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1 SUICIDALITY SUICIDALITY CLASSIFICATION PROJECT CLASSIFICATION PROJECT Kelly Posner, Ph.D. Kelly Posner, Ph.D. Maria Oquendo, M.D. Maria Oquendo, M.D. Barbara Stanley, Ph.D. Barbara Stanley, Ph.D. Madelyn Gould, Ph.D, M.P.H Madelyn Gould, Ph.D, M.P.H Statistical Consultant: Mark Davies, Statistical Consultant: Mark Davies, M.P.H. M.P.H.
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1 SUICIDALITY CLASSIFICATION PROJECT Kelly Posner, Ph.D. Maria Oquendo, M.D. Barbara Stanley, Ph.D. Madelyn Gould, Ph.D, M.P.H Statistical Consultant:

Jan 04, 2016

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Page 1: 1 SUICIDALITY CLASSIFICATION PROJECT Kelly Posner, Ph.D. Maria Oquendo, M.D. Barbara Stanley, Ph.D. Madelyn Gould, Ph.D, M.P.H Statistical Consultant:

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SUICIDALITY SUICIDALITY CLASSIFICATION CLASSIFICATION

PROJECTPROJECT

Kelly Posner, Ph.D.Kelly Posner, Ph.D.Maria Oquendo, M.D.Maria Oquendo, M.D.

Barbara Stanley, Ph.D.Barbara Stanley, Ph.D.Madelyn Gould, Ph.D, M.P.H Madelyn Gould, Ph.D, M.P.H

Statistical Consultant: Mark Davies, M.P.H.Statistical Consultant: Mark Davies, M.P.H.

Page 2: 1 SUICIDALITY CLASSIFICATION PROJECT Kelly Posner, Ph.D. Maria Oquendo, M.D. Barbara Stanley, Ph.D. Madelyn Gould, Ph.D, M.P.H Statistical Consultant:

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Rationale for Rationale for ReclassificationReclassification The Problem:The Problem:

– Field challenged by lack of conceptual clarity about Field challenged by lack of conceptual clarity about suicidal behavior and corresponding lack of well-suicidal behavior and corresponding lack of well-defined terminology defined terminology

– Lack of systematic or standardized language used Lack of systematic or standardized language used to define suicidal behavior in the 25 industry to define suicidal behavior in the 25 industry antidepressant trialsantidepressant trials

– Difficulty in interpreting the meaning of reported Difficulty in interpreting the meaning of reported adverse events that occurred in these trialsadverse events that occurred in these trials

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The Problem…The Problem…

AEs that should have been called AEs that should have been called suicidal may have been missed suicidal may have been missed

AEs may have been AEs may have been inappropriately classified as inappropriately classified as suicidalsuicidal

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Examples of Difficulties in Examples of Difficulties in Adverse Event LabelingAdverse Event Labeling

Original LabelOriginal Label NarrativesNarrativesPersonality Personality DisorderDisorder

Age 10: The patient exhibited symptoms of personality disorder, Age 10: The patient exhibited symptoms of personality disorder, assessed as moderate in severity, and was discontinued from assessed as moderate in severity, and was discontinued from the study due to this event. One day later (date), the patient the study due to this event. One day later (date), the patient attempted to hang himself with a rope after a dispute with his attempted to hang himself with a rope after a dispute with his father. The investigator did not consider this event to be a father. The investigator did not consider this event to be a suicide attempt, but rather to be part of the personality disorder, suicide attempt, but rather to be part of the personality disorder, which was still ongoing. which was still ongoing.

Suicide EventSuicide Event this patient is reported to have engaged in an episode of this patient is reported to have engaged in an episode of ‘automutilation’ where she slapped herself in the face.‘automutilation’ where she slapped herself in the face.

Medication ErrorMedication Error Age 14: The patient took 11 tablets impulsively and then went to Age 14: The patient took 11 tablets impulsively and then went to school…the patient denied that it was a suicide attempt. school…the patient denied that it was a suicide attempt.

