Adcs-Adl Mci v1 Annotated Crf

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Alzheimer's Disease Cooperative StudyMild Cognitive Impairment

M CSubject Number Subject Initials

Month Day Year

Examination DateExaminer Initials

Center:

ADCS-MCI Activities of Daily Living Inventory - Page 1 of 11Month 6 Visit

Information obtained through: 1 Subject visit2 Telephone call

Subscore for Page 1(Range = 0-10)

INSTRUCTIONS: Complete questions 1-18 and 19-24. Then go back to page 8of this ADL exam to calculate the total score for questions 1-18 and proceed topage 9 of this ADL exam to complete the Dont Know answers worksheet forquestions 1-18.

DontYes No Know

1. In the past 4 weeks, did {S} usually manage to find his/her personalbelongings at home?If yes, which best describes how he/she usually performed:

3 without supervision or help

2 with supervision

1 with physical help

2. In the past 4 weeks, did {S} select his/her first set of clothes for the day?If yes, which best describes his/her usual performance:


2 with supervision


3. Regarding physically getting dressed, which best describes his/her usualperformance in the past 4 weeks: (check one)

4 dressed completely without supervision or physical help

3 dressed completely with supervision, but without help

2 needed physical help only for buttons, clasps, or shoelaces

1 needed some help even if clothes needed no fastening or buttoning

0 someone else dressed him/her

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5. In the past 4 weeks, did {S} balance his/her checkbook or a credit cardstatement?

If yes, which best describes how he/she usually performed:


1 with supervision


6. In the past 4 weeks, did {S} ever write things down?Note: If {S} wrote things only after encouragement or with help, the response

should still be yes.

If yes, which best describes the most complicated things that he/she wrote:

2 letters or long notes that other people understood

1 short notes or messages that other people understood

0 his/her signature or name

DontYes No Know

4. In the past 4 weeks, did {S} clean a living-, sitting-, or family room?If yes, which best describes how he/she usually performed:


1 with supervision


7. In the past 4 weeks, did {S} clean a load of laundry ?If yes, which best describes how he/she usually performed:


1 with supervision














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Subject Number


DontYes No Know

8. In the past 4 weeks, did {S} keep appointments or meetings with otherpeople, such as relatives, a doctor, the hairdresser, etc.?

If yes, which best describes his/her awareness of the meeting ahead of time:

3 usually remembered without written or verbal reminders

2 usually referred to notes, a diary, or calendar

1 usually remembered the appointment after verbal reminders on

the day

0 usually did not remember, in spite of verbal reminders on the day

9. In the past 4 weeks, did {S} use a telephone?If yes, which best describes his/her highest level of performance:

4 made any call necessary e.g., after looking up numbers in white or

yellow pages, or by dialing directory assistance

3 made calls only to well-known numbers, without referring to a

directory or list

2 made calls only to well-known numbers, by using a directory or list

1 answered the phone and spoke to callers; did not make calls

0 did not answer the phone, but spoke when put on the line

10. In the past 4 weeks, did {S} make him/herself a meal or snack at home?If yes, which best describes his/her highest level of food preparation:

3 cooked or microwaved food, with little or no help

2 cooked or microwaved food, with extensive help

1 mixed or combined food items for a meal or snack, without

cooking or microwaving (e.g. made a sandwich)

0 obtained food on his/her own, without mixing or cooking it











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DontYes No Know

11. In the past 4 weeks, did {S} get around (or travel) outside of his/her home?If yes, which best describes his/her optimal performance:

3 traveled alone, went at least 1 mile away from home

2 traveled alone, but remained within 1 mile of home

1 traveled only with a chaperone for supervision regardless of the trip

0 traveled only with physical help, regardless of the trip

12. In the past 4 weeks, did {S} talk about current events? (This means events orincidents that occurred during the past month.)

If yes, ask questions 12a, 12b, 12c and 12d :

12a) Did {S} talk about regional, national, or international events

(including sports)?

1 Yes 0 No

12b) Did {S} talk about events outside home involving family, friends, or

neighbors?

1 Yes 0 No

12c) Did {S} talk about events that occurred at home that he/she

took part in or watched?

1 Yes 0 No

12d) Did {S} converse without repeating him/herself, or asking the

same questions repeatedly?

1 Yes 0 No




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DontYes No Know

13. In the past 4 weeks, did {S} read a magazine, newspaper or book for morethan 5 minutes at a time?

If yes, ask questions 13a, 13b and 13c:

13a) Did {S} usually select or ask for something to read?1 Yes 0 No

13b) Did {S} usually talk about what he/she read while or shortly after reading (less than 1 hour)?

1 Yes 0 No

13c) Did {S} usually talk about what he/she read 124 hours

after reading?

1 Yes 0 No

14. In the past 4 weeks, did {S} watch television?If yes, ask questions 14a, 14b and 14c:

14a) Did {S} usually select or ask for different programs or his/her favorite show?

1 Yes 0 No

14b) Did {S} usually talk about the content of a program while watching it?

1 Yes 0 No

14c) Did {S} talk about the content of a program within a day (24 hours)

after watching it?1 Yes 0 No











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DontYes No Know

15. In the past 4 weeks, did {S} ever go shopping at a store?If yes, ask questions 15a and 15b:

15a) Did {S} usually select correct items without supervision or help?

1 Yes 0 No

15b) Did {S} usually pay for items on his/her own?

1 Yes 0 No

16. In the past 4 weeks, was {S} ever left on his/her own?If yes, ask questions 16a, 16b and 16c:

16a) Was {S} left away from home, for 15 minutes or longer, during the day?

