Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio

This paper presents an approximate closed form sample size formula for determining non-inferiority in active-control trials with binary data. We use the odds-ratio as the measure of the relative treatment effect, derive the sample size formula based on the score test and compare it with a second, well-known formula based on the Wald test. Both closed form formulae are compared with simulations based on the likelihood ratio test. Within the range of parameter values investigated, the score test closed form formula is reasonably accurate when non-inferiority margins are based on odds-ratios of about 0.5 or above and when the magnitude of the odds ratio under the alternative hypothesis lies between about 1 and 2.5. The accuracy generally decreases as the odds ratio under the alternative hypothesis moves upwards from 1. As the non-inferiority margin odds ratio decreases from 0.5, the score test closed form formula increasingly overestimates the sample size irrespective of the magnitude of the odds ratio under the alternative hypothesis. The Wald test closed form formula is also reasonably accurate in the cases where the score test closed form formula works well. Outside these scenarios, the Wald test closed form formula can either underestimate or overestimate the sample size, depending on the magnitude of the non-inferiority margin odds ratio and the odds ratio under the alternative hypothesis. Although neither approximation is accurate for all cases, both approaches lead to satisfactory sample size calculation for non-inferiority trials with binary data where the odds ratio is the parameter of interest.

Overgeneral autobiological memory in women: association with childhood abuse and history of depression in a community sample

Objective. Numerous studies have reported elevated levels of overgeneral autobiographical memory among depressed patients and also among those previously exposed to a traumatic event. No previous study has examined their joint association with overgeneral memory in a community sample, nor examined whether the associations are with both juvenile- and adult-onset depression. Methods. The current study examined the relative importance of exposure to childhood abuse and neglect in overgeneral memory of women with and without a history of major depressive disorder (MDD). Autobiographical memory test together with standardized interviews of childhood experiences and MDD were assessed in a risk-stratified community sample of 103 women aged 25–37. Results. Overgenerality in memory was associated with recalled childhood sexual abuse (CSA) but not other adversities. A history of CSA was predictive of overgeneral memory bias even in the absence of MDD. Our analyses indicated no significant association between a history of MDD and overgeneral memory in women who reported no CSA. However, overgeneral memory was increased in women who reported CSA and MDD with a significant difference found in relation to positive cues, the highest scores being seen among those with adult rather than juvenile-onset depression. Conclusions. The findings highlight the significance of CSA in predicting overgeneral memory, differential response in relation to positive and negative cue memories, and point to a specific role in the development of depression for overgeneral memory following CSA.

Effects of a multi-session Cognitive Bias Modification program on interpretative biases and social anxiety symptoms in a sample of Iranian socially-anxious students

This study examines the effects of a multi-session Cognitive Bias Modification (CBM) program on interpretative biases and social anxiety in an Iranian sample. Thirty-six volunteers with a high score on social anxiety measures were recruited from a student population and randomly allocated into the experimental and control groups. In the experimental group, participants received 4 sessions of positive CBM for interpretative biases (CBM-I) over 2 weeks in the laboratory. Participants in the control condition completed a neutral task matched the active CBM-I intervention in format and duration but did not encourage positive disambiguation of socially ambiguous scenarios. The results indicated that after training the positive CBM-I group exhibited more positive (and less negative) interpretations of ambiguous scenarios and less social anxiety symptoms relative to the control condition at both 1 week post-test and 7 weeks follow-up. It is suggested that clinical trials are required to establish the clinical efficacy of this intervention for social anxiety.

Reverse correlation reveals how observers sample visual information when estimating three-dimensional shape

Human observers exhibit large systematic distance-dependent biases when estimating the three-dimensional (3D) shape of objects defined by binocular image disparities. This has led some to question the utility of disparity as a cue to 3D shape and whether accurate estimation of 3D shape is at all possible. Others have argued that accurate perception is possible, but only with large continuous perspective transformations of an object. Using a stimulus that is known to elicit large distance-dependent perceptual bias (random dot stereograms of elliptical cylinders) we show that contrary to these findings the simple adoption of a more naturalistic viewing angle completely eliminates this bias. Using behavioural psychophysics, coupled with a novel surface-based reverse correlation methodology, we show that it is binocular edge and contour information that allows for accurate and precise perception and that observers actively exploit and sample this information when it is available.