1.Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators
Teguh Haryo Sasongko ; Nor Hayati Othman ; Nik Hazlina Nik Hussain ; Yeong Yeh Lee ; Sarimah Abdullah ; Azlan Husin ; Hans Van Rostenberghe
Malaysian Journal of Medical Sciences 2017;24(4):1-4
The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.
2.The Availability of Information on Induced Lactation in Malaysia
Norsyamlina Che Abdul Rahim ; Zaharah Sulaiman ; Tengku Alina Tengku Ismail
Malaysian Journal of Medical Sciences 2017;24(4):5-17
Induced lactation is a method of stimulating the production of breast milk in women who have not gone through the process of pregnancy. Recent advances in technology have given such women the opportunity to breastfeed adopted children. Previous studies conducted in Western countries have explored the breastfeeding of adopted children, as well as the experiences, successes and challenges of this process. However, research on procedures for breastfeeding adopted children is lacking in Malaysia. The authors have therefore reviewed literature related to induced lactation in Malaysia to fill this gap. Of the 30 related articles identified, 19 described the breastfeeding practices and experiences of adoptive mothers in Malaysia. Out of 19 articles, there were four journal articles, five circulars and regulations, two books, two post-graduate theses, four blogs posts and forum discussions, and two online newspaper articles. Medical information relating to induced lactation procedures was also reviewed, showing that there was a lack of scientific studies focusing on induced lactation practices among adoptive mothers. Information on religious, specifically Islamic, perspectives on breastfeeding and child adoption laws was gathered from websites, social networks, blogs, magazines and online news sources. In consideration of recent advancements in medical technology and the dire need among Malaysians, it is crucial that evidence-based, accurate and reliable information on induced lactation is made available to professionals and other individuals in this country.
3.The Study of Apoptosis-inducing Effects of Three Pre-apoptotic Factors by Gallic Acid, Using Simulation Analysis and the Comet Assay Technique on the Prostatic Cancer Cell Line PC3
Javad Saffari-Chaleshtori ; Ehsan Heidari-Sureshjani ; Fahimeh Moradi ; Hojjatollah Molavian Jazi ; Esfandiar Heidarian
Malaysian Journal of Medical Sciences 2017;24(4):18-29
Background: In this study, we demonstrated the effects of the Gallic Acid (GA) molecule on the prostate cancer cells line PC3 using the comet assay (Alkaline electrophoresis) technique and its effects on some important apoptotic factors including BAD (Bcl-2-Associated Death promoter), BAK (Bcl-2 homologous Antagonist/Killer), and BIM (Bcl-2-like protein 11) via simulation analysis by using the Auto Dock and Gromacs software. Methods: Following the MTT assay on the PC3 cells, and determining IC50, we used three concentrations of GA to around IC50 to treat PC3 cells. 100 comet pictures were obtained by alkaline electrophoresis and have been analysed with the CASP version 1.2.2 software; all the results were thereafter analysed by the SPSS version 21 statistical software. Results: The IC50 value for GA was determined to be 35 μM. The ratio of tail to head in alkaline electrophoresis for the three concentrations below the IC50 of GA in 25, 30, and 35 μM were measured as 24.7 (2.7), 44.5 (1.8), and 57.3 (1.3) percent, respectively. The results of the preapoptotic factors (BAD, BAK, and BIM) in the performed simulation in the absence and presence of GA showed that the GA protein causes the structural instability in the BAD protein, and the effect of GA can be explained by the creation of hydrogen bonds with proteins. Conclusion: GA is a polyphenol compound in plants that can suppress cell growth and induce apoptosis in PC3 cells in prostate cancer in the range of IC50 concentrations. The apoptotic properties of GA induce pre-apoptotic factors.
4.Difficulties Encountered by Final-Year Male Nursing Students in Their Internship Programmes
Malaysian Journal of Medical Sciences 2017;24(4):30-38
Background: The cultural norms of the Kingdom of Saudi Arabia do not encourage men to choose nursing as a career. Understanding male nursing students' experiences of their clinical exposure to the nursing profession throughout their internship might increase their retention. This study explored the experiences of final-year male nursing students as they transitioned to the role of registered nurse. Methods: A qualitative descriptive research design with an inductive content-analysis approach was used. The experiences of 22 final-year male nursing students from three public hospitals in a major city of Saudi Arabia were explored. The data were collected using focus-group interviews and documentary analysis in March 2015 and May 2015. Results: Content analysis revealed three major themes: the societal and cultural image of male nurses, male students' engagement in nursing practice, and restructuring the internship programmes' policies to suit male students' needs. Conclusion: The findings reveal issues that mainly stem from negative social views of nursing as a male profession. Considering the students' social and cultural needs during their internship programme will facilitate their transition into the role of registered nurse and their retention in the nursing profession.