1 Yes 0 No

16b) Was {S} left at home, for an hour or longer, during the day?1 Yes 0 No

16c) Was {S} left at home, for less than 1 hour, during the day?

1 Yes 0 No











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Subject Number


DontYes No Know

17. In the past 4 weeks, did {S} use a household appliance to do chores?(This does not include a TV.)If yes, ask about all of the following, and check those that apply:

washer dryer vacuumdishwasher power tool(s) toaster ovenrange microwave food processorother _____________________________

If yes, ask question 17a:

17a) For the 1 or 2 most commonly used appliances, which best describes how {S} usually used them:

4 without help, and operated all necessary controls

3 without help, but operated only on/off controls

2 with supervision (e.g., instructions), but no physical help


Note: plugging in and switching on = 3; switching on and adjusting volume/power = 4




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DontYes No Know

18. In the past 4 weeks, did {S} perform a pastime, hobby or game?If yes, ask about all of the following, check all that apply:

card or board games (including bridge, chess, checkers)bingo crosswords artmusical instrument knitting sewingreading gardening golftennis workshop fishingother _____________________________

Note: Walking does NOT count as a hobby/pastime for this scale.

If yes, ask questions 18a and 18b:

18a) Did {S} require supervision, or help, to perform any of these hobbies?

3 no supervision required

2 supervision

1 help

18b) List any hobby(ies) that the subject has lost the ability to perform:__________________________________________________________________________________________________________________________________________

Proceed to questions 19-24 on pages 10 and 11 of this ADL exam,Then return to this page to total the scores for questions 1-18.



ADL TOTAL SCORESum the page subscores forpages 1-8 of the ADL (items 1-18)

ADL Total Score.(Range = 0-53)



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Were any questions (1-18) answered Dont Know?

1 Yes (Complete worksheet below)2 No (Enter 00 for Total

Dont Know points)

WORKSHEETINSTRUCTIONS:Only for specific questions in 1-18which were answered Dont Know:

Enter the value from the pointscolumn in the corresponding DontKnow box for that question.

For example, if question 1 wasanswered Dont Know then write3 in the Dont Know box forquestion 1.

Only fill in boxes which correspondto Dont Know answers.

Question#

Sum the DontKnow pointswhich wereentered above.Enter 00 if none.

DontKnowPoints

Total Points forDont Know

1 32 3

3 4

4 25 2

6 2

7 28 3

9 410 3

11 3

12 413 3

14 3

15 216 3

17 4

18 3

Dont Know Answers Worksheet



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20. During the past 4 weeks, did {S} take his/her medications regularly ?If yes, was this:

4 Independently 3 Only after frequent verbal reminders to do so 2 Took medications without help if they were set out or arranged

for him/her

1 Usually or only when someone else gave the medications

21. During the past 4 weeks, did {S} usually carry through complex ortime-consuming activities to completion ?

If yes, which best describes extent to which he/she needed reminders:

3 Rarely or never needed reminders or prompts 2 Sometimes needed reminders or prompts (several times per week) 1 Needed regular reminders or prompting (daily)

Instrumental Activities of Daily Living(Do not include these questions in the Total Score)

DontYes No Know

19. In the past 4 weeks, did {S} drive a car ?If yes, which best describes his/her optimal performance:

3 {S} drove anywhere, without limitation or help 2 {S} drove short distances locally, without limitation or help 1 {S} drove short distances locally, only with a passenger who provided

input such as directions or instructions








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23. During the past 4 weeks, how long did it usually take {S} to complete com-plex or time-consuming tasks or activities ? (check one)

3 Normal speed or duration, compared to {S}s performance overthe past few years

2 Slower than would have been the case a year or two ago 1 Occasionally failed to complete complex tasks, or made errors


22. During the past 4 weeks, to what extent did {S} initiate complex daily activitiesor projects (e.g., hobbies, travel) ? (check one)

3 Rarely or never needed reminders or prompts 2 Sometimes needed reminders or prompts (several times per week) 1 Needed regular reminders or prompting (daily)

24. Has an EXTENUATING CIRCUMSTANCE (such as a physical healthproblem, change in residence, change in support network, death of a family

member, etc.) contributed to a recent alteration in the subjects activities of

daily living?

If yes, explain: ____________________________________________________________________________________________________________________________________________________

DontYes No Know

REMINDER: After completing all of the questions, please go back to pages8 and 9 of this ADL exam to complete the scoring for questions 1-18.





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55

General Remarks

There are widely varying methodsof carrying out activities of dailyliving (ADL), especiallyInstrumental ADL. This can leadto difficulty when trying to obtainADL ratings from an informant ina standardized way for a clinicaltrial. The ADL Inventoryapproaches this problem byproviding detailed descriptions ofkey elements of each activity, andby asking the informant todescribe observed actions orbehaviors.

The informant is asked to focuson the past 4 weeks. In the MCIprotocol, subjects will begenerally high functioning, andchanges may be subtle andintermittent. Information coveringthe past 2-3 months may bepermissible if the ADL in questionis only attempted veryinfrequently.

The informant must not estimatewhat the subject might be able todo had an opportunity arisen, butshould report what the subjectactually did. The informant shouldnot try to interpret the subjectsthought processes or intentions.To help the informant to remainfocused on observed actions, itmay be helpful to ask him/her forexamples of what the subject didregarding the ADL in question.

Content of the ADL Inventory forMCI

The ADCS ADL Inventory hasbeen adapted for the MCIprotocol, retaining only those

questions that distinguishedbetween elderly controls andpatients with mild diagnosed AD(CDR 1, MMSE > 20). In addition,several new questions are beingtested. The new questions appearat the end of the inventory andare not used in deriving a pointscore.

