BackgroundSelective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals.MethodsWe searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined.Results180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results.ConclusionAcross trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.
Journal of Patient-Centered Research and Reviews ( JPCRR) is a peerreviewed scientific journal whose mission is to communicate clinical and bench research findings, with the goal of improving the quality of human health, the care of the individual patient, and the care of populations. Recommended CitationGaskamp M, Blubaugh M, McCarthy LH, Scheid DC. Can bedside ultrasound inferior vena cava measurements accurately diagnose congestive heart failure in the emergency department? A Clin-IQ. J Patient Cent Res Rev. 2016;3:230-4 Clinical QuestionIn adults, 18 years of age and older, who present to the emergency department (ED) with dyspnea, are inferior vena cava (IVC) measurements using bedside ultrasound as accurate as B-type natriuretic peptide (BNP) levels for identifying heart failure? Brief AnswerYes. Bedside ultrasound measurement of the IVC is a highly specific and rapid tool for diagnosing heart failure in the ED setting compared with BNP. BNP costs less than bedside ultrasound but is less specific and may take up to one hour or more at a clinical juncture when rapid detection of volume overload can rule in or rule out heart failure. In the studies reviewed, the specificity of the IVC measurement was as good as, or better than, BNP values. Ultrasound IVC measurements may be especially useful for cases in which BNP values fall into a nondiagnostic "gray zone" range. Based on current evidence, it seems reasonable to conclude that ultrasound IVC measurements, taken by properly trained ED clinicians, alone or in combination with BNP, would likely increase accuracy of diagnosing heart failure, allow earlier initiation of appropriate treatment and potentially reduce morbidity and mortality.Date of Literature Search: March/April 2016. Level of Evidence: B. Search TermsUltrasound, heart failure, inferior vena cava, pro-Btype natriuretic peptide, NR-PRoBNP, emergency department, diagnosis Inclusion CriteriaCurrent systematic reviews, meta-analyses, cohort studies, clinical research trials investigating the AbstractCongestive heart failure (CHF) is a major cause of morbidity and mortality. Early diagnosis of CHF in patients presenting to the emergency department with undifferentiated dyspnea would allow clinicians to begin appropriate treatment more promptly. Current guidelines recommend B-type natriuretic peptide (BNP) levels for more accurate diagnosis of CHF in dyspneic patients. Although BNP levels are relatively inexpensive, the test is not usually performed at bedside and results may take up to an hour or more. BNP also may have a "gray zone" in which the values can neither confirm nor rule out CHF. BNP has a reported sensitivity of 87% and specificity of 74% at a cutoff of 400 pg/ml. Studies investigating bedside ultrasound inferior vena cava (IVC) measurements for identifying CHF report a specificity of 84% to 96% and sensitivity values ranging from 37% to 93%, depending on the study. efficacy of ultrasound measurements of the IVC for diagnosing heart failure in the ED. Exclusion CriteriaChildren less than 1...
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