title: A CONSORT analysis of randomised controlled trials for the treatment of invasive aspergillosis.
abstract: There is no assessment of the reporting quality of antifungal randomized, controlled trials (RCT), upon which guidelines for the treatment of invasive aspergillosis (IA) in patients with hematological malignancy are based. Trial reports were identified through Trip, Cochrane, Medline, and Embase database searches. Report quality was assessed using the 25-item CONSORT checklist and a rating scale of 1 (strongly disagree) to 4 (strongly agree). The primary endpoint was quality as assessed by mean group-scores among papers published at the time of the most recent IA treatment guidelines. Seven RCTs were identified for analysis. Overall mean group-score for all seven papers was 2.44 (out of a total of four). There were significant differences between publications regarding overall reporting quality (P < .001) and specifically for the Methods and Results (P = .004 and P = .010, respectively), which best reflect data quality. The Cornely trial report achieved the highest mean group-score overall (3.15 ± 0.93; 95% CI, 2.82, 3.47), as well as for Methods (3.36) and Results (3.40). Mean group scores also showed that it was of significantly higher overall quality than the other six publications (P-value range; .012 to <.001), and of higher quality for Methods than five publications (P-value range; .013 to <.001). Incorporating this CONSORT analysis into the evidence-based grading systems in North American (IDSA), European (ECIL and ESCMID) IA guidelines could alter the value placed on these RCTs, thereby impacting on clinical recommendations.
authors.affiliation: Department of Clinical Microbiology, Royal Infirmary, Glasgow, United Kingdom, and University of Glasgow, Glasgow, United Kingdom.
authors.forename: Brian L
authors.initials: BL
authors.lastname: Jones
authors.affiliation: Mycology Reference Centre, and Manchester Academic Health Science Centre, Education and Research Centre, University Hospital of South Manchester, Manchester, United Kingdom.
authors.forename: Malcolm D
authors.initials: MD
authors.lastname: Richardson
authors.affiliation: 47 Tring Avenue, London, United Kingdom.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Ingram
authors.affiliation: Division of Haemato-Oncology, St Bartholomew's Hospital, Barts Health NHS Trust and Queen Mary University of London, London, United Kingdom.
authors.forename: Samir G
authors.initials: SG
authors.lastname: Agrawal
mesh_terms: D001228:Aspergillosis / Q000628:therapy*; D017408:Guidelines as Topic; D006801:Humans; D000072742:Invasive Fungal Infections / Q000628:therapy*; D010506:Periodicals as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards; D058028:Research Report / Q000592:standards*
keywords: CONSORT; RCT; hemato-oncology; invasive aspergillosis