Hongrui Chen, Qinqi Yu, Zening Huang, Bin Sun, Chen Hua, Xiaoxi Lin
{"title":"透明质酸相关随机对照试验中的试验废弃物。","authors":"Hongrui Chen, Qinqi Yu, Zening Huang, Bin Sun, Chen Hua, Xiaoxi Lin","doi":"10.1111/joor.13889","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A notable obstacle in applying the findings of hyaluronic acid (HA)-related randomised controlled trials (RCTs) to real-world patient treatment is trial waste (TW). To date, the extent of TW in RCTs for HA is not clear.</p><p><strong>Objectives: </strong>To analyse the extents of TW within HA-RCTs and identify protective factors against TW.</p><p><strong>Methods: </strong>In July 2024, we searched the ClinicalTrials database using the 'hyaluronic acid' as keyword. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analysed based on bias risk and whether the article referenced a relevant systematic review. Subsequently, we evaluated extent of TW (unpublished studies, insufficient reporting and design flaws).</p><p><strong>Results: </strong>One hundred and eighty-four RCTs met the inclusion criteria. The analysis of TW excluded 53 RCTs completed after June 2020 that remained unpublished. Among the remaining 131 RCTs, 72 were published, 47 had adequate reporting and 19 had design limitations. Taken together, 96 RCTs (73.3%) exhibited at least one characteristic of TW. Characteristics of these RCTs included early registration (p < 0.001) and the absence of a multi-blind approach (p = 0.007). Registration prior to 2014 (p < 0.001) and the open-label or single-blinding design (p = 0.003) emerged as independent risk factor for TW.</p><p><strong>Conclusion: </strong>We delineated the features of 184 HA-related RCTs. 73.3% of the RCTs included in TW analysis exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future HA-RCTs more rationally and efficiently.</p>","PeriodicalId":16605,"journal":{"name":"Journal of oral rehabilitation","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Trial Waste in Hyaluronic Acid-Related Randomised Controlled Trials.\",\"authors\":\"Hongrui Chen, Qinqi Yu, Zening Huang, Bin Sun, Chen Hua, Xiaoxi Lin\",\"doi\":\"10.1111/joor.13889\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A notable obstacle in applying the findings of hyaluronic acid (HA)-related randomised controlled trials (RCTs) to real-world patient treatment is trial waste (TW). To date, the extent of TW in RCTs for HA is not clear.</p><p><strong>Objectives: </strong>To analyse the extents of TW within HA-RCTs and identify protective factors against TW.</p><p><strong>Methods: </strong>In July 2024, we searched the ClinicalTrials database using the 'hyaluronic acid' as keyword. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analysed based on bias risk and whether the article referenced a relevant systematic review. Subsequently, we evaluated extent of TW (unpublished studies, insufficient reporting and design flaws).</p><p><strong>Results: </strong>One hundred and eighty-four RCTs met the inclusion criteria. The analysis of TW excluded 53 RCTs completed after June 2020 that remained unpublished. Among the remaining 131 RCTs, 72 were published, 47 had adequate reporting and 19 had design limitations. Taken together, 96 RCTs (73.3%) exhibited at least one characteristic of TW. Characteristics of these RCTs included early registration (p < 0.001) and the absence of a multi-blind approach (p = 0.007). Registration prior to 2014 (p < 0.001) and the open-label or single-blinding design (p = 0.003) emerged as independent risk factor for TW.</p><p><strong>Conclusion: </strong>We delineated the features of 184 HA-related RCTs. 73.3% of the RCTs included in TW analysis exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future HA-RCTs more rationally and efficiently.</p>\",\"PeriodicalId\":16605,\"journal\":{\"name\":\"Journal of oral rehabilitation\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of oral rehabilitation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/joor.13889\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of oral rehabilitation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/joor.13889","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
Trial Waste in Hyaluronic Acid-Related Randomised Controlled Trials.
Background: A notable obstacle in applying the findings of hyaluronic acid (HA)-related randomised controlled trials (RCTs) to real-world patient treatment is trial waste (TW). To date, the extent of TW in RCTs for HA is not clear.
Objectives: To analyse the extents of TW within HA-RCTs and identify protective factors against TW.
Methods: In July 2024, we searched the ClinicalTrials database using the 'hyaluronic acid' as keyword. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analysed based on bias risk and whether the article referenced a relevant systematic review. Subsequently, we evaluated extent of TW (unpublished studies, insufficient reporting and design flaws).
Results: One hundred and eighty-four RCTs met the inclusion criteria. The analysis of TW excluded 53 RCTs completed after June 2020 that remained unpublished. Among the remaining 131 RCTs, 72 were published, 47 had adequate reporting and 19 had design limitations. Taken together, 96 RCTs (73.3%) exhibited at least one characteristic of TW. Characteristics of these RCTs included early registration (p < 0.001) and the absence of a multi-blind approach (p = 0.007). Registration prior to 2014 (p < 0.001) and the open-label or single-blinding design (p = 0.003) emerged as independent risk factor for TW.
Conclusion: We delineated the features of 184 HA-related RCTs. 73.3% of the RCTs included in TW analysis exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future HA-RCTs more rationally and efficiently.
期刊介绍：
Journal of Oral Rehabilitation aims to be the most prestigious journal of dental research within all aspects of oral rehabilitation and applied oral physiology. It covers all diagnostic and clinical management aspects necessary to re-establish a subjective and objective harmonious oral function.
Oral rehabilitation may become necessary as a result of developmental or acquired disturbances in the orofacial region, orofacial traumas, or a variety of dental and oral diseases (primarily dental caries and periodontal diseases) and orofacial pain conditions. As such, oral rehabilitation in the twenty-first century is a matter of skilful diagnosis and minimal, appropriate intervention, the nature of which is intimately linked to a profound knowledge of oral physiology, oral biology, and dental and oral pathology.
The scientific content of the journal therefore strives to reflect the best of evidence-based clinical dentistry. Modern clinical management should be based on solid scientific evidence gathered about diagnostic procedures and the properties and efficacy of the chosen intervention (e.g. material science, biological, toxicological, pharmacological or psychological aspects). The content of the journal also reflects documentation of the possible side-effects of rehabilitation, and includes prognostic perspectives of the treatment modalities chosen.
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