Sarawak General Hospital

BACKGROUND: Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). METHODS: In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival. RESULTS: The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001). The objective response rate was similar in the two groups: 80% with osimertinib and 76% with standard EGFR-TKIs (odds ratio, 1.27; 95% CI, 0.85 to 1.90; P=0.24). The median duration of response was 17.2 months (95% CI, 13.8 to 22.0) with osimertinib versus 8.5 months (95% CI, 7.3 to 9.8) with standard EGFR-TKIs. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard EGFR-TKIs (hazard ratio for death, 0.63; 95% CI, 0.45 to 0.88; P=0.007 [nonsignificant in the interim analysis]). Adverse events of grade 3 or higher were less frequent with osimertinib than with standard EGFR-TKIs (34% vs. 45%). CONCLUSIONS: Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125 .).

BACKGROUND: Reliability studies are commonly used in questionnaire development studies and questionnaire validation studies. This study reviews the sample size guideline for Cronbach's alpha test. METHODS: Manual sample size calculation using Microsoft Excel software and sample size tables were tabulated based on a single coefficient alpha and the comparison of two coefficients alpha. RESULTS: For a single coefficient alpha test, the approach by assuming the Cronbach's alpha coefficient equals to zero in the null hypothesis will yield a smaller sample size of less than 30 to achieve a minimum desired effect size of 0.7. However, setting the coefficient of Cronbach's alpha larger than zero in the null hypothesis could be necessary and this will yield larger sample size. For comparison of two coefficients of Cronbach's alpha, a larger sample size is needed when testing for smaller effect sizes. CONCLUSIONS: In the assessment of the internal consistency of an instrument, the present study proposed the Cronbach's alpha's coefficient to be set at 0.5 in the null hypothesis and hence larger sample size is needed. For comparison of two coefficients' of Cronbach's alpha, justification is needed whether testing for extremely low and extremely large effect sizes are scientifically necessary.

BACKGROUND: Different study designs and population size may require different sample size for logistic regression. This study aims to propose sample size guidelines for logistic regression based on observational studies with large population. METHODS: We estimated the minimum sample size required based on evaluation from real clinical data to evaluate the accuracy between statistics derived and the actual parameters. Nagelkerke r-squared and coefficients derived were compared with their respective parameters. RESULTS: -squared. CONCLUSIONS: refers to number of independent variables in the final model.

From April through June 1997, 29 previously healthy children aged <6 years (median, 1.5 years) in Sarawak, Malaysia, died of rapidly progressive cardiorespiratory failure during an outbreak of hand, foot, and mouth disease caused primarily by enterovirus 71 (EV71). The case children were hospitalized after a short illness (median duration, 2 days) that usually included fever (in 100% of case children), oral ulcers (66%), and extremity rashes (62%). The illness rapidly progressed to include seizures (28%), flaccid limb weakness (17%), or cardiopulmonary symptoms (of 24 children, 17 had chest radiographs showing pulmonary edema, and 24 had echocardiograms showing left ventricular dysfunction), resulting in cardiopulmonary arrest soon after hospitalization (median time, 9 h). Cardiac tissue from 10 patients showed normal myocardium, but central nervous system tissue from 5 patients showed inflammatory changes. Brain-stem specimens from 2 patients were available, and both specimens showed extensive neuronal degeneration, inflammation, and necrosis, suggesting that a central nervous system infection was responsible for the disease, with the cardiopulmonary dysfunction being neurogenic in origin. EV71 and possibly an adenovirus, other enteroviruses, or unknown cofactors are likely responsible for this rapidly fatal disease.

