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 ] 22 scores for lifetime suicidal ideation were almost identical across the two modes. One of the most stringent tests of equivalence is to compare the agreement between modes to the test-retest reliability of the original mode. 10 The design of the current study allowed for this by administering either the IVR or text-based version twice during the study protocol. The ICCs for the different modes was almost identical to the single- mode test-retest ICCs for the ordinal measures of most severe lifetime and past six month ideation. This is compelling evidence for the equivalence of the two modes of administration. Another novel aspect of the study was the comparison of responses from the patient and hospital staff subgroups. Patients were expected to report significantly higher levels of SIB than staff. This was observed across all lifetime and recent SIB variables. The difference between the groups was non-significant only for the non-suicidal, self-injurious behavior variable, which includes behaviors that were intended to cause harm but not result in suicide (e.g., actions used to relieve stress, feel better, get sympathy, or get something else to happen 16 ). Endorsement rates for this variable were low in both groups. The patient/hospital staff SIB differences were observed across the IVR and tablet modes. The statistical significance of the group comparison differed across modes in only one instance—for lifetime aborted attempts— and even in this case the non-significant finding was at a statistical trend level (p<0.10). Additionally, the non-significant result was observed with the IVR administration, which has been tested in other studies and found to be comparable to clinician C- SSRS ratings. 5 The novel text-based administration discriminated the groups in all tests where there were enough patients to conduct a reliable test (all lifetime variables). These data also support the equivalence of the modes and provide additional known-groups validity data to support the eC-SSRS more generally. There was some modest evidence for order effects in the data—in two cases the equivalence metrics were higher when the IVR mode was administered first, and in one case the metric was higher when the tablet was administered first. Since there was no consistent advantage for one order of presentation over another and no reason to expect one order to produce superior results, we do not believe that these findings impact the overall conclusions of the study. Users' acceptance of both modes was high. While users generally preferred the tablet, both modes were rated very easy to use by the majority of users. Limitations. The study was limited in some respects. Approximately 25 percent of the enrolled sample was excluded from the analysis because of randomization violations or errors in the administration of the eC-SSRS. This reduced the sample size, and, if anything, made it more difficult to identify differences between the patient and hospital worker groups. It would have also made the equivalence metrics less reliable (e.g., increased the confidence interval around the ICCs). However, differences between the groups were still observed, and the equivalence metrics were robust and statistically significant. Although the exclusion of these patients did not seem to adversely impact the overall results of the study, having additional patients may have increased the ability to test group differences for recent suicidal behaviors; with more patients contributing data, there may have been more reports of recent suicidal behaviors among the hospital workers. Additionally, the original clinician-administered CSSRS was not included in the study as a comparator. However, the IVR version has already been shown to be equivalent to the clinician version; 5 therefore, we can transitively draw the conclusion that all three versions produce equivalent data. CONCLUSION Accurately assessing SIB is a critical part of many clinical trials. The C-SSRS and eC-SSRS are recommended by FDA as valid and reliable assessments of SIB. 1 It is important to provide as many mode of administration options as possible, so that all stakeholders—clinical sites, investigators, clinicians, and patients— have access to modes that meet their unique needs and preferences. This study provides empirical support for the use of the patient-reported text-based eC-SSRS in clinical trials. The study further demonstrates that multiple modes could be used in the same study and that data can be pooled across modes. This provides and important new eC-SSRS option that can advance the systematic measurement of SIB. FIGURE 2A. Users' experiences with the two electronic Columbia-Suicide Severity Rating Scale modes. Ease of use: "How easy or difficult did you find using the telephone/tablet questionnaires in the study?" FIGURE 2B. Users' experiences with the two electronic Columbia-Suicide Severity Rating Scale modes. Preference: "Which questionnaire did you prefer using?"

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