Treating schizophrenia: the quality of evidence behind treatment recommendations and how it can improve.

OBJECTIVE: To assess the methodological and reporting quality of systematic reviews that comprise the American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Schizophrenia and to determine the extent to which results from Cochrane systematic reviews published after guideline development would alter or confirm current recommendations. PARTICIPANTS: Systematic reviews that underpinned recommendations in the APA guidelines and Cochrane systematic reviews. MAIN OUTCOME: Three independent reviewers scored all systematic reviews referenced in the guideline for quality and reporting using AMSTAR and PRISMA checklist, respectively. Items in both tools were individually graded and compared to identify consistently low-performing areas within the systematic reviews. Post hoc analysis of the Cochrane systematic reviews since the latest revision of APA's guidelines were performed to determine whether their findings were congruent with recent recommendations. RESULTS: The mean score of the 57 reviews on the PRISMA checklist was 70%. The mean AMSTAR score was 6.8, correlating with a moderate quality score. Post hoc analysis revealed that 171 Cochrane reviews had been published since the APA guideline release. Only half of the reviews of pharmacological interventions confirmed current recommendations. CONCLUSIONS AND RELEVANCE: The methodological quality of the systematic reviews included in the APA guideline was deficient in key areas. Our study brings to light the importance of using high-quality evidence in the development of clinical practice guidelines. An updated APA guideline (last updated in 2009) is necessary to provide the highest quality treatment recommendations for clinicians in the management of schizophrenia. TRIAL REGISTRATION NUMBER: UMIN-CTR, UMIN000023099.

Evidence of selective reporting bias in hematology journals: A systematic review.

INTRODUCTION: Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. METHODS: Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. RESULTS: Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. CONCLUSION: Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making.