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 ] 18 clinical trials involving any drug being developed for any psychiatric indication, as well as for all antiepileptic drugs and other neurologic drugs with central nervous system (CNS) activity, both inpatient and outpatient, including multiple-dose Phase 1 trials involving healthy volunteers." 1 Systematic SIB monitoring not only can protect patients who are participating in clinical trials, it also allows for an estimation of the SIB risk associated with new treatments should they receive marketing approval. There are several methods for assessing SIB. One option involves the use of broad assessments of mood and behavior that include SIB questions or subscales (e.g., Beck Depression Inventory, 2 Hamilton Rating Scale 3 ). Alternatively, SIB-specific assessments have been developed for use in clinical trials and practice. The most widely used SIB-specific measure is the Columbia Suicide Severity Rating Scale (C-SSRS). 4 The original C-SSRS is a paper and pencil measure that is completed by a clinician through a semi- structured interview with a patient. An electronic version of the measure—the eC-SSRS—was developed as an interactive voice response (IVR) system alternative that is completed directly by the patient through a structured, standardized, automated interview. In this modality, the subject calls a dedicated phone line and hears a recorded script with instructions and questions. The subject responds by pressing the appropriate keys on the telephone touch pad (e.g., 1 for Yes, 2 for No). The electronic version has several unique strengths, including directly representing the patient's view, rather than a clinician interpretation of the patient, 5 not requiring clinical staff time and effort for all interviews, and consequently allowing staff to focus on patients who are at highest risk and who are most in need of medical care and attention. The eC-SSRS has been administered over 75,000 times in Phase 2 and 3 clinical trials. 6 This primarily includes trials in psychiatric clinical populations (e.g., major depressive disorder [MDD], posttraumatic stress disoder [PTSD], and generalized anxiety disorder [GAD]. However, the eC-SSRS has also been widely used in non-psychiatric trials, as well (e.g., chronic obstructive pulmonary disease, epilepsy, fibromyalgia). The IVR version of the eC-SSRS provides data that are consistent, but not redundant, with data from the clinician-administered CSSRS. As with other sensitive areas where patients may report more to computers than clinicians, patients report more SIB on the eC-SSRS than on the C-SSRS. 7,8 Although the IVR version of the e- CSSRS is widely used, it has some potential limitations. First, as other assessments are rarely completed through IVR, it decreases clinical site efficiency by requiring them to provide a telephone to patients for the exclusive purpose of completing the eC-SSRS. It would be ideal to have an option to administer the eC-SSRS via an electronic platform that may also be used for other assessment purposes. Second, patients may prefer visual, text-based modalities (e.g., tablet, laptop) to the auditory IVR mode. This may be a simple personal preference for one or another mode. Alternatively, preference could occasionally be driven by a clinically relevant factor, such as hearing problems, that would threaten the validity of the eC-SSRS data. For these reasons, a new text-based version of the eC-SSRS was developed as an alternative to the IVR version. It would be ideal to provide patients and sites with the option to use either eC-SSRS solution within a single clinical trial. This would require pooling of text- based and IVR-based data within a single trial. The use of both options across trials would also require data pooling, in order to examine wider trends in SIB in a therapeutic area or treatment class. Pooling of data within and across trials requires that the multiple modes of administration produce equivalent data (i.e., that the administration modes do not introduce error or bias into the SIB data). 9 Although there is substantial evidence supporting the equivalence of paper and electronic versions of patient-reported outcomes (PRO) instruments, 10 the equivalence of different electronic modes is less well understood. In particular, the equivalence of IVR and text-based modes is unclear. 11 Therefore, the goal of this study was to empirically test the equivalence of the new text-based and original IVR-based eC-SSRS. The assessments were administered to recently admitted psychiatric inpatients and to normal volunteers (employees of the hospital site) in order to explore the broadest range of SIB. A double- crossover, three-period design was used to allow assessment of both agreement between modalities and test-retest reliability within modalities. METHODS Study design. The study used a three-period, crossover design, with the first two periods using the two modalities (IVR and tablet) in randomized order, and the third period using the same modality as the first period (Table 1). All three periods took place within a single half-day session. There were two intervals, during which subjects completed a distractor task. Participants. Adult patients were recruited from a single hospital in the United States to participate in the study. Two groups of participants were enrolled: A) individuals who were recently admitted to an inpatient psychiatric ward and B) hospital staff. None of the enrolled hospital staff had any prior experience with the C-SSRS or eC-SSRS. Participants were required to be at least 18 years old, speak English, and be able and willing to provide written informed consent. Participants with dementia, delirium, or psychosis were excluded. Patients were also excluded if they had hearing or vision impairments that were sufficient to cause problems with either of the assessment modalities or if they had received electroconvulsive therapy in the past 28 days. Patients could only begin the study protocol following the approval of their attending physician. The study protocol was approved by an Institutional Review Board, and all patients provided informed consent prior to participation. Procedures. Hospital staff were recruited through flyers posted in the hospital. Site staff doing chart reviews recruited inpatients. If a patient appeared

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