BACKGROUND: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. METHODS: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. RESULTS: After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. CONCLUSIONS: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

PURPOSE: To ascertain the relationship among early (first 48 h) deep sedation, time to extubation, delirium and long-term mortality. METHODS: We conducted a multicentre prospective longitudinal cohort study in 11 Malaysian hospitals including medical/surgical patients (n = 259) who were sedated and ventilated ≥24 h. Patients were followed from ICU admission up to 28 days in ICU with 4-hourly sedation and daily delirium assessments and 180-day mortality. Deep sedation was defined as Richmond Agitation Sedation Score (RASS) ≤-3. RESULTS: The cohort had a mean (SD) age of 53.1 (15.9) years and APACHE II score of 21.3 (8.2) with hospital and 180-day mortality of 82 (31.7%) and 110/237 (46.4%). Patients were followed for 2,657 ICU days and underwent 13,836 RASS assessments. Midazolam prescription was predominant compared to propofol, given to 241 (93%) versus 72 (28%) patients (P < 0.0001) for 966 (39.6%) versus 183 (7.5%) study days respectively. Deep sedation occurred in (182/257) 71% patients at first assessment and in 159 (61%) patients and 1,658 (59%) of all RASS assessments at 48 h. Multivariable Cox proportional hazard regression analysis adjusting for a priori assigned covariates including sedative agents, diagnosis, age, APACHE II score, operative, elective, vasopressors and dialysis showed that early deep sedation was independently associated with longer time to extubation [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.89-0.97, P = 0.003], hospital death (HR 1.11, 95% CI 1.05-1.18, P < 0.001) and 180-day mortality (HR 1.09, 95% CI 1.04-1.15, P = 0.002), but not time to delirium (HR 0.98, P = 0.23). Delirium occurred in 114 (44%) of patients. CONCLUSION: Irrespective of sedative choice, early deep sedation was independently associated with delayed extubation and higher mortality, and thus was a potentially modifiable risk in interventional trials.

OBJECTIVES: To examine the prevalence of radiation-associated lens opacities among interventional cardiologists and nurses and correlate with occupational radiation exposure. BACKGROUND: Interventional cardiology personnel are exposed to relatively high levels of X-rays and based on recent findings of radiation-associated lens opacities in other cohorts, they may be at risk for cataract without use of ocular radiation protection. METHODS: Eyes of interventional cardiologists, nurses, and age- and sex-matched unexposed controls were screened by dilated slit lamp examination and posterior lens changes graded using a modified Merriam-Focht technique. Individual cumulative lens X-ray exposure was calculated from responses to a questionnaire and personal interview. RESULTS: The prevalence of radiation-associated posterior lens opacities was 52% (29/56, 95% CI: 35-73) for interventional cardiologists, 45% (5/11, 95% CI: 15-100) for nurses, and 9% (2/22, 95% CI: 1-33) for controls. Relative risks of lens opacity was 5.7 (95% CI: 1.5-22) for interventional cardiologists and 5.0 (95% CI: 1.2-21) for nurses. Estimated cumulative ocular doses ranged from 0.01 to 43 Gy with mean and median values of 3.4 and 1.0 Gy, respectively. A strong dose-response relationship was found between occupational exposure and the prevalence of radiation-associated posterior lens changes. CONCLUSIONS: These findings demonstrate a dose dependent increased risk of posterior lens opacities for interventional cardiologists and nurses when radiation protection tools are not used. While study of a larger cohort is needed to confirm these findings, the results suggest ocular radio-protection should be utilized.

