8 Recent communications regarding estrogen or estrogen + progestin treatment and clinical cardioprotection, breast cancer risk and cerebral aging have produced considerable confusion and concerns among women, caregivers and the media. The actions of the United States’ Food and Drug Administration (FDA) and other National Safety of Medicine Boards, such as the European Medicine Evaluation Agency...

Nineteen (Mage = 45, SD = 12.8) group leaders who received extensive leadership training were surveyed regarding their experiences in leading a 10-week program with one of three randomized clinical trial (RCT) conditions (cognitive behavior training, parenting skills training, information-only support). While a high percentage indicated that the intervention led by them was beneficial, leaders ...

In their paper [1], Drs. Mehta and Pocock illustrate the use of a particular approach to revising the maximal sample size of a randomized clinical trial (RCT) by using an interim estimate of the treatment effect. Slightly extending the results of Gao, Ware, and Mehta [2], the authors define conditions on an adaptive rule such that one can know that the naive statistical hypothesis test that ign...

BACKGROUND An important step toward improvement of the conduct of pediatric clinical research is the standardization of the ages of children to be included in pediatric trials and the optimal age-subgroups to be analyzed. METHODS We set out to evaluate empirically the age ranges of children, and age-subgroup analyses thereof, reported in recent pediatric randomized clinical trials (RCTs) and ...

PURPOSE To provide a synthesis of the highest-quality literature available comparing early passive motion (EPM) with strict sling immobilization during the first 4 to 6 weeks after surgery. METHODS The Medline, Cochrane, and Embase databases were searched for eligible studies. We reviewed 886 citations, and 5 randomized clinical trials (RCTs) (Level II) met the inclusion criteria for meta-ana...

BACKGROUND/AIMS Racial and ethnic minorities remain underrepresented in clinical research, yet few recruitment strategies have been rigorously evaluated. METHODS We experimentally tested whether targeted recruitment letters acknowledging diabetes health disparities and health risks specific to recipients' racial/ethnic group improved two metrics of trial participation: willingness to be scree...

Meta-analyses of data from randomized clinical trials (RCTs) are often used by hematologists to compare the efficacy of therapies of blood diseases. This is especially so when results of RCTs are not decisive. This situation in RCTs arises when the magnitude of differences in treatment outcomes between therapies tested is small, when trials are unpowered to detect differences (these are confoun...

INTRODUCTION A number of research studies have shown that the new generation of neuroleptic medications can more effectively contribute to treating negative symptoms of schizophrenia compared with the first generation by influence cognitive functioning. The present study examined the therapeutic effectiveness of manufactured Risperidone and Haloperidol in Iran on treating the negative symptoms ...

world assumptions [9–11]. In particular, a re-analysis of data from 4 randomized clinical trials (RCTs) found that efficacy estimates and confidence intervals for the gold standard RCT analysis and the alternative TND analysis were virtually identical [11]. Other than age, confounding variables have been notably absent in most vaccine effectiveness studies using theTND.Medicationconfoundingmayb...

Presentation This article summarizes the three types of hybrid effectiveness-implementation designs and associated evaluation methods. It includes a discussion of how hybrid designs have the potential to enhance knowledge development and application of clinical interventions and implementation strategies in “real world” settings. The authors propose implications of hybrid designs for quality im...