ファクトリアルランダム化試験の報告: CONSORT 2010 声明の拡張

Brennan C Kahan¹, Sophie S Hall², Elaine M Beller³

¹MRC Clinical Trials Unit at UCL, London, United Kingdom.

JAMA

|December 5, 2023

まとめ

新しい CONSORT 拡張により,因数学的ランダム化試験の報告が改善されました. このガイドラインは,複雑な試験設計の透明性と理解を高め,結果のよりよい批判的評価を保証します.

科学分野:

臨床試験の方法論
健康研究に関する報告基準

背景:

ランダム化試験の透明な報告は批判的な評価に不可欠です
複数の介入を同時に評価する因数学的試験は,独自の報告の必要性があります.
現行の報告慣行は,因数学的試験では最適ではない.

研究の目的:

臨床試験の報告の統合基準 (CONSORT) 2010 声明の合意に基づく拡張を,特に因数学的試験のために開発する.

主な方法:

方法論的論文のスコーピングレビューが行われました.
14カ国から104人のパネリストが参加した3ラウンドのデルフィー調査が行われました.
15人のパネリストによるハイブリッド・コンセンサス・ミーティングで報告書のチェックリストが完成しました

主要な成果:

CONSORTの拡張は,既存の16項目を修正し,CONSORT 2010のチェックリストに1つの新しい項目を追加します.
重要な推奨事項は,因数式設計の根拠を報告し,主要な比較群を特定し,相互作用効果を報告することです.

結論:

このCONSORTの拡張は,因数学的ランダム化試験の報告に不可欠な指針を提供します.
この拡張は,透明性を向上させ,これらの複雑な試験設計のよりよい理解を促進することを目的としています.

さらに関連する動画

00:04

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

10.7K

06:55

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

14.5K

関連する概念動画

01:16

Clinical Trials

6.7K

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

6.7K

01:13

Randomized Experiments

7.0K

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...

7.0K

02:01

Factorial Design

13.0K

Factorial Analysis is an experimental design that applies Analysis of Variance (ANOVA) statistical procedures to examine a change in a dependent variable due to more than one independent variable, also known as factors. Changes in worker productivity can be reasoned, for example, to be influenced by salary and other conditions, such as skill level. One way to test this hypothesis is by categorizing salary into three levels (low, moderate, and high) and skills sets into two levels (entry level...

13.0K

01:12

Hazard Ratio

130

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...

130

01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

130

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

130

01:11

Blinding

2.5K

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.