HostilityHostility Age 10: Before his mother’s call to the site and again after Age 10: Before his mother’s call to the site and again after arguing with his stepfather, he wrapped a cord from the arguing with his stepfather, he wrapped a cord from the miniblinds around his neck, threatening to kill himself.miniblinds around his neck, threatening to kill himself.

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How to Address this How to Address this Problem? Problem? a common set of guidelines a common set of guidelines

needed to be appliedneeded to be applied Data needed to be examined Data needed to be examined

consistently across trials consistently across trials Used research-supported Used research-supported

definitions/concepts with definitions/concepts with reliability and validityreliability and validity

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Broaden Range of Broaden Range of Adverse Events: Adverse Events: To avoid bias in ratings (would To avoid bias in ratings (would

not want raters to only have what not want raters to only have what sponsors had identified as sponsors had identified as possibly suicidal)possibly suicidal)

To identify suicidal events that To identify suicidal events that may have been missedmay have been missed

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What Was Included to What Was Included to Broaden Range:Broaden Range: Events originally identified by Events originally identified by

sponsors as possibly suicide sponsors as possibly suicide relatedrelated

Accidental Injuries (including Accidental Injuries (including accidental overdoses)accidental overdoses)

Serious Adverse Events (this Serious Adverse Events (this includes life-threatening events includes life-threatening events and all hospitalizations)and all hospitalizations)

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Why Were Experts in Why Were Experts in Suicide Needed?Suicide Needed?

Limited information provided in Limited information provided in narratives, particularly frequent narratives, particularly frequent lack of stated suicidal intentlack of stated suicidal intent

Allowed for inference based on Allowed for inference based on details of behaviors and related details of behaviors and related clinical informationclinical information

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Expert Rater PanelExpert Rater Panel

Annette Beautrais, Ph.D David Brent, M.D. Greg Brown, Ph.D. Kees van Heeringen, M.D., Ph.D. Cheryl King, Ph.D., ABPP Peter Marzuk, M.D. Patrick O'Carroll, M.D., M.P.H David Rudd, Ph.D., ABPP Anthony Spirito, Ph.D., ABPP Alternate: Alec Miller, PsyD.

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Columbia Suicidality Columbia Suicidality Classification Rating ScaleClassification Rating Scale

Behavior Behavior Towards Towards

Self InjurySelf Injury

Suicidal Suicidal Thoughts: Intent Thoughts: Intent or Wish to Dieor Wish to Die

Event categoryEvent category RatingRating

++++ ++

Suicide AttemptSuicide Attempt

__ __ Check if intent is inferredCheck if intent is inferred

___ Check if “Suicide Attempt” is only information provided___ Check if “Suicide Attempt” is only information provided

++ ++ Preparatory Actions Towards Imminent Suicidal BehaviorPreparatory Actions Towards Imminent Suicidal Behavior

++++ ?? Self-Injurious Behavior, Intent UnknownSelf-Injurious Behavior, Intent Unknown

++++ __ Self-Injurious Behavior, No Suicidal Intent, (To Affect Self-Injurious Behavior, No Suicidal Intent, (To Affect Internal State /Circumstance)Internal State /Circumstance)

__ ++ Suicidal IdeationSuicidal Ideation

__ passive __ active__ active w/ plan __type unknown__ passive __ active__ active w/ plan __type unknown

__ __ Other: No indication of deliberate self-injury or suicidal Other: No indication of deliberate self-injury or suicidal behavior or ideation behavior or ideation

Accident________ Medical*________ Psychiatric*________Accident________ Medical*________ Psychiatric*________

?? ?? Not Enough InformationNot Enough Information

*Please specify

Comments:

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Definitions Definitions for the Columbia Suicidality Classification Scale

Suicide AttemptSuicide Attempt Self- injurious behavior associated with some intent to die. Intent can be Self- injurious behavior associated with some intent to die. Intent can be stated or inferred by rater. No injury needed.stated or inferred by rater. No injury needed.

