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.

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.

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.

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.

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.

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.

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.

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, age at diagnosis, clinical characteristics and treatment of diabetes in the young in Pahang, Malaysia.

The prevalence, age at diagnosis, clinical characteristics and treatment of young diabetics, younger than 40 years were determined on the basis of a cross-sectional study of medical records of 2 health districts in Pahang, Malaysia. There were only 20 insulin-dependent diabetics (IDDM), prevalence 0.07 per 1000 inhabitants. There were 84 non-insulin-dependent diabetics (NIDDM), prevalence 0.3 per 1000 inhabitants. Three of the NIDDM patients could have malnutrition-related diabetes. Many NIDDM patients were asymptomatic which is an important reason why many of them remain undetected in the community. Seventy-four percent of the patients below the age of 30 years at diagnosis had NIDDM, 56% of the patients below the age of 20 years at diagnosis also had NIDDM and 54% of the NIDDM patients had a strong family history of diabetes. Many NIDDM patients were misdiagnosed as IDDM, especially if they were underweight, leading to considerable overuse of insulin. This study confirms that IDDM is rare in Malaysia, as in other Asian countries. Most young diabetics have NIDDM and have a strong family history. This pattern of diabetes in the young is unlike that seen in the West.

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.

The Mentakab Hypertension Project. Part IV--Hypertension care: is it adequate? A criterion-based audit of hypertension care in a hospital.

An audit to assess the adequacy of hypertension care was performed by examining the records and interviewing 55 selected hypertensive patients on treatment and follow-up at the outpatient department of a hospital. The patients selected had no previous record of drop out of treatment and had excellent compliance with drug therapy, so that ineffective blood pressure control cannot be attributable to these two reasons. Adequacy of care was measured by the number of patients whose management as indicated in their records complied with pre-defined criteria of adequate care. Only 18% of patients had achieved adequate blood pressure control. Assessment of patients was inadequate. None of the patients had been screened for secondary causes though 16% of patients had some basic investigations (urinalysis, blood urea and serum potassium), 5% had an assessment of target-organ damage, and 2% had been screened for other cardiovascular risk factors. Only 5% had a surveillance of side-effects from drug-therapy, 45% of the patients demonstrate adequate knowledge concerning complications of hypertension. The use of non-drug treatment was non-existent. The results of this study suggest that there were considerable deficiencies in the management of hypertension. Measures needed to overcome this are discussed.

The Mentakab Hypertension Study Project Part VI--Blood pressure measurement and hypertension: a questionnaire survey of medical staff.

A questionaire concerning various aspects of blood pressure measurement and hypertension was answered by 84 out of 98 (86%) doctors and 73 out of 100 (73%) nurses working in various parts of the state of Pahang. 59% and 85% of doctors and nurses respectively agreed that blood pressure should be measured routinely in all out-patients. 48% of medical staff were taught to use and 38% were actually using phase 4 as the diastolic blood pressure despite the general agreement that phase 5 should be used to denote diastolic pressure. 52% of doctors believed that hypertensive patients present with symptoms, the common symptoms cited were headache and dizziness, although it is well documented that hypertension is essentially asymptomatic. 93%, 80%, 69% and 82% of doctors believed that treatment of hypertension can prevent cerebrovascular disease, heart failure, renal failure and coronary artery disease respectively, although prevention of the last complication is yet unproven. Most doctors would begin treating a patient at rather low level of blood pressure, for example, for a man in the age group 40-49, 40% of doctors would begin drug treatment at diastolic pressure of 90 mmHg and 55% at diastolic pressure 95 mmHg. 79% of nurses and 55% of doctors were dissatisfied with the sphygmomanometer they have, the most common complaint was that the cuff-bladder 'blow up' on being inflated.

The Mentakab Hypertension Study project. Part II--Why do hypertensives drop out of treatment?

Sixty hypertensives admitted into medical wards were interviewed in depth to determine reasons for their previous drop out of treatment. Eighty five percent of the patients were lacking in motivation. This was related to patients' lack of understanding concerning hypertension and its treatment, erroneous beliefs concerning hypertension held by patients and patients' perceived barrier to treatment. The evidence for these reasons were as follows: 95% of the patients were unaware that hypertension is a long term condition requiring life-long treatment, 60% were unable to state the likely consequences of uncontrolled hypertension, 78% equated relief of symptoms like headache, dizziness with control of hypertension, 52% believed long term consumption of 'western' medication was harmful, 12% believed they had been cured by traditional (bomoh or sinseh) treatment, 72% complained of long waiting time required to obtain care. Economic reasons however were unimportant. Patient education and more convenient clinic locations are necessary but insufficient to ensure compliance. They are particular elements, among others, of a 'good' doctor-patient relationship, which fundamentally is the critical determinant of compliance.

The Mentakab Hypertension Study Project. Part III--Detection of hypertension in the outpatient department.