Administering the ADL

The Inventory has beendeveloped and tested as aninterview given by a rater, either inperson or by telephone. It shouldnot be filled out by the informant.

If the most knowledgeableinformant is not the person whoaccompanies the subject to clinicvisits during the study, then theinformation should be collectedby telephone from the bestinformant.

Change of informant: forconsistency of information, thesame informant should be usedthroughout the study. If itbecomes essential, a change ofinformant can be made.

Format of ADCS MCI-ADLQuestions

Most items start with a mainquestion did the subjectperform the ADL? for whichthe first answer is yes, no or dontknow. No or dont knowresponses act as fast forwardcues to proceed to the next item.

After an initial yes response,there are 3 types of questions:

n forced choice of bestresponse: e.g. #3: gettingdressed

n choice of level of ability:independent, withsupervision, with physicalhelp (e.g. #1 findingbelongings at home)

n a set of sub-questions, eachof which has a yes or noresponse. The instructionsdirect you to answer eachsub-question.

Standardizing independently,with supervision and with help

Independently = the subjectcompleted the ADL withoutphysical help, and at the mostafter reminders to do the task, ora brief prompt while carrying outthe activity. Time taken to performthe ADL does not matter.

With supervision = the subjectrequired verbal reminders andinstructions while carrying out theADL. This occupied the caregiver/informants time.

With physical help = Thesubject was given some degreeof physical help to perform theADL. The subject still made auseful contribution to the ADL.

For the MCI protocol, the mostfrequent judgment will be thedistinction betweenindependence versus supervision,instructions or guidance.

Usual performance of ADL

Subjects may vary from day today in their ADL performance. Ifan informant responds that thesubject sometimes performs ADLat one level and sometimes at

Guidelines for interviewers for the MCI Trial

ADCS MCI Activities of Daily Living inventoryDouglas Galasko, MD / 10/1998

ADL

56

another, the interviewer shouldask him/her to choose the mostconsistently applicabledescription for the prior 4weeks.

When in doubt about whetherthere is any degree of loss ofindependence of a particularADL, choose independent ifthat is the most consistentway that the subject performsthe activity. The rationale is thatunequivocal impairment offunctional ability is necessary tosupport the diagnosis ofdementia, not inconsistent errorsin carrying out ADL eventhough these may be warningsthat progression to dementia islikely. This is very conservative,and will result in subjects beingscored as independent foractivities where they arebeginning to show decline.However, it will prevent overcallingADL impairment.

ADL that are not attempted forreasons such as habit, gender,etc.

If specific ADL have not beenattempted recently by the subject,they should be scored as noregardless of whether they havebeen abandoned/lost or neverhabitually performed. This willdecrease the subjects potentialADL total score by the sameamount each time the ADLinstrument is given, and does notinfluence progressive decline ofADL ability as measured by serialscores.

ADL where help is provided forphysical reasons: e.g. subjecthas physical impairment such asarthritis.

Here the subject should bescored as requiring supervision orhelp for the ADL. Again, the abilityto perform the specific ADL inquestion is not likely to changespontaneously on later visits.

Scoring questions for the MCIADL:

The worksheet on page 9 shouldbe filled out after completing theADL interview. Follow theinstructions on the worksheet tocalculate the total points forDont Know responses.

Comments about specificquestions in the Inventory:

1. Find belongings at home:keys, wallet and glasses maybe used as prompts fortypical belongings.

2. Selecting clothes for the day:implies that subject can findall necessary clothes andmake decisions.

3. Dressing: it does constitutesupervision if the subjectfrequently forgets importantitems of clothing or itemsessential because of climateconditions e.g. a raincoat,hat or gloves.

4. Clean a room: presumablysupervision or help willbecome necessary ascognition declines. Howeverit is possible that, as alifelong habit, a cognitivelyintact subject will clean aroom only when helped. In

that case, the only type ofchange over time that can bedetected will be completeloss of the ability.

5. Balance checkbook/creditcard statement: if the subjectgives this task to someoneelse, they will score no (0)throughout the trial. If he/shealways balances thecheckbook/statement withhelp, they do have room todecline; he/she may lose theability to have meaningfulinput into this task as theircognition declines

6. Write things down: MCIsubjects can receive fullcredit for being independent(writing intelligible letters orlong notes) even if they showslightly impaired quality ofwriting. Writing a messagethat someone else dictates,or preparing an intelligibleshopping list or to do listwould count as writing.

7. Clean a load of laundry:Again note that supervisionmeans more than a reminderto get started on the task.

8. Keep appointments ormeetings: evaluates memoryability. If the subjectsometimes uses memoryaids (notes, calendar, etc.),and sometimes not, thenchoice between the highestand second highest levelshould depend on the usualpattern of behavior.


ADL

57

9. Use a telephone: remindersor prompts are allowable,e.g. the subject can be toldto call directory assistance ortold where to look upnumbers in a commercial orpersonal directory. If he/shethen uses the telephoneindependently, this should berated as the highest level.

10. Prepare a meal or snack:subtle impairment of cookingability e.g. errors whilecooking complex recipes, willnot be captured by thisquestion unless the amountof help changes.

11. Travel beyond home:intended to cover thesubjects ability to remainoriented, not to get lost andto venture beyond home toany destination. It does notmatter whether the subjectwalks, drives or takes publictransport, or is a passengerin a car. The distance of 1mile is arbitrary and impliestravel beyond sight of home.We have decided not to rategetting lost.

12. Current events: For most MCIpatients, responses are likelyto be yes for talking aboutevents regardless of wherethey occurred. However theymay repeat themselves as anearly sign of significantmemory impairment.


