Karim Saab, Umang Gada, Eva Culakova, Brian Burnette, Carla Jorgensen, Dhaval Shah, Gary Morrow, Karen Mustian, Michael B Sohn, Robert R Edwards, Roy Freeman, Dale J Langford, Michael P McDermott, Jennifer S Gewandter
{"title":"神经性疼痛的个性化疗效：一项随机对照试验的临床相关性和检测敏感性分析。","authors":"Karim Saab, Umang Gada, Eva Culakova, Brian Burnette, Carla Jorgensen, Dhaval Shah, Gary Morrow, Karen Mustian, Michael B Sohn, Robert R Edwards, Roy Freeman, Dale J Langford, Michael P McDermott, Jennifer S Gewandter","doi":"10.1093/pm/pnae095","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To explore the clinical relevance and assay sensitivity of using personalized outcomes using data from a randomized clinical trial (RCT) in people with chemotherapy induced peripheral neuropathy (CIPN).</p><p><strong>Design: </strong>This study is a secondary analysis that leveraged data from a RCT of transcutaneous electrical stimulation for CIPN to test whether personalized outcomes could minimize potential floor effects and increase the assay sensitivity of pain clinical trials (ie, ability to detect a true treatment effect).</p><p><strong>Setting: </strong>Participants were recruited for a RCT from community oncology clinics in the U.S.</p><p><strong>Participants: </strong>Adults with CIPN (N = 72) who reported on average ≥4 intensity (measured via a 7-day baseline diary) for at least one of the following pain qualities hot/burning pain, sharp/shooting pain and/or cramping.</p><p><strong>Methods: </strong>Personalized outcomes were defined based on participants' unique presentation of pain qualities at baseline, measured via 0-10 numeric rating scales (NRS), or ranking of the distress caused by the pain qualities. Analysis of covariance models estimated the treatment effect as measured by personalized and non-personalized outcomes.</p><p><strong>Results: </strong>The adjusted mean difference between groups was higher using personalized outcomes (ie, 1.21-1.25 NRS points) compared to a non-personalized outcome (ie, 0.97 NRS points), although the standardized effect sizes were similar between outcomes (0.49-0.54).</p><p><strong>Conclusions: </strong>These results suggest that personalized pain quality outcomes could minimize floor effects, while providing similar assay sensitivity to non-personalized pain quality outcomes. Personalized outcomes better reflect an individual's unique experience, inherently providing more clinically relevant estimates of treatment effects. Personalized outcomes may be advantageous particularly for clinical trials in populations with high inter-individual variability in pain qualities.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":null,"pages":null},"PeriodicalIF":2.9000,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Personalized Outcomes in Neuropathic Pain: A Clinical Relevance and Assay Sensitivity Analysis from a Randomized Controlled Trial.\",\"authors\":\"Karim Saab, Umang Gada, Eva Culakova, Brian Burnette, Carla Jorgensen, Dhaval Shah, Gary Morrow, Karen Mustian, Michael B Sohn, Robert R Edwards, Roy Freeman, Dale J Langford, Michael P McDermott, Jennifer S Gewandter\",\"doi\":\"10.1093/pm/pnae095\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To explore the clinical relevance and assay sensitivity of using personalized outcomes using data from a randomized clinical trial (RCT) in people with chemotherapy induced peripheral neuropathy (CIPN).</p><p><strong>Design: </strong>This study is a secondary analysis that leveraged data from a RCT of transcutaneous electrical stimulation for CIPN to test whether personalized outcomes could minimize potential floor effects and increase the assay sensitivity of pain clinical trials (ie, ability to detect a true treatment effect).</p><p><strong>Setting: </strong>Participants were recruited for a RCT from community oncology clinics in the U.S.</p><p><strong>Participants: </strong>Adults with CIPN (N = 72) who reported on average ≥4 intensity (measured via a 7-day baseline diary) for at least one of the following pain qualities hot/burning pain, sharp/shooting pain and/or cramping.</p><p><strong>Methods: </strong>Personalized outcomes were defined based on participants' unique presentation of pain qualities at baseline, measured via 0-10 numeric rating scales (NRS), or ranking of the distress caused by the pain qualities. Analysis of covariance models estimated the treatment effect as measured by personalized and non-personalized outcomes.</p><p><strong>Results: </strong>The adjusted mean difference between groups was higher using personalized outcomes (ie, 1.21-1.25 NRS points) compared to a non-personalized outcome (ie, 0.97 NRS points), although the standardized effect sizes were similar between outcomes (0.49-0.54).</p><p><strong>Conclusions: </strong>These results suggest that personalized pain quality outcomes could minimize floor effects, while providing similar assay sensitivity to non-personalized pain quality outcomes. Personalized outcomes better reflect an individual's unique experience, inherently providing more clinically relevant estimates of treatment effects. Personalized outcomes may be advantageous particularly for clinical trials in populations with high inter-individual variability in pain qualities.</p>\",\"PeriodicalId\":19744,\"journal\":{\"name\":\"Pain Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-10-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/pm/pnae095\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/pm/pnae095","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
Personalized Outcomes in Neuropathic Pain: A Clinical Relevance and Assay Sensitivity Analysis from a Randomized Controlled Trial.
Objective: To explore the clinical relevance and assay sensitivity of using personalized outcomes using data from a randomized clinical trial (RCT) in people with chemotherapy induced peripheral neuropathy (CIPN).
Design: This study is a secondary analysis that leveraged data from a RCT of transcutaneous electrical stimulation for CIPN to test whether personalized outcomes could minimize potential floor effects and increase the assay sensitivity of pain clinical trials (ie, ability to detect a true treatment effect).
Setting: Participants were recruited for a RCT from community oncology clinics in the U.S.
Participants: Adults with CIPN (N = 72) who reported on average ≥4 intensity (measured via a 7-day baseline diary) for at least one of the following pain qualities hot/burning pain, sharp/shooting pain and/or cramping.
Methods: Personalized outcomes were defined based on participants' unique presentation of pain qualities at baseline, measured via 0-10 numeric rating scales (NRS), or ranking of the distress caused by the pain qualities. Analysis of covariance models estimated the treatment effect as measured by personalized and non-personalized outcomes.
Results: The adjusted mean difference between groups was higher using personalized outcomes (ie, 1.21-1.25 NRS points) compared to a non-personalized outcome (ie, 0.97 NRS points), although the standardized effect sizes were similar between outcomes (0.49-0.54).
Conclusions: These results suggest that personalized pain quality outcomes could minimize floor effects, while providing similar assay sensitivity to non-personalized pain quality outcomes. Personalized outcomes better reflect an individual's unique experience, inherently providing more clinically relevant estimates of treatment effects. Personalized outcomes may be advantageous particularly for clinical trials in populations with high inter-individual variability in pain qualities.
期刊介绍：
Pain Medicine is a multi-disciplinary journal dedicated to pain clinicians, educators and researchers with an interest in pain from various medical specialties such as pain medicine, anaesthesiology, family practice, internal medicine, neurology, neurological surgery, orthopaedic spine surgery, psychiatry, and rehabilitation medicine as well as related health disciplines such as psychology, neuroscience, nursing, nurse practitioner, physical therapy, and integrative health.
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