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Biomedical subjects

K J Lui

Publications and source records attributed to K J Lui.

At least 19 recordsLinked to original sources

A revisit on tests for homogeneity of the risk difference.

Lipsitz et al. (1998, Biometrics 54, 148-160) discussed testing the homogeneity of the risk difference for a series of 2 x 2 tables. They proposed and evaluated several weighted test statistics, including the commonly used weighted least squares test statistic. Here we suggest various important improvements on these test statistics. First, we propose using the one-sided analogues of the test procedures proposed by Lipsitz et al. because we should only reject the null hypothesis of homogeneity when the variation of the estimated risk differences between centers is large. Second, we generalize their study by redesigning the simulations to include the situations considered by Lipsitz et al. (1998) as special cases. Third, we consider a logarithmic transformation of the weighted least squares test statistic to improve the normal approximation of its sampling distribution. On the basis of Monte Carlo simulations, we note that, as long as the mean treatment group size per table is moderate or large (> or = 16), this simple test statistic, in conjunction with the commonly used adjustment procedure for sparse data, can be useful when the number of 2 x 2 tables is small or moderate (< or = 32). In these situations, in fact, we find that our proposed method generally outperforms all the statistics considered by Lipsitz et al. Finally, we include a general guideline about which test statistic should be used in a variety of situations.

Biometry↗

A note on interval estimation of kappa in a series of 2 x 2 tables.

When there are confounders in reliability studies, failing to stratify data to account for these confounding effects may produce a misleading estimate of the interrater agreement. In this paper, we focus discussion on interval estimation of kappa for measuring agreement between two raters with stratified data. Using Monte Carlo simulation, we compare four asymptotic interval estimators of kappa for stratified data: estimator (1), a weighted average of the stratum-specific kappa estimates with weights equal to the inverse of the estimated asymptotic variances of these estimates; the two estimators, (2) and (3), with use of the logarithmic and the square root transformations, respectively, and a principle similar as used in estimator (1); estimator (4), a weighted average of the stratum-specific kappa estimates with weights equal to stratum sizes. We find that while the coverage probability of the first three interval estimators (1)-(3) can often be less than the desired confidence level, the fourth interval estimator (4) consistently performs well in all the situations considered here. We further find that when the underlying kappa is moderate (0.30</=kappa</=0.50), we can substantially improve the performance of the first three estimators by using a point estimator recently proposed elsewhere for kappa in estimation of weights. Because interval estimator (4) outperforms the other three estimators in a variety of situations, we recommend this estimator for general use.

Computer Simulation↗

A note on interval estimation of the relative difference in data with matched pairs.

For controlled comparative trials with matched pairs, in an attempt to improve the asymptotic interval estimator of the relative difference proposed elsewhere, I develop two asymptotic closed-form interval estimators with use of the logarithmic transformation and an idea used for deriving Fieller's theorem, respectively. I use Monte Carlo simulation to compare the performance of these three interval estimators. Findings reveal that when the number of pairs is as small as 20, the asymptotic interval estimator with use of the logarithmic transformation can actually perform quite well and is generally preferable to the other two asymptotic interval estimators with respect to both the coverage probability and the average length of the resulting confidence intervals. When the number of pairs is large (n > or = 100), results show that the three interval estimators considered here are all appropriate for use; they are essentially equivalent in a variety of situations.

Clinical Trials as Topic↗

Interval estimation of the risk ratio between a secondary infection, given a primary infection, and the primary infection.

This paper discusses interval estimation of the risk ratio (RR) between a secondary infection, given a primary infection, and the primary infection. Three asymptotic closed-form interval estimators are developed using Wald's test statistic, the logarithmic transformation, and Fieller's theorem. The performance of these interval estimators is compared with respect to the coverage probability and the expected length of the resulting confidence intervals. When the underlying probability of a primary infection is high (say, 0.80), all three estimators perform reasonably well. In fact, in this case, they are all essentially equivalent when the number of subjects n > or = 100. When the probability of a primary infection is small (say, 0.20) or moderate (say, 0.30 to 0.50), the interval estimator using the logarithmic transformation outperforms the other two estimators when n < or = 100. In fact, the coverage probability of the former estimator is consistently greater than or equal to the desired confidence level in all the situations considered in this paper and hence is recommended for general use.

Animals↗

Exact equivalence test for risk ratio and its sample size determination under inverse sampling.

When data are dichotomous, this paper notes the utility of inverse sampling in establishing equivalence with respect to the risk ratio. This paper develops an exact equivalence test that accounts for the risk ratio under inverse sampling and further discusses the relationship between the exact equivalence test and the exact conditional confidence limits. Also included are an exact and two asymptotic procedures for calculation of the minimum required number of index subjects for a desired power 1--beta at a given alpha-level. Finally, this paper provides a table that summarizes the minimum required number of index subjects for powers equal to 0.90 and 0.80 in application of the proposed exact equivalence test at 0.05-level in a variety of situations.

