Discussion
operability
SEPARATION
In the present study, there were two independent evaluations of each subject at different time points of the visit after treatment, which can be considered a sample size of 22. If we assume that Kappa=0.7 represents a better agreement, while we evaluated the blinded and non-blinded state, we found Kappa=0.248 (about 0.25). With α=0.05, proportions=0.4, 0.6, and according to the above parameters, we used PASS 22 to calculate power=0.75. The findings from our study suggest that even with a relatively small sample size, the outcomes are notably indicative of similar future investigations.The current study showed that the post-treatment IDSA/IWGDF grading results were compared in 11 subjects, and the consistency test showed inconsistent results between the non-blinded and center reading blinded evaluations (Kappa=0.248, While double-blinding is a pivotal measure to control subjective bias from investigators and subjects, it is equally crucial to establish independent blinded evaluations of investigators in scenarios where medications cannot be completely blinded. Even in double-blind trials, independent blinded evaluations are necessary to avoid investigators or patients guessing about intervention groupings by comparing study drugs or based on post-dose responses. However, a research study showed that blinded evaluations were not adequately used and reported, while open trials did not use independent evaluators more frequently than double-blind trials [One study addressed the issue of bias in determining the results of an open randomized controlled trial by administering a questionnaire to the evaluators at the end of the trial [The implementation of blinded evaluation is a significant challenge for the design and implementation of the study. In open clinical trials where wound observation is the primary indicator of efficacy, it is recommended that there be an independent blinded investigator at each trial site, and a series of standard operating procedures (SOPs) for blinded evaluation should be implemented. We have described above the basic requirements for blinded evaluations by setting up standard processes: separation of duties for investigators, subject management, collection of efficacy and safety indicators, and management of trial drugs. In some studies, when scientificity and operability permit, we propose that blinded evaluation can be conducted by taking photos and centralized evaluation by an independent evaluation committee to ensure the objectivity and consistency of the results. For some of the objective result data (e.g., essential test data, metabolomics data) for which there is a risk of blinding, we suggest that blinded management can be used, where the personnel blinded to the evaluation of efficacy and safety indicators are not exposed to these data results. Meanwhile, research team members at the back of the data chain (e.g., data management, data statistics) should also be in a blinded state to reduce bias. Research quality control personnel should follow the PDCA cycle model (e.g., planning, doing, checking, and acting) for all phases of quality management-related work. Through the above process, ensure the maintenance of blinded evaluation throughout the trial and improve the quality of open clinical trials.Although we have proposed various measures to mitigate bias in open clinical trials, further exploration and innovation are necessary to enhance the reliability of trial outcomes. For instance, introducing objective efficacy evaluation tools, like sensor-equipped insoles, can provide unbiased, quantifiable data [Despite these strengths, our study is not without limitations. The relatively small sample size may raise questions about the reliability of the results. Future research should validate our findings with larger sample sizes and further explore the best practices for maintaining blinded evaluation in clinical trials.