Undetected hypertension is an obstacle to effective blood pressure control in the community. A study was done to assess the justification of screening in the outpatient department. Only 13% of all visits to the outpatient department resulted in an attempt to detect hypertension. The common reasons leading to blood pressure measurement were headache and dizziness. Current practice of hypertension detection appeared inadequate and irrational. Nine per cent of all visits to the outpatient department were already accounted for by hypertensives. A screening survey found that 30% of all non-hypertensive patients attending outpatient department aged 30 years or more had blood pressure greater than or equal to 140/90 mmHg. The drop out rate among these newly diagnosed hypertensives was 100%. Existing resources are already inadequate and existing hypertension care has also been shown to be inadequate. Screening can only be expected to considerably increase hypertensive patient load without however any assurance that effective long term care can be delivered. Labelling people as hypertensives in this manner may be harmful. The question of screening cannot be considered individually, separate from the entire problem of hypertension control. Detection must be linked to treatment in a programme designed to promote compliance and capable of delivering adequate care before it can be justified.

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.

Comparison of serum fructosamine and blood glucose concentrations as indices of glycaemic control in non-insulin dependent diabetic out-patients.

The usefulness and validity of blood glucose measurement as an index of diabetic control were assessed with reference to serum fructosamine. Two hundred and twenty-eight non-insulin dependent diabetic out-patients were studied in the usual clinical setting. Fasting blood glucose (FBG) concentration was positively correlated with serum fructosamine (r = 0.42, t = 6.78 p less than 0.01). On the basis of their serum fructosamine concentrations, patients were divided into 3 groups. They were good control (fructosamine less than or equal to 288 umol/l), acceptable control (fructosamine less than or equal to 320 umol/l) and poor control groups (fructosamine greater than 320 umol/l). The mean fasting blood glucose concentration was significantly higher in the latter than the former 2 groups. However, at each level of control, there was a wide range of FBG concentrations. Thus, the value of FBG in predicting glycaemic control is limited. Its positive predictive value was only 32%, and its overall accuracy as an index of diabetic control was only 58% though its negative predictive value was high (93%). In 162 patients with poor diabetic control as indicated by their serum fructosamine concentrations, 81 (50%) of them had FBG less than 10 mmol/l on their clinic visit day. Fasting blood glucose is therefore not a reliable measure of good diabetic control, though it is useful in predicting poor control. FBG is simple to measure, cheap and rapidly available on clinic day, thus ensuring its continuing use. Doctors should be aware of its limitations and should not rely solely on FBG to assess diabetic control.

The Mentakab Hypertension Study project. Part I--Complicated hypertensives in hospital: who are they?

Consecutive hypertensives admitted with cardiovascular complications were studied. One hundred and eight complicated hypertensives (10%) out of 1,066 medical admissions were seen in the three month study. Thirty three per cent had cerebrovascular disease, 30% ischaemic heart disease, 2% had malignant hypertension and 85% had hypertensive heart disease. All patients had uncontrolled hypertension at admission (mean blood pressure 184/115 mmHg). Twenty-four patients (22%) were newly diagnosed; of the rest of previously diagnosed hypertensives (78%), 3% had never been on treatment and 56% had dropped out of treatment, which explained their ineffective blood pressure control. However, 18% of patients had apparently been on regular follow up and treatment, and yet their blood pressure control was poor. Many patients had evidence of renal disease. The prevalence of cardiovascular risk factors was also high; 56% had hypercholesterolaemia; 46% had hypertriglyceridaemia; 44% smoked, 38% were overweight or obese, and 18% were diabetic. This indicates that hypertension is best regarded as an ingredient of a cardiovascular risk profile and its management requires multifactorial correction of all risk factors identified.

Morbidity associated with asthma and audit of asthma treatment in out-patient clinics.

A study was undertaken to determine the extent of morbidity associated with asthma and to audit the management of asthma in two out-patient clinics of two district hospitals. Patients were recruited for the study during a 3-month period from December 1990 to February 1991. Seventy asthmatic patients were studied. Eighty-six percent of the patients had their sleep disturbed by asthma, 77% took daily medication regularly, 63% felt that their activities were restricted by asthma, 60% had at least one acute exacerbation in the preceding six months. Of those who had their peak expiratory flow rate (PEFR) measured, 40% had a PEFR below 50% predicted, and only 11% had normal PEFR (greater than 80% predicted). The morbidity of asthma was thus considerable. On the other hand, the drug treatment of these asthmatics was grossly inadequate. They were prescribed on average 2.1 item of drugs, which for most patients comprised an oral beta agonist and a theophylline. Only 43% of the patients received inhaler therapy, but no patients were given steroids, inhaled or oral. The drug treatment was unrelated to the severity of patients' asthma. Further, objective measurement of severity was under-used in the assessment of asthma, only 8.5% of patients ever had their PEFR recorded. This study has found that asthma is poorly managed in out-patient clinics. We need to improve the training of doctors in the optimal management of asthma.