A randomized cross-over study comparing the performance of HD integra™ central concentrate system versus pre-produced concentrate in hemodialysis.

BACKGROUND: Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption. METHODS: We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting. RESULTS: Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%. CONCLUSION: Modern CCS is bacteriologically safe and its performance statistically equivalent to PPC.

Community-based cardiovascular Risk Factors Intervention Strategies (CORFIS) in managing hypertension: A pragmatic non-randomised controlled trial.

BACKGROUND: Hypertension is the number one cardiovascular risk factor in Malaysia. This study aimed to evaluate the effectiveness of a Community-Based Cardiovascular Risk Factors Intervention Strategies (CORFIS) in the management of hypertension in primary care. METHODS: This is a pragmatic, non-randomized controlled trial. Seventy general practitioners (GPs) were selected to provide either CORFIS (44 GPs) or conventional care (26 GPs) for 6 months. A total of 486 hypertensive patients were recruited; 309 were in the intervention and 177 in the control groups. Primary outcome was the proportion of hypertensive patients who achieved target blood pressure (BP) of <140/90mmHg (for those without diabetes mellitus) and <130/80mmHg (with diabetes mellitus). Secondary outcomes include change in the mean/median BP at 6-month as compared to baseline. RESULTS: The proportion of hypertensive patients who achieved target BP at 6-month was significantly higher in the CORFIS arm (69.6%) as compared to the control arm (57.6%), P=0.008. Amongst those who had uncontrolled BP at baseline, the proportion who achieved target BP at 6-month was also significantly higher in the CORFIS arm (56.6%) as compared to the control arm (34.1%), p<0.001. There was no difference in the patients who had already achieved BP control at baseline. There were significant reductions in SBP in the CORFIS arm (median -9.0mmHg; -60 to 50) versus control (median -2mmHg; -50 to 48), p=0.003; as well as in DBP (CORFIS arm: median -6.0mmHg; ranged from -53 to 30 versus control arm: median 0.0mmHg; ranged from -42 to 30), p<0.001. CONCLUSIONS: Patients who received CORFIS care demonstrated significant improvements in achieving target BP.

The National Medical Research Register--a vital link between current and future research.

Registration of research proposal to a publicly accessible website with searchable function allows information sharing and ensures research transparency. The National Institutes of Health Malaysia, realising the importance of research registration, established the National Medical Research Register (NMRR) in 2007. The NMRR functions more than just a local register: it also links to ethics approval and MOH medical research grant application. It thus facilitates researchers in their application to the Ministry of Health Research and Ethics Committee (MREC) and for Ministry of Health research grant. In addition, MREC committee members can review research protocol on NMRR website, thus saving much time and resources. From May 2007 till December 2009, more than 3000 people have registered as NMRR public users and more than 1000 research proposals have been uploaded in NMRR. The number of registration of research proposals, clinical trials and industrial sponsored trials steadily increased from year 2007 to year 2009. The web-based NMRR is the first research register in the world that links research proposal registration to ethical review and research grant application. Its future plan is to be linked with publication. Therefore, it is indeed an innovation that Malaysians should be proud of.

Investigator-initiated clinical trials in Malaysia and the role of the Clinical Research Centre of the Ministry of Health.

The objective of this review is to better understand the concept of investigator-initiated trials and its benefits. While investigator-initiated trials can be an invaluable tool, there are several challenges in its initiation and management. However, it is for these reasons that Clinical Research Centre (CRC) had developed the Investigator Initiated Trial (IIT) Programme where financial support and technical assistance are provided to local investigators embarking on their own clinical trials. In the course of preparing the review, we found that the inclination of investigator-initiated trials has yet to be well established in Ministry of Health, Malaysia. Given the potential and impact of such trials, clinicians should be aware of their ability as well as the availability of a supportive network in mobilising their concerted research efforts. Greater research collaboration among investigators could foster more innovative, insightful and constructive research.

Malaysia Shape of the Nation (MySoN): a primary care based study of abdominal obesity in Malaysia.

