Sexual interest

Insomnia early

Insomnia middle

Insight

Insomnia late

Loss of weight

Loss of appetite

Suicide

Hypochondriasis

Psychomotor retardation

All other responses

0 20 40 60 80 100

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RESEARCH INSTITUTE©2013 MedAvante Inc.

INTRODUCTION

An International Study of the GRID-HAMD: Has it Fulfilled its Promise?

Williams JBW1,2, Ondrus M1,3, Kitzinger M1, Persson J1, Popescu M1, Valjakka R1

1MedAvante Inc.; 2Dept. of Psychiatry, Columbia University College of Physicians and Surgeons, 3simaMENT s.r.o., Psychiatric outpatient clinics, Bratislava

The Hamilton Depression Rating Scale (HAM-D) has been the target of many critiques (Bagby et al, 2004). An international group representing academia, clinical practice, the pharmaceutical industry and government developed the GRID-HAMD in an attempt to address these critiques and improve administration of the HAM-D (Williams et al, 2008).

The GRID-HAMD provides a novel grid scoring structure that separates frequency and intensity to allow clinicians to rate these as independent axes. The newly-formulated instrument also provides a structured interview guide and scoring conventions on the same page as each item. Finally, the GRID-HAMD presents revised anchor points for items that were problematic or inconsistently rated.

The GRID-HAMD has now been available for five years and has been the major outcome measure for several large clinical trials. This poster presents the results of a survey of a global cohort of 74 highly trained and calibrated clinical interviewers who have collectively administered the GRID-HAMD 4850 times in global clinical trials.

METHODS

The survey was distributed to 74 experienced and well-trained clinical raters in July 2013. It was completed by 60 (81 percent) raters with the following characteristics: •Meanage:40years •Educationalbackground:40(67percent)wereMDorPhD,theremaining33percentwerepsychologists,social workers,or psychotherapists •Allrespondentshadatleastthreeyear’sexperienceassessingdepression •Location:53percentliveinEurope;40percentinUS;5percentinRussia;2percentinSouthAfrica

The survey included statements about the GRID-HAMD that were to be rated on a seven point scale from strongly disagree (1) to strongly agree (7). Statements covered usability and ease of use as well as the new page layout, the revised item wordings and the grid format. Strongly disagree Neutral Strongly agree 1------------2------------3------------4------------5-------------6------------7Inaddition,raterswereaskedtonominatetheitemstheyfoundmostdifficulttoadministeraswellasthosetheyfoundthe easiest to administer, and to describe the reasons for these opinions.

Finally,thequestionnairelistedfourstatementsaskingraterstocomparetheGRID-HAMDwiththeSIGH-D,a widely-used version of the HAM-D (Williams, 1988), with a response from 1=GRID-HAMD to 7=SIGH-D.

GRID-HAMD Neutral SIGH-D 1------------2------------3------------4------------5-------------6------------7

RESULTS

REFERENCES

BagbyRM,RyderAG,SchullerDR,MarshallMB:TheHamiltonDepressionRatingScale:Hasthegoldstandardbecomealeadweight?AmJPsychiatry2005;161:2163-2177WilliamsJBW:AstructuredinterviewguidefortheHamiltonDepressionRatingScale.ArchivesofGeneralPsychiatry1988;45:742-747(contactauthorforlatestversion)WilliamsJBW,KobakKA,BechP,EngelhardtN,EvansK,LipsitzJ,OlinJ,PearsonJ,KalaliA.TheGRID-HAMD:StandardizationoftheHamiltonDepressionRatingScale.InternationalClinicalPsychopharmacology2008;23:120-129

Acknowledgment: ThisworkwassupportedbyMedAvante,Inc.TheauthorswouldliketoacknowledgethehelpofElanCohen,PhD.,andLoriM.Garzio,MS.

Note: The GRID-HAMD may be downloaded, free of charge, at www.iscdd.org. The SIGH-D is available from Janet Williams, PhD at jwilliams@medavante.com, who receives royalties from this instrument.Oneormoreauthorsreportpotentialconflictsthataredescribedintheprogram.

