日本の臨床試験報告におけるCONSORT声明の適用

臨床医学界では、医療介入の評価に関する情報が不足していた。研究方法や結果の詳細が不明だったため、医療サービスの質と費用対効果を判断するのが難しかった。CONSORT (Consolidated Standards of Reporting Trials) 声明がこの問題に取り組むために登場した。

CONSORT声明は1996年に開発され、2010年に最新版が作成された。世界中の400以上の医学雑誌がこの声明を支持し、臨床試験報告の質を向上させている。日本でも、CONSORT声明の内容が整理され、他国との比較が行われている。

これにより、臨床試験の実施と結果報告の透明性と再現性が向上した。適切な医療保健介入の評価が期待されるようになった。

Key Takeaways

CONSORT声明は1996年に開発され、透明性と再現性の高い臨床試験報告を目指している
世界中の400以上の雑誌がCONSORT声明を支持し、報告の質を改善している
日本においても、CONSORT声明の内容が整理され、他国の登録内容との比較が行われている
CONSORT声明の適用により、臨床試験の結果報告の透明性と再現性が高まる
適切な医療保健介入の評価が期待される

Introduction to CONSORT Statement

The CONSORT (Consolidated Standards of Reporting Trials) Statement is a set of guidelines. It helps in reporting randomized controlled trials (RCTs) clearly and in a standard way. The main goal of the CONSORT声明目的 is to make RCT reports better. This way, readers can better understand and judge the results.

Definition and Purpose

The CONSORT声明定义 lists important details for RCT reports. These include the study design, who can take part, the treatments used, and how outcomes are measured. It also covers how big the sample should be, how participants are chosen, and the statistical methods used. By following these guidelines, researchers can make their reports more complete and clear. This helps in making medicine based on solid evidence.

History and Development

The CONSORT Statement started in 1996 and has been updated several times, with the latest being CONSORT 2010. The CONSORT声明历史和发展 has been led by the CONSORT Group. This group includes experts in methodology, clinical trials, medical journals, and statistics. They have kept the Statement current with new research and experience in RCT reporting.

The history and development of CONSORT have greatly improved how clinical trials are reported. This has helped researchers, doctors, and the public make better choices about healthcare.

Importance of CONSORT Statement

The CONSORT Statement is key for better reporting in randomized controlled trials (RCTs). It offers a checklist and flow diagram. This makes sure all important details are included for readers to understand the study well. CONSORT声明提高RCT报告质量, helping to reduce bias and make RCT reports clearer.

Improving Quality of RCT Reporting

Studies show that using the CONSORT Statement boosts RCT reporting quality. A review of over 2,000 schizophrenia trials saw a 44% quality boost. Another study found a 45% quality increase in cost-effectiveness analyses after CONSORT.

Setting Standards for Trial Design and Conduct

The CONSORT Statement mainly focuses on reporting. But it also shapes how RCTs are planned and done. CONSORT声明设置临床试验设计和实施标准, pushing researchers to be more rigorous and open. This makes trial results more reliable and helps patients.

“The CONSORT Statement has been widely adopted and has had a substantial impact on the quality of reporting of randomized trials.”

Components of CONSORT Statement

The CONSORT Statement is a detailed guide for reporting randomized controlled trials (RCTs). It has two main parts: a 25-item checklist and a flow diagram.

25-Item Checklist

The checklist covers key aspects of an RCT. This includes the title, abstract, introduction, methods, results, and discussion. It makes sure researchers share all important details about the trial.

It focuses on essential elements like the study design, who can take part, what treatments are used, and how outcomes are measured. It also looks at the statistical methods and how participants move through the trial.

Flow Diagram

The CONSORT Statement also includes a flow diagram. This diagram shows how participants move through the trial, from start to finish. It helps readers see the trial’s progress and any changes or exclusions.