BACKGROUND: Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions. Luspatercept, a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands, may enhance erythroid maturation and reduce the transfusion burden (the total number of red-cell units transfused) in such patients. METHODS: In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.00 to 1.25 mg per kilogram of body weight) or placebo for at least 48 weeks. The primary end point was the percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval. Other efficacy end points included reductions in the transfusion burden during any 12-week interval and results of iron studies. RESULTS: A total of 224 patients were assigned to the luspatercept group and 112 to the placebo group. Luspatercept or placebo was administered for a median of approximately 64 weeks in both groups. The percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval was significantly greater in the luspatercept group than in the placebo group (21.4% vs. 4.5%, P<0.001). During any 12-week interval, the percentage of patients who had a reduction in transfusion burden of at least 33% was greater in the luspatercept group than in the placebo group (70.5% vs. 29.5%), as was the percentage of those who had a reduction of at least 50% (40.2% vs. 6.3%). The least-squares mean difference between the groups in serum ferritin levels at week 48 was -348 μg per liter (95% confidence interval, -517 to -179) in favor of luspatercept. Adverse events of transient bone pain, arthralgia, dizziness, hypertension, and hyperuricemia were more common with luspatercept than placebo. CONCLUSIONS: The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment. (Funded by Celgene and Acceleron Pharma; BELIEVE ClinicalTrials.gov number, NCT02604433; EudraCT number, 2015-003224-31.).

This article is a narrative review that discusses the recommended sample size requirements to design a pilot study to assess the reliability of a questionnaire. A list of various sample size tables that are based on the kappa agreement test, intra-class correlation test and Cronbach's alpha test has been compiled together. For all calculations, type I error (alpha) was set at a maximum value of 0.05, and power was set at a minimum value of 80.0%. For the kappa agreement test, intra-class correlation test, and Cronbach's alpha test, the recommended minimum sample size requirement based on the ideal effect sizes shall be at least 15, 22, and 24 subjects respectively. By making allowances for a non-response rate of 20.0%, a minimum sample size of 30 respondents will be sufficient to assess the reliability of the questionnaire. The clear guideline of minimum sample size requirement for the pilot study to assess the reliability of a questionnaire is discussed and this will ease researchers in preparation for the pilot study. This study provides justification for a minimum requirement of a sample size of 30 respondents specifically to test the reliability of a questionnaire.

Background and aims: To estimate sample size for Cohen’s kappa agreement test can be challenging especially when it is expected that the true marginal rating frequencies are not the same. This study aims to present the tables that display a minimum sample size determination for an agreement test when certain assumptions are hold. Method: We adopted the sample size formula provided by Flack and colleagues (1988) to calculate the minimum sample sizes required using PASS software. The power is pre-specified to be at least 80% and the alpha to be less than 0.05. The effect sizes were derived from several pre-specified estimates such as the pattern of the true marginal rating frequencies and the difference between the two kappa coefficients in the hypothesis testing. Results: When the true marginal rating frequencies are the same, the minimum sample size determination can range from 2 to 698 depending on the actual value of the effect size. When the true marginal rating frequencies are not the same, then the majority of the minimum sample size required for this condition is more than double than that required sample size when the true marginal rating frequencies are the same. Conclusion: Concerning that the sample size formula could produce a very extreme small sample size, therefore, the determination of K1 and K2 should be based on reasonable estimates. We recommend for all sample size determinations for Cohen’s kappa agreement test, the true marginal rating frequencies can be assumed the same. Otherwise, it will be necessary to multiple the estimated minimum sample size by two to accommodate if the true marginal rating frequencies is not the same.

Rotavirus remains the most common cause of severe, dehydrating diarrhea among children worldwide. Several rotavirus vaccines are under development. Decisions about new vaccine introduction will require reliable data on disease impact. The Asian Rotavirus Surveillance Network, begun in 2000 to facilitate collection of these data, is a regional collaboration of 36 hospitals in nine countries or areas that conduct surveillance for rotavirus hospitalizations using a uniform World Health Organization protocol. We summarize the Network's organization and experience from August 2001 through July 2002. During this period, 45% of acute diarrheal hospitalizations among children 0-5 years were attributable to rotavirus, higher than previous estimates. Rotavirus was detected in all sites year-round. This network is a novel, regional approach to surveillance for vaccine-preventable diseases. Such a network should provide increased visibility and advocacy, enable more efficient data collection, facilitate training, and serve as the paradigm for rotavirus surveillance activities in other regions.