Preparatory Acts Towards Imminent Preparatory Acts Towards Imminent Suicidal Behavior Suicidal Behavior

Person takes steps to injure self but is stopped by self or other. Intent to Person takes steps to injure self but is stopped by self or other. Intent to die is either stated or inferred.die is either stated or inferred.

Self-Injurious Self-Injurious

Behavior, Intent Unknown Behavior, Intent Unknown

Self- injurious behavior where associated intent to die is unknown and Self- injurious behavior where associated intent to die is unknown and cannot be inferred. cannot be inferred.

Self-Injurious Self-Injurious

Behavior, No Intent, Primarily to Affect Behavior, No Intent, Primarily to Affect Circumstance Circumstance

Self- injurious behavior associated with no intent to die – behavior is Self- injurious behavior associated with no intent to die – behavior is intended to effect change in others or the environment. intended to effect change in others or the environment.

Self-Injurious Behavior, No Intent, Self-Injurious Behavior, No Intent, Primarily to Affect Internal StatePrimarily to Affect Internal State

Self- injurious behavior associated with no intent to die intended to relieve Self- injurious behavior associated with no intent to die intended to relieve distress. Typical examples are superficial cuts or scratches, distress. Typical examples are superficial cuts or scratches, hitting/banging, or burns. hitting/banging, or burns.

Suicidal IdeationSuicidal Ideation Passive thoughts about wanting to be dead or active thoughts about Passive thoughts about wanting to be dead or active thoughts about killing oneself, not accompanied by preparatory behavior. killing oneself, not accompanied by preparatory behavior.

Other: AccidentOther: Accident Passive thoughts about wanting to be dead or active thoughts about Passive thoughts about wanting to be dead or active thoughts about killing oneself, not accompanied by preparatory behavior. killing oneself, not accompanied by preparatory behavior.

Other: Psychiatric*_____________Other: Psychiatric*_____________ Psychiatric symptoms only (when no evidence of any type of suicidality) Psychiatric symptoms only (when no evidence of any type of suicidality)

Other: Medical*______________ Other: Medical*______________ Medical symptoms or procedure onlyMedical symptoms or procedure only

Not Enough InformationNot Enough Information Insufficient information to classify the event Insufficient information to classify the event

* Infer intent if the behavior is clinically impressive or there is more than one piece of evidence suggesting suicidal intent

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What is the What is the Classification Scheme?Classification Scheme?

Suicidal Non Suicidal

Suicide AttemptCode= 1N= 36

Suicidal IdeationCode=6N=62

Self-InjuriousBehaviorWithout SuicidalIntent Codes=4,5,,11N=17

Other:-Accidental-Psychiatric-MedicalCodes=7,8,9,12N= 260

Indeterminate

Non-ConsensusN = 0

Not Enough Information:Unable to Classify Whether Deliberate Self-

Injury or “other” Code = 10N = 9

Preparatory Actions Towards Imminent Suicidal BehaviorCode =2N = 8

Self-Injurious Behavior

With Unknown

IntentCode=3N=35

? Suicidal

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What Was Done?: What Was Done?: Classification Classification MethodologyMethodology Chose expert panelChose expert panel

– Expertise in adolescent suicide and suicide Expertise in adolescent suicide and suicide assessmentassessment

– Based on reputation and publicationsBased on reputation and publications– No involvement in industry youth depression trials in No involvement in industry youth depression trials in

questionquestion– No expert rater was employee of Columbia UniversityNo expert rater was employee of Columbia University

Training teleconference to review classification Training teleconference to review classification parametersparameters

Training reliability exercises (to ensure appropriate Training reliability exercises (to ensure appropriate application of classification)application of classification)

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Design continued……Design continued……