13. Read a magazine,newspaper or book: as forthe television question, theresponses target makingchoices and recalling details.Subtle decrements in abilitymay not be captured.

14. Watch television: thesubquestions assess whetherthe subject made choicesabout what to watch or not,and whether theyremembered enough aboutthe program to talk about itscontent afterwards. A subtlechange in memory ability willnot be captured by thesequestions.

15. Shopping: we have focusedon two aspects of shopping:selecting items appropriately,and paying. Transport to thestore is covered by a priorquestion.

16. Left alone: this question maynot be sensitive enough formost MCI patients, althoughclear conversion to milddementia may involvechange.

17. Use a household appliance: amenu of appliances isprovided. An appliance isdefined as a device with oneor more switches or controls,used to do householdchores. It usually has apower supply. For men,power tools would apply, buta hammer or screwdriverwould not. Again, supervisiongoes beyond reminding tobegin the task.

18. Pastime or hobby: a menu isprovided. Hobbies shouldinvolve concentration,knowledge and memory, manual skills. If a hobby noton the list is selected, pleasedescribe what the patientactually does to permitmonitoring.

24. Changes in ADL performancemay occur for reasons otherthan cognitive decline. Thisquestion asks the informantwhether other factors couldbe responsible for ADLworsening, or evenimprovement. These includea physical problem (e.g. hipfracture); or a change insocial circumstances (e.g.moving to a different type ofhome.) The yes, no ordont know response mustbe transcribed on the SubjectEvaluation Summary.

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58

The next group of questions are new and targeted at MCI subjects. Their data will be entered butshould not be tallied into the total ADCS MCI-ADL Score.

Drive a car: loss of driving ability isunlikely for MCI patients beforeentry to the study. For habitualnon-drivers or patients who havestopped driving for physicalreasons, there will be no furtherdeterioration over time.

Take medications regularly: thismay be a moot point in a drugstudy, because most subjects arelikely to be supervised. We willcollect the data to see whetherfurther changes occur over time.

Initiate complex daily activities orprojects: Presumably MCIsubjects will be involved in someactivities that met this standard;hobbies, shopping trips, trips tounfamiliar places or trips withmultiple stops are examples. The

question probes whether theymake the necessary plans andarrangements themselves, or doso only after prodding.

Carry through complex dailyactivities or projects: havingbegun a complex activity, doesthe subject sustain attention andpersevere to completion, or issome degree of ongoingencouragement/supervision/helpneeded?

Time taken to complete complexdaily activities or projects: Thisasks the informant to make arelative judgment on two issues:1) speed, and 2) accuracy. Again,overall usual performance isassessed, so that occasionalinfrequent lapses or errors areallowed even at the highest level.


ADL

ADCS - ACTIVITIES OF DAILY LIVING (ADL) INVENTORY

NOTES: (1) {P} refers to the participant and should be replaced by the participantsname or relationship to the study partner each time an ADL questionis asked of the study partner.

(2) This ADL inventory must be given in the format of an interview of thestudy partner, either directly or by telephone. The form should NOT begiven to a study partner to complete on his/her own.

READ THE FOLLOWING INSTRUCTIONS TO THE STUDY PARTNER:

I am going to ask you about a number of daily activities that {P} may have performedduring the past 4 weeks. Please tell me about {P}s actual performance, not about whathe/she could have done if an opportunity had arisen. For each activity that {P}attempted, Im going to ask you to choose one out of a number of descriptions that bestfits his/her most usual performance.

For some activities, Ill ask about whether {P} performed independently, or withsupervision or help. Let me explain how we are defining these words:

Independently means that {P} completed the activity without being helped. We stillconsider it independent if {P} was reminded or prompted to get started, orreceived a little prompting while performing the activity.

With supervision means that {P} required verbal reminders and instructions whiledoing the activity.

With help means that {P} was given some degree of physical assistance by anotherperson to perform the activity.

INSTRUCTIONS FOR THE RATER:

If the study partner states that {P} had no opportunity to perform the task during the pastfour weeks (e.g., {P} did not have access to a telephone, therefore could not possiblymake phone calls), the response should be recorded as no.

If either the study partners answer or the questionnaire are unclear, please make noteson the case report form detailing the problem.

For questions regarding specific ADL items, please refer to the ADL Response Card.

Alzheimer Diseaseand AssociatedDisordersVol. 11, Suppl. 2, S33-S39@ 1997Lippincott-Raven Publishers,Philadelphia

An Inventoryto AssessActivitiesof Daily Living for ClinicalTrialsin Alzheimer'sDisease

)

DouglasGalasko,*DavidBennett,tMary Sano,ChrisEmesto,RonaldThomas,MichaelGrundman,:j:StevenFerris,andtheAlzheimer'sDiseaseCooperativeStudy

DepartmentofNeurosciences(Neurology),Universityof California,SanDiego,California;*RushAlzheimer'sDiseaseCenterandDepartmentofNeurologicalSciences,Rush-Presbyterian-St.LukesMedicalCenter,Chicago,Illinois;tDepartmentof

Neurology,ColumbiaUniversityandtheSergievskyCenter,NewYork,NewYork;and:j:DepartmentofPsychiatry,NewYorkUniversityMedicalCenter,NewYork,NewYork,u.S.A.