Generally, respondents used the whole range of the response scale, with almost every response category from 1 to 7for each item having at least one selection. For all items, respondents rated most frequently on the positive end of the scale (average mean score=5.14).

Survey questions and percent respondents who disagreed (scored 1, 2, or 3) and those who agreed (scored 5, 6, or 7).

CONCLUSIONS

The GRID-HAMD is well accepted by clinical raters. Raters positively endorsed its new grid format with separate ratings for symptom intensity and frequency, as well as the new page layout, including the scale conventions on the same page as each item. Also, its revised anchor points were endorsed as clearly defined and useful. Raters prefer the graphical layout of the GRID-HAMD, with each item, its interview questions, and its conventions, all on the same page. Surprisingly, however, raters indicated an overall preference for the SIGH-D versus the GRID-HAMD.

RespondentswereaskedtonominatetheitemstheyfoundeasiestandmostdifficultintheGRID-HAMD,andwhy.Easiest and most difficult GRID-HAMD items

Reasons cited:•Conceptofitemisclearlydefined,straightforward.•Fewconventionsandthereforefewerfollow-upquestions are necessary. •Insomniaratingsarebasedonquantitativereportswithconcrete constructs and have fewer scoring options for each item.•Conceptisclearlyunderstoodbysubjects,andresponses are unambiguous.

Reasons cited:•Itemis“toocomplex”and“toobroad,”withtoomany dimensions, a wide range of symptoms and constructs, requiring a greater number of follow-up questions in order to arrive at a rating.•Difficulttoscorewhensubjectsreportvariabilityovertheweek,ordifferentintensitiesofthesymptomfordifferent areas of their life.

Comparison of GRID-HAMD with SIGH-D SIGH-D Sample Item

What’s your mood been like this past week (comparedtowhenyoufeelOK)?

Have you been feeling down or depressed?

IFYES:Canyoudescribewhatthisfeelinghasbeenlikeforyou?How bad is the feeling?

Does the feeling lift at all if something good happens?

How are you feeling about the future?

Inthelastweek,howoftenhaveyoufelt(OWNEQUIVALENT)?Everyday?Allday?

Have you been crying at all?

DEPRESSED MOOD (sadness, hopeless, helpless, worthless):

0 - absent

1 - indicated only on questioning (occasional, mild depression)

2 - spontaneously reported verbally (persistent, mild to moderate depression)

3 - communicated non-verbally, i.e., facial expression, posture, voice, tendency to weep (persistent, moderate to severe depression)

4-VIRTUALLYONLYthosefeelingstatesreportedinspontaneous verbal and non-verbal communication (persistent, very severe depression, with extreme hopelessness or tearfulness)

Forty-six (77 percent) reported enough experience with both scales to compare the SIGH-D to the GRID-HAMD. Surprisingly, the SIGH-D was rated as slightly preferable on all items except graphical layout.

The graphical layout of the pages (with the items, questions, and conventions on the page for the GRID-HAMD, and just the items and questions on the page for the SIGH-D).

Overalleaseofuse(includingadministrationandscoring).

Efficiencyinobtainingtheinformationneededtodotheratings.

Overallpreference.

PREFER PREFERGRID-HAMD SIGH-D

57% 35%

41% 52%

34% 40% 40% 47%

GRID-HAMD Sample Item1. Depressed Mood

This item assesses feelings of sadness, hopelessness, helplessness, and worthlessness.

Note: This is not a global rating of depressive illness.

AbsentNot occurringor clinicallyinsignificant

OccasionalInfrequent,lessthan3days;up to 30% of the week

Much of the timeOften;3-5days;31%-75%oftheweek

Almost all of the timePersistent;6-7days;morethan75%oftheweek

Symptom Intensity

Frequency

Absent

MildFeelings of sadness, discouragement, low self-esteem, pessimism

ModerateClearnonverbalsignsofsadness(suchastearfulness),feelings of hopelessness, helplessness, or worthlessness about some aspects of life

SevereIntense sadness, weeping, hopelessness about most aspects of life, feelings of complete helplessness or worthlessness

Very Severeextreme sadness, intractable hopelessness or helplessness

What’s your mood been like this past week (compared to when you feel OK)?

