Properties of the weighted log‐rank test in the design of confirmatory studies with delayed effects

Proportional hazards are a common assumption when designing confirmatory clinical trials in oncology. This assumption not only affects the analysis part but also the sample size calculation. The presence of delayed effects causes a change in the hazard ratio while the trial is ongoing since at the beginning we do not observe any difference between treatment arms, and after some unknown time point, the differences between treatment arms will start to appear. Hence, the proportional hazards assumption no longer holds, and both sample size calculation and analysis methods to be used should be reconsidered. The weighted log‐rank test allows a weighting for early, middle, and late differences through the Fleming and Harrington class of weights and is proven to be more efficient when the proportional hazards assumption does not hold. The Fleming and Harrington class of weights, along with the estimated delay, can be incorporated into the sample size calculation in order to maintain the desired power once the treatment arm differences start to appear. In this article, we explore the impact of delayed effects in group sequential and adaptive group sequential designs and make an empirical evaluation in terms of power and type‐I error rate of the of the weighted log‐rank test in a simulated scenario with fixed values of the Fleming and Harrington class of weights. We also give some practical recommendations regarding which methodology should be used in the presence of delayed effects depending on certain characteristics of the trial.     

Wage and Non-Wage Compensation Among Young Alcoholic and Heavy Drinking Women: A Preliminary Analysis

The association between drinking and selected job characteristics among women aged 24 to 31 is examined. Using the 1989 NLSY, women are classified as alcohol abusers or dependent based on DSM-III-R criteria or as heavy drinkers based on reported frequency of six or more drinks. Heavy drinking is negatively associated with wage and non-wage compensation. These effects diminish when human capital measures are controlled. Current alcoholism and current and past heavy drinking are strongly negatively associated with years of schooling. The association between alcoholism and job compensation and characteristics is not as strong as that seen for heavy drinking. It is not known if this is a consequence of errors in identifying alcoholic women in population-based surveys.     

A NOTE ON EVANESCENT PROCESSES

This note examines the connection between μ-invariant measures for the transition function of a continuous-time Markov chain and those of its q-matrix, Q. The major result establishes a necessary and aufficient condition for a convergent μ-invariant measure for Q to be μ-inhant for the minimal transition function, P, under the assumption that P is honest. This corrects Theorem 6 of Vere-Jones (1969) and the first part of Corollary 1 of Pollett (1986), both of which assert that the above conclusion holds in the absence of this condition. The error was pointed out by E.A. van Doom (1991) and the counterexample which be presented provides the basis for the present arguments. In determining where the error occurred in the original proof, we are able to identify a simple sufficient condition for μ-invariance.     

Don't mention Stonehenge!

It rises massive and magnificent above Salisbury Plain. The extraordinary monoliths of Stonehenge leave us as impressed today as ever—and as baffled. Archaeologists argue about how it was made. Can statisticians tell the answer? Chris Jones thinks they can be of considerable assistance.     

Dementia Problem Behavior and the Production of Informal Caregiving Services

Informal caregivers of individuals with Alzheimer's disease spend a considerable amount of time providing care. In this paper, we use Grossman's health production and Becker's time allocation models to develop a model of informal care provision to elderly dementia patients. In our model, time inputs produce caregiving services, which provides utility to the caregiver, but reduces leisure. We assume that time is less productive of services on the margin as the disease progresses. In this framework, an increase in patients' disease severity does not necessarily increase informal caregiver time input. The cost of formal care establishes a reservation price for informal caregiving. When the costs of informal caregiving rise above this reservation level, the patient is institutionalized. We test empirically the effect of deterioration in the patients' condition, proxied by both disease severity and dementia problem behavior, on informal caregiving time. We find that dementia-related problem behaviors and functional limitations significantly increase inputs of informal caregiving time. Patients' problem behavior exerts a modifying effect on functional limitations, and patients' comorbidities have no effect on informal caregiving time.     

THE IMPLICATIONS OF CHOOSING "NO RACE" ON THE SALIENCE OF HISPANIC IDENTITY: How Racial and Ethnic Backgrounds Intersect among Hispanic Adolescents

Using data from the National Longitudinal Study of Adolescent Health (Add Health), a nationally representative sample of youth from 7th to 12th grades, we examined how racial and ethnic identification overlap among Hispanic adolescents. We evaluated the relative proximity between race and ethnic identifiers among Hispanics. Empirical analyses suggest that the racial identification of other students at school has a significant impact on the odds of choosing particular racial identifiers. Both Hispanic and non-Hispanic schoolmates' racial identification is related to the racial identification of Hispanic adolescents. We also find evidence that both ethnicity and race are distinct stratifiers among Hispanics. Overall, our findings support the notion that Hispanic may be a more meaningful "racial" identity than black, white, or other, but we also find that racial identification and ethnic background are still important and meaningful dividers among Hispanic youth.     

How Welfare Policies Affect Adolescents' School Outcomes: A Synthesis of Evidence From Experimental Studies

Using data from 8 random assignment studies and employing meta‐analytic techniques, this article provides systematic evidence that welfare and work policies targeted at low‐income parents have small adverse effects on some school outcomes among adolescents ages 12 to 18 years at follow‐up. These adverse effects were observed mostly for school performance outcomes and occurred in programs that required mothers to work or participate in employment‐related activities and those that encouraged mothers to work voluntarily. The most pronounced negative effects on school outcomes occurred for the group of adolescents who had a younger sibling, possibly because of the increased home and sibling care responsibilities they assumed as their mothers increased their employment.     

Preparing Parents for Adoption: An Agency Experience

To prepare for the complexities of family formation, 78 prospective adoptive parents participated in Pre-Adopt, a psychosocial educational orientation program offered by one private nonprofit agency. The five-session curriculum included an overview of adoption policies and procedures, discussion of the child placement process, exploration of couples' adoption concerns and expectations about child characteristics, information about adoption laws and birth-parent/child searches, and examination of anticipatory fantasies about birth parents. Program evaluation yielded statistically significant and clinically meaningful findings about changes in emotional readiness to adopt, parenting knowledge, and satisfaction with group participation, adoption policies and agency practices. Practice implications are considered.