General Features Of Itcwm Interventional Rcts For Ap
The number of ITCWM interventional RCTs for AP during 2017–2020 was increasing, despite a decrease arisen in 2021 (e.g., COVID-19 epidemic influence) [35]. Clear reporting of diagnosis is the key for ITCWM-related studies [36]. Although 89.14% studies diagnosed AP according to both TCM and WM criteria, however, some trials represented inadequate reporting, such as did not specify the types of AP, or TCM diagnosis reference. Through the calculation of TCM patterns included in the articles, three critical pattern elements of “Qi deficiency”, “Intertwined phlegm”, and “Blood stasis” were identified as major pathogenesis of cardiovascular disease, which is consistent with the mechanism recognition of WM [37]. Among TCM various interventions, Chinese herbal formula was the most common therapy (84.48%), but 14.41% studies did not include TCM related outcome for efficacy assessment. The inconsistent adoption of TCM pattern, Chinese herbal formula intervention, and TCM outcome assessments would induce potential problems in terms of appropriate evaluation for ITCWM designed studies [38].
Quality Assessment Of The Consort
Regarding the reporting compliance of the CONSORT items, the average reporting rate was 42.64% (ranging from 0 to 100%). 20 items were reported poorly (< 50%), most of which (55%, 11/20) related to methodological domains, such as trial design (item 3a and 3b), primary and secondary outcome measures (item 6a and 6b), sample size (items 7a and 7b), sequence generation (items 8b), allocation concealment mechanism (item 9), randomization implementation (item 10), blinding (item 11a), and statistical methods (item 12a). Previous studies have indicated that the methodology-related items are crucial for the assessment of bias risk and the reliability of reported effects [39, 40, 41]. Other items, including title (item 1a), losses and exclusions after randomization (item 13b), dates of recruitment and follow-up (item 14a), outcome (item 17a and 17b), generalizability (item 21), registration (item 23), protocol (item 24), and funding (item 25) were also reported poorly. Skepticism and criticism invited by inadequate reporting of trial registration, protocol, and ethical approval significantly damage the values of RCTs for AP [42]. In addition, a considerable number of the CONSORT for Abstract items were missing or incompletely reported; the average reporting rate was only 30.86%, with a range of 0 to 100%. 13 items (1, 3, 4, 5, 7, 8, 9, 11, 12, 13, 14, 16 and 17) were reported poorly, covering several sections of “Title”, “Trial design”, “Methods”, “Results” and “Other information”. In a manuscript, the “Abstract” is designed to highlight key points of the research, which provides crucial details to facilitate readers’ understanding and decide whether it is relevant to their interests [43]. This review found that the reporting of Abstracts should be urgently improved. Generally, the international journals have a better endorsement of the CONSORT than those in Chinese journals. In this review, we also found that the reporting score of the CONSORT in English papers was higher than that in Chinese papers (p<0.05), which is similar to previous studies [44]. However, there was no significant difference regarding the CONSORT for Abstract (p>0.05). Thus, more attention should be paid to the reporting of Abstracts of ITCWM interventional RCTs for AP.
Quality Assessment Of Itcwm-specific Items
For ITCWM items, the average reporting rate was 49.24%, with a range of 2–100%. The least reported information about ITCWM details can be summarized in the following aspects: identification of ITCWM in title and keywords, the rationale of the ITCWM was being used, trial design of ITCWM, and the description of ITCWM interventions. It is important for subsequent research in this field that readers can clearly distinguish different research areas from thousands of literatures and recognize the significance of the use of ITCWM therapy. The first identifier, with no doubt, includes the title and keywords. Further, the details of the implementations with related factors for quality control are essential for the replication of trials [45, 46, 47]. Unfortunately, in this study, we still found unsatisfactory reporting for ITCWM interventions although relevant reporting guidelines were issued, either the CONSORT 2010 or its Extensions (e.g., CONSORT Extension for Chinese Herbal Medicine Formulas 2017) [38]. In the comparison of different subgroups, we found that the reporting quality in Chinese Dissertations was better than those in journal publications regarding the ITCWM specifics (p < 0.05). This could be attributed to the page and words limitations for Chinese journal publications. Additionally, as the Dissertation is the basis for scholars to obtain their degree, higher requirements of quality were included [48]. Thus, more attention should be paid on Dissertations in the field of ITCWM interventional RCTs for AP.
Improvement Measures And Suggestions
According to the deficiencies of reporting identified in this study, specific improvements are needed. Previous findings confirm that guidelines do help improve the quality of reporting. Therefore, editors and reviewers should be more rigorous in their requirements that authors should adhere to the reporting standards of the CONSORT (especially for the CONSORT for Abstract) in RCTs. There are two paths forward: strengthen reporting of the CONSORT and develop a series of standard reporting items relevant to RCTs with ITCWM interventions [49].
Limitations
This study has some limitations. First, we only identified RCTs of AP with ITCWM published from 1st January 2017 to 6th August 2022 in English and Chinese, so we have not assessed other trials published before 2017 or in other languages. Second, methodology quality (e.g., using a Cochrane tool) assessment was not conducted because this review focused on the reporting quality. Although the results of this review may not necessarily be comprehensive, we do believe that the general trends indicated by this study are valid.