Warrier Kiran, Jayanthi C R
Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India.
Perspect Clin Res. 2022 Apr-Jun;13(2):77-81. doi: 10.4103/picr.PICR_64_20. Epub 2021 Jan 8.
Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences.
The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred.
This cross-sectional study was conducted in the department of pharmacology.
Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed.
Descriptive statistics were used to summarize the data.
Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison.
Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.
随机对照试验（RCT）是高质量临床证据生成的基石之一。然而，试验报告的不完整或有偏倚会阻碍试验及其结果的审查过程。结果转换，无论是有意还是无意，都会导致报告有偏倚，并可能导致错误的推断。
本研究旨在分析《报告试验的统一标准》（CONSORT）2010清单项目的报告完整性，并检测是否发生了结果转换。
本横断面研究在药理学系进行。
访问印度医学专业协会2017年至2019年出版的期刊在线版，并下载其中发表的RCT全文。记录CONSORT清单中每个项目的报告情况。还确定了试验注册和CONSORT认可对关键方法学参数报告的影响。访问注册试验的方案，并评估结果转换情况。
采用描述性统计对数据进行总结。
从2017年到2019年，报告的平均完整性有显著提高。报告不足的主要领域是可推广性、方案可用性、试验注册、招募日期、分配隐藏和患者流程图。获得CONSORT认可的期刊报告情况较差，而注册试验对关键方法学指标的报告较好。在86项注册试验中有84项可在线获取试验方案以供比较，未观察到明显的结果转换。
印度医学期刊中临床试验报告的质量有所提高，但仍不充分。未获得CONSORT认可会妨碍试验报告的完整性。