BACKGROUND: Telemedicine has been increasingly integrated into chronic disease management through remote patient monitoring and consultation, particularly during the COVID-19 pandemic. We did a systematic review and meta-analysis of studies reporting effectiveness of telemedicine interventions for the management of patients with cardiovascular conditions. METHODS: In this systematic review and meta-analysis, we searched PubMed, Scopus, and Cochrane Library from database inception to Jan 18, 2021. We included randomised controlled trials and observational or cohort studies that evaluated the effects of a telemedicine intervention on cardiovascular outcomes for people either at risk (primary prevention) of cardiovascular disease or with established (secondary prevention) cardiovascular disease, and, for the meta-analysis, we included studies that evaluated the effects of a telemedicine intervention on cardiovascular outcomes and risk factors. We excluded studies if there was no clear telemedicine intervention described or if cardiovascular or risk factor outcomes were not clearly reported in relation to the intervention. Two reviewers independently assessed and extracted data from trials and observational and cohort studies using a standardised template. Our primary outcome was cardiovascular-related mortality. We evaluated study quality using Cochrane risk-of-bias and Newcastle-Ottawa scales. The systematic review and the meta-analysis protocol was registered with PROSPERO (CRD42021221010) and the Malaysian National Medical Research Register (NMRR-20-2471-57236). FINDINGS: ; p=0·0064) by remote consultation in primary prevention settings. INTERPRETATION: Telemedicine including both remote disease monitoring and consultation might reduce short-term cardiovascular-related hospitalisation and mortality risk among patients with heart failure. Future research should evaluate the sustained effects of telemedicine interventions. FUNDING: The British Heart Foundation.

Using China's national surveillance data on hand, foot and mouth disease (HFMD) for 2008-2015, we described the epidemiologic and virologic features of recurrent HFMD. A total of 398,010 patients had HFMD recurrence; 1,767 patients had 1,814 cases of recurrent laboratory-confirmed HFMD: 99 reinfections of enterovirus A71 (EV-A71) with EV-A71, 45 of coxsackievirus A16 (CV-A16) with CV-A16, 364 of other enteroviruses with other enteroviruses, 383 of EV-A71 with CV-A16 and CV-A16 with EV-A71, and 923 of EV-A71 or CV-A16 with other enteroviruses and other enteroviruses with EV-A71 or CV-A16. The probability of HFMD recurrence was 1.9% at 12 months, 3.3% at 24 months, 3.9% at 36 months, and 4.0% at 38.8 months after the primary episode. HFMD severity was not associated with recurrent episodes or time interval between episodes. Elucidation of the mechanism underlying HFMD recurrence with the same enterovirus serotype and confirmation that HFMD recurrence is not associated with disease severity is needed.

This is prospective case-control study of more than 18 months performed to assess the effectiveness of maggot debridement therapy (MDT) with the sterile larvae of Lucilia cuprina (a tropical blowfly maggot) for the treatment of diabetic foot ulcers. Literature thus far has only reported results with the temperate maggot, Lucilia sericata. This study documents outcome in diabetic foot wounds treated with maggot debridement versus those treated by conventional debridement alone. In this series of 29 patients treated with MDT, 14 wounds were healed, 11 were unhealed and 4 were classified under others. The control group treated by conventional debridement had 30 patients of which 18 wounds were healed, 11 unhealed and 1 classified under others. There was no significant difference in outcome between the two groups. The conclusion that can be made from this study is that MDT with L. cuprina is as effective as conventional debridement in the treatment of diabetic foot ulcers. It would be a feasible alternative to those at high risk for surgery or for those who refuse surgery.

Determination of a minimum sample size required for a study is a major consideration which all researchers are confronted with at the early stage of developing a research protocol. This is because the researcher will need to have a sound prerequisite knowledge of inferential statistics in order to enable him/her to acquire a thorough understanding of the overall concept of a minimum sample size requirement and its estimation. Besides type I error and power of the study, some estimates for effect sizes will also need to be determined in the process to calculate or estimate the sample size. The appropriateness in calculating or estimating the sample size will enable the researchers to better plan their study especially pertaining to recruitment of subjects. To facilitate a researcher in estimating the appropriate sample size for their study, this article provides some recommendations for researchers on how to determine the appropriate sample size for their studies. In addition, several issues related to sample size determination were also discussed.

