Innovations In Clinical Neuroscience

MAR-APR 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 4 , N U M B E R 3 – 4 , M A R C H – A P R I L 2 0 1 7 ] 21 hospital worker groups on the suicidal behavior variables. As expected, patients reported higher suicidal behavior rates across all variables. The only cases where the statistical analyses did not reveal a statistically significant relationship were instances where few or no hospital workers reported recent behaviors; therefore, the statistical test was either underpowered to detect an effect or impossible to complete (see recent actual attempts, Table 2). For the lifetime variables, the group effect was consistent across the IVR and tablet modes (Table 2; not calculated for recent behaviors due to small sample sizes). Also, as expected, the patients and hospital workers did not differ on non- suicidal, self-injurious behavior. Figure 2 shows the responses to the questionnaire administered at the end of the study. The majority of users found both modes very easy to use (Figure 2A). This number was rather higher for the tablet, and this was reflected in the preference data (Figure 2B), with the majority of patients preferring the tablet. DISCUSSION Prospectively assessing SIB is a critical step in protecting patients and evaluating product safety in many therapeutic areas. 1 In order to seamlessly incorporate prospective SIB assessments into clinical trials, it is important to have several different administration options and platforms that can be matched to particular patients or sites. This matching can be done based on preference (e.g., patients prefer to use a text-based platform for privacy reasons) or clinical need (e.g., a patient is unable to read, so an IVR administration or clinician assessment is needed). This study examined the equivalence of two eC-SSRS administration modes—an IVR system that has been evaluated in previous studies 5,6 and a novel text-based version that is completed by the patient. The data strongly support the equivalence of the two modes. The eC-SSRS includes measures of lifetime and recent SIB. Across all of these question types, the IVR and text- based modes of administration were remarkably similar. Indeed, the average TABLE 2. Equivalence of IVR and Tablet eC-SSRS Versions: Suicidal Behavior VARIABLE EQUIVALENCE KAPPA/TAU B a KNOWN GROUPS VALIDITY b Actual attempts (lifetime) 0.81, p<0.001 Patients=53%, Workers=11% c2=14.43, p<0.001 (both) c2=7.78, p<0.01 (IVR) c2=7.00, p<0.01 (tablet) Actual attempts (recent– last 2 years; n=31) 0.73, p<0.001 Patients=42%, Workers=0% No workers reported recent behavior; thus no test possible Number of lifetime actual attempts 0.81, p<0.001 Patients=1.0±1.4, Workers=0.2±0.7 t(84)=3.36, p<0.01 (both) t(42)=2.37, p<0.05 (IVR) t(40)=2.38, p<0.05 (tablet) Interrupted attempts (lifetime) 0.78, p<0.001 Patients=55%, Workers=7% c2=18.22, p<0.001 (both) c2=4.33, p<0.05 (IVR) c2=15.75, p<0.001 (tablet) Interrupted attempts (recent–last 2 years; n=28) 0.62, p<0.001 Patients=66%, Workers=50% c2=0.20, ns (both) Only 2 cases in the hospital worker group Aborted attempts (lifetime) 0.54, p<0.001 Patients=57%, Workers=14% c2=13.99, p<0.001 (both) c2=3.22, p<0.10 (IVR) c2=12.30, p<0.001 (tablet) Aborted attempts (recent–last 2 years; n=24) 0.74, p<0.001 Patients=64%, Workers=25% c2=2.21, ns (both) Only 4 cases in the hospital worker group Preparatory behaviors (lifetime) 0.77, p<0.001 Patients=36%, Workers=4% c2=10.56, p=0.001 (both) c2=5.28, p<0.05 (IVR) c2=5.57, p<0.05 (tablet) Preparatory behaviors (recent–last 2 years; n=19) 0.89, p<0.001 Patients=57%, Workers=0% c2=1.26, ns (both) Only 1 case in the control group Non-suicidal, self-injurious behavior 0.73, p<0.001 Patients=4%, Workers=8% c2=0.81, ns (both) c2=0.36, ns (IVR) c2=0.45, ns (tablet) a Statistic is Kappa for all except number of lifetime actual attempts b Group percentages are from the IVR administration IVR: interactive voice response; ns: not significant

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