Abdominal obesity (AO), measured by waist circumference (WC), is a stronger predictor of subsequent development of cardiovascular disease (CVD) than generalised obesity, which is measured by body mass index (BMI). This study aimed to measure WC and prevalence of AO in Malaysians visiting primary care physicians. 1893 patients between the ages of 18 and 80 attending primary care clinics in Malaysia were recruited over two days for this multi-centre cross-sectional study. Pregnant women were excluded, their medical history, weight, height and WC were examined. The prevalence of co-morbidities were as follows: (1) CVD-4%, lipid disorder-17%, hypertension-26%, diabetes-14% and any of the clinical characteristics of CVD/lipid disorder/hypertension/diabetes-38%. The mean BMI for men and women was 25.62 +/- 4.73 kg/m2 and 26.63 +/- 5.72 kg/m2, respectively. Based on WHO criteria for BMI (overweight, 25-29.9 kg/m2; obese, > 30 kg/m2), 34.2% were overweight and 20.4% were obese. The mean WC for men and women was 89.03 +/- 13.45 cm and 84.26 +/- 12.78 cm, respectively. Overall, 55.6% had AO and there was higher prevalence among women (based on International Diabetes Federation criteria: WC > or = 90 cm for men and > or = 80 cm for women). AO was present in approximately 71% patients with lipid disorder, in 76% with hypertension and in 75% with diabetes. Patients with AO were also at a higher risk of developing co-morbidities. Malaysia has a high prevalence of AO and associated cardiovascular risk factors. This needs to be addressed by public health programs, which should also include routine measurement of WC.

Malaysian Cardiothoracic Surgery Registry--a patient registry to evaluate the health outcomes of patients undergoing surgery for cardiothoracic diseases in Malaysia.

The formulation of the Cardiothoracic Registry. Cardiothoracic surgery is the field of medicine involved in surgical treatment of diseases affecting organs inside the thorax (the chest). It is a general treatment of conditions of the heart (heart disease) and lungs (lung disease). In Malaysia, due to lack of data collection we do not have estimates of number and outcome of such procedure in the country. Western figures are often used as our reference values and this may not accurately reflect our Malaysian population. The Malaysian Cardiothoracic Surgery Registry (MyCARE) by the Ministry of Health will be a valuable tool to provide timely and robust data of cardiology practice, its safety and cost effectiveness and most importantly the outcome of these patients in the Malaysian setting.

A report of the Malaysian dialysis registry of the National Renal Registry, Malaysia.

The Malaysian National Renal Registry was set up in 1992 to collect data for patients on renal replacement therapy (RRT). We present here the report of the Malaysian dialysis registry. The objectives of this papar are: (1) To examine the overall provision of dialysis treatment in Malaysia and its trend from 1980 to 2006. (2) To assess the treatment rate according to the states in the country. (3) To describe the method, location and funding of dialysis. (4) To characterise the patients accepted for dialysis treatment. (5) To analyze the outcomes of the dialysis treatment. Data on patients receiving dialysis treatment were collected at initiation of dialysis, at the time of any significant outcome, as well as yearly. The number of dialysis patients increased from 59 in 1980 to almost 15,000 in 2006. The dialysis acceptance rate increased from 3 per million population in 1980 to 116 per million population in 2006, and the prevalence rate from 4 to 550 per million population over the same period. The economically advantaged states of Malaysia had much higher dialysis treatment rates compared to the less economically advanced states. Eighty to 90% of new dialysis patients were accepted into centre haemodialysis (HD), and the rest into the chronic ambulatory peritoneal dialysis (CAPD) programme. The government provided about half of the funding for dialysis treatment. Patients older than 55 years accounted for the largest proportion of new patients on dialysis since the 1990s. Diabetes mellitus has been the main cause of ESRD and accounted for more than 50% of new ESRD since 2002. Annual death rate averaged about 10% on HD and 15% on CAPD. The unadjusted 5-year patient survival on both HD and CAPD was about 80%. Fifty percent of dialysis patients reported very good median QoL index score. About 70% of dialysis patients were about to work full or part time. There has been a very rapid growth of dialysis provision in Malaysia particularly in the older age groups. ESRD caused by diabetes mellitus, despite being a preventable and treatable cause of ESRD--has increased and accounted for more than 50% of incident dialysis patients. Death and survival rates on dialysis are comparable to those from other countries.

Use of prescription medicines in Malaysia 2005.

The National Medicines Use Survey (NMUS) which started in 2004 and is still ongoing was conducted with the intent to continuously and systematically collect data on the use of medicines, to provide an overview on the use of medicines in Malaysia. The objective of the NMUS is therefore to quantify the present state and time trends of medicines utilization at various levels of our health care system whether national, regional, local or institutional. From the data available, for the Year 2005, the most commonly used medicine in Malaysia were anti-diabetic medications, of which glibenclamide is the most common followed by metformin, were the top 2 of the list of drugs utilized in DDD/1000 population/day. Collectively, however, taking into account the various antihypertensives by therapeutic groups, anti-hypertensive medicines were more commonly used than anti-diabetics. Hypertension and diabetes mellitus are the two most prevalent chronic disorders in the country and thus, such high medicines utilization rates for these conditions are to be expected. From the general practice prescription data, it was estimated that a patient with hypertension was prescribed a median of only one (1) anti-hypertensive medication. This means, the vast majority of patients (81%) were on monotherapy, which is hardly sufficient to achieve treatment target. Clearly then, given the prevalence of hypertension, many patients were not on drug treatment at all, and of those treated, their drug treatment are likely to be inadequate.

