. The translated Malay version was tested for face and content validity. Validity and reliability testing were further conducted with 100 migraine patients (1st administration) followed by a retesting session 21 days later (2nd administration). RESULTS: A total of 100 patients between 15 and 60 years of age were recruited. The majority of the patients were single (66%) and students (46%). Cronbach's alpha values were 0.84 (1st administration) and 0.80 (2nd administration). The test-retest reliability for the total MIDAS score was 0.73, indicating that the MIDAS-M questionnaire is stable; for the five disability questions, the test-retest values ranged from 0.77 to 0.87. CONCLUSION: The MIDAS-M questionnaire is comparable with the original English version in terms of validity and reliability and may be used for the assessment of migraine in clinical settings.

Development and validation of a new Prescription Quality Index.

AIMS: The aims were to develop and validate a new Prescription Quality Index (PQI) for the measurement of prescription quality in chronic diseases. METHODS: The PQI were developed and validated based on three separate surveys and one pilot study. Criteria were developed based on literature search, discussions and brainstorming sessions. Validity of the criteria was examined using modified Delphi method. Pre-testing was performed on 30 patients suffering from chronic diseases. The modified version was then subjected to reviews by pharmacists and clinicians in two separate surveys. The rater-based PQI with 22 criteria was then piloted in 120 patients with chronic illnesses. Results were analysed using SPSS version 12.0.1 RESULTS: Exploratory principal components analysis revealed multiple factors contributing to prescription quality. Cronbach's α for the entire 22 criteria was 0.60. The average intra-rater and inter-rater reliability showed good to moderate stability (intraclass correlation coefficient 0.76 and 0.52, respectively). The PQI was significantly and negatively correlated with age (correlation coefficient -0.34, P<0.001), number of drugs in prescriptions (correlation coefficient -0.51, P<0.001) and number of chronic diseases/conditions (correlation coefficient -0.35, P<0.001). CONCLUSIONS: The PQI is a promising new instrument for measuring prescription quality. It has been shown that the PQI is a valid, reliable and responsive tool to measure quality of prescription in chronic diseases.