Summary:Wedevelopeda setof infonnant-baseditemsdescribingperfonnanceofactivitiesofdailyliving(ADL) bypatientswithAlzheimer'sdisease(AD)toidentifywhichADL areusefulforassessmentofpatientsin clinicaltrials.EvaluationofADLis animportantoutcomemeasureinAD clinicaltrials.Forclinicaltrialmeasurement,ADL shouldhavebroadapplicability,goodtest-retestreliability,scalingto coverarangeofperfonnance,andsensitivytodetectchangeindiseaseprogression.A totalof45ADL itemsdevelopedfromliteraturereviewandclinicalexperiencewereadmin-isteredtoinformantsof 242AD patientsand64elderlycontrolsaspartof themul-ticenterAlzheimer'sDiseaseCooperativeStudyInstrumentprotocol.Halfofthesub-jectswerere-evaluatedat 1 and2 monthsandall at 6 and12months.Controlsperformedvirtuallyall ADL itemsoptimallyatbaselineandat12months.AmongsubjectswithAD,27ofthe45ADL werewidelyapplicable,i.e.,performedatbaselineor premorbidlyby >90%of subjects;showedgoodtest-retestreliabilitybetweenbaselineand1 and2 months;correlatedwithMMSE scoresof AD patientscross-sectionally;andshowedadeclineinperformancefrombaselineto12monthsinatleast20%ofAD patients.ADL couldbeidentifiedthatcapturechangeinfunctionalabilityin patientsacrosstheentirerangeof theMMSE. Theremaining18ADL includedseveralthatmaybeusefulfortrialsthattargetspecificpopulations,e.g.,womenwithAD. BecausechangeonspecificitemsdependsonbaselineMMSE, ADL evaluationshouldincludeitemsrelevantto theseverityof dementiaof patientsenrolledin aclinicaltrial.Key Words:Alzheimer'sdisease-Activitiesof dailyliving-Clinicaltrials-Patientassessment.

Functionalassessmentof patientswith Alzheimer'sdisease(AD), in termsof performanceof activitiesofdaily living (ADL), is a criticalelementin patientcare.For investigationaldrugstudies,changesin ADL perfor-mancecanbe usedasa secondaryoutcomemeasuretodocumentthatcognitiveor othereffectsof an anti-AD

Address correspondenceand reprintrequeststo Dr. D. Galasko atNeurologyV127, VA Medical Center,3350La Jolla Village Drive, SanDiegoCA 92161,U.S.A. (TheInventoryof ADL andanaccompanyingmanualareavailableon requestfrom Dr. Galasko.)

drug are clinically relevant.Treatmentthat enhancescognitivefunctionshouldleadtoimprovementin perfor-manceof ADL, whereastreatmentthat slows the pro-gressionor delaystheonsetof AD shouldbe associatedwithpreservationor slowerdeteriorationof ADL perfor-mance.

Althoughscoresof ADL scalesandcognitivetestsarecorrelatedin patientswith AD (Pfefferet aI., 1982;Vi-talianoetaI., 1984),ADL performancealsodependsonfactorssuchassustainedattention,motivation,andmo-tor performance.It is difficult to predictfrom overall

S34 D. GALASKOET AL.

cognitivetestscoresor evenfromtestsof specificcog-nitivedomainswhichADL arelikely to be impairedorhow severetheimpairmentwill be (Loewensteinet aI.,1992).The amountof cognitivechangeneededto pro-ducea changein ADL performanceis unknown.

ADL evaluationfor clinical trials is an understudied

area.Most ADL scalesweredevelopedfor generalge-riatric assessmentand to help determinethe needforservices,andfocuson basicactivitiessuchas walking,feeding,andtoileting(Katz et aI., 1963;Lawton et aI.,1969).A fewscales,suchasthoseof Blessed(BlessedetaI., 1968),Lawton(LawtonetaI., 1969),Pfeffer(Pfefferet aI., 1982),Weintraub (Weintraub, 1986), and theNOSGER (Spiegelet aI., 1991)wereintroducedfor ge-riatric assessmentor for clinical evaluationof patientswithAD, andincludeitemsthatassessmorecomplicatedactivities(instrumentalADL, IADL). Some of thesescalescontaingender-specificitemsor itemsperformedatinfrequentintervals,suchasfilling outformsor docu-ments.Othersaskwhethera subject"can" performanADL ratherthanrelyingon purelyobservedactivities,which introducesjudgmentor opinion into the infor-mant'sreport.Severalscalescombineboth ADL andbehavioralinformation(Blessedet aI., 1968;SpiegeletaI., 1991).Many IADL showa floor effectin AD, i.e.,patientsloseIADL veryearlyin thecourseof dementia,whereasbasicADL showa ceilingeffect,with normalperformanceuntillatein thecourseof AD (SpectoretaI.,1978).The approachof usingloss of ADL or IADL asmilestones(GalaskoetaI., 1995)is similarto thatof theFunctionalAssessmentScale (Reisberg,1988)and isbestsuitedto clinical studieswith long follow-up peri-ods.

PerformanceADL (PADL) scalesrequiresubjectstoperformADL tasksin a structuredsettingusingprops(Loewensteinet aI., 1992).Scoringis standardizedandcancaptureelementsof performancesuchassequencing,initiation,andmotivation.However,PADL scalescovera relatively small number of activities, are time-consuming,anddonotevaluateperformancein thesub-jects'ownhomeenvironments.In viewof thelimitationsof existinginstrumentsfor usein clinicaltrials,theAlz-heimer'sDiseaseCooperativeStudy(ADCS) developeda setof informant-basedADL.

