A CHecklist for statistical Assessment of Medical Papers (the CHAMP statement): explanation and elaboration.

Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors' and readers' practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper.

The CONSORT Statement: Application within and adaptations for orthodontic trials.

High-quality randomized controlled trials (RCTs) are an integral part of evidence-based medicine. RCTs are the bricks and mortar of high-quality systematic reviews, which are important determinants of health care policy and clinical practice. For published research to be used most effectively, investigators and authors should follow the guidelines for accurate and transparent reporting of RCTs. The consolidated standards of reporting trials (CONSORT) statement and its extensions are among the most widely used reporting guidelines in biomedical research. CONSORT was adopted by the American Journal of Orthodontics and Dentofacial Orthopedics in 2004. Since 2011, this Journal has been actively implementing compliance with the CONSORT reporting guidelines. The objective of this explanatory article is to highlight the relevance and implications of the various CONSORT items to help authors to achieve CONSORT compliance in their research submissions of RCTs to this and other orthodontic journals.

Improving the completeness and transparency of reports of randomized trials in oral health: the CONSORT statement.

PURPOSE: Randomized trials provide essential evidence of the effect of interventions in oral health. Such trials need to be appraised by readers in order to decide whether to incorporate new findings into clinical practice and policy in a timely manner. The CONSORT (Consolidated Standards of Reporting of Trials) Statement is a guidance to facilitate reporting of randomized controlled trials (RCTs) and was first introduced in 1996. The purpose of this article is to highlight the importance of rigorous reporting of trials in oral health and to discuss the impact of CONSORT on trial reporting. RESULTS: Empirical studies demonstrate that key aspects of trial methods influence the size of estimates of studied interventions and bias is a plausible mechanism for some of this effect. Complete and transparent reporting of these methods allows appraisal of the value of trials to be undertaken and the potential for bias to be estimated. Systematic reviews have shown that the reported quality of trials in dentistry is poor, thus hindering the understanding of the value of individual trials. Since 1996, CONSORT has been adopted by hundreds of medical journals, international editorial groups, and five dental journals. A systematic review has shown that the quality of reporting of trials improves in journals that have adopted this guidance, although with significant variation, most likely due to differing levels of editorial adherence to it.

Do declarative titles affect readers' perceptions of research findings? A randomized trial.

BACKGROUND: Many journals prohibit the use of declarative titles that state study findings, yet a few journals encourage or even require them. We compared the effects of a declarative versus a descriptive title on readers' perceptions about the strength of evidence in a research abstract describing a randomized trial. METHODS: Study participants (medical or dental students or doctors attending lectures) read two abstracts describing studies of a fictitious treatment (Anticox) for a fictitious condition (Green's syndrome). The first abstract (A1) described an uncontrolled, 10-patient, case series, and the second (A2) described a randomized, placebo-controlled trial involving 48 patients. All participants rated identical A1 abstracts (with a descriptive title) to provide baseline ratings and thus reduce the effects of inter-individual variability. Participants were randomized so that half rated a version of A2 with a descriptive title and half with a declarative title. For each abstract, participants indicated their agreement with the statement "Anticox is an effective treatment for pain in Green's syndrome" using 100 mm visual analogue scales (VAS) ranging from "disagree completely" to "agree completely." VAS scores were measured by an investigator who was unaware of group allocation. RESULTS: One hundred forty-four participants from four centres completed the study. There was no significant difference between the declarative and the descriptive title groups' confidence in the study conclusions as expressed on VAS scales-in fact, the mean difference between A1 and A2 was smaller for the declarative title group than that for the descriptive title group (32.6 mm, SD 27.4 vs. 39.8 mm, SD 22.6, respectively, p = 0.09). CONCLUSIONS: We found no evidence that the use of a declarative title affected readers' perceptions about study conclusions. This suggests that editors' fears that declarative titles might unduly influence readers' judgements about study conclusions may be unfounded, at least in relation to reports of randomized trials. However, our study design had several limitations, and our findings may not be generalizable to other situations.