5.Confirmatory Factor Analysis of the Malay Version of the Confusion, Hubbub and Order Scale (CHAOS-6) among Myocardial Infarction Survivors in a Malaysian Cardiac Healthcare Facility
Kurubaran Ganasegeran ; Kamaraj Selvaraj ; Abdul Rashid
Malaysian Journal of Medical Sciences 2017;24(4):39-46
Background: The six item Confusion, Hubbub and Order Scale (CHAOS-6) has been validated as a reliable tool to measure levels of household disorder. We aimed to investigate the goodness of fit and reliability of a new Malay version of the CHAOS-6. Methods: The original English version of the CHAOS-6 underwent forward-backward translation into the Malay language. The finalised Malay version was administered to 105 myocardial infarction survivors in a Malaysian cardiac health facility. We performed confirmatory factor analyses (CFAs) using structural equation modelling. A path diagram and fit statistics were yielded to determine the Malay version's validity. Composite reliability was tested to determine the scale's reliability. Results: All 105 myocardial infarction survivors participated in the study. The CFA yielded a six-item, one-factor model with excellent fit statistics. Composite reliability for the single factor CHAOS-6 was 0.65, confirming that the scale is reliable for Malay speakers. Conclusion: The Malay version of the CHAOS-6 was reliable and showed the best fit statistics for our study sample. We thus offer a simple, brief, validated, reliable and novel instrument to measure chaos, the Skala Kecelaruan, Keriuhan & Tertib Terubahsuai (CHAOS-6), for the Malaysian population.
6.Awareness and Knowledge of Oral Cancer among Siamese Ethnic Group in Tumpat, Kelantan
Nur Karyatee Kassim ; Munirah Mohd Adnan ; Chew Wei Wern ; Lim Zheng Ru ; Muhammad Hafiz Hanafi ; Azizah Yusoff
Malaysian Journal of Medical Sciences 2017;24(4):47-54
ntroduction: Oral cancer is a life-threatening disease. Lack of public awareness is a potent barrier for the early detection of oral cancer, especially for high-risk populations. Objective: This study aimed to determine the awareness and knowledge of the signs, symptoms and risk factors of oral cancer among a Siamese ethnic group in Tumpat, Kelantan. Methods: A cross-sectional study was conducted, using a guided questionnaire on sociodemography, habits, awareness and knowledge of the signs, symptoms and risk factors of oral cancer. Individuals under 18 years old and who had been diagnosed with oral cancer were excluded from this study. Results: A total of 195 respondents participated, 61.5% were female and the mean age was 46 (1.64). About 41% of the respondents had received secondary education and 35.4% were illiterate. Most respondents were self-employed (21.5%), followed by farmers (19.5%) and housewives (20%). The majority of them had a monthly income that fell below the poverty level of RM 830 (76.9%). Among the respondents, 22.6% had the habit of smoking, 25.6% consumed alcohol, 8.2% were betel quid chewers and 2.6% chewed tobacco. Out of 195 respondents, only 6.7% were aware of oral cancer. About 16.9% of the respondents correctly answered all of the questions regarding the signs and symptoms of oral cancer and only 4.1% knew the risk factors of oral cancer. Conclusion: The awareness and knowledge of oral cancer in this targeted population were unsatisfactory. Future effective health promotion programs and education should be emphasised.
7.Effects of Whole Body Vibration on Glycemic Indices and Peripheral Blood Flow in Type II Diabetic Patients
Nuttaset Manimmanakorn ; Apiwan Manimmanakorn ; Warinthorn Phuttharak ; Michael J Hamlin
Malaysian Journal of Medical Sciences 2017;24(4):55-63
Background: Whole body vibration (WBV) training is a regime of training on a vibration platform that provides oscillatory movement to the body. Vibration training may be a potentially useful therapeutic strategy to control diabetes and its complications. This study aimed to evaluate the effect of WBV on glycemic indices and peripheral blood flow in type II diabetic patients. Methods: A parallel group clinical trial was conducted with 1:1 allocation ratio at Khon Kaen University between February and May 2010. The study included diabetic patients receiving diet or oral medication control over the previous year and excluded patients with serious medical and musculoskeletal disorders. Forty type II diabetic patients [14 males, 26 females, 63.2 (7.7) y, mean (SD)] were randomised into two groups (WBV and control) by computer software using a block of four design. The WBV group was given two sets of six one-minute vibration squats, three times per week for twelve weeks. The control group maintained their normal physical activity levels. The primary outcome was the patients glycemic indices. Results: We found no significant difference in glycosylated haemoglobin (HbA1c), fasting blood sugar, insulin level and insulin sensitivity between WBV and control groups. Compared to the control group, WBV training resulted in a substantial reduction in resting diastolic blood pressure -7.1 mmHg (95% CI: -10.9, -3.3, P = 0.001) and peak systolic velocity -7.3 cm.sec-1 (95% CI: -14.7, -0.03, P = 0.049), but made little difference to resting heart rate, systolic blood pressure, end diastolic velocity, and popliteal artery diameter. Conclusion: Whole body vibration improved resting diastolic blood pressure and peak systolic velocity, however, any beneficial effect of WBV on glycemic indices remains unclear.