Confidence Intervals↗

Sample size determination for repeated measurements in bioequivalence test.

When the measurement of outcome is unreliable or the cost of obtaining an additional subject is relatively high compared to the cost of obtaining an additional measurement from the same subject, it may be desirable to consider taking more than one measurement per subject to increase power or to minimize the cost in a clinical trial. When each subject in two comparison groups has a fixed number of repeated measurements, this paper develops an asymptotic procedure to calculate the number of subjects per group required to achieve a given power for an a-level bioequivalence test. Furthermore, Monte Carlo simulation is used to evaluate the accuracy of the approximate sample size calculation procedure and a brief discussion on how to determine the optimal number of repeated measurements is included.

Humans↗

Assessing children's ultraviolet radiation exposure: the use of parental recall via telephone interviews.

OBJECTIVES: This study evaluated the validity of a parental report measure of children's solar protection behaviors. METHODS: Fifty-eight children had skin color assessed twice with a colorimeter. Between measurement sessions, parents were interviewed by telephone to assess children's indoor-outdoor status and solar protection across 40 hourly intervals. RESULTS: Parental report of child's indoor-outdoor status was significantly correlated with the colorimeter values, whereas the use of sunscreen and protective clothing was not. CONCLUSIONS: This measure was feasible for assessing ultraviolet exposure in young children. The component that assessed the number of intervals spent outdoors evidenced predictive validity.

Child↗

Sample size for the exact conditional test under inverse sampling.

Inverse sampling is a sampling design in which one continues sampling subjects until one obtains a predetermined number of index subjects. This paper derives a procedure for calculation of the minimum required number of index subjects on the basis of the exact conditional test under inverse sampling. This paper studies quantitatively the effect on power calculations of the number of index subjects. To facilitate use of inverse sampling in study designs, this paper further provides a table that summarizes, in a variety of situations, the minimum required number of index subjects for powers equal to 0.90 and 0.80 at 0.05-level. It also includes a discussion on use of the approximation sample size formula derived on the basis of a variance-stabilizing transformation and large sample theory.

Analysis of Variance↗

Assessing children's ultraviolet radiation exposure: the potential usefulness of a colorimeter.

OBJECTIVES: This study evaluated the colorimeter as an objective measure of children's ultraviolet (UV) radiation exposure. METHODS: Fifty-eight children, ages 6 to 9 years, attended two summer measurement sessions, with 46 attending a subsequent winter session. RESULTS: Comparisons between summer sessions for the L* scale showed that only the upper arm significantly changed in the tanner direction, while b* scale values indicated significant tanning for all body sites. All exposed body sites changed significantly in the less tan direction between summer and winter measurements. CONCLUSIONS: Using colorimeters to objectively measure children's UV exposure has potential applications for skin cancer prevention programs.

Child↗

Notes on conditional confidence limits under inverse sampling.

When the number of subjects in a two-by-two table is small or moderate, we may commonly use the exact conditional distribution with all marginals fixed to derive the conditional confidence limits on the underlying parameter. Under inverse sampling, in which we continue to sample subjects until we obtain exactly a pre-determined number of subjects failing into a specific category, this paper notes that derivation of a confidence interval, which has the coverage probability equal to or larger than a nominal 1-alpha confidence level, for relative risk and relative difference in cohort studies is straightforward. This paper further finds that, when the underlying disease is rare, we can similarly apply an inverse sampling to produce an approximate 1-alpha conditional confidence limits on attributable risk in case-control studies as well. When the number of subjects is small and the test statistic derived on the basis of large sample theory is not strictly adequate for use, this paper also presents an exact hypothesis testing procedure for the above parameters in the corresponding study designs.

Case-Control Studies↗

Confidence limits for the population prevalence rate based on the negative binomial distribution.

This paper shows that the extension of the simple procedure of George and Elston in calculation of confidence limits for the underlying prevalence rate to accommodate any finite number of cases in inverse sampling is straightforward. To appreciate the fact that the length of the confidence interval calculated on the basis of the first single case may be too wide for general utility, I include a quantiative discussion on the effect due to an increase in the number of cases requested in the sample on the expected length of confidence intervals. To facilitate further the application of the results presented in this paper, I present a table that summarizes in a variety of situations the minimum required number of cases for the ratio of the expected length of a confidence interval relative to the underlying prevalence rate to be less than or equal to a given value. I also include a discussion on the relation between Clemans's confidence limits on the expected number of trials before the failure of a given device and those presented here.

Binomial Distribution↗

The performance of the O'Brien-Fleming multiple testing procedure in the presence of intraclass correlation.

