Based on the CONSORT 2025 guidelines, the areas that were generally underreported can be discussed as follows. First, there was insufficient reporting on Open Science, including trial registration, the protocol, and statistical analysis plan, and data sharing. These elements were newly added in the 2025 revision of CONSORT to reflect the global trend toward open science, emphasizing openness and accountability in research through registration, data and code sharing, and conflict of interest reporting [6]. When examining five-year reporting trends, no studies published between 2011 and 2020 reported items related to Open Science, whereas 75% of those published between 2021 and 2024 did. Considering that the revision was made in 2025, it is evident that reporting on these elements had begun to emerge gradually even before the formal update, reflecting the evolving trend of the times.

Regarding the public disclosure of protocols and statistical analysis plans, discrepancies were identified between the registered protocol and the full report, particularly concerning primary outcome variables and sample sizes [17]. This finding suggests that making statistical analysis plans (SAP) publicly available could play a crucial role in preventing discrepancies between research design and reporting. The insufficient reporting of data sharing is consistent with previous studies [18], which have shown that although many journals require a data sharing statement in their submission guidelines, published articles still often lack this information. Data sharing not only promotes transparency but also enhances the reproducibility of research findings, enables secondary analyses and meta-analyses, and contributes to public health and scientific progress. Therefore, it is essential to ensure that data sharing involves not only a formal declaration but also actual execution and reporting [18].

To ensure transparency and validity in research, it is particularly important to emphasize the role of trial registration, the public disclosure of protocols and statistical analysis plans, and data sharing. Recent studies have shown that when these elements are insufficient, they can lead to bias in outcome reporting and potentially distort the estimates for adverse events (harms) or primary outcomes [19]. CONSORT 2025 emphasizes registration, protocols, SAP, and data sharing as separate sections. In the case of JKBNS, the CRIS system is primarily used, and all three relevant articles were documented in the main text rather than in the abstracts. Specifically, these items were reported in the Ethical Considerations section of the main text [20].

This study highlights the need for researchers to place greater emphasis on reporting within the open science framework. By faithfully applying these standards, including the transparent reporting of registered protocols, analysis plans, and data availability, future research will be able to enhance both the credibility and impact of its findings.

On the other hand, there was insufficient reporting in the Methods section regarding changes to the trial protocol, harm definition and assessment, and interim analyses and stopping guidelines. First, reporting changes to the trial protocol was insufficient, limiting transparency into procedural modifications or alterations to analysis plans that occurred during the study. Second, reporting related to harm definition and assessment was inadequate, making it difficult to systematically evaluate adverse events or unintended effects resulting from interventions, thereby posing challenges for readers attempting to replicate or interpret the findings. In accordance with CONSORT Harms and the 2025 CONSORT update, nursing intervention studies should explicitly define, systematically monitor, and report adverse events. Although nursing interventions are generally considered low-risk, specific outcomes—such as increased patient fatigue, procedural discomfort, transient anxiety, or minor physiological changes—should be prospectively identified and documented using standardized criteria. Transparent reporting of such events not only strengthens methodological rigor but also ensures ethical accountability and reproducibility in nursing research. Lastly, interim analyses and stopping guidelines were not reported, which meant there was no clear evidence provided regarding safety reviews through interim analyses or the possibility of early trial termination. Such limitations in reporting may weaken the credibility and reproducibility of research [21]. Therefore, future studies should provide detailed descriptions of these elements in accordance with the CONSORT 2025 guidelines.