Prevalence, awareness, treatment and control of hypertension in the Malaysian adult population: results from the national health and morbidity survey 1996.

We determined the prevalence of hypertension and the level of awareness, treatment and control of hypertension among Malaysian adults in a population based cross-sectional survey. Twenty-one thousand and three hundred ninety-one adults aged 30 or older in all 13 states of Malaysia in 1996 were sampled using a stratified two-stage cluster sampling design. Thirty-three percent of adults had hypertension with a higher percentage among women. Among hypertensives, 33% were aware of their hypertension, 23% were currently on treatment and a mere 6% had controlled hypertension. There was practically no difference in mean BP between treated and untreated hypertensives. Concerted public health effort is urgently required to improve the detection, treatment and control of hypertension in Malaysia.

Familial aggregation and determinants of post challenge blood glucose in four ethnic populations.

We determine the familial aggregation and determinants of post challenge blood glucose (BG) in four ethnic populations. A national health survey was conducted in Malaysia in 1996. 18,372 subjects aged 30 years or older had post challenge BG measurements and another 846 subjects were pre-diagnosed to have diabetes on drug treatment. We imputed the BG of diagnosed diabetics by randomly selecting a value from the BG distribution of undiagnosed diabetics. Covariates of interest include ethnicity, gender, age, urban-rural residence, body mass index (BMI), physical activity, education, and household income. Ethnic and gender differences in mean BG persisted after adjustment for other covariates. Age and BMI were the only two factors with strong, positive and consistent effects on mean BG in all ethnic-sex groups. Family resemblance for BG as measured by intraclass correlation was small and homogenous across all ethnic groups and did not differ from resemblance in BG between spouses. In conclusion, BMI was the only consistent modifiable predictor of BG in all ethnic-sex groups. Environmental factors are probably more important than genetic factors as determinant of BG in the four ethnic populations studied.

Cross-cultural adaptation and validation of the English version of the International Index of Erectile Function (IIEF) for use in Malaysia.

We adapted the English International Index of Erectile Function (IIEF) into Malay. This was difficult as many sex-related terms do not exist in colloquial Malay. In the pretest, there was no difficulty with comprehension and all subjects judged the Malay IIEF equivalent to the English IIEF. After slight modification, a final instrument was evaluated in two studies. Study A included 136 subjects. It showed that the instrument had good reliability and discriminant validity. The factor structure of the English IIEF was not reproducible. Study B included 26 ED subjects who underwent oral sildenafil therapy. The Malay IIEF was sensitive to treatment response. The area under the ROC curve of the Malay IIEF-5 was 0.86; the optimal cutoff score has a sensitivity of 85% and specificity of 75%. The results suggest that the Malay IIEF requires more work, but the Malay IIEF-5 has acceptable measurement properties to recommend its use in clinical practice and research.

Prevalence of blindness and low vision in Malaysian population: results from the National Eye Survey 1996.

BACKGROUND: A national eye survey was conducted in 1996 to determine the prevalence of blindness and low vision and their major causes among the Malaysian population of all ages. METHODS: A stratified two stage cluster sampling design was used to randomly select primary and secondary sampling units. Interviews, visual acuity tests, and eye examinations on all individuals in the sampled households were performed. Estimates were weighted by factors adjusting for selection probability, non-response, and sampling coverage. RESULTS: The overall response rate was 69% (that is, living quarters response rate was 72.8% and household response rate was 95.1%). The age adjusted prevalence of bilateral blindness and low vision was 0.29% (95% CI 0.19 to 0.39%), and 2.44% (95% CI 2.18 to 2.69%) respectively. Females had a higher age adjusted prevalence of low vision compared to males. There was no significant difference in the prevalence of bilateral low vision and blindness among the four ethnic groups, and urban and rural residents. Cataract was the leading cause of blindness (39%) followed by retinal diseases (24%). Uncorrected refractive errors (48%) and cataract (36%) were the major causes of low vision. CONCLUSION: Malaysia has blindness and visual impairment rates that are comparable with other countries in the South East Asia region. However, cataract and uncorrected refractive errors, though readily treatable, are still the leading causes of blindness, suggesting the need for an evaluation on accessibility and availability of eye care services and barriers to eye care utilisation in the country.

Obesity in Malaysia.

