Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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Page 93 of 201

Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] 94 5. Sensitive to change in suicidal ideation and behavior 6. Compatible with the United States Food and Drug Administration ( FDA) categories for prospective assessment of suicidal ideation and behavior 1,2 7. Useful in clinical as well as research settings 8. Useful in detecting an efficacy signal for anti-suicidal medications 9. Capable of use in pediatric and geriatric settings. Because of the risks associated with suicidality and in the interest of safety, the expectations and hurdles for a suicide assessment scale are higher than for other scales in psychiatry. To meet these expectations and in response to much valuable feedback, the S-STS has evolved over time. This article aims to provide a 2014 status update on the scale, its properties, and its potential uses. WHY AND HOW WAS THE S-STS DEVELOPED? Suicide is a leading cause of premature death among psychiatric patients and a leading source of malpractice suits against psychiatrists and mental health professionals. 3 –5 A suicidality module was included in the Mini International Neuropsychiatric Interview (MINI) 6 (a structured diagnostic interview coauthored by author D.S.) as early as 1992, because other structured diagnostic interviews did not provide this. The suicidality module, like the other modules in the MINI, is in a yes/no response format. Subsequently, the first author of this article (D.S.), who developed the scales in the MINI Tracking Scales, changed the MINI modules, including the suicidality module, into a set of Likert scales for treatment-outcome tracking. With the FDA expectations of more thorough suicide assessments in clinical trials, several sponsors asked the first author of this article (D.S.) to accommodate all the FDA suicide assessment expectations into the suicidality module of the MINI Tracking. In this process, the S-STS was developed as a separate scale. As it was modified, we modified the MINI suicidality module to keep pace with changes in the S-STS. The MINI 7 structured diagnostic interview for the D iagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) is now fully compatible item by item with the S-STS. The S-STS scale evolved further with considerable and thoughtful feedback from regulatory agencies, patients, sponsors, and researchers to its current state. The scale author's consistent primary goal was to develop a scale that could sensitively discriminate anti-suicidal properties between drug and placebo in standard clinical trial sample sizes. In addition, the scale should serve as a sensitive, adverse-event, suicidality detector in modest samples. CURRENT SCALE VARIANTS Standard S-STS. The standard version of the S-STS (Appendix A) is a 16-item scale that assesses the seriousness of suicidality phenomena on a Likert-type scale (0–4) ranging from "not at all" (0) to "extremely" (4). It also assesses the frequency of key phenomena and the overall time spent in suicidality. The standard version is available in clinician- and patient-rated formats. These formats are identical, except that the clinician rates the former and the patient rates the latter. There is also a "reconciled" version, which can be used to reconcile discrepancies, if they exist, between the patient and clinician on specific items. The standard S-STS can be used for screening and other purposes (e.g., tracking suicidality as an adverse effect in trials or in clinical practice). Page 1 of the two-and-a-half pages layout can be used as a stand-alone suicidality tracking scale for clinical practice settings. The last page (page 3) is only completed if the patient misses a follow-up appointment and is unavailable to allow completion of the scale. This section captures the best available information on the patient's disposition. This information is usually required by regulatory agencies to close the loop as completely as possible on the outcome in a clinical trial in relation to suicidality. The Clinically Meaningful Change Measure (CMCM) version of the S-STS (Appendix B). This version is a much more expanded v ersion developed for specific testing of the anti-suicidal effects of medications. The main reason for developing this variant was to address an expectation of European regulators that any drug seeking regulatory approval for an anti-suicidal indication needs to demonstrate a clinically meaningful change in addition to showing statistically significant superiority over a placebo on a suicide ideation and behavior scale, given the risks and gravity involved in suicidality. Assessment of clinically meaningful change has become increasingly important for treatment planning, monitoring progress, and evaluating treatment response in clinical trials and in clinical practice. Minimally important change has been defined as "the difference in score on a health- related [...] instrument that corresponds to the smallest change in status that stakeholders (persons, patients, significant others, or clinicians) consider important." 7 Clinically meaningful or important change can facilitate interpretation of scores obtained on self-report measures of health status used to assess treatment effects at the aggregate and individual level. 8 An anti-suicidal medication might show a statistically significant difference compared to placebo, but that change might not also be clinically meaningful. The effects of such an anti-suicidal medication should be impressive enough so that it is able to alter the clinician's judgment of risk and decisions about the acute clinical management or disposition of the case. The S-STS CMCM is designed to meet that need. Appendix B shows the additional domains that should be altered by an anti-suicidal treatment and how these domains are measured, anchored, and statistically analyzed (as seen in Appendix C) in a way that any clinician could judge the extent of an anti-suicidal medication's clinically meaningful effect.

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