All case narratives blinded to any potentially biasing All case narratives blinded to any potentially biasing informationinformation

Random distribution of 427 events to 9 expertsRandom distribution of 427 events to 9 experts– PI blind to randomization proceduresPI blind to randomization procedures– Each case independently rated by 3 ratersEach case independently rated by 3 raters– Each rater received approx. 125 events to rateEach rater received approx. 125 events to rate– Any group of 3 raters shared only 5 casesAny group of 3 raters shared only 5 cases

Review of all ratings for QA and identification of non-Review of all ratings for QA and identification of non-agreement casesagreement cases

Consensus teleconferences for any disagreement Consensus teleconferences for any disagreement casescases

Double data entry for quality assuranceDouble data entry for quality assurance

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Consensus ProcessConsensus Process

If ratings did not have unanimous agreement, If ratings did not have unanimous agreement, consensus discussion heldconsensus discussion held

Each case discussed by 3 raters involvedEach case discussed by 3 raters involved Discussion of each case led by an expert Discussion of each case led by an expert otherother

than those originally assigned the casethan those originally assigned the case Goal of discussion was to reach 100% Goal of discussion was to reach 100%

agreementagreement If 100% agreement could not be reached, case If 100% agreement could not be reached, case

became indeterminantbecame indeterminant Original majority opinion did not always end up Original majority opinion did not always end up

as the final consensed classificationas the final consensed classification

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What Was Rated? Blinding What Was Rated? Blinding of Event Narratives to Avoid of Event Narratives to Avoid BiasBias Received from FDA blind to all potential drug identifying Received from FDA blind to all potential drug identifying

information:information:– Drug nameDrug name– Company/sponsor nameCompany/sponsor name– Patient identification numbersPatient identification numbers– Active or placebo armActive or placebo arm– Any and allAny and all medication names and types (e.g. tx with medication names and types (e.g. tx with

other meds may be associated with a particular other meds may be associated with a particular antidepressant side effect profile and thus could antidepressant side effect profile and thus could potentially bias)potentially bias)

– Primary DiagnosisPrimary Diagnosis

Additional Blinding of potentially biasing information:Additional Blinding of potentially biasing information:– Original label of event given by investigator or sponsorOriginal label of event given by investigator or sponsor– ““serious” or “non-serious” labelsserious” or “non-serious” labels

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Rating Guidelines: How Was Rating Guidelines: How Was Classification Scheme Classification Scheme Applied?Applied? Applied concepts using their clinical Applied concepts using their clinical

expertise and judgmentexpertise and judgment Used experience to integrate clinical Used experience to integrate clinical

information and infer when appropriateinformation and infer when appropriate ““Reasonable” certainty in order to commit to Reasonable” certainty in order to commit to

a ratinga rating Rating based on what was probable or likely, Rating based on what was probable or likely,

not what was “possible”not what was “possible”

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Guidelines for Intent Guidelines for Intent InferenceInference

Infer if “clinically impressive” orInfer if “clinically impressive” or Using 2 smaller pieces of clinical Using 2 smaller pieces of clinical

informationinformation Clinical information that could inform Clinical information that could inform

inference of intent included:inference of intent included:– Clinical circumstances (method used, number Clinical circumstances (method used, number

of pills)of pills)– Past history of suicide attemptPast history of suicide attempt– Past history of self-injurious behavior/self-Past history of self-injurious behavior/self-

mutilationmutilation– Family history of suicide/suicide attemptsFamily history of suicide/suicide attempts

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Case Example of Inferred Case Example of Inferred Intent: “Clinically Intent: “Clinically Impressive” Impressive” CircumstancesCircumstances Clinical impressiveness overrules Clinical impressiveness overrules

stated intentstated intent

““The subject attempted suicide by immolation. Her The subject attempted suicide by immolation. Her siblings doused the flames immediately. She was left siblings doused the flames immediately. She was left with minor burns on her abdomen and one on her left with minor burns on her abdomen and one on her left shoulder that were treated. The subject admitted that shoulder that were treated. The subject admitted that she was angry with her parents for going away and she was angry with her parents for going away and leaving her alone at home, because she was fearful. leaving her alone at home, because she was fearful. The subject admitted that she had acted impulsively The subject admitted that she had acted impulsively and had not intended to kill herself.” and had not intended to kill herself.”

