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Finding
Finding
adverse
The overall incidence risk of experiencing a serious adverse event was 3.8 times higher in DBS patients than in BMT patients, with 49 DBS patients (40%) experiencing at least 1 serious adverse event compared with 15 BMT patients (11%), including 1 death from cerebral hemorrhage.
| Effect size | Incidence risk ratio 3.8 (DBS vs BMT); 40% of DBS patients vs 11% of BMT patients experienced at least 1 serious adverse event |
| CI | 95% CI, 2.3-6.3 |
| Follow-up | 6 months |
| Comparator | Best medical therapy actively managed by movement disorder neurologists |
| Effect summary | adverse; Incidence risk ratio 3.8 (DBS vs BMT); 40% of DBS patients vs 11% of BMT patients experienced at least 1 serious adverse event; CI: 95% CI, 2.3-6.3 |
| Adverse events | 82 serious AEs, 2 deaths (1 from cerebral hemorrhage, 1 from lung cancer), 16 infections (surgical site infection), 49 DBS patients (40%) experienced at least 1 serious AE, 15 BMT patients (11%) experienced serious AEs |
| Effect modifiers | [{"modifier": "Age (>=70 vs <70 years)", "interaction_p": "", "direction": "null", "stratum_details": "No difference in serious adverse event rate between older (26%) and younger (25%) patients, and no differences in types of serious adverse events by age.", "plain_language": "Older patients did not have a higher rate of serious complications from DBS than younger patients.", "annotation_notes": "This is a notable safety finding \u2014 older patients were not at higher surgical risk, contrary to common concern."}] |
Connected entities
Interventions
Outcomes
Populations
Source
PMC2814800
Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease A Randomized Controlled Trial