BACKGROUND: The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) is an objective and appropriate scoring system for risk-adjusted comparative general surgical audit. This score was devised in the UK and has been used widely, but application of POSSUM to centres outside the UK has been limited, especially in developing countries. This prospective study validated its application in a surgical practice with a different population and level of resources. METHODS: All general surgical patients who were operated on under regional or general anaesthesia as inpatients over a 4-month period at Sarawak General Hospital in 1999 were entered into the study. All data (12 physiological and six operative factors) were analysed for mortality only with the POSSUM equation and the modified Portsmouth POSSUM (P-POSSUM) equation. Comparisons were made between predicted and observed mortality rates according to four groups of risk: 0-4, 5-14, 15-49 and 50 per cent or more using the 'linear' method of analysis. RESULTS: There were 605 patients who satisfied the criteria for the study. Some 56.7 per cent of patients were in the lowest risk group. The POSSUM predictor equation significantly overestimated the mortality in this group, by a factor of 9.3. The overall observed mortality rate was 6.1 per cent and, again, the POSSUM predictor equation overestimated it at 10.5 per cent (P < 0.01). In contrast, the observed and predicted mortality rates for all risk groups, including the predicted overall mortality rate of 4.8 per cent, were comparable when the P-POSSUM predictor equation was used. CONCLUSION: The POSSUM scoring system with the modified P-POSSUM predictor equation for mortality was applicable in Malaysia, a developing country, for risk-adjusted surgical audit. This scoring system may serve as a useful comparative audit tool for surgical practice in many geographical locations.

Background: MLR and ANCOVA are common statistical techniques and are used for both experimental and non-experimental studies. However, both types of study designs may require different basis of sample size requirement. Therefore, this study aims to proposed sample size guidelines for MLR and ANCOVA for both experimental and non-experimental studies. Methods: We estimated the minimum sample sizes required for MLR and ANCOVA by using Power and Sample Size software (PASS) based on the pre-specified values of alpha, power and effect size (R2). In addition, we also performed validation of the estimates using a real clinical data to evaluate how close the approximations of selected statistics which were derived from the samples were to the actual parameters in the targeted populations. All the coefficients, effect sizes and r-squared obtained from the sample were then compared with their respective parameters in the population. Results: Small minimum sample sizes required for performing both MLR and ANCOVA when r-squared is used as the effect size. However, the validation results based on an evaluation from a real-life dataset suggest that a minimum sample size of 300 or more is necessary to generate a close approximation of estimates with the parameters in the population. Conclusions: We proposed sample size calculation when r-squared is used as an effect size is more suitable for experimental studies. However, taking a larger sample size such as 300 or more is necessary for clinical survey that is conducted in a non-experimental manner.