Reporting Aspect	Checklist Items
Title and Abstract	Identification as a randomized trial in the title Structured summary of trial design, methods, results, and conclusions
Introduction	Scientific background and explanation of rationale Specific objectives or hypotheses
Methods	Description of trial design (such as parallel, factorial) including allocation ratio Eligibility criteria for participants Precisely defined primary and secondary outcome measures, including how and when they were assessed How sample size was determined Method used to generate the random allocation sequence Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding (masking): If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how If relevant, description of the similarity of interventions
Results	Participant flow (such as diagram, numbers randomized, withdrawn, and analyzed) Dates defining the periods of recruitment and follow-up Baseline demographic and clinical characteristics of each group Number of participants (denominator) in each group included in each analysis and whether the analysis was by original assigned groups For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended For any other analyses performed, including subgroup analyses and adjusted analyses, results for each group and a description of the direction and magnitude of the effect All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Discussion	Interpretation of the results, considering objectives, hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes Generalizability (external validity, applicability) of the trial findings The overall evidence and its relevance
Other	Registration number and name of trial registry Where the full trial protocol can be accessed, if available Sources of funding and other support (such as supply of drugs), role of funders

The CONSORT CONSORT声明25条目清单 and CONSORT声明流程图 work together. They ensure RCTs are reported fully and clearly. This helps readers understand the study’s design, conduct, and findings.

CONSORT声明

CONSORT声明在全球范围内广泛使用,包括日本。它是报告随机对照试验结果的标准。纳入CONSORT指南有助于提高研究的透明度和重复性。

随机对照试验(RCT)被认为是评估治疗效果的最佳方法。1996年,国际小组发布了临床试验报告的统一标准(CONSORT)。2010年,CONSORT声明更新为25个条目,详细说明了如何准确报告RCT。

越来越多的国际学术期刊要求作者按照CONSORT声明的标准准备稿件。包括《柳叶刀》、《英国医学杂志》、《美国医学协会杂志》和《内科学年鉴》等顶尖期刊。CONSORT声明旨在规范RCT报告标准。

CONSORT声明适用于多种临床试验,如整群随机对照试验和针灸临床试验。有了CONSORT声明,研究者更注重研究方法学质量,增加论文发表机会。

Adoption by Medical Journals

The CONSORT Statement has won big support from doctors and journals worldwide. The International Committee of Medical Journal Editors (ICMJE) backs it. Over 400 journals now support the CONSORT Statement, showing it makes RCT reports better.

Medical journals have really taken to the CONSORT Statement. They’ve set up special groups like CONSORT Harms and CONSORT Non-inferiority. These groups help with different types of trials and studies.

These groups have published important data in top journals. You can find their work in BMJ, JAMA, Lancet, PLoS Med, J Clin Epidemiol, Trials, Nat Med, Complement Ther Med, Chin Med, Am J Orthod Dentofacial Orthop, Simul Healthc, Pilot and Feasibility Stud. They share guidelines, templates, and checklists for various trials and studies.

But, not all journals follow the 医学期刊采用CONSORT声明 perfectly. There are still problems with how trials are set up and reported. Issues include unclear treatment methods, missing details on blinding, and not enough on adverse events.

“The widespread adoption of the CONSORT Statement by medical journals has been a crucial step in improving the quality and transparency of reporting for randomized controlled trials. However, continued efforts are needed to ensure full compliance and address remaining gaps in the implementation of these important guidelines.”

Impact on Trial Reporting

The CONSORT Statement has greatly improved how Randomized Controlled Trials (RCTs) are reported. Now, RCT reports are more complete and clear. This makes it easier to understand and use the study’s findings.

Before and After CONSORT

Studies show that CONSORT has made RCT reports better. Reports after CONSORT include important details like study goals, who can take part, and how the study was done. They also list the main and secondary results and how participants were assigned.

A study found big changes. Before CONSORT, 27% of reports mentioned sample size calculations. After, it was 45%. Also, 21% of reports described how the random allocation sequence was made before CONSORT. After, it was 34%.

Reporting Characteristic	Pre-CONSORT	Post-CONSORT
Sample Size Calculation	27%	45%
Random Allocation Sequence	21%	34%

These changes make RCT reports more useful. Now, readers can trust the study’s results more. This helps make better healthcare decisions.

CONSORT Extensions

The CONSORT Statement is a key tool for reporting randomized controlled trials (RCTs). However, the CONSORT Group realized the need for specific guidelines for different trial designs. They have created various CONSORT extensions to keep the guidelines up-to-date and relevant for all clinical research.

