Biomedical subjects

Richard J Cook

Publications and source records attributed to Richard J Cook.

6 recordsLinked to original sources

PubMed2003

Incremental net benefit in randomized clinical trials with quality-adjusted survival.

Owing to induced dependent censoring, estimating mean costs and quality-adjusted survival in a cost-effectiveness comparison of two groups using standard life-table methods leads to biased results. In this paper we propose methods for estimating the difference in mean costs and the difference in mean effectiveness, together with their respective variances and covariance in the presence of dependent censoring. We consider the situation in which the measure of effectiveness is either the probability of surviving a duration of interest or mean quality-adjusted survival time over a duration of interest. The methods are illustrated in an example using an incremental net benefit analysis.

Amiodarone↗

PubMed2003

Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies.

BACKGROUND: Prophylactic platelet transfusions are given to thrombocytopenic patients to prevent bleeding. The benefit of platelet transfusions has frequently been assessed by measuring the count increment; however, more recently, an assessment of bleeding has been used because it is a more clinically relevant outcome measure. The purpose of this study was to identify platelet transfusion trigger studies that used bleeding as an outcome measure, compare and contrast methods used to document bleeding and analyze bleeding outcomes, and identify and discuss methodologic issues to consider when bleeding is used as a study outcome. STUDY DESIGN AND METHODS: A systematic search to identify platelet transfusion trigger studies was performed. Relevant articles were reviewed to identify how bleeding data was captured and analyzed, and methodologic considerations were identified. RESULTS: Seven articles meeting the predefined entry criteria were identified. Methods used to document bleeding included chart review and clinical assessment. The frequency of assessment and the type of personnel performing the assessment were variable. Four approaches to analysis were identified: descriptive; comparison of the proportions of patients having at least one bleed; comparison of patient days with bleeding expressed as a proportion of the total days at risk of bleeding; and time-to-event (first bleed) analysis. CONCLUSION: Methodologic issues for consideration when designing a clinical study with bleeding as the outcome measure included approaches to minimize bias in the documentation and classification of bleeding and selection of an analysis approach that is appropriate to the question being asked. The need for development of a valid and reliable bleeding scale was also identified.

Data Collection↗

PubMed2003

Conditional analysis of mixed Poisson processes with baseline counts: implications for trial design and analysis.

The design of clinical trials is typically based on marginal comparisons of a primary response under two or more treatments. The considerable gains in efficiency afforded by models conditional on one or more baseline responses has been extensively studied for Gaussian models. The purpose of this article is to present methods for the design and analysis of clinical trials in which the response is a count or a point process, and a corresponding baseline count is available prior to randomization. The methods are based on a conditional negative binomial model for the response given the baseline count and can be used to examine the effect of introducing selection criteria on power and sample size requirements. We show that designs based on this approach are more efficient than those proposed by McMahon et al. (1994).

Algorithms↗

PubMed2003

Monitoring the evolutionary process of quality: risk-adjusted charting to track outcomes in intensive care.

OBJECTIVE: To present graphical procedures for prospectively monitoring outcomes in the intensive care unit. DESIGN: Observational study: risk-adjusted control chart analysis of a case series. SETTING: Tertiary referral adult intensive care unit: Princess Alexandra Hospital, Brisbane, Australia. PATIENTS: A total of 3398 intensive care unit admissions from January 1, 1995, to January 1, 1998. CONCLUSIONS: Risk-adjusted process control charting procedures for continuous monitoring of intensive care unit outcomes are proposed as quality management tools. A modified Shewhart p chart and cumulative sum process control chart, using the Acute Physiology and Chronic Health Evaluation III model mortality prediction for risk adjustment, are presented. The risk-adjusted p chart summarizes performance at arbitrary intervals and plots observed against predicted mortality rate to detect large changes in risk-adjusted mortality. The risk-adjusted cumulative sum procedure is a likelihood-based scoring method that adjusts for estimated risk of death, accumulating evidence from outcomes of all previous patients. It formally tests the hypothesis of a change in the odds of death. In this application, we detected a decrease from above to predicted risk-adjusted mortality. This was temporally related to increased senior staffing levels and enhanced ongoing multidisciplinary review of practice, quality improvement, and educational activities. Formulas and analyses are provided as appendices.

Adult↗

PubMed2002

Selection effects in randomized trials with count data.

Selection criteria are specified in clinical trials to define the study population from which the sample will be obtained. It is common for one of these criteria to be based on historical or baseline measurements of the clinical sign or symptom that will serve as the response variable in the trial. The effect of such selection criteria has been studied extensively for normally distributed responses, but less is known about the situation in which the response is a count or a possibly recurrent event. In this paper we examine the bias and relative efficiency of some common methods of analysis for count data in the presence of selection criteria. The investigation is carried out using asymptotic theory pertaining to misspecified models and by simulation. Applications involving data from an epilepsy trial and a study of transient myocardial ischaemia illustrate the effect of ignoring the selection mechanism.

Anticonvulsants↗

PubMed2002

A generalized mover-stayer model for panel data.

A generalized mover-stayer model is described for conditionally Markov processes under panel observation. Marginally the model represents a mixture of nested continuous-time Markov processes in which sub-models are defined by constraining some transition intensities to zero between two or more states of a full model. A Fisher scoring algorithm is described which facilitates maximum likelihood estimation based only on the first derivatives of the transition probability matrices. The model is fit to data from a smoking prevention study and is shown to provide a significant improvement in fit over a time-homogeneous Markov model. Extensions are developed which facilitate examination of covariate effects on both the transition intensities and the mover-stayer probabilities.

Journal Article↗