Table 2.
PICO-Based Inclusion/Exclusion Criteria for Literature Screening
Participants | Among patients with: • Epilepsy (controlled or uncontrolled) • Recurrent seizure-like events • Suspected epilepsy based on multiple episodes Receiving treatment at epilepsy centers including a focus on: • Inpatient (EMU, exclude ICU monitoring for complex neurologic conditions other than epilepsy) • Outpatient (office-based clinic care, telehealth) • Accreditation level • Patient characteristic (adult, pediatric, mixed) • Geographic setting (rural medically underserved, urban medically underserved, suburban, rural not medically underserved, urban not medically underserved) Subgroups of interest: age 65+, pediatric patients, women, rare epilepsy syndromes/conditions |
Interventions | Services including but not limited to: • Electrodiagnostic (e.g., 24-h video-EEG with either surface electrodes or sphenoidal electrodes, intracarotid amobarbital (Wada) testing, functional cortical mapping, evoked potential recording capable of being safely used with intracranial electrodes, electrode localization) • Neurosurgery (e.g., emergency or elective including biopsy and removal of incidental lesions, treatment of cerebral complications of epileptic seizures, stereotactic techniques, management of surgical complications, corpus callosotomy) • Imaging (e.g., computerized axial tomography, cerebral angiography, interictal positron emission tomography, fMRI) • Pharmacologic expertise (e.g., quality-assured anticonvulsant serum drug levels) • Neuropsychological (e.g., comprehensive test batteries for cerebral dysfunction) • Psychosocial services (e.g., inpatient and outpatient psychological services for assessment and treatment of chronic epilepsy) • Rehabilitation (e.g., physical, occupational, speech therapy) • Access to higher level care (e.g., ICU, anesthesia, emergency resuscitative equipment) • Care coordination (e.g., medication authorizations, home medical equipment, transition from inpatient to outpatient) • Genetic testing and counseling • Patient and caregiver education • Dietary management • Services for special populations (e.g., language interpretation services, rare epilepsies) Essential elements of the inpatient EMU including but not limited to: • The design and layout of the physical space to provide access, observation and monitoring needs of patients, and safety considerations • The equipment needed to perform services • Data collection protocols and management • Additional facility protocols (e.g., transportation, fall prevention, medication reduction, standard order set) Personnel including but not limited to: • Epilepsy specialists • Providers associated with neurosurgery • Providers associated with diagnostic testing • Psychosocial and care coordinators • Nursing • Advance practice providers |
Comparators | Not applicable (include all) |
Outcomes and outcome measures | Any center outcomes including but not limited to: Center-wide clinical outcomes determined from data sets Reduced hospitalizations, morbidity, or mortality (over a period of time) Nonclinical outcomes including but not limited to: Patient volumes Financial outcomes Staff turnover rates Number of times the center was sued Patient complaints Patients signing out or leaving prematurely due to dissatisfaction with care or requesting a new source of care Patient satisfaction Press Gainey scores, wait times for appointments, in-clinic wait, return of phone calls Patient outcomes including but not limited to: Seizure frequency Seizure freedom Emergency department visits Hospital readmission Quality of life Functional status Behavioral health Mortality Education/employment status |
Timing | Any |
Study designs | Keep: • RCT (phase 1–4) • Non-RCTs (phase 1–4) • Observational, noncomparative • Observational studies, comparative • Cross-sectional • Prospective cohort • Retrospective cohort • Nonconcurrent cohort • Systematic reviews/meta-analyses • Pooled analyses • Case-control Reject (wrong study design): • Case reports/series • Prognostic course/factor studies • Modeling studies • Preclinical • Narrative reviews Reject (other reason for rejection): • In vitro • Not a clinical study • Not a treatment study • Animal studies • Non-English • Duplicate publication |
Notes | Despite a long intervention list, any intervention/institution characteristic is acceptable Despite a long outcome list, any outcome reported is acceptable Hierarchy is to reject all nonepilepsy studies for wrong population > reject studies with no new data for not a clinical study > reject studies with no center information for wrong intervention |
Abbreviations: ICU = intensive care unit; EMU = epilepsy monitoring unit; PICO = Populations/Interventions/Comparators/Outcomes; RCT = randomized clinical trial.