This study was undertaken to assess the recent data on Malaysian adult body weights and associations of ethnic differences in overweight and obesity with comorbid risk factors, and to examine measures of energy intake, energy expenditure, basal metabolic rate (BMR) and physical activity changes in urban and rural populations of normal weight. Three studies were included (1) a summary of a national health morbidity survey conducted in 1996 on nearly 29 000 adults > or =20 years of age; (2) a study comparing energy intake, BMR and physical activity levels (PALs) in 409 ethnically diverse, healthy adults drawn from a population of 1165 rural and urban subjects 18-60 years of age; and (3) an examination of the prevalence of obesity and comorbid risk factors that predict coronary heart disease and type 2 diabetes in 609 rural Malaysians aged 30-65 years. Overweight and obesity were calculated using body mass index (BMI) measures and World Health Organization (WHO) criteria. Energy intake was assessed using 3-d food records, BMR and PALs were assessed with Douglas bags and activity diaries, while hypertension, hyperlipidaemia and glucose intolerance were specified using standard criteria. The National Health Morbidity Survey data revealed that in adults, 20.7% were overweight and 5.8% obese (0.3% of whom had BMI values of >40.0 kg m(-2)); the prevalence of obesity was clearly greater in women than in men. In women, obesity rates were higher in Indian and Malay women than in Chinese women, while in men the Chinese recorded the highest obesity prevalences followed by the Malay and Indians. Studies on normal healthy subjects indicated that the energy intake of Indians was significantly lower than that of other ethnic groups. In women, Malays recorded a significantly higher energy intake than the other groups. Urban male subjects consumed significantly more energy than their rural counterparts, but this was not the case in women. In both men and women, fat intakes (%) were significantly higher in Chinese and urban subjects. Men were moderately active with the exception of the Dayaks. Chinese women were considerably less active than Chinese men. Chinese and Dayak women were less active than Malay and Indian women. In both men and women, Indians recorded the highest PALs. Hence, current nutrition and health surveys reveal that Malaysians are already affected by western health problems. The escalation of obesity, once thought to be an urban phenomenon, has now spread to the rural population at an alarming rate. As Malaysia proceeds rapidly towards a developed economy status, the health of its population will probably continue to deteriorate. Therefore, a national strategy needs to be developed to tackle both dietary and activity contributors to the excess weight gain of the Malaysian population.

Assessing doctors' competence: application of CUSUM technique in monitoring doctors' performance.

BACKGROUND: Quality assurance of medical practice requires assessment of doctors' performance, whether informally via a system such as peer review or more formally via one such as credentialing. Current methods of assessment are, however, subjective or implicit. More objective methods of assessment based on statistical process control technique such as cumulative sum (CUSUM) procedure may be helpful. OBJECTIVE: To determine the usefulness and acceptability of CUSUM charting for assessing doctors' performance. METHOD: We applied CUSUM charting to assess doctors' performance of endoscopic retrograde pancreatography, renal and breast biopsies, thyroidectomy, and instrumental deliver. A CUSUM chart is a graphical representation of the trend in the outcome of a series of consecutive procedures. At acceptable levels of performance, the CUSUM curve is flat, while at unacceptable levels of performance, the curve slopes upward and eventually crosses a decision interval. When this occurs, the CUSUM chart indicates unsatisfactory performance. Thus, it provides an early warning of an adverse trend. RESULTS: All participating doctors found the technique useful to objectively measure their proficiency. CUSUM charts showed the progress of trainees in acquiring new skills. As they become more skillful with training, their CUSUM curves flatten. Among consultants, level CUSUM curves demonstrated ongoing maintenance of competence. All participants found the technique acceptable as a self-assessment tool. They were, however, less certain of its acceptability as a basis for credentialing. CONCLUSION: We recommend the use of CUSUM charting as a tool for personal audit at an individual level. It may also be used to show proof of technical competence for the purpose of credentialing.

Distribution of blood glucose in a national sample of Malaysian adults.

We describe the distribution of capillary blood glucose (BG) by age, sex and ethnicity in Malaysian adults. A national sample of 20,041 individuals aged 30 or older had usable data. They were selected by stratified 2-stage cluster sampling. BG was measured using reflectance photometer. Percentile tables and curves by age, sex and ethnicity are presented. The BG distribution was right skewed and showed the expected increase with age. Except in Indian, women had higher BG than men. There were also marked ethnic differences. Indian had the highest BG concentration, followed by Chinese, Malay and other indigenous ethnic group.

Distribution of blood total cholesterol in a national sample of Malaysian adults.

We describe the distribution of capillary blood total cholesterol (BC) by age, sex and ethnicity in Malaysian adults. A national sample of 20,041 individuals aged 30 or older had usable data. They were selected by stratified 2-stage cluster sampling. BC was measured using reflectance photometer. Percentile tables and curves by age, sex and ethnicity are presented. The BC distribution was right skewed and showed the expected increase with age. There were ethnic differences. Malay had the highest BC concentration, followed by Indian, Chinese and other indigenous ethnic group. However, for all ethnic groups, BC concentrations were low in comparison those prevailing in Western populations.