title: Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and patient outcomes.
abstract: OBJECTIVE
  Adverse event (AE) rates for deep brain stimulation (DBS) are variable, due to various methodologies used for identifying, collecting, and reporting AEs. This lack of a prospective, standardized AE collection method is a shortcoming in the advancement of DBS. In this paper the authors disclose the standardized and prospectively recorded AE data from their institution, correlated with clinical outcome and quality of life (QOL) measures.
  
  
  METHODS
  All patients who underwent operations at the authors' institution for Parkinson disease (PD), essential tremor, dystonia, other tremor, and obsessive-compulsive disorder were included. Complications occurring intraoperatively or within the first 180 days following surgery were recorded, analyzed, and classified as mild, moderate, or severe, regardless of their perceived relationship to the procedure. The presence, frequency, and severity of AEs were compared with the following outcome measurements: postoperative change in the QOL scales (Medical Outcomes Study 36-Item Short-Form Survey, 39-Item PD Questionnaire); motor scales (Tremor Rating Scale, Unified Dystonia Rating Scale, Unified PD Rating Scale); and Patient Global Impression Scale (PGIS).
  
  
  RESULTS
  Two hundred seventy DBS procedures were performed in 198 patients. Three hundred AEs were recorded in 146 (54.1%) of the 270 procedures, and the AEs were recorded in 119 (60.1%) of 198 patients. Of the 198 patients, the maximum severity of AEs was mild in 28 (14.1%), moderate in 35 (17.7%), and severe in 56 (28.3%). Of the 300 AEs, 102 (34.1%) of 299 were mild, 106 (35.5%) were moderate, and 91 (30.4%) were severe. The AEs were classified as probably not stimulation induced in 10 (3.4%) of 297, probably in 44 (14.9%), unclear for 89 (30%), and not applicable to stimulation in 154 (51.9%). Adverse events were also classified as probably related to surgery in 111 (37.2%) of 298, possibly related in 96 (32.2%), and probably not related to surgery in 91 (30.5%). There was no significant difference (p = 0.22) in QOL outcomes among patients who had no AEs compared with those who experienced mild, moderate, or severe AEs. There was no significant difference in QOL outcomes between patients who did not experience an AE compared with those who experienced any AE. There was no significant difference in the mean General PGIS score between patients without an AE versus those with any AE, as well as on the Symptom-Specific PGIS. Motor function outcomes did not vary between patients with or without AEs. For patients with PD with or without AEs, there was no significant difference in preoperative off-medicine Unified PD Rating Scale score and postoperative 6-month on-medication/on-stimulation change scores (p = 0.59). For patients with tremor there were no differences between those with or without AEs on the Tremor Rating Scale for motor function or activities of daily living. Patients with dystonia with and without AEs showed no differences in the Unified Dystonia Rating Scale.
  
  
  CONCLUSIONS
  Prospectively and systematically recording AEs may result in higher AE rates, but this does not correlate with poorer QOL, motor function, or patient-oriented outcome scores.
authors.affiliation: Department of Neurosurgery, University of Florida, Gainesville, Florida 32610, USA.
authors.forename: Adam P
authors.initials: AP
authors.lastname: Burdick
authors.forename: Hubert H
authors.initials: HH
authors.lastname: Fernandez
authors.forename: Michael S
authors.initials: MS
authors.lastname: Okun
authors.forename: Yueh-Yun
authors.initials: YY
authors.lastname: Chi
authors.forename: Charles
authors.initials: C
authors.lastname: Jacobson
authors.forename: Kelly D
authors.initials: KD
authors.lastname: Foote
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D003625:Data Collection / Q000592:standards*; D046690:Deep Brain Stimulation / Q000009:adverse effects* / Q000379:methods; D004421:Dystonia / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009069:Movement Disorders / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000628:therapy; D011446:Prospective Studies; D011788:Quality of Life; D013238:Stereotaxic Techniques / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014202:Tremor / Q000628:therapy