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This means, essentially, that a core of data must be collected for each patient. The rating scales and data processing services are provided at no charge - our sole "remuneration" be- ing the opportunity to add the investigator's data to the data bank. :: ::&: ::9:: 1- ::&: ::9:: ::7:: ::8:: ::*: 25:a:yp:©3? :*: :4r: Days -z2:z PERIOD ^reorasho dilate c 22 "fiz :;± 23 r A: =:a= 24:rft: "3: 25 "6:= -iz 26rre:= :=J= 27-6:: ::]= 28::a:r i H: 29=:e:: : Hr 30 -z Oiz ;: J: 31 llftr 1=3: ::2:: "3:: ::2:: ::3:: ::2:-_ ::i: ::2:i iiil rri: ::i: 32::ft: :it 33 1*1 :: :: :i: ::3:: ::4:: 34::fc: := :: :i: ::3:: ::*:: 35 I A: :: :: :i: :*: ::4:: 36:*: -: ::2:: ::3:: ::«:: 37:*: :: :: :±: :*: :d4:: 38:*: :: :: ::2:: ::3:: :d4:- 39:*: :: :: :±: :*: ::4: 40:*: :: :: zziiz :*: ::4: 41:*: :: 1:: :±: :*: ::4: Cols: 1 2 3 4 5 ::»: :: St: :: S:: ::»:: :: Sb: :3t: ::ft: :: Sb: : J:: ::ft: ::9:: :? twiddling, arm flapping RA TE THE FOLLOWING 34 ITEMS ON THE BASIS OF THE CHILD'S VERBAL REPORT OF OCCURRENCE AT THE TIME OF THE INTERVIEW OR DURING THE PAST 7 DA VS. See Table 9 for the Conversion of Interviewer-Rated Raw Scores to the DSl Z Scores. Submit a Research Plan Report (021-RPR) and agree to send the study data to the Biometric Laboratory. Collect sufficient information about the subjects in his study so that the data can be entered into the ECDEU data bank. Once the trial is completed, the forms are returned to the Biometric Laboratory for processing and data analyses, the results of which are sent to the investigator in the form of a standard data package. ^ ::2:: ::3:: ::4:: ::&: ::&: ::fc: ::6:: ;:ft: ::ft: "^ 23gecrfeas«d }«tetor Acti^^ 24::e:: ::lr: :it: :*: ::*: ::*: ty - ::6:: r:? := :ift: ::9:: =:3:: lit: :=5:= z:fci ==S= :it: ==9:= ~~ |=L i-O- r:2:: SHEET I NO. OTHER SPEECH DEVIANCE 27 Echolalia, question-like melody, neologisms; sentences fragmented, unusual syntax. RHYTHMIC MOTIONS (STEREOTYPE) 28 Rocking, whirling, head banging, rolling, repetitive jumping, hand movements, alhetoid. The DSl provides a global measure of the intensity of depressive symptomatology. Additional ratings are at the discretion of the investigator, TIME SPAN RATED Now or in the last week CARD 01 = (19x, 2011 , l Ox, \k) Item Column 11 30 12 31 13 32 ]k 33 15 3^ 16 35 17 36 18 37 19 38 20 39 Z Score-'- 50-53 "The Z score is derived by dividing the sum of the raw item scores by the maximum possible score (80) multiplied by 100. The instructional header and the appropriate item pages for a specific scale are color-coded for the convenience of the rater. Inadequate or no information should be rated as zero. Hypochondriasis (0-^) - The severe states of this symptom, concerning delusions and hallucinations of rotting and blockages, etc., which are extremely uncommon in men, are rated as k.

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Table I catalogues all of the scales which comprise the standard ECDEU Assessment Battery and classifies them by applicabili- ty, format, content and rater. It may be that he is denying that he is insane and may willingly recognize that he has a 'nervous' illness.