These extensions focus on specific trial types, such as:

Cluster-randomized trials
Non-inferiority and equivalence trials
Trials of non-pharmacological interventions
Pragmatic trials
Harms reporting
Patient-reported outcomes
Abstracts and Pilot/Feasibility studies

The CONSORT CONSORT声明扩展版本 extensions address the unique needs of each trial type. This ensures that the guidelines are comprehensive and adaptable to the diverse world of clinical research. Researchers, clinicians, and journal editors can use these extensions to improve the transparency and quality of trial reports in Japan and worldwide.

CONSORT Extension	Focus	Year Released
CONSORT Cluster	Cluster-randomized trials	2012
CONSORT Non-Inferiority	Non-inferiority and equivalence trials	2006
CONSORT Non-Pharmacologic	Trials of non-pharmacological interventions	2008
CONSORT Pragmatic	Pragmatic trials	2008
CONSORT Harms	Reporting of harms in randomized trials	2004
CONSORT PRO	Patient-reported outcomes	2013
CONSORT Abstract	Reporting of trial abstracts	2008
CONSORT Pilot/Feasibility	Pilot and feasibility studies	2016

By using these specialized CONSORT CONSORT声明扩展版本 extensions, researchers, clinicians, and journal editors in Japan can improve the quality of clinical trial reports. This supports the growth of evidence-based medicine.

“The CONSORT extensions provide valuable guidance to ensure that diverse types of clinical trials are reported in a clear, complete, and transparent manner. This supports the credibility and usefulness of research findings.”

Comparison with Other Registries

The CONSORT statement is a key standard for reporting on randomized controlled trials (RCTs). It’s important to see how it stacks up against other major clinical trial registries. We’ll look at the differences between the CONSORT statement and three big registries: the World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and the European Union Clinical Trials Register (EU-CTR).

WHO ICTRP

The WHO ICTRP is a central spot for clinical trial data. But, it doesn’t match the CONSORT statement in detail for reporting trial results. The WHO ICTRP has a lot of data, but more from the CONSORT statement is needed for a full report.

ClinicalTrials.gov

ClinicalTrials.gov is run by the U.S. National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). It has the most detailed registration needs among big registries. ClinicalTrials.gov’s needs closely follow the CONSORT statement, making it a top choice for detailed trial reports.

EU-CTR

The European Union Clinical Trials Register (EU-CTR) is needed for trials in EU member states. But, it only asks for a few details for trial results. Compared to the detailed CONSORT statement, the EU-CTR doesn’t cover all the bases for clear and reliable trial reports.

In short, the CONSORT statement is a solid guide for RCTs, but it doesn’t perfectly match all registries. ClinicalTrials.gov is the closest match in detail, while WHO ICTRP and EU-CTR are missing some key points for full reports.

Japan’s Clinical Trial Registries

In Japan, several key clinical trial registries are crucial for reporting and transparency in clinical research. These include UMIN-CTR, JMACCTCTR, and JapicCTI. Each plays a vital role in the field.

UMIN-CTR

The UMIN-CTR is a major clinical trial registry in Japan. It offers some details on trial results, like progress and publication status. However, it doesn’t match the detailed reporting of the CONSORT Statement.

JMACCTCTR

The JMACCTCTR is another registry used in Japan. It also reports trial results, including discussions and conclusions. Yet, it doesn’t meet the detailed CONSORT Statement’s reporting needs.

JapicCTI

The JapicCTI is Japan’s third major clinical trial registry. It collects some trial result information. But, it doesn’t offer the detailed reporting of the CONSORT Statement.

These registries are key for clinical research reporting in Japan. However, they don’t yet meet the CONSORT Statement’s standards. This highlights the need for better alignment and quality in clinical trial reporting.

Registry	Key Features	Alignment with CONSORT
UMIN-CTR	Includes trial progress and publication status	Limited – does not provide comprehensive CONSORT reporting
JMACCTCTR	Includes fields for trial results and conclusions	Limited – does not fully align with CONSORT reporting guidelines
JapicCTI	Collects some trial result information	Limited – does not provide detailed CONSORT-level reporting

Japan’s clinical trial registries are important but need improvement. Aligning their reporting with the CONSORT Statement would boost transparency and quality in clinical research.

Challenges and Limitations

The CONSORT Statement has greatly improved how we report on randomized controlled trials (RCTs). Yet, there are still hurdles to overcome. Getting everyone to follow the CONSORT guidelines consistently is a big challenge, especially in places with different reporting styles.

