Melissa M J Chua, Aaron E L Warren, G Rees Cosgrove, John D Rolston
{"title":"脑深部和反应性神经刺激临床试验的发表率和特点。","authors":"Melissa M J Chua, Aaron E L Warren, G Rees Cosgrove, John D Rolston","doi":"10.1159/000531161","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of intracranial neurostimulation treatments, including deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication, and reasons for reporting delays, are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design. Here, we examine DBS and RNS trials from 1997 to 2022, chart their characteristics, and examine rates and predictors of results reporting.</p><p><strong>Methods: </strong>Trials were identified using <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link>. Associated publications were identified using <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link> and <ext-link ext-link-type=\"uri\" xlink:href=\"http://PubMed.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">PubMed.gov</ext-link>. Pearson's χ2 tests were used to assess differences in trial characteristics between published and unpublished trials.</p><p><strong>Results: </strong>Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson's disease (40.55%) and the subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link>, and 107/169 (63.31%) were published. ∼80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.</p><p><strong>Conclusion: </strong>We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished >1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":" ","pages":"287-300"},"PeriodicalIF":1.9000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Publication Rates and Characteristics of Clinical Trials in Deep Brain and Responsive Neurostimulation.\",\"authors\":\"Melissa M J Chua, Aaron E L Warren, G Rees Cosgrove, John D Rolston\",\"doi\":\"10.1159/000531161\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of intracranial neurostimulation treatments, including deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication, and reasons for reporting delays, are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design. Here, we examine DBS and RNS trials from 1997 to 2022, chart their characteristics, and examine rates and predictors of results reporting.</p><p><strong>Methods: </strong>Trials were identified using <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://ClinicalTrials.gov\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">ClinicalTrials.gov</ext-link>. Associated publications were identified using <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://ClinicalTrials.gov\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">ClinicalTrials.gov</ext-link> and <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://PubMed.gov\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">PubMed.gov</ext-link>. Pearson's χ2 tests were used to assess differences in trial characteristics between published and unpublished trials.</p><p><strong>Results: </strong>Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson's disease (40.55%) and the subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://ClinicalTrials.gov\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">ClinicalTrials.gov</ext-link>, and 107/169 (63.31%) were published. ∼80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.</p><p><strong>Conclusion: </strong>We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished >1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.</p>\",\"PeriodicalId\":22078,\"journal\":{\"name\":\"Stereotactic and Functional Neurosurgery\",\"volume\":\" \",\"pages\":\"287-300\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Stereotactic and Functional Neurosurgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000531161\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/8/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"NEUROIMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Stereotactic and Functional Neurosurgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000531161","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/8/8 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"NEUROIMAGING","Score":null,"Total":0}
Publication Rates and Characteristics of Clinical Trials in Deep Brain and Responsive Neurostimulation.
Introduction: Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of intracranial neurostimulation treatments, including deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication, and reasons for reporting delays, are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design. Here, we examine DBS and RNS trials from 1997 to 2022, chart their characteristics, and examine rates and predictors of results reporting.
Methods: Trials were identified using ClinicalTrials.gov. Associated publications were identified using ClinicalTrials.gov and PubMed.gov. Pearson's χ2 tests were used to assess differences in trial characteristics between published and unpublished trials.
Results: Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson's disease (40.55%) and the subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on ClinicalTrials.gov, and 107/169 (63.31%) were published. ∼80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.
Conclusion: We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished >1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.
期刊介绍：
''Stereotactic and Functional Neurosurgery'' provides a single source for the reader to keep abreast of developments in the most rapidly advancing subspecialty within neurosurgery. Technological advances in computer-assisted surgery, robotics, imaging and neurophysiology are being applied to clinical problems with ever-increasing rapidity in stereotaxis more than any other field, providing opportunities for new approaches to surgical and radiotherapeutic management of diseases of the brain, spinal cord, and spine. Issues feature advances in the use of deep-brain stimulation, imaging-guided techniques in stereotactic biopsy and craniotomy, stereotactic radiosurgery, and stereotactically implanted and guided radiotherapeutics and biologicals in the treatment of functional and movement disorders, brain tumors, and other diseases of the brain. Background information from basic science laboratories related to such clinical advances provides the reader with an overall perspective of this field. Proceedings and abstracts from many of the key international meetings furnish an overview of this specialty available nowhere else. ''Stereotactic and Functional Neurosurgery'' meets the information needs of both investigators and clinicians in this rapidly advancing field.
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