METHODS

Developmentof theInventory

A subcommitteeof theADCS, composedof clinicianswithexpertisein dementiaassessmentandclinicaltrials,developedan inventorycomprisinga wide rangeofADL. The initial itempool consistedof activitiesthat

AlzheimerDiseaseand AssociatedDisorders, Vol. 11, Suppl.2, 1997

normalelderly individualsregularlyperformand thatwere likely to be relevantto patientswith AD over abroadrangeof severityof dementia.The inventoryin-cludedADL from existingscalesandnovelitemsbasedon clinical experience,i.e.,ADL necessaryfor personalcare,communicatingandinteractingwith otherpeople,maintaininga household,conductinghobbiesandinter-ests,andmakingjudgmentsanddecisions.

For eachADL, an informantis first askedwhetherornot thepatientattemptedthe activityduringthepast4weeks.If apatientdid attempttheADL, theinformantisaskedtochoosethesinglemostaccuratedefinitionof thepatient'slevel of performancefroma setof descriptionsof alternativemethodsof carryingout the ADL. ForADL in whichdifferentmethodsof performancedo notapply,theinformantis askedwhetherthesubjectusuallycarried out the ADL "independently" (the highestlevel), "with supervision"(needingverbalinstructionsduringADL performance,an intermediatelevelof abil-ity), or "with physicalhelp" (a lower level of perfor-mance).If a subjectneededremindersto getstartedbutthenperformedanADL independentlyandsuccessfully,thatis ratedasindependently.Thesedefinitionsof levelsof independenceareexplainedto informantsbeforetheinventoryis administered.To verifythatnonperformanceof ADL wasduetolossof ability,for eachADL thatwasnotattemptedduringthe4-weekperiod,informantswereaskedwhetheror not patientsperformedthe activitypremorbidly.

The ADL questionswere pretestedat three sites,modified where necessaryto enhancetheir clarity,andan inventoryof 45 ADL was administeredto ADpatientsand controlsas part of an ADCS multicenterstudy.

Subjects

TheADCS studyof instrumentdevelopmentforADclinical trialsenrolledelderlycontrols(n =64;24menand40women)andsubjectswithAD (242AD patients;94menand148women)asdescribed(FerrisetaI.,thisissue).RecruitmentofsubjectswithAD wasstratifiedbyMini-MentalStateExamination(MMSE;FolsteinetaI.,1975)scoresat baseline,andall werecommunity-dwellingatthetimeof enrollmentin thestudy.All sub-jectswereevaluatedatbaselineandat6 and12months,andhalf of thesubjectswereevaluatedat 1 and2months.Thepresentstudymadeuseof dataatbaseline,1,2,and12months.

Procedures

ForeachAD patient,aninformantwhospentatleast2 daysperweekwiththepatientwasidentifiedandin-

ADL INVENTORY

terviewedwith the ADL Inventory.Controls actedastheirowninformants.ADL interviewswereconductedin

personatbaseline.To increasefollow-upparticipation,ifinformantswereunabletotravelto a center'sclinic site,interviewswereconductedby telephone.A representa-tive from eachparticipatingcenterattendeda trainingse~sionatwhichuseof theinventorywasdescribed,andea~hsitereceiveda proceduralmanualdescribingeachquestionin theADL Inventory.The personnelwho car-ried out ADL interviewswerepsychometristsor clini-cianswithexperiencein assessmentof patientswithAD.The ADL Inventorytook from 30 to 45 min to admin-ister.

DataAnalysis

DatawereanalyzedusingSPSS (version6.1).WeusedseveralcriteriatodeterminewhichADL in thein-ventorywerelikelytobebestsuitedforusein monitor-ingpatientsinclinicaltrials.Theseincludedwideappli-cability,goodtest-retestreliability,abilityof theADL toshowstepwisescalingandto correlatewithdementiaseverity,anddeclineof ADL performancein anappre-ciablepercentageof patientswithAD over12months(FeinsteinetaI.,1986;StreinerandNorman,1995).Ap-plicabilitywasmeasuredasthepercentageof subjectswhoattemptedeachADL atbaseline,orpremorbidlyinthecaseof AD patientswhodid notattemptspecificADL. As anindexof short-term(test-retest)reliabilityforeachADL, theextentofagreementbetweenratingsatbaseline,oneandtwomonthswascalculatedusinga Kstatistic(O'ConnellandDobson,1984).To determinewhetherthelevelsof performingeachADL relatedtodementiaseverity,wecomparedMMSE scoresbetweenpatientswhocarriedouttheADL ineachspecifiedman-neratbaselinebyANOVA. If MMSE scoresofpatientsperforminganADL atdifferentdescriptorsor"levels"of ADL performancedid not differ significantly(p

S36 D. GALASKOET AL.

baseline,a floor effectthatrendersit unsuitablefor ageneral-purposeADL scale.

We nextexaminedshort-term(test-retest)reliability,usingK statisticsto assesstheextentto whichratingsofperformanceof eachADL itemagreedatbaselineandatI and2 months.Over2 months,theprogressionof ADshouldnotbe greatenoughto leadto a changein ADLperformance.In general,KSfell into the0.4-0.75range,indicatingmoderateto very good agreement.AmongADL with the highestKSwereactivitieswhoseratingsweredichotomous(yesor no) andthe traditionalbasicADL. Severalitems,i.e.,cleaningup spills,beingawareof toiletingneeds,andparticipatingin a groupeventhadlow KS0.4, indicatingonly fair agreement)andwereeliminatedfromcontention.