Reporting related to randomization and blinding was found to be insufficient. Specifically, while descriptions of sequence generation in the randomization process were provided, reporting on allocation concealment —known to significantly affect a study's internal validity— was lacking. This may be due to the nature of nursing research, in which researchers often act as facilitators, making it challenging to maintain allocation concealment. Similarly, given the nature of nursing interventions, it may have been challenging to implement blinding effectively. In this study, the reporting of both the randomization procedure and the blinding methods was insufficiently detailed. Without a clear explanation of the randomization process and allocation concealment, it is difficult to completely rule out selection bias. Likewise, inadequate reporting on whether participants, researchers, and outcome assessors were blinded — as well as the level of blinding (single-blind, double-blind, assessor-blind, etc.) — can reduce the objectivity of outcome measurement and introduce performance and detection bias when interpreting the results. The findings of this study revealed that the reporting rates for “Who was blinded” and “How blinding was achieved” were generally low. In this review, blinding was explicitly reported only in studies in which both participants and data collectors were blinded [22] and in which only participants were blinded [23,24]. This low rate of reporting is likely attributable to the fact that most nursing interventions are non-pharmacological, making it inherently difficult to implement blinding procedures. The CONSORT 2025 guidelines emphasize the need to provide detailed descriptions of randomization and blinding procedures [6]. Previous studies have repeatedly pointed out that a lack of such information undermines the credibility and reproducibility of clinical trial findings [16,25]. Therefore, in situations where blinding is challenging due to the nature of nursing interventions, strategies to minimize bias—such as separating participants from outcome assessors—should be implemented. Future research should also systematically report on the specific methods used for randomization and blinding to ensure transparency and rigor. Moreover, nursing research often operates with limited funding resources and is typically conducted on a small scale. As a result, researchers themselves often perform multiple roles—including randomization, intervention delivery, and data collection—rather than assigning these tasks to separate personnel. Such structural constraints may further hinder the feasibility of implementing blinding procedures. Therefore, future nursing studies should explore practical strategies to strengthen blinding procedures during the design phase and advocate for institutional and policy-level efforts to expand funding support. Increased funding for nursing research is essential to enhance the methodological rigor and credibility of intervention studies in this field.

In the Statistical Methods section, insufficient reporting was provided on missing data handling, additional analyses, and participant flow. Similarly, in the Reason for Trial Ending section, reporting was limited to the reasons for trial ending, harms, and ancillary analyses. Only one study [26] reported an incident related to harm, such as a needlestick injury. Apart from this, no other studies provided information regarding harm. This may be due to the nature of the interventions included in nursing research, which are generally non-invasive, educational, or non-pharmacological. Consequently, the absence of reported harm likely reflects the lack of adverse events rather than a failure to report them. However, it is essential to note that any adverse event arising from an intervention should be explicitly reported in accordance with the CONSORT Harms extension.

Specifically, there was a lack of detailed descriptions of missing-data handling, making it difficult for readers to clearly understand the potential bias introduced by the method used to address missing data. Reporting on additional analyses (e.g., subgroup analyses, sensitivity analyses) was also limited. Furthermore, the reporting of participant flow was insufficient, making it difficult to transparently identify participant enrollment, dropouts, and inclusion in the final analysis. In addition, there were notable limitations in the Reason for Trial Ending section. Without a clear explanation of why the trial was terminated, it becomes difficult to assess the study's legitimacy and validity fully. The incomplete reporting of harms reduces the reliability of evaluating adverse events and safety outcomes. Moreover, the lack of reporting on ancillary analyses limits the potential for additional interpretation of the study’s findings. Given the increasing emphasis on transparency, safety, and reproducibility in research [27], improvements in the reporting of statistical methods are needed to strengthen the overall quality and credibility of studies.

In this study, the number of published RCTs was relatively low in 2016, 2020, 2022, and 2023. This finding is consistent with previous reviews conducted across multiple countries that reported substantial enrollment delays, operational gaps, and difficulties in participant recruitment during this period [28]. The overall social context of the coronavirus disease 2019 pandemic, characterized by restrictions on face-to-face interactions and disruptions in healthcare operations, likely contributed to these challenges. Given that experimental studies require rigorous control of interventions and study conditions, it is reasonable to infer that conducting RCTs during this time was particularly constrained by pandemic-related limitations.