One major issue is that CONSORT mainly focuses on reporting. This means it doesn’t directly influence how trials are designed or conducted. The guidelines help make reports clear and complete. But they don’t cover the quality of trial methods or the research process itself.

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) initiative has resulted in a 22-item checklist for observational studies. This shows we need guidelines for more than just RCTs.
A study showed that only 49% of observational studies followed the STROBE statement. This highlights the need for more people to use these guidelines.
Also, 30% of studies didn’t report on adverse effects or harms well. This shows how important it is to report all outcomes, not just the main ones.

Despite these challenges, the CONSORT Statement is still very useful. It helps make RCT reports clearer and better. To overcome these issues, we need to keep improving and spreading the word about CONSORT. We also need to create guidelines for other study types.

Statistic	Value
Percentage of observational studies that used the STROBE statement	49%
Percentage of studies that did not adequately report on adverse effects or harms	30%
Percentage of longitudinal studies	17%
Percentage of studies that included information on exposed and unexposed groups	12%
Percentage of studies published in high-impact medical journals	7%

The CONSORT statement and initiatives like STROBE are key to better clinical research reporting. But, we must keep working to solve the ongoing challenges and limitations.

Conclusion

The CONSORT Statement is now a global standard for better reporting of randomized controlled trials. It has been widely adopted, including in Japan. This has made clinical research more transparent and reproducible.

By following the CONSORT guidelines, researchers and journals can share trial results clearly. This makes it easier to review and use the research. It helps in making better decisions in healthcare.

In Japan, the CONSORT voice declaration has boosted transparency and reproducibility in clinical trials. This standard way of reporting trial methods and results helps in a more thorough review of evidence. It leads to better patient care and advances in medicine.

The CONSORT Statement is growing and will play a bigger role in the future of clinical trial reporting. By using the CONSORT guidelines, you help improve the quality and transparency of clinical research. This benefits the scientific community and the patients they help.

FAQ

What is the CONSORT Statement?

The CONSORT Statement is a set of guidelines for reporting randomized controlled trials (RCTs). It aims to make trial reports clear and consistent. This helps readers understand and evaluate the findings better.

What is the history and development of the CONSORT Statement?

The CONSORT Statement was first introduced in 1996. It has been updated several times, with the latest version being CONSORT 2010. The CONSORT Group, made up of experts, has led these updates.

How does the CONSORT Statement improve the quality of RCT reporting?

The CONSORT Statement offers a checklist and flow diagram. These tools help ensure that trial reports include all necessary details. This makes it easier for readers to evaluate the study’s quality.

What are the key components of the CONSORT Statement?

CONSORT 2010 has a 25-item checklist. It covers the title, abstract, introduction, methods, results, and discussion. It also includes a flow diagram to show the trial’s progress.

How has the CONSORT Statement been adopted in Japan?

The CONSORT Statement is widely used globally, including in Japan. It has improved the transparency and reproducibility of healthcare research in Japan.

How have medical journals supported the CONSORT Statement?

Over 400 journals worldwide support the CONSORT Statement. This shows that using these guidelines improves RCT reporting quality. The International Committee of Medical Journal Editors (ICMJE) also backs the CONSORT guidelines.

How has the CONSORT Statement impacted the quality of trial reporting?

Studies show that CONSORT has made RCT reporting better. Reports that follow CONSORT guidelines are more complete and transparent. This makes it easier to understand and evaluate the findings.

What are the CONSORT extensions and how do they address different trial types?

The CONSORT Group has created extensions for various trial types. These include cluster-randomized trials, non-inferiority trials, and trials of non-pharmacological interventions. These extensions help CONSORT guidelines cover a wide range of research designs.

How does the CONSORT Statement compare to other clinical trial registries?

While registries like ClinicalTrials.gov collect trial information, they don’t fully match CONSORT’s guidelines. CONSORT provides more comprehensive reporting standards.

What are the challenges and limitations of the CONSORT Statement?

CONSORT has greatly improved RCT reporting, but challenges remain. Ensuring all trials follow CONSORT guidelines is a big task. CONSORT mainly focuses on reporting, which might limit its impact on trial design and conduct.