Stepwisescalingof levelsof ADL performanceandcorrelationwithdementiaseveritywasthenextcriterion.TablesI and2 includethenumberof levelsspecifiedfor

AlzheimerDisease andAssociatedDisorders, Vol. 11, Suppl.2, 1997

eachADL in the inventory;an ADL questionwith adichotomous(yesor no) responsehastwo levels,whileonethatcanbe performedindependently,with supervi-sion,with somephysicalhelp,or not atall hasfour.Todeterminewhethertheselevelshavehierarchicalproper-ties,wefirstexaminedtheMMSE scoresofpatientswhoperformedeachADL ateachspecifiedlevelatbaseline.As anexample,MMSE scoresfor levelsof usinga tele-phonearedisplayedin Fig. 1. For mostADL, as eachlevel indicatedless independentor less complexADLperformance,theMMSE scoresshowedapatternof pro-gressivedecrease.If two descriptorsof an ADL corre-spondedto a similarrangeanddistributionof MMSEscores,thenthedescriptorswere assumedto representcognitivelyequivalentlevelsof theADL. This suggestedthatthepair of descriptorscouldbe mergedandperfor-manceof thatADL couldbe adequatelydescribedusingone level less. This situationarosevery infrequently,

TABLE 1. Metricpropertiesof selectedADL Inventoryquestionsin patientswithAD

Applicability:%of subjects Changeat12months:attemptingADL atbaseline Test-retest Correlation % of subjectswhodeclinedonADL

By MMSE stratab reliability withMMSE By MMSE stratabADL question

(numberof levelst Overall >20 16 10 5 0 (K) (SpearmanR) Overall >20 16 10 5 0

Handlesmail(3) 30 1 1 I 0.41* 0.50** 22 .. .. 0 0Discussescurrentevents(4) 44 . 1 1 0.51* 0.48** 30 .. .. . 0Makesa snackormeal(5) 50 . 1 1 I 0.62* 0.55** 30 0 .. .. 0Writesnote/letter/name(4) 51 . 1 1 I 0.59* 0.57** 33 0 .. .. .. 0Useshouseholdappliance(4)C 53 . 1 1 1 0.62* 0.61** 34 0 .. .. .. 0Reads(4) 54 . 1 1 1 0.45* 0.56** 30 .. .. .. .. 0Hobby/pastime/game(3r 56 . 1 1 1 I 0.59* 0.44** 29 0 0 .. .. 0Choosesclothestowear(3Y 56 . 1 1 I 0.59* 0.54** 36 0 .. .. .. 0Turnsoff lights(2) 60 . 1 1 1 I 0.61* 0.44** 24 0 0 .. .. 0Putsawaybelongings(4)C 61 . 1 1 1 I 0.45* 0.46** 35 0 .. .. .. 0Canbeleftalone(4) 62 . 1 . 1 0.52* 0.55** 35 .. .. . .. 0Goesshopping(3) 63 . 1 . 1 I 0.48* 0.47** 36 .. .. .. .. ..Keepsappointments(4) 70 . 1 . 1 1 0.46* 0.44** 35 0 0 .. .. .Obtainsabeverage(5) 70 . . . 1 I 0.54* 0.61** 40 .. . . .. 0Findsbelongings(3)C 71 . . 1 1 I 0.40* 0.42** 37 0 .. .. .. ..Clearsatable(4)C 71 . 1 . 1 1 0.60* 0.45** 32 0 0 .. .. ..Disposesof litter(4)C 73 . . . 1 1 0.43* 0.49** 35 0 .. .. .. ..Makesconversation(4) 75 . 1 1 1 1 0.41* 0.40** 35 0 0 .. .. ..Grooms(5) 75 . . . 1 I 0.55* 0.64** 35 0 .. . 0Getsdressed(5) 75 . . . 1 I 0.55* 0.66** 42 0 . . . 0Bathes(5) 77 . . . 1 I 0.73* 0.66** 40 0 .. .. . ..Usesa telephone(4) 80 . . . 1 1 0.50* 0.70** 47 .. . . . ..Travelsoutsidehome(5) 90 . . . . . 0.59* 0.50** 44 .. 0 .. .. ..WatchesTV (5) 92 . . . . . 0.45* 0.44** 34 .. .. .. . ..Toileting(4) 92 . . . . . 0.66* 0.61** 37 0 .. . .Walking(5) 97 . . . . . 0.45* 0.28** 14 0 0 0Eating(5) 97 . . . . . 0.60* 0.55** 30 0 .. . .

a ADL arearrangedin ascendingorderaccordingtotheoverallpercentageof patientswithAD whoattemptedtheADL atbaseline.bMMSE strataareasfollows:>20,20-28points;16,16-20;10,10-15;5,5-9;0,0-4.SymbolsindicatethepercentageofsubjectsinMMSE strata

whoattemptedeachADL atbaseline:. >80%;161-80%;141-60%;121-40%;blank0-20%.Symbolsforthepercentageof subjectswhodeclinedat 12monthsareas follows: . 50%; .. 30-49%; 0 10-29%; blank 0-9%.

C ADL descriptorshadtheformat"independently,""withsupervision,"or "withphysicalhelp."All otherADL hadspecificallywordeddescriptorsof differentlevelsof ADL performance.

* p < 0.01;**p < 0.001.

ADL INVENTORY S37

a ADL descriptorshadtheformat"independently,""with supervision,"or "with physicalhelp."All otherADL hadspecificallywordeddescriptorsof differentlevelsof ADL performance.

bSev: impairedperformancewasnotedonly in severelydementedpatients.

almost exclusively for the descriptorsthat indicatedminimal performanceof the ADL (e.g., "with helponly") andcompletelossof theADL.