8.Psychometric Properties of the Malay Version of the Dutch Eating Behaviour Questionnaire (DEBQ) in a Sample of Malaysian Adults Attending a Health Care Facility
Kavitha Subramaniam ; Wah Yun Low ; Karuthan Chinna ; Kin Fah Chin ; Saroja Krishnaswamy
Malaysian Journal of Medical Sciences 2017;24(4):64-73
Objective: This study aims to investigate the psychometric properties of the Malay version of the Dutch Eating Behaviour Questionnaire (DEBQ) among Malaysian adults. Method: The Malay version of the DEBQ instrument was administered to 398 outpatients (269 women and 129 men) at the University of Malaya Medical Centre (UMMC). Confirmatory Factor Analysis (CFA) was conducted to study the construct validity of the instrument. Composite reliability coefficient, Raykov's rho, was used to determine the internal consistency. Results: The proposed three-factor structure for the DEBQ instrument was appropriate, although three items (Items 21, 14 and 27) showed problematic loadings with inappropriate model fit and were removed. The modified version had an appropriate model fit χ2/df = 2.129, TLI = 0.908, CFI = 0.918, RMSEA = 0.053 (90%CI = 0.048–0.058), close-fit P-value = 0.136 and satisfactory internal consistency of 0.914 for emotional eating scale, 0.819 for external eating scale and 0.856 for restrained eating scale. Discussion: The Malay version of the DEBQ is a valid instrument to study eating behaviour traits among Malaysian adults. Further research is warranted to determine if Items 14 and 27 are appropriate for the Malaysian population.
9.Psychometric Testing of an Arabic Translation of the Revised-Illness Perception Questionnaire (IPQ-R) for Chronic Illness Patients
Malaysian Journal of Medical Sciences 2017;24(4):74-85
Background: Researchers lack a properly validated instrument to measure perceptions of chronic disease in Arabic language contexts. This study aimed to adapt and validate the Revised- Illness Perception Questionnaire (IPQ-R) for Arabic speaking chronic illness patients. Methods: A cross-sectional design was conducted to examine the psychometric properties of the adapted English version of the IPQ-R for Arabic speaking chronic illness patients. The study instrument was an Arabic version of the IPQ-R prepared through a translation process. The reliability and validity of the instrument were assessed using exploratory and confirmatory factor analysis and Cronbach’s alpha coefficient. Three hundred and sixteen participants (ages 16–79) from the Batna region in Algeria completed the IPQ-R. Results: A total of 316 (100%) patients responded to this study. Regarding internal consistency, Cronbach’s alpha a coefficient was consistently higher than 0.45. Several areas of fit were identified and substantial changes to the measurement model were made, such as the deletion of 22 items from the original 38 -item IPQ-R and two items from the original 18 causal items this accounted for 64.63% of the total variance, and the respecification of indicators had to be applied to achieve acceptable model fit. The final model consists of two sections: The 16– item Arabic IPQ-R, which had a good fit; (CMIN/Df = 1.30, P < 0.001, CFI = 0.93, RMSEA = 0.08, SRMR = 0.03), and was similar to the Arabic 16 causal items (CMIN/DF = 1.11, P < 0.001, CFI = 0.95, RMSEA = 0.080, SRMR = 0.02). Conclusion: The factor structure concurred with prior finding despite differences to the type of sample and cultural considerations that might explain these findings. Replication of this study in Algerian patients with specific illness, such as silicosis, breast cancer and multiple sclerosis. Further psychometric testing on other large samples is recommended.
10.Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus
Mohamad Adam Bujang ; Mastura Ismail ; Nur Khairul Bariyyah Mohd Hatta ; Siti Haslina Othman ; Nurakmal Baharum ; Siti Sara Mat Lazim
Malaysian Journal of Medical Sciences 2017;24(4):86-96
Objective: We aimed to validate the Malay version of Diabetes Quality of Life (DQOL) questionnaire for Malaysian adult population with type 2 diabetes mellitus (DM). Methods: This is a cross-sectional study to validate Malay version of DQOL among the adult diabetic patients. DQOL questionnaire has 46 items consist of three domains, namely Satisfaction Domain, Impact Domain and Worry Domain. Both forward and backward translations from the English version of DQOL into Malay version were performed. After the face validity of the Malay version was established, it was then pilot-tested. Finally, the validity and reliability of the final Malay version of DQOL questionnaire were evaluated. Results: There were 290 patients participated in this study with a mean (SD) age of 53.1 (10.0) years. The Cronbach's alpha coefficients of the overall items and the main domains were between 0.846 and 0.941. The Pearson's correlation coefficients for the three domains were between 0.228 and 0.451. HbA1C was found to be positively correlated with Impact Domain (P = 0.006). The Worry Domain was associated with diabetic retinopathy (P = 0.014) and nephropathy (P = 0.033). Conclusion: The Malay version of diabetes quality of life (DQOL) questionnaire was found to be a valid and reliable survey instrument to be used for Malaysian adult patients with diabetes mellitus.