Limited evidence, mostly from studies in Western populations, suggests that the prognostic effects of lifestyle-related risk factors may be molecular subtype-dependent. Here, we examined whether pre-diagnostic lifestyle-related risk factors for breast cancer are associated with clinical outcomes by molecular subtype among patients from an understudied Asian population. In this population-based case series, we evaluated breast cancer risk factors in relation to 10-year all-cause mortality (ACM) and 5-year recurrence by molecular subtype among 3012 women with invasive breast cancer in Sarawak, Malaysia. A total of 579 deaths and 314 recurrence events occurred during a median follow-up period of ~ 24 months. Subtypes (luminal A-like, luminal B-like, HER2-enriched, triple-negative) were defined using immunohistochemical markers for hormone receptors and human epidermal growth factor receptor 2 (HER2) in conjunction with histologic grade. Hazard ratios (HRs) and 95% confidence intervals (CIs) for the associations between risk factors and ACM/recurrence were estimated in subtype-specific Cox regression models. We observed heterogeneity in the relationships between parity/breastfeeding, age at first full-term pregnancy (FFP), family history, body mass index (BMI), and tumor subtype (p value < 0.05). Among luminal A-like patients only, older age at menarche [HR (95% CI) ≥15 vs ≤ 12 years = 2.28 (1.05, 4.95)] and being underweight [HRBMI < 18.5kg/m2 vs. 18.5–24.9kg/m2 = 3.46 (1.21, 9.89)] or overweight [HR25–29.9kg/m2 vs. 18.5–24.9kg/m2 = 3.14 (1.04, 9.50)] were associated with adverse prognosis, while parity/breastfeeding [HRbreastfeeding vs nulliparity = 0.48 (0.27, 0.85)] and older age at FFP [HR > 30 vs < 21 years = 0.20 (0.04, 0.90)] were associated with good prognosis. For these women, the addition of age at menarche, parity/breastfeeding, and BMI, provided significantly better fit to a prognostic model containing standard clinicopathological factors alone [LRχ2 (8df) = 21.78; p value = 0.005]. Overall, the results were similar in relation to recurrence. Our finding that breastfeeding and BMI were associated with prognosis only among women with luminal A-like breast cancer is consistent with those from previously published data in Western populations. Further prospective studies will be needed to clarify the role of lifestyle modification, especially changes in BMI, in improving clinical outcomes for women with luminal A-like breast cancer.

The radiation dose received by cardiologists during percutaneous coronary interventions, electrophysiology procedures and other interventional cardiology procedures can vary by more than an order of magnitude for the same type of procedure and for similar patient doses. There is particular concern regarding occupational dose to the lens of the eye. This document provides recommendations for occupational radiation protection for physicians and other staff in the interventional suite. Simple methods for reducing or minimizing occupational radiation dose include: minimizing fluoroscopy time and the number of acquired images; using available patient dose reduction technologies; using good imaging-chain geometry; collimating; avoiding high-scatter areas; using protective shielding; using imaging equipment whose performance is controlled through a quality assurance programme; and wearing personal dosimeters so that you know your dose. Effective use of these methods requires both appropriate education and training in radiation protection for all interventional cardiology personnel, and the availability of appropriate protective tools and equipment. Regular review and investigation of personnel monitoring results, accompanied as appropriate by changes in how procedures are performed and equipment used, will ensure continual improvement in the practice of radiation protection in the interventional suite. These recommendations for occupational radiation protection in interventional cardiology and electrophysiology have been endorsed by the Asian Pacific Society of Interventional Cardiology, the European Association of Percutaneous Cardiovascular Interventions, the Latin American Society of Interventional Cardiology, and the Society for Cardiovascular Angiography and Interventions.

BACKGROUND: Recent studies have reported a significant increase in eye lens opacities among staff in the cardiac catheterization laboratory but indicated further studies are needed to confirm the findings. OBJECTIVE: To evaluate the prevalence of opacities in eyes of cardiologists, radiographers and nurses working in interventional cardiology. METHODS: The eyes of 52 staff in interventional cardiology facilities and 34 age- and sex-matched unexposed controls were screened in a cardiology conference held in Kuala Lumpur by dilated slit-lamp examination, and posterior lens changes were graded. Individual cumulative lens X-ray exposures were calculated from responses to a questionnaire in terms of workload and working practice. RESULTS: The prevalence of posterior lens opacities among interventional cardiologists was 53%, while in nurses and radiographers it was 45%. Corresponding relative risks were 2.6 (95% CI: 1.2-5.4) and 2.2 (95% CI: 0.98-4.9), for interventional cardiologists and support staff, respectively. CONCLUSIONS: This study confirms a statistically significant increase in radiation-associated posterior lens changes in the eyes of interventional cardiology staff.