Reporting quality and information consistency of randomized, controlled trials presented as abstracts at the American Urological Association annual meetings.

PURPOSE: We assessed the quality of randomized, controlled trial reporting in abstracts from the annual meetings of the American Urological Association and determined whether the information provided is consistent with subsequent full text publications. MATERIALS AND METHODS: All randomized, controlled trials presented in abstract form at the 2002 and 2003 American Urological Association annual meetings were identified for review. A systematic PubMed search based on authorship and key words from the study title was done to identify all subsequent full text publications. A standardized evaluation form was developed based on the published literature, pilot tested in a separate sample and applied by 2 independent reviewers. RESULTS: A total of 126 randomized, controlled trials were identified for review, including 56 in 2002 and 70 in 2003. Approximately a third of the trials (43 or 34.1%) identified the study design as a randomized, controlled trial in the abstract title. The method of randomization, allocation concealment and blinding was reported in 0% (0), 0% (0) and 40.5% (51) of studies, respectively. Mean/median followup was provided in 27.0% of studies (34). Of 126 randomized, controlled trials presented in abstract form 62.7% (79) were subsequently published as full text articles. Study sample size and the number of randomized subjects differed in 24.1% and 28.9% of abstracts, respectively. From the small proportion of randomized, controlled trials (23 or 29.1%) that identified a single primary end point results differed in 9 of 23 (39.1%). CONCLUSIONS: Most abstracts fail to provide the necessary information to assess methodological quality. Organizers of urological meetings should consider implementing a more structured abstract format that requires authors to provide the necessary study details, thereby allowing urologists to critically appraise study validity.

Levels of evidence ratings in the urological literature: an assessment of interobserver agreement.

OBJECTIVE: To determine to what extent urologists with no specific training agree upon level of evidence (LoE) ratings of studies published in the urological literature, as LoE are commonly referenced as a measure of evidence quality. MATERIALS AND METHODS: In all, 86 clinical research studies published in four major urology journals were reviewed. Each article was independently reviewed by eight reviewers using a standardized data abstraction form. Articles were assessed for type of study (therapy, prognosis, diagnosis or economic) and LoE (I, II, III or IV). Reviewers received only written instructions and no formal training in the application of this classification system. RESULTS: Of the 86 articles, 69% related to therapy, 16% to prognosis, and 15% to diagnosis. Eight studies (9%) provided Level I evidence, 18 studies (21%) Level II, 14 studies (16%) Level III and 46 studies (54%) Level IV evidence. The intraclass correlation coefficient (95% confidence interval) based on all reviewers (eight reviewers) was 0.67 (0.59-0.74; P= 0.001) for the type of study and 0.55 (0.48-0.64; P= 0.001) for the LoE. In an analysis limited to a subset of studies in which all reviewers agreed upon the type of study question (n= 40) the intraclass correlation coefficient was 0.79 (0.70-0.86; P= 0.001). CONCLUSION: In the present study there was a low interobserver agreement for LoE ratings by urologists with no specific training. These findings suggest caution in the interpretation of LoE ratings and emphasize the importance of specific training for individuals that are charged with quality of evidence determinations.

Alveolar interleukin-10 regulates neutrophil apoptosis in severely traumatized patients.

BACKGROUND: The lung produces a localized immunologic response to systemic trauma, characterized by an initial proinflammatory period with production of interleukin (IL)-8 and IL-18, followed by an anti-inflammatory phase with elevated levels of IL-10. Recent studies have shown a correlation between alveolar IL-10 and the rate of local neutrophil apoptosis. The aim of the present study was to further characterize the association of alveolar IL-8 and IL-10 after trauma with neutrophil activation, apoptosis, and phagocytic capacity. METHODS: Bronchoalveolar lavage fluid (BALF) was obtained from 17 trauma patients with an Injury Severity Score >/=16 who required mechanical ventilation. Neutrophils from venous blood of healthy volunteers were incubated in either (1) cell culture media (control), (2) culture media + BALF, (3) culture media + BALF + anti-IL-8 neutralizing antibody, or (4) culture media + BALF + anti-IL-10. Surface CD11b expression, ability to phagocytose fluorescent bacteria, and neutrophil apoptosis were determined by flow cytometry. RESULTS: Phagocytosis and CD11b expression were both augmented on postinjury day 1 when compared with controls. Neutralization of IL-10 or IL-8 produced no significant differences in phagocytosis or CD11b expression. However, neutralization of IL-10 significantly decreased the rate of apoptosis in samples from postinjury day 1. CONCLUSION: Phagocytosis and CD11b expression on neutrophils are IL-8 and IL-10 independent. However, our data indicate that alveolar neutrophil apoptosis is dependent on IL-10 at early time points after injury. Elucidation of this pathway may allow novel interventions to prevent posttraumatic pulmonary dysfunction.