听觉脑干植入物:MAUDE数据库中不良事件的分析
Olivia E Speed1, Soroush Farsi1, Kaersti Rickels1
1University of Arkansas for Medical Sciences - Little Rock, AR, USA.
Neuro-Chirurgie
|May 29, 2024
概括
听力脑干植入物 (ABI) 可能无法提供听力益处或功能障碍,导致扩展. 医生应该就这些风险向患者提供建议,并管理对ABI设备结果的期望.
科学领域:
- 神经外科 神经外科
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 生物医学工程 生物医学工程
背景情况:
- 听力脑干植入物 (ABI) 对于耳异常或神经问题患者的听力恢复至关重要.
- 分析与ABI相关的不良事件对于改善患者的治疗结果和设备管理至关重要.
研究的目的:
- 使用FDA的MAUDE数据库调查听力脑干植入物 (ABI) 的不良事件和解释原因.
- 为更好的患者咨询和管理有关ABI绩效的期望提供见解.
主要方法:
- 在美国FDA的MAUDE数据库中对与ABI相关的医疗器械报告 (MDR) 进行了回顾性分析.
- 纳入标准适用于265个患者报告,其中55个符合研究要求.
主要成果:
- 解释的常见原因包括未能提供听力补助 (27 个报告),设备故障 (10) 和不使用 (6).
- 手术后的并发症包括感染,脑脊液泄漏,高血压,手术部位问题和脑膜炎.
- 两名患者在MRI期间经历了磁位移;发生了35个完全和1个部分扩张.
结论:
- 听力不佳的结果,设备故障和不使用是导致ABI解释的重要因素.
- 这些发现可以帮助临床医生为患者和家人提供咨询,为ABI设备功能设置现实的期望.
相关概念视频
Nonsense-mediated mRNA Decay
9.4K
The Upf proteins that carry out nonsense-mediated decay (NMD) are found in all eukaryotic organisms, including humans. Each protein has an individual role, but they need to work in collaboration. Upf1 is an ATP-dependent RNA helicase that unwinds the RNA helix. Because Upf1 can unwind any RNA, Upf2 and Upf3 are required to help Upf1 discriminate between nonsense and normal mRNAs.
Usually, Upf3 binds to an Exon Junction Complex (EJC) at mRNA splice sites. If a ribosome fully translates the mRNA,...
Usually, Upf3 binds to an Exon Junction Complex (EJC) at mRNA splice sites. If a ribosome fully translates the mRNA,...
9.4K
Mismatch Repair
5.4K
Organisms are capable of detecting and fixing nucleotide mismatches that occur during DNA replication. This sophisticated process requires identifying the new strand and replacing the erroneous bases with correct nucleotides. Mismatch repair is coordinated by many proteins in both prokaryotes and eukaryotes.
The Mutator Protein Family Plays a Key Role in DNA Mismatch Repair
The human genome has more than 3 billion base pairs of DNA per cell. Prior to cell division, that vast amount of genetic...
The Mutator Protein Family Plays a Key Role in DNA Mismatch Repair
The human genome has more than 3 billion base pairs of DNA per cell. Prior to cell division, that vast amount of genetic...
5.4K
Errors occurring during blood pressure monitoring
1.6K
Blood pressure monitoring is a crucial clinical procedure in diagnosing and managing various cardiovascular conditions. Despite its significance, the accuracy of blood pressure measurements can be compromised by multiple factors, potentially leading to either falsely high or low readings. These inaccuracies are critical as they can significantly impact patient care. So, it is vital to understand these challenges deeply and adopt strategic approaches to minimize errors.
Several factors...
Several factors...
1.6K
Pharmacovigilance
2.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
2.0K
Therapeutic Drug Monitoring: Affecting Factors
429
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
429
Censoring Survival Data
689
Survival analysis is a statistical method used to analyze time-to-event data, often employed in fields such as medicine, engineering, and social sciences. One of the key challenges in survival analysis is dealing with incomplete data, a phenomenon known as "censoring." Censoring occurs when the event of interest (such as death, relapse, or system failure) has not occurred for some individuals by the end of the study period or is otherwise unobservable, and it might have many different...
689