Reflecting differences in reporting feasibility across study designs, this study found that crossover trials tended to yield lower compliance scores when assessed against RCT reporting guidelines. This pattern may reflect the inherent methodological challenges of crossover designs, in which complete blinding of participants and data collectors is often unfeasible. Moreover, essential methodological details—such as blinding procedures or allocation concealment—were frequently underreported or ambiguously stated, possibly because they were regarded as self-evident within the study design. Although specific items may have been deemed “non-applicable,” we adhered strictly to the CONSORT-based evaluation criteria and assigned a score of 0 when reporting was insufficient. Therefore, lower compliance scores in crossover trials should be interpreted with consideration of the study design’s inherent limitations, underscoring the need for transparent, detailed reporting in future research to enhance methodological rigor and interpretability.

In this study, we compared (mapped) the items of the CONSORT 2025 reporting guideline with those of three major quality assessment tools: RoB 2, SIGN, and JBI Critical Appraisal Criteria. The characteristics of each tool are as follows: RoB 2 is a risk of bias assessment tool for RCTs developed by Cochrane. It evaluates the systematic risk of bias in five key domains: randomization process, implementation of interventions, measurement of outcomes, and selective reporting [7]. It categorizes each domain as “Low risk,” “Some concerns,” or “High risk,” providing an overall judgment of study reliability. The SIGN checklist is applicable to a variety of study designs, including RCTs, cohort studies, and case-control studies [8]. It evaluates factors such as the clarity of the research question, randomization and blinding, handling of missing data, and appropriateness of analysis. The quality of studies is graded as ++ (High quality), + (Acceptable), or - (Low quality). The JBI Critical Appraisal Tools, developed by the JBI in Australia, provide tailored checklists for nearly all study designs, including RCTs, cohort studies, single-case studies, and qualitative research [9]. Each item is evaluated as Yes, No, Unclear, or Not Applicable. A key strength of the JBI tools is their ability to assess the quality of evidence across a wide range of healthcare research, including qualitative and mixed methods studies.

In this study, a comparison was made between the CONSORT 2025 reporting guideline and the key items of major quality assessment tools (RoB 2, SIGN, and JBI Critical Appraisal Criteria). The results showed that these quality assessment tools primarily focus on evaluating the internal validity and reliability of studies, particularly by examining factors that may threaten validity. In this respect, their purpose aligns with that of CONSORT. In the Methods domain, most items matched closely between CONSORT and the quality assessment tools, while in the Results domain, partial alignment was also observed.

However, certain technical aspects, such as risk of bias, emphasized in RoB 2 and JBI [7,29], were less well addressed in CONSORT, which overall tended to focus more on methodological reporting. These findings indicate that while CONSORT plays an essential role as a guideline for enhancing the transparency of clinical trial reporting, its focus differs from that of tools designed to evaluate research quality. Therefore, for a comprehensive interpretation of clinical trial reporting and evaluation, it is necessary to use CONSORT alongside quality assessment tools such as RoB 2, SIGN, and JBI.

This integrated approach is meaningful in that it goes beyond simply assessing RCT bias. A multilayered evaluation of study quality based on research design provides a stronger foundation for systematically interpreting the credibility and applicability of research findings.

This study evaluated the completeness of reporting of RCTs published in the JKBNS between 2011 and 2024, using the CONSORT 2025 guidelines. The results showed that most RCTs adopted a standard parallel-group design, and a significant portion of the intervention studies focused on non-pharmacological interventions, particularly aromatherapy. While some CONSORT checklist items were consistently reported, essential methodological elements — such as protocol modifications, interim analyses, and handling of missing data — were notably underreported. In addition, 14 CONSORT items were found to conceptually align with the methodological quality domains of RoB 2.0, SIGN, and JBI critical appraisal tools.

These findings suggest that the overall reporting quality of RCTs published in JKBNS is moderate. Moving forward, nursing researchers should more comprehensively and systematically adhere to standardized reporting guidelines, such as the CONSORT checklist, when designing and reporting RCTs. By doing so, it will be possible to enhance the transparency and credibility of research and strengthen its applicability in clinical practice.