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Protocol - Antipsychotic Medication Extrapyramidal Side Effects

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Description:

The Extrapyramidal Symptom Rating Scale (ESRS) is a clinician-administered rating scale that includes four subscales and four Clinical Global Impression Severity (CGI-S) scales. The four subscales include drug-induced movement disorders (12-item questionnaire rated on a 4-point scale), parkinsonism and akathisia (7-item examination rated on a 7-point scale), dystonia (10-item examination rated on a 7-point scale), and dyskinesia (7-item examination rated on a 7-point scale). The four clinical global impression severity scales capture tardive dyskinesia, parkinsonism, dystonia, and akathisia and are rated according to the clinician’s experience using an 8-point rating scale.

Protocol:

Extrapyramidal Symptom Rating Scale (ESRS)

Summary of the ESRS examination procedure

1. Patient is asked to remove their shoes (omitted if judged clinically inappropriate or when patient hesitates, or delayed after patient has walked (after # 7). The patient is asked to remove anything from their mouth (except dentures). The patient is asked to sit facing the examiner on a chair with no armrests.

2. Observe facial expressiveness, speech, and dyskinesia while completing the questionnaire and while completing items 4, 5, and 6 below.

3. Patient is asked to extend both arms forward, with palms down and eyes closed.

4. The patient is asked to carry out pronation and supination of both hands as fast as possible, and to perform rapid alternate movements of both wrists. Repeat as necessary.

5. While the patient sits facing the examiner on a chair with no armrests about 1 foot (approx. 30 cm) from a table with his upper body turned, the patient is asked to copy a spiral with each hand and to write the name of his town, province/state and country.

6. Patient is asked to walk a distance of 12-15 feet (4-5 m) away from, and then back towards the examiner. Repeat as necessary.

7. Patient is asked to stand erect with eyes open with feet slightly apart (1-2 cm). The examiner pushes the patient on each shoulder, the back and pushes the chest or pulls from the back while asking the patient to keep his balance.

8. Carry out the examination of the muscular tonus of the four limbs.

In case of doubt score the lesser severity.

I. QUESTIONNAIRE: Parkinsonism, Akathisia, Dystonia and Dyskinesia. In this questionnaire, take into account the verbal report of the patient on the following: 1) the duration of the symptom during the day; 2) the number of days where the symptom was present during the last week; and, 3) the evaluation of the intensity of the symptom by the patient.

Enquire into the status of each symptom and rate accordingly

Absent

Mild

Moderate

Severe

1. Impression of slowness or weakness, difficulty in carrying out routine tasks

0

1

2

3

|__|

2. Difficulty walking or with balance

0

1

2

3

|__|

3. Stiffness, stiff posture

0

1

2

3

|__|

4. Restless, nervous, unable to keep still

0

1

2

3

|__|

5. Tremors, shaking

0

1

2

3

|__|

6. Oculogyric crisis, abnormal sustained posture

0

1

2

3

|__|

7. Abnormal involuntary movements (dyskinesia) of tongue, jaw, lips, face, extremities or trunk

0

1

2

3

|__|

II. EXAMINATION: PARKINSONISM AND AKATHISIA

Items based on physical examinations for Parkinsonism

Occasional

Frequent

Constant or Almost So

1. Tremor

None:

0

Right upper limb

|__|

Borderline:

1

Left upper limb

|__|

Small amplitude:

2

3

4

Right lower limb

|__|

Moderate amplitude:

3

4

5

Left lower limb

|__|

Large amplitude:

4

5

6

Head |__|

Jaw/chin |__|

Tongue |__|

Lips |__|

2. Bradykinesia

0

normal

1

global impression of slowness in movements

2

definite slowness in movements

3

very mild difficulty in initiating movements

|__|

4

mild to moderate difficulty in initiating movements

5

difficulty in starting or stopping any movement, or freezing on initiating voluntary act

6

rare voluntary movement, almost completely immobile

3. Gait & posture

0

normal

1

mild decrease of pendular arm movement

2

moderate decrease of pendular arm movement, normal steps

3

no pendular arm movement, head flexed, steps more or less normal

|__|

4

stiff posture (neck, back) small step (shuffling gait)

5

more marked, festination or freezing on turning

6

triple flexion, barely able to walk

4. Postural Stability

0

normal

1

hesitation when pushed but no retropulsion

2

retropulsion but recovers unaided

3

exaggerated retropulsion without falling

|__|

4

absence of postural response would fall if not caught by examiner

5

unstable while standing, even without pushing

6

unable to stand without assistance

5. Rigidity

0

normal muscle tone

Right upper limb

|__|

1

very mild, barely perceptible

Left lower limb

|__|

2

mild (some resistance to passive movements)

Right lower limb

|__|

3

moderate (definite difficulty to move the limb)

Left lower limb

|__|

4

moderately severe (moderate resistance but still easy to move limb)

5

severe (marked resistance with definite difficulty to move the limb)

6

extremely severe (limb nearly frozen)

Items based on overall observation during examination for Parkinsonism

6. Expressive automatic movements (Facial mask/speech)