Evidence map›Paper›PMID 41437288›Full record

ArticleSystematic reviews2025

Assessing reporting completeness and characteristics in decentralized randomized controlled trials: a scoping review protocol.

Juntao Wang, Shuhui Li, Chen Zhao, Juan Wang, Weifeng Xiong, Lihan Hu, Xuan Zhang

Abstract read
In one paragraph

Article in Systematic reviews, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Juntao WangSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Shuhui LiSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Chen ZhaoInstitute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences, Beijing, China.
Juan WangSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Weifeng XiongChongqing University of Chinese Medicine, Chongqing, China.
Lihan HuSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Xuan ZhangSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. zhangxuan@hkbu.edu.hk.ORCID 0000-0002-9230-9210

Funding

Chinese Medicine Development Fund, Hong Kong 23B2-027A_R1
6 · The paper itself

Abstract

backgroundWith the development of remote technology, decentralized clinical trials have rapidly increased in recent years. Despite the comprehensive reporting guidance provided by the CONSORT 2025 guideline, decentralized randomized controlled trials still face specific reporting challenges. Therefore, we aim to evaluate the reporting characteristics and completeness of decentralized randomized controlled trials, using a specially designed checklist that has been extended according to the CONSORT 2025 original items.

methodsWe will search six databases (Embase, Ovid MEDLINE®, PubMed, CNKI, VIP, Wanfang) for decentralized randomized controlled trials published in Chinese or English during 2023. A pre-designed form will be used to extract general characteristics. Reporting completeness will be assessed using a custom 26-item "CONSORT-DRCT" checklist. This checklist includes 17 items focused on design, implementation, quality control, and key technologies related to decentralized elements, while 9 items pertain specifically to intervention details (5 for pharmacological interventions and 4 for non-pharmacological interventions). To ensure consistency, a standard operating procedure for scoring reporting completeness will be developed. Each item will be evaluated independently by two reviewers, and inter-rater agreement will be calculated to assess consistency between reviewers. Data will undergo descriptive analysis, with subgroup analyses performed where applicable to explore factors influencing reporting completeness. DISCUSSION: This protocol outlines a methodological framework for conducting the review, which aims to identify the current reporting characteristics and completeness of decentralized randomized controlled trials. The results may offer valuable insights into the development of a CONSORT extension guideline for decentralized randomized controlled trials. SYSTEMATIC REVIEW REGISTRATION: This study has been registered with the Open Science Framework ( https://osf.io/c9pdx/ ).

Indexed as

Randomized Controlled Trials as TopicResearch DesignChecklistHumansQuality ControlScoping Reviews as TopicCONSORT 2025Decentralized clinical trialDecentralized randomized controlled trialReporting completeness

Identifiers

PMID41437288
PMCPMC12836950

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.