Jackie L. Whittaker , Raneem Kalsoum , James Bilzon , Philip G. Conaghan , Kay Crossley , George R. Dodge , Alan Getgood , Xiaojuan Li , Elena Losina , Deborah J. Mason , Brian Pietrosimone , May Arna Risberg , Frank Roemer , David Felson , Adam G. Culvenor , Duncan Meuffels , Nicole Gerwin , Lee S. Simon , L. Stefan Lohmander , Martin Englund , Fiona E. Watt
{"title":"设计人类干预研究，预防膝关节损伤后的骨关节炎：跨学科 OARSI 2023 研讨会报告","authors":"Jackie L. Whittaker , Raneem Kalsoum , James Bilzon , Philip G. Conaghan , Kay Crossley , George R. Dodge , Alan Getgood , Xiaojuan Li , Elena Losina , Deborah J. Mason , Brian Pietrosimone , May Arna Risberg , Frank Roemer , David Felson , Adam G. Culvenor , Duncan Meuffels , Nicole Gerwin , Lee S. Simon , L. Stefan Lohmander , Martin Englund , Fiona E. Watt","doi":"10.1016/j.ocarto.2024.100449","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies.</p></div><div><h3>Design</h3><p>An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward.</p></div><div><h3>Results</h3><p>Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population.</p></div><div><h3>Conclusions</h3><p>Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.</p></div>","PeriodicalId":74377,"journal":{"name":"Osteoarthritis and cartilage open","volume":"6 2","pages":"Article 100449"},"PeriodicalIF":0.0000,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2665913124000165/pdfft?md5=6f50c58e056dcf0e2bddb41e974a816e&pid=1-s2.0-S2665913124000165-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Toward designing human intervention studies to prevent osteoarthritis after knee injury: A report from an interdisciplinary OARSI 2023 workshop\",\"authors\":\"Jackie L. Whittaker , Raneem Kalsoum , James Bilzon , Philip G. Conaghan , Kay Crossley , George R. Dodge , Alan Getgood , Xiaojuan Li , Elena Losina , Deborah J. Mason , Brian Pietrosimone , May Arna Risberg , Frank Roemer , David Felson , Adam G. Culvenor , Duncan Meuffels , Nicole Gerwin , Lee S. Simon , L. Stefan Lohmander , Martin Englund , Fiona E. Watt\",\"doi\":\"10.1016/j.ocarto.2024.100449\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies.</p></div><div><h3>Design</h3><p>An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward.</p></div><div><h3>Results</h3><p>Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population.</p></div><div><h3>Conclusions</h3><p>Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.</p></div>\",\"PeriodicalId\":74377,\"journal\":{\"name\":\"Osteoarthritis and cartilage open\",\"volume\":\"6 2\",\"pages\":\"Article 100449\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2665913124000165/pdfft?md5=6f50c58e056dcf0e2bddb41e974a816e&pid=1-s2.0-S2665913124000165-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Osteoarthritis and cartilage open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2665913124000165\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Osteoarthritis and cartilage open","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2665913124000165","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Toward designing human intervention studies to prevent osteoarthritis after knee injury: A report from an interdisciplinary OARSI 2023 workshop
Objective
The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies.
Design
An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward.
Results
Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population.
Conclusions
Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.
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