Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma.

Abstract

PURPOSE:

To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality.

METHODS AND MATERIALS:

Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events.

RESULTS:

We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately.

CONCLUSIONS:

Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

• Authors: Yu-Pei Chen, Lei Chen, Wen-Fei Li, Anne W M Lee, Jan B Vermorken, Joseph Wee, Brian O'Sullivan, Avraham Eisbruch, Jin-Ching Lin, Hai-Qiang Mai, Li Zhang, Ying Guo, Ai-Hua Lin, Ying Sun, Jun Ma
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 98 Issue 1 Pg. 170-176 (05 01 2017) ISSN: 1879-355X [Electronic] United States
• PMID: 28586958 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Topics

• Carcinoma (radiotherapy)
• Chemoradiotherapy
• Humans
• Intention to Treat Analysis
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms (radiotherapy)
• Random Allocation
• Randomized Controlled Trials as Topic (standards)
• Regression Analysis
• Research Report (standards)
• Selection Bias