Have you been feeling down or depressed? Sad or hopeless? Helpless? Worthless?(Canyoudescribewhatthisfeelinghasbeenlikeforyou?Howbadisthefeeling?)

Does the feeling lift at all if something good happens?(Does it go away completely, or is it just less intense?)

How long have you been feeling this way?

How are you feeling about the future?

Haveyoubeencryingatall?IfYES:Howoften?

Frequency •Duringthepastweek,howoftendidyoufeelthisway? •Howmuchofthetimedidyoufeelthisway? •Howmanydaysinthepastweek? ( Was it every day? How much of each day?)

Conventions•ThisitemshouldNOTbeconsideredaglobalmeasureof depressive severity. Item 1 assesses one of several core symptoms of depression.

•Normalmoodfluctuationswithoutclinicalsignificanceshouldberated“0.”

•Ratedepressedmoodevenifpatientattributesmood to reallife problems (e.g., depressed due to bad job, maritalconflict).

•Somepatientsdescribefeelingsoflowmoodwithoutacknowledging“sadness”or“depression”(e.g.,“down”“blah”“numb”).Rateassymptomatic.

•Nonverbalsigns(e.g.,slumpedposture,infrequent eye contact, frowning, sad facial expression) are also considered in assessing severity.

•Donotrateangry,irritable,oranxiousmoodonthisform.

0

0 1 1 2

1 2 3

2 3 4

3 4 4

USABILITY AND EASE OF USE Disagree Agree

Ingeneral,thewordingofthequestionsintheGRID-HAMDmakesiteasytoadminister. 12% 80%

The interview conventions (that appear in the GRID on each item page) are written clearly. 8% 85%

Thescoringconventionsaresufficientlycomprehensive. 15% 73%

In general, the scoring conventions in the GRID-HAMD are unambiguous. 12% 75%

Theexamplesfordifferentlevelsoffrequencysimplifythescoringofitems. 12% 78%

In general, it is easy to decide on a frequency level. 18% 65%

The questions are worded appropriately for most subjects. 10% 77%

TheGRID-HAMDisanefficientwayformetogetalotofrelevantinformationinashortperiodoftime. 18% 68%

REVISED ANCHOR POINTS Disagree Agree

In general, the symptom intensity levels are defined clearly. 12% 82%

TheclinicalexamplesintheGRID-HAMDhavehelpedmedistinguishbetweendifferentsymptom 7% 78%intensity level ratings.

The resulting item scores are usually in line with my clinical impression of the symptom intensity. 10% 88%

PAGE LAYOUT Disagree Agree

Having the scoring conventions integrated into the interview guide has made scoring easier. 5% 87%

The interview conventions (that appear in the GRID on each item page) are helpful when 5% 90%administering the scale.

Workandactivities

Depressed mood

Anxiety, somatic

Guilt

Somatic symptoms,general

Psychomotor agitation

Anxiety, psychic

Psychomotor retardation

Loss of weight

Suicide

All other responses

0 10 20 30 40 50

Which items do you find the easiest to administer in the GRID-HAMD? Which items do you find most difficult to administer in the GRID-HAMD?

GRID FORMAT Disagree Agree

Assessingsymptomintensityandfrequencyseparatelymakesiteasiertoscoretheitems. 10% 78%

In general, it is easy to decide on a symptom intensity level. 8% 85%

Scoring on the GRID-HAMD gives too much weight/importance to frequency (reverse scoring). 38% 23%

ExperiencewiththeGRIDscoringsystemhashelpedmebalancesymptomintensityand 13% 72%frequency when scoring other scales.

% Respondents % Respondents