To analyzescalingfurther,we calculatedthe Spear-manrank-ordercorrelationcoefficientsbetweenlevelsof

ADL performanceanddementiaseverity,asindexedby

30

20~(IJ::E

::E 10

0 2 3 54

Level for using a telephone

FIG. 1. Descriptorsfor usinga telephoneandcorrespondingrangeofMMSE scores.This box plot showstherangeandthe25th,50th(me-dian),and75thpercentilesof MMSE scoresfor patientswith AD whouseda telephoneatbaselineaccordingto oneof five specifieddescrip-tors(coded0-5). 0,did notuseatelephone;1,didnotanswerthephonebutspokeif puton line;2, answeredthephoneandspoketo callersbutdid notmakecalls;3, madecalls only to well-knownnumbers,usingadirectory, list, or presetdialing; 4, made calls only to well-knownnumberswithoutreferringto a directoryor list; 5, madecalls to anynumbers,could look up numbersin a directoryor dial directoryassis-tanceif needed.Levels 0 and 1 covereda comparableMMSE range,and the descriptorfor level 1 can be omittedwithout affectingthescalingpropertiesof this ADL item.

MMSE scores.Thesecorrelations(R)weregenerallyinthe0.4-0.7rangeandwerehighlystatisticallysignificant(Table1).A fewADL correlatedweakly(R

S38 D. GALASKO ET AL.

patientswith milddementia(MMSE >20),to ensurethatchangewasadequatelycapturedin thatsubgroupof pa-tients.AmongtheAD cohortoverall,12ADL wererela-tively insensitiveto declineat 12 months,as listed inTable 2. Althoughtheratingof walking abilitydid notmeetthiscriterion,it is includedin Table1becauseof itstraditionaluseasa fundamentalbasicADL.

We nextexaminedtherelationshipbetweenbaselineMMSE severitystratumandthenumberof ADL items(fromthe27 in Table 1)on which subjectsshowedde-cline of performanceat 12 months(Fig. 2). Note thatsubjectswith AD in everyMMSE stratumshowedde-clineon ADL, butsubjectswith moderatecognitiveim-pairmentat baseline(MMSE 5-20) declinedon moreADL thandid thosewithmildorverysevereimpairment.

ItemsLessSuitedfor ADL Assessmentin aClinicalTrial

Table2 liststheADL thatfailedtomeetoneormorecriteria.ThemostcommonproblemswithADL in thisgroupwerelackof wideapplicability(usuallyduetoagendereffect),poorscaling,e.g.,low correlationwithdementiaseverity,littlechangeover12months,andchangerestrictedto severelydementedpatientsonly.Mostof theseADL hadgoodreliability,andseveraloftheitemsin Table2 wouldbesuitablefor usein cus-tomizedADL scalesfor a clinical trial thattargetswomen,or forastudyof severelyimpairedpatients.

DISCUSSION

Many ADL itemswerewidely applicable,had goodtest-retestreliability,correlatedsignificantlywiththeex-tentof cognitiveimpairmentin AD asmeasuredby theMMSE, andshoweddeclinein performancein a signifi-cantpercentageof AD subjectsat 12 months.Thesepropertiesindicatethatthey shouldprovevaluableforratingfunctionalabilityin AD clinicaltrials.Thefindingthatoverone-thirdof theADL failedtomeetoneormore

of thesecriteriaillustratestheproblemsinherentin mea-

suringADL in a spectrumof patientswith AD who aretypicallythesubjectof clinicaltrials.

Most of theitemsshowedgood test-retestreliabilityover 1-2 months,whichpresumablywas aidedby pre-testingthe itemsto improvetheir clarity,conductingabrief trainingsession,distributinga proceduresmanual,andspecifyingtheamountof contactaninformanthadtohavewith thepatient.It is difficult to obtainconsistentratingsof intermediatelevelsof ADL performance,es-peciallywhenADL havemanypotentiallevelsor meth-ods of performance,evenwhen theseare specifiedascarefullyaspossible.To improvetest-retestreliability,itmaybenecessaryto improvethespecificdescriptorsoflevelsof performance,to collapselevelsof performanceon someADL, andto provideadditionaltrainingto rat-ers.

Thevalidityof informant-deriveddescriptionsof ADLability is difficult to establishdirectly.Observationofsubjectsathomeor in thecommunitywouldbe idealbutis notpractical.As a substitute,we estimatedconcurrentvalidityof ADL reportsby comparingADL abilitywithcognitiveperformanceand found a substantialcross-sectionalcorrelationbetweenADL performanceandMMSE scoresfor mostitems.LongitudinaldeclineonmanyADL itemsover1yearamongsubjectswithAD isconsistentwithdeclineoncognitiveandglobalmeasures(Ferris et aI., 1997,this issue) and providesa furtherindicationof validity.

The optimal ADL performanceby controls in thisstudyneedsto be qualified.Among an elderlycontrolpopulation,one would typicallyexpectsomedegreeofADL impairmentas a resultof physicaldisability,im-pairedspecialsenses,or medicalillness.The controlsinthis studywerejudged to be cognitivelynormal,andrepresenthigh-functioningindividuals living indepen-dentlyin thecommunity.Their resultsarethereforecon-sistentwith expectationsfor a group of very healthyelderlyindividualsbutdo not necessarilyextrapolatetotheelderlyin general,or to the "oldest old."

The largenumberof itemsin theADL Inventoryal-

FIG. 2. Numberof ADL itemsin the Inventory(fromthe 27 listed in Table 1) on which subjectswith ADshoweddeclinein performanceat 12months.The boxplot showsthe25th,50th(median),and75thpercentilesas well as 95% limits for the totalnumberof ADL onwhich subjectsin eachMSE stratumdeclined.

Controls 21- 30 16- 20 10- 15 5-9

BaselineMMSE groupforsubjectswithAD

AlzheimerDiseaseand AssociatedDisorders, Vol. 11, Suppl. 2, 1997

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