Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design

BACKGROUND Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question. METHODS/DESIGN We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs'). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials. DISCUSSION To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit.

Descriptive/Inferential Cognitive Processes and Evaluative Cognitive Processes: Relationships Among Each Other and with Emotional Distress

We aimed to delineate key constructs from two forms of cognitive-behavioral therapy: cognitive therapy and rational-emotive behavior therapy. Furthermore, we aimed to investigate the interrelations among each other and with emotional distress. The key constructs of the underlying theories of these therapies (i.e., descriptive/inferential beliefs, evaluative beliefs) are often treated together as distorted cognitions and included as such in various scales. We used a cross-sectional design. Seventy-four undergraduate students (mean age = 24.68) completed measures of automatic thoughts and emotional distress. Three therapists trained in cognitive-behavioral therapy divided automatic thoughts into descriptive/inferential beliefs and evaluative beliefs by consensus. Correlation and mediation analyses were performed. These constructs showed medium to high associations to each other and to distress. The relationship between descriptive/inferential beliefs and distress was mediated by evaluative beliefs. Descriptive and inferential cognitions may not produce emotions without first being appraised in terms of personal relevance.