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Another Examples of Clinically Another Examples of Clinically Impressive Circumstance: Impressive Circumstance: Suicide AttemptSuicide Attempt

CASE 1: The patient, age 16, claimed to have ingested CASE 1: The patient, age 16, claimed to have ingested 100 tablets of the taper study medication after a fight with 100 tablets of the taper study medication after a fight with her mother. her mother.

The patient informed her mother, who then brought the The patient informed her mother, who then brought the patient to an emergency room. The patient reportedly felt patient to an emergency room. The patient reportedly felt “shaky” “shaky”

The emergency room physician stated that the patient The emergency room physician stated that the patient “looked okay,” but was “slightly tachycardic” with a pulse “looked okay,” but was “slightly tachycardic” with a pulse of 100 of 100

Tox screen negativeTox screen negative The patient remained in the emergency room for several The patient remained in the emergency room for several

hours until she was completely asymptomatic hours until she was completely asymptomatic The patient was later admitted to psych unitThe patient was later admitted to psych unit

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Examples of Suicide Attempt, Examples of Suicide Attempt, cont.cont.

CASE 2: After a conflict with her CASE 2: After a conflict with her father, the patient, age 17, took an father, the patient, age 17, took an overdose of 20 (several) tablets. In her overdose of 20 (several) tablets. In her father’s opinion, the overdose was 5 father’s opinion, the overdose was 5 tablets. The patient did not have any tablets. The patient did not have any symptoms of an overdose, “not even symptoms of an overdose, “not even nausea”. nausea”.

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Examples of Suicide Attempt, Examples of Suicide Attempt, cont.cont.

CASE 3: Following a disagreement with her mother, CASE 3: Following a disagreement with her mother, the patient, age 15, intentionally overdosed. She the patient, age 15, intentionally overdosed. She consumed 12 tablets of study meds, 23 __, 12 __, consumed 12 tablets of study meds, 23 __, 12 __, 23 ___, 29 ___, 4 ___ and 10 __ tablets. 23 ___, 29 ___, 4 ___ and 10 __ tablets. Consumed 113 tablets.Consumed 113 tablets.

CASE 4: The patient, age 15, impulsively slit her CASE 4: The patient, age 15, impulsively slit her wrists following an altercation with her mother. The wrists following an altercation with her mother. The wounds were superficial and were not stitched. wounds were superficial and were not stitched.

CASE 5: Age 17, she attempted suicide by taking 8 CASE 5: Age 17, she attempted suicide by taking 8 tablets of ____ after a fight with her father, whom tablets of ____ after a fight with her father, whom she considered harsh and rejecting. she considered harsh and rejecting.

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Examples of Self-Injurious Examples of Self-Injurious Behavior, Intent UnknownBehavior, Intent Unknown

CASE 1: The patient, age 10, had superficial CASE 1: The patient, age 10, had superficial scratches, left arm, scratched self with scissors scratches, left arm, scratched self with scissors

CASE 2: The patient, age 14, ingested or simulated CASE 2: The patient, age 14, ingested or simulated ingestion of 2-3 cigarettes. The patient was ingestion of 2-3 cigarettes. The patient was reported as feeling tired and playing a theatrical role reported as feeling tired and playing a theatrical role

CASE 3: Subject, age 9, reported he had ingested CASE 3: Subject, age 9, reported he had ingested four of his brother’s tablets “on a dare”four of his brother’s tablets “on a dare”

CASE 4: The patient, age 10, swallowed a small CASE 4: The patient, age 10, swallowed a small amount of aftershave lotion while angryamount of aftershave lotion while angry

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Examples of Preparatory Examples of Preparatory ActionsActions

CASE 1: Age 16: on day 63, she tried to hang herself and CASE 1: Age 16: on day 63, she tried to hang herself and was prevented from doing so by her family. was prevented from doing so by her family.

