Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials from 2002 to 2017

This cross-sectional study evaluates the existence and timing of trial registration for randomized clinical trials (RCTs) published from 2002 to 2017 as well as substantive changes to the primary outcomes entered into registry information after those studies started

Inequalities' Impacts: State of the Art Review

By way of introduction This report provides the fi rm foundation for anchoring the research that will be performed by the GINI project. It subsequently considers the fi elds covered by each of the main work packages: ● inequalities of income, wealth and education, ● social impacts, ● political and cultural impacts, and ● policy effects on and of inequality. Though extensive this review does not pretend to be exhaustive. The review may be “light” in some respects and can be expanded when the analysis evolves. In each of the four fi elds a signifi cant number of discussion papers will be produced, in total well over 100. These will add to the state of the art while also covering new round and generating results that will be incorporated in the Analysis Reports to be prepared for the work packages. In that sense, the current review provides the starting point. At the same time, the existing body of knowledge is broader or deeper depending on the particular fi eld and its tradition of research. The very motivation of GINI’s focused study of the impacts of inequalities is that a systematic study is lacking and relatively little is known about those impacts. This also holds for the complex collection of, the effects that inequality can have on policy making and the contributions that policies can make to mitigating inequalities but also to enhancing them. By contrast, analyses of inequality itself are many, not least because there is a wide array of inequalities; inequalities have become more easily studied comparatively and much of that analysis has a signifi cant descriptive fl avour that includes an extensive discussion of measurement issues. @GINI hopes to go beyond that and cover the impacts of inequalities at the same time

Selective outcome reporting across psychopharmacotherapy randomized controlled trials

Objective: Selective reporting impairs the valid interpretation of trials and leads to bias with regards to the clinical evidence. We aimed to examine factors associated with selective reporting in psychopharmacotherapy trials and thus enable solutions to prevent such selective reporting in the future. Methods: We retrieved all registry records of trials investigating medication for depressive, bipolar and psychotic disorders. Multivariate logistic regression was performed with selective reporting as outcome, and funding source, psychiatric disorder, year of study start date, participating centers, and anticipated sample size as explanatory variables, after testing for multicollinearity. Adjusted odds ratios (AOR) were calculated. Two-sided Fisher exact test was used to compare the proportions of newly added positive primary outcomes with the proportions of positive results in the overall group of primary outcomes. Results: Of 151 included trials (N = 94,303 participants), 21 (14%) showed irregularities between registered and published primary outcomes. Higher odds of such irregularities were associated with non-industry-funded RCTs (AOR 5.3; p = 0.014) and trials investigating major depressive disorder (AOR 12.7; p = 0.024) or schizophrenia (AOR 14.5; p = 0.016; Table 1). Conclusion: We demonstrate discrepancies between trial registrations and publications across RCTs investigating debilitating psychiatric disorders, especially in non-industry funded RCTs