Assuming that all subject responses were independent, O'Brien and Fleming (1979, Biometrics 35, 549-556) proposed a simple and useful multiple testing procedure for clinical trials for comparing two treatments with dichotomous data. Differences in the methods of evaluating subject responses at each evaluation time, however, may induce an intraclass correlation among these responses used in calculating the O'Brien-Fleming multiple testing procedure. On the basis of Monte Carlo simulations, we note that even a small intraclass correlation among subject responses in the same analysis can substantially inflate the Type I error of the O'Brien-Fleming multiple testing procedure. Furthermore, this inflation generally increases as either the number of analyses or the underlying response probability increases. We also have demonstrated that if we were able to maintain a uniform medical test procedure between the two treatments for each analysis, the actual Type I error of the O'Brien-Fleming multiple testing procedure may conversely become conservative.

Analysis of Variance↗

A note on the application of simple linear regression methods for trend detection at multiple sites and visits.

In comparing running median, tolerance, cusum, and regression methods for trend detection over a small number of visits, Yang et al. found that application of multiple Z-tests on the basis of a simple linear regression for each site separately was the most efficient for detection of trends at several sites simultaneously. Because the use of multiple Z-tests completely ignores the covariance among measurements taken from different sites, to improve the power we propose a global chi 2-test. Assuming the covariance matrix known, we have found that the proposed chi 2-test procedure is more powerful than multiple Z-tests for two-sided alternatives when both the correlation among measurements and the number of sites are small. We also have found that the former procedure can have power uniformly larger than the latter when ratios of slopes to standard deviations of measurements at different sites vary and the number of sites is large. In fact, in the latter situation, the proposed global chi 2-test procedure, usually used only for two-sided alternatives, can even have power larger than that of multiple Z-tests for one-sided alternatives. In the situation where the ratios of slopes to standard deviations of measurements are all equal, however, the proposed multivariate approach based on the chi 2-test distribution is the least efficient, especially when the number of sites and the correlation are moderate or large. Finally, to account for the effect of multiple tests over a series of visits on the overall alpha-level, on the basis of Monte Carlo simulations, we compute critical values for sequential use of the proposed multivariate test procedure.

Bias↗

A note on the effect of the intraclass correlation in the multiple reading procedure with a unanimity rule.

The use of multiple reading procedures to improve the performance of a diagnostic test occurs often in practice. Evaluation of the utility of multiple reading procedures, however, usually ignores the effect of the intraclass correlation. This paper provides a quantitative assessment of this effect in the multiple reading procedure with a unanimity rule with respect to sensitivity, specificity, positive and negative predictive values. We have found that when the disease prevalence is rare or moderate (less than or equal to 0.20), use of the multiple reading procedure with a unanimity rule is effective in increasing the positive predictive value of a single reading procedure for the situation in which the variation of responses among different subjects and the intraclass correlation among repeated tests are small. This is, however, not true for the situation in which the disease is rare and the variation of responses among different subjects is large, even when the intraclass correlation is small or 0. Furthermore, when the disease is rare and the variation of responses among subjects is small, a small or moderate intraclass correlation can substantially decrease the positive predictive value that one calculates under the assumption that the intraclass correlation is equal to 0. In general, when the disease is rare or moderate (less than or equal to 0.20), the intraclass correlation between repeated tests and the variation of responses among subjects have little effect on the negative predictive value.

Data Interpretation, Statistical↗

Sample size requirement for repeated measurements in continuous data.

In this paper we extend Bloch's discussion on the usefulness and the limitations in the application of repeated measurements per subject in study designs. We derive general sample size formulae for any finite number of comparison groups to calculate the required number of subjects with repeated measurements, that do not have to be conditionally independent. For fixed total cost, we discuss the optimal sample allocation for repeated measurements needed to maximize the power and the underestimation when using Bloch's sample size formula if in the hypothesis testing procedure the variance parameters are unknown. We have also included a quantitative investigation of the effectiveness of taking repeated measurements per subjects to reduced the required number of subjects for a given power at a given alpha-level.

Analysis of Variance↗

Sample size determination under an exponential model in the presence of a confounder and type I censoring.

In controlled clinical trials, random assignment of treatments to individuals is usually used to eliminate the effects of confounding variables. When there is censorship in data, however, confounding effects may not be automatically removed solely by random assignment of treatments to individuals under the exponential model. Therefore, it is important to incorporate the confounding effect into the sample size calculation even after randomization of treatments to individuals. In this paper, the discussion is restricted only to the situation where there are two comparison groups and one single Bernoulli confounding variable. Based on an exponential covariate model, an explicit sample size formula considering the confounding effect has been derived for the design of trials with type I censoring, in which an end time is fixed in advance and all responses occurring after that time are censored. The resulting sample size formula can also be applied to nonrandomized clinical trials. Finally, to provide insight into the influence of different factors on sample size calculation, a discussion on the effects of treatments, the confounder, the length of follow-up times for studied individuals, and the joint distribution of the treatment and the confounder has been included.

Clinical Trials as Topic↗