Dataset Information

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review.

ABSTRACT:

Importance

Spin, the inaccurate reporting of randomized clinical trials (RCTs) with results that are not statistically significant for the primary end point, distorts interpretation of results and leads to misinterpretation. However, the prevalence of spin and related factors in noninferiority cancer RCTs remains unclear.

Objective

To examine misleading reporting, or spin, and the associated factors in noninferiority cancer RCTs through a systematic review.

Data sources

A systematic search of the PubMed database was performed for articles published between January 1, 2010, and December 31, 2019, using the Cochrane Highly Sensitive Search Strategy.

Study selection

Two investigators independently selected studies using the inclusion criteria of noninferiority parallel-group RCTs aiming to confirm effects to cancer treatments published between January 1, 2010, and December 31, 2019, reporting results that were not statistically significant for the primary end points.

Data extraction and synthesis

Standardized data abstraction was used to extract information concerning the trial characteristics and spin based on a prespecified definition. The main investigator extracted the trial characteristics while both readers independently evaluated the spin. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was followed.

Main outcomes and measures

The main outcome was spin prevalence in any section of the report. Spin was defined as use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite no statistically significant difference for the primary outcome, or to distract the reader from results that are not statistically significant. The associations (prevalence difference and odds ratios [ORs]) between spin and trial characteristics were also evaluated.

Results

The analysis included 52 of 2752 reports identified in the PubMed search. Spin was identified in 39 reports (75.0%; 95% CI, 61.6%-84.9%), including the abstract (34 reports [65.4%; 95% CI, 51.1%-76.9%]) and the main text (38 reports [73.1%; 95% CI, 59.7%-83.3%]). Univariate analysis found that the spin prevalence was higher in reports with data managers (prevalence difference, 27%; 95% CI, 1.1%-50.3%), reports without funding from for-profit sources (prevalence difference, 31.2%; 95% CI, 4.8%-53.8%), and reports of novel experimental treatments (prevalence difference, 37.5%; 95% CI, 5.8%-64.7%). Multivariable analysis found that novel experimental treatment (OR, 4.64; 95% CI, 0.98-22.02) and funding only from nonprofit sources only (OR, 5.20; 95% CI, 1.21-22.29) were associated with spin.

Conclusions and relevance

In this systematic review, most noninferiority RCTs reporting results that were not statistically significant for the primary end points showed distorted interpretation and inaccurate reporting. The novelty of an experimental treatment and funding only from nonprofit sources were associated with spin.

SUBMITTER: Ito C

PROVIDER: S-EPMC8652604 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:Poor reporting in randomized clinical trial (RCT) abstracts reduces quality and misinforms readers. Spin, a biased presentation of findings, could frequently mislead clinicians to accept a clinical intervention despite non-significant primary outcome. Therefore, good reporting practices and absence of spin enhances research quality. We aim to assess the reporting quality and spin in abstracts of RCTs evaluating the effect of periodontal therapy on cardiovascular (CVD) outcomes. METHODS:PubMed, Scopus, the Cochrane Central Register of Controlled Trials (CENTRAL), and 17 trial registration platforms were searched. Cohort, non-randomized, non-English studies, and pediatric studies were excluded. RCT abstracts were reviewed by 2 authors using the CONSORT for abstracts and spin checklists for data extraction. Cohen's Kappa statistic was used to assess inter-rater agreement. Data on the selected RCT publication metrics were collected. Descriptive analysis was performed with non-parametric methods. Correlation analysis between quality, spin and bibliometric parameters was conducted. RESULTS:24 RCTs were selected for CONSORT analysis and 14 fulfilled the criteria for spin analysis. Several important RCT elements per CONSORT were neglected in the abstract including description of the study population (100%), explicitly stated primary outcome (87%), methods of randomization and blinding (100%), trial registration (87%). No RCT examined true outcomes (CVD events). A significant fraction of the abstracts appeared with at least one form of spin in the results and conclusions (86%) and claimed some treatment benefit in spite of non-significant primary outcome (64%). High-quality reporting had a significant positive correlation with reporting of trial registration (p = 0.04) and funding (p = 0.009). Spinning showed marginal negative correlation with reporting quality (p = 0.059). CONCLUSION:Poor adherence to the CONSORT guidelines and high levels of data spin were found in abstracts of RCTs exploring the effects of periodontal therapy on CVD outcomes. Our findings indicate that journal editors and reviewers should consider strict adherence to proper reporting guidelines to improve reporting quality and reduce waste.