12 FIGURE I THE ASSESSMENT PACKET PACKET CLOSED Header PAGES AND HEADERS OPENED COVER OPENED f^kvcr^ot'fprfcrtu T vj*=t-tr-T^ -i A^^'^TI^ Pages Header and page opened to a specific scale Positioning Tab General Scoring Sheet 13 In addition to the 28 scales contained within 5 packets, there are 15 inde- pendent (self-contained) instruments. Excessive preoccupation with bodily functions is the essence of a hypochondriacal attitude and trivial or doubtful symptoms count as 1 point. Loss of insight (0-2) - This is not necessarily present when the patient denies that he is suffering from mental disorder.

Format indicates whether a scale is designed for opscan or not and whether it is contained within a packet or is independent. Finally, information concerning the disposition of subjects; e.g.. For this reason, an obvious or severe loss is rated as 2 and a slight or doubtful loss as 1 point. Diurnal variation (0-2) - This symptom has been excluded from Hamilton's factors as it indicates the type of illness, rather than presenting an addition to the patient's disabilities.

Applicability refers to the population (s) for which a scale is appropriate. Self Report Symptom Inventory (SCL-90) Along with appropriate demographic information, the assessment of side effects, and the recording of dosages through the use -of an instrument such as the Dosage Record and Treatment Emergent Symptom Scale (DOTES) should be considered. In case of doubt, enquiries should be directed to the patient's attitude to his symptoms of Guilt and Hypochondriasis. Loss of weight (0-2) - The simplest way to rate this would be to record the amount of loss, but many patients do not know their normal weight.

To the entire staff of the Biometric Laboratory - and particularly to those cited below - I want to extend special thanks for the ingenu- ity and patience they have shown during the several years of almost continuous de- signing and redesigning of BLIPS. Neuroleptic Studies with Schizophrenic Populations a. With appropriate programming, many - but not all - of these extraneous positions can be suppressed. The Rating of Female Patients The same general principles apply to the rating of women as of men, but there are special problems which need to be considered in detail, I. Together with the Re- search Plan Report, the RCR permits a detailed historical reconstruction of the in- dividual trial as well as providing data for subsequent collation with other trials. REFERENCE Robinson, R, A., The Diagnosis and Prognosis of Dementia, Current Achievements in Geriatrics, W. Either of the following formats can be used for encoding: SCALE POINTS 123^5 123^5 I tem 1 ziftr "i: i:2:r "i: "*= "S: r:(c: z:? "t: ----i-- "i: -*: "ii "fcz zz Tzz zz8:: :z9zz 3---.

Planning phase - Having developed an hypothesis and a research design to test it, the investigator decides to utilize the assessment instruments and services of the ECDEU program. The new Data Shipment (071-DS) serves such a vital function in BLIPS II that process- ing of a study simply cannot proceed without an accompanying DS. The clear presence of diurnal variation is rated as 2 and the doubtful presence is 1 point. TIME TABLE FOR USING THE ECDEU BATTERY Table 2 depicts the usual order in which investigators employ various instru- ments in the ECDEU Assessment Battery during the 3 major phases of a research study ■ planning, data collection and analyses. Analytic phase - Two administrative forms are completed at this phase. A small number of patients insist that they feel worse in the afternoon. The content areas are: demographic (Dem) , efficacy (Ef f) , toxicity (Tox) , medical (Med), psychometric (Psy) and administrative (Adm) . Fourteen of the ^3 instruments are "universal" - reflecting the integration and compatibility of the Battery across diverse research populations. Patient Termination Record (PTR) , should be gathered. The commonest form consists of an increase of symptoms in the morning, but this is only slightly greater than worsening in the evening. Along the top are "headers", i.e., sections which contain instructions and scalepoints for a specific scale. The assess- ment is based on a pathological change, i.e. Figure 1 illustrates the manner in which the packets are used. Upon opening the cover, there are 3 sections each attached to one of the spiral binders. unmarried, whose sexual activity is usually at a low level. To offset these problems, items and response positions were separated. Subsequent editions of the Adult Packet will contain the 5-point scale and raters are urged to employ the 5-point scale for this item. Anxiety (psychic symptoms) (0-4) - Many symptoms are included here, such as tension and difficulty in relaxing, irritability, worrying over trivial matters, apprehension and feelings of panic, fears, difficulty in concentration and forgetful- ness , 'feeling jumpy'.

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