Publications by authors named "Daniel Lammertse"

Study Design: Narrative review.

Purpose: To provide an overview of adaptive trial designs, and describe how adaptive methods can address persistent challenges encountered by randomized controlled trials of people with spinal cord injury (SCI).

Results: With few exceptions, adaptive methodologies have not been incorporated into clinical trial designs of people with SCI.

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Study Design: Narrative review by individuals experienced in the recruitment of participants to neurotherapeutic clinical trials in spinal cord injury (SCI).

Objectives: To identify key problems of recruitment and explore potential approaches to overcoming them.

Methods: Published quantitative experience with recruitment of large-scale, experimental neurotherapeutic clinical studies targeting central nervous system and using primary outcome assessments validated for SCI over the last 3 decades was summarized.

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Study Design: This is a focused review article.

Objectives: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research.

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Study Design: Secondary analysis of prospectively collected observational data.

Objectives: To assess the representativeness of the Spinal Cord Injury Model Systems National Database (SCIMS-NDB) of all adults aged 18 years or older receiving inpatient rehabilitation in the United States (US) for new onset traumatic spinal cord injury (TSCI).

Setting: Inpatient rehabilitation centers in the US.

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Context/objective: To describe current and future directions in spinal cord injury (SCI) research.

Design: The SCI Model Systems (SCIMS) programs funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) during the 2011 to 2016 cycle provided abstracts describing findings from current research projects. Discussion among session participants generated ideas for research opportunities.

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Objective: To assess the patterns of sacral sparing and recovery in newly injured persons with traumatic spinal cord injury (SCI).

Design: Retrospective analysis of data from the national Spinal Cord Injury Model Systems (SCIMS) database for patients enrolled from January 2011 to February 2015.

Setting: SCIMS centers.

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Article Synopsis
  • The study focuses on improving clinical trial designs for spinal cord injury by efficiently enrolling and stratifying participants with incomplete spinal cord injury (iSCI).
  • Researchers used data from the European Multicenter Study about Spinal Cord Injury (EMSCI) and applied conditional inference trees to sort participants into more homogeneous groups based on their recovery potential.
  • The results showed that this algorithm can effectively create decision rules for trial inclusion and stratification, making it a useful tool for future clinical research in iSCI.
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Objective: To investigate the amount of variation in short- and medium-term spinal cord injury (SCI) rehabilitation outcomes explained by various comorbidity measures, over and above patient preinjury characteristics and neurologic and functional status.

Design: Prospective observational cohort study of traumatic SCI patients receiving inpatient rehabilitation and followed up at 1 year postinjury.

Setting: Inpatient rehabilitation and community follow-up at 6 SCI treatment centers.

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Effective treatment after cervical spinal cord injury (SCI) is imperative as so many activities of daily living (ADLs) are dependent on functional recovery of arm and hand actions. We focus on defining and comparing neurological and functional endpoints that might be used during acute or subacute Phase 2 clinical trials involving subjects with cervical sensorimotor complete SCI (ASIA Impairment Scale [AIS-A]). For the purposes of this review, the trial would examine the effects of a pharmaceutical small molecule, drug, biologic, or cell transplant on spinal tissue.

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Background: For therapeutics directed to the injured spinal cord, a change in neurological impairment has been proposed as a relevant acute clinical study end point. However, changes in neurological function, even if statistically significant, may not be associated with a functional impact, such as a meaningful improvement in items within the self-care subscore of the Spinal Cord Independence Measure (SCIM).

Objective: The authors examined the functional significance associated with spontaneously recovering upper-extremity motor function after sensorimotor-complete cervical spinal cord injury (SCI).

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Article Synopsis
  • This study focuses on how sensory and motor functions in the spinal cord impact classification of neurologic impairment after spinal cord injuries, emphasizing the importance of S4-S5 examination for accurate assessment.
  • The researchers aimed to see if sensory and motor outcomes from higher sacral segments (like S1, S2, and S3) could effectively predict sparing at the lower S4-S5 segments.
  • The findings showed that preserved sensation at the S1 segment could accurately predict caudal sacral sparing in 90.5% of cases, indicating potential for using higher segment assessments to infer lower segment function.
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Article Synopsis
  • Population aging is a global trend characterized by reduced fertility and increased longevity, with significant but overlooked effects on individuals with spinal cord injuries (SCI).
  • Despite rising life expectancy among the general population, individuals with SCI show a slower rate of improvement, likely due to a combination of factors including an aging SCI demographic and susceptibility to health issues.
  • This paper aims to clarify the differences in aging between the general population and those with SCI, summarize existing research on health conditions for aging individuals with SCI, and propose future research directions.
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Objective: To examine differences in perceived quality of life (QOL) at 1 year postinjury between people with tetraplegia who required mechanical ventilation assistance at discharge from rehabilitation and those who did not.

Design: Prospective cross-sectional examination of people with spinal cord injury (SCI) drawn from the SCI Model Systems National Database.

Setting: Community.

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Article Synopsis
  • The study aimed to assess how sensory sparing in people with complete spinal cord injuries affects their recovery and quality of life one year post-rehabilitation.
  • Over half of the participants completed a follow-up, focusing on various outcomes like health status, functional independence, and social participation.
  • Results indicated that those with some sensory function (AIS grade B) experienced significantly better physical health and social engagement compared to those with no sensory function (AIS grade A).
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Objective: To present upper- (UEMS) and lower-extremity motor score (LEMS) recovery, American Spinal Injury Association Impairment Scale (AIS) change, and motor level change in persons with traumatic tetraplegia from the Spinal Cord Injury Model Systems (SCIMS).

Design: Longitudinal cohort; follow-up to 1 year.

Setting: U.

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Objective: To examine the amount and type of therapy services received in inpatient and postdischarge settings during the first year after spinal cord injury (SCI).

Design: Prospective observational longitudinal cohort design. Data were obtained from systematic recording of interventions by clinicians and from patient interview.

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Article Synopsis
  • As more individuals with spinal cord injuries age, they confront several secondary health issues that hinder their independence and community involvement.
  • The article outlines health challenges by body system that those with spinal cord injuries may face as they grow older.
  • It also discusses interventions aimed at reducing aging effects and improving the perceived quality of life in this population, drawing from both research and clinical practice.
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Object: Permanent neurological loss after spinal cord injury (SCI) is a well-known phenomenon. There has also been a growing recognition and improved understanding of the pathophysiological mechanisms of late progressive neurological loss, which may occur after SCI as a result of posttraumatic spinal cord tethering (SCT), myelomalacia, and syringomyelia. A clinical study of 404 patients sustaining traumatic SCIs and undergoing surgery to arrest a progressive myelopathy caused by SCT, with or without progressive myelomalacia and cystic cavitation (syringomyelia) was undertaken.

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Background/objective: To test the hypothesis that apolipoprotein E (APOE) polymorphisms are associated with outcomes after spinal cord injury (SCI).

Methods: Retrospective cohort study, from rehabilitation admission to discharge.

Participants: Convenience sample of 89 persons with cervical SCI (C3-C8) treated from 1995 through 2003.

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