CASE 2: The voice commanded the patient, age 18, to CASE 2: The voice commanded the patient, age 18, to jump from the roof. Although the patient went to the roof, jump from the roof. Although the patient went to the roof, he did not jump. he did not jump.

CASE 3: The patient, age 10, experienced suicidal CASE 3: The patient, age 10, experienced suicidal ideation with plan. Reportedly, the subject held a kitchen ideation with plan. Reportedly, the subject held a kitchen knife to her neck while alone but did not cut herself and knife to her neck while alone but did not cut herself and the event was not witnessed. At her next scheduled visit, the event was not witnessed. At her next scheduled visit, the subject reported the suicidal ideation described above. the subject reported the suicidal ideation described above.

CASE 4: The patient, age 18, was noted to be hostile, CASE 4: The patient, age 18, was noted to be hostile, hopeless, and helpless and had written suicide notes. hopeless, and helpless and had written suicide notes.

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Examples of Self-Injurious Examples of Self-Injurious Behavior, No IntentBehavior, No Intent

CASE 1: The patient stated that there is increased CASE 1: The patient stated that there is increased family tension over the past six days and that she family tension over the past six days and that she made superficial cuts on her wrist with an Exacto made superficial cuts on her wrist with an Exacto Knife. The patient and mother reported that the Knife. The patient and mother reported that the cuts weren’t deep and that they looked like a “cat cuts weren’t deep and that they looked like a “cat scratched her.” The patient adamantly denied scratched her.” The patient adamantly denied any suicidal gestures or intent. The patient any suicidal gestures or intent. The patient stated that she only wanted “a release” and that stated that she only wanted “a release” and that cutting and hitting her legs offers a “release.” cutting and hitting her legs offers a “release.”

CASE 2: Denies suicidal thoughts. The first time CASE 2: Denies suicidal thoughts. The first time she cut herself was at age 16 and stated that she she cut herself was at age 16 and stated that she did it for attention. Today her cutting was more did it for attention. Today her cutting was more spontaneous. She reported that cutting gives her spontaneous. She reported that cutting gives her “a good weird feeling.” “a good weird feeling.”

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Results: Number of Results: Number of Events and CasesEvents and Cases

427 Events427 EventsFDA

Severity Hierarchy

378 Cases

Suicide AttemptPreparatory Actions Suicidal IdeationSIB, intent unknownNot enough Information

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Results: Expert Rater Results: Expert Rater ConsensusConsensus

Only 2/427 cases had no Only 2/427 cases had no agreement among the 3 ratersagreement among the 3 raters

59 cases had agreement among 2 59 cases had agreement among 2 of 3 raters, had to go to of 3 raters, had to go to teleconferenceteleconference

No cases in which consensus not No cases in which consensus not able to be reached during able to be reached during teleconferenceteleconference

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Discordant Cases Discordant Cases Between Sponsor and Between Sponsor and Columbia ClassificationsColumbia Classifications 40/427 cases in which sponsor and 40/427 cases in which sponsor and

Columbia classification differedColumbia classification differed– 26 new cases identified that had not been 26 new cases identified that had not been

identified by sponsors as possibly suicide-identified by sponsors as possibly suicide-relatedrelated

– 2 new cases of self-injurious behavior 2 new cases of self-injurious behavior without suicidal intent that had been labeled without suicidal intent that had been labeled something other than deliberate self-harmsomething other than deliberate self-harm

-12 cases originally called possibly suicidal -12 cases originally called possibly suicidal changed to something other than possibly changed to something other than possibly suicidal suicidal

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Discordant Cases: Discordant Cases: Newly IdentifiedNewly Identified 26 new possibly suicide-related cases 26 new possibly suicide-related cases

identified among expanded body of identified among expanded body of events events – 26 possibly suicide-related26 possibly suicide-related

1 Suicide Attempt1 Suicide Attempt 1 Preparatory Act1 Preparatory Act 13 Suicide Ideation Events13 Suicide Ideation Events 4 Self-Injurious Behavior Intent Unknown4 Self-Injurious Behavior Intent Unknown 7 Not Enough Information to say whether 7 Not Enough Information to say whether

deliberate self-harmdeliberate self-harm

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Example of Newly Identified Example of Newly Identified Suicidal Event: Preparatory Suicidal Event: Preparatory ActAct The patient, age 11, held a knife to his wrist The patient, age 11, held a knife to his wrist

and threatened to harm himself. The patient and threatened to harm himself. The patient was hospitalized with an acute exacerbation was hospitalized with an acute exacerbation of major depressive disorder. The patient of major depressive disorder. The patient was treated with __ and discharged in was treated with __ and discharged in stable condition. stable condition.

Original Adverse Event Label: Exacerbation of Original Adverse Event Label: Exacerbation of Major Depressive DisorderMajor Depressive Disorder

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Discordant Cases: Events Discordant Cases: Events Changed from Suicidal to Changed from Suicidal to Something “Other”Something “Other” 12 Events12 Events

– 2 changed to psychiatric2 changed to psychiatric– 1 changed to accident1 changed to accident– 9 changed to self-injurious behavior no 9 changed to self-injurious behavior no

suicidal intentsuicidal intent

Example Event:Example Event:““this patient is reported to have engaged this patient is reported to have engaged in an episode of ‘automutilation’ where in an episode of ‘automutilation’ where she slapped herself in the face. The event she slapped herself in the face. The event resolved the same day without any resolved the same day without any intervention.” intervention.”

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Results: Results: Agreement with Sponsor Agreement with Sponsor (I): Possibly Suicidal (I): Possibly Suicidal (1,2,6,3,10)(1,2,6,3,10)

237237 2626

1212 102102

Columbia Classification-

Possibly Suicide Related:

Yes

No

No Yes

263

114

128249

Sponsor Classification-Possibly Suicide Related:

Kappa=.77

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3333

Results: Results: Agreement with Sponsor Agreement with Sponsor (II) Definitely Suicidal (II) Definitely Suicidal (1,2,6)(1,2,6)

248248 1515

3232 8282

Columbia Classification-

Definitely Suicide Related:

Yes

No

No Yes

263

114

97280

Sponsor Classification-Definitely Suicide Related:

Kappa=.69

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Results: Reliability of Results: Reliability of Columbia University Columbia University ClassificationClassificationPrimary OutcomePrimary Outcome:: ICCICC

Suicide AttemptSuicide Attempt .81.81Preparatory ActionsPreparatory Actions .89.89Suicidal IdeationSuicidal Ideation .97.97

Sensitivity OutcomeSensitivity Outcome::SIB, Intent UnknownSIB, Intent Unknown .67.67Not Enough InfoNot Enough Info .47.47

Median ICCMedian ICC .86.86

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Future DirectionsFuture Directions

Improve adverse event reporting for suicide-Improve adverse event reporting for suicide-related events by:related events by:

Developing a consistent terminology Developing a consistent terminology Developing guidelines for classification of Developing guidelines for classification of

suicidality (so adequate info provided by suicidality (so adequate info provided by clinician)clinician)

Utilization of research assessment tools (what Utilization of research assessment tools (what questions to ask, how to ask, and what questions to ask, how to ask, and what measures aid this)measures aid this)

Improved, More Valid Identification andImproved, More Valid Identification andDocumentation Of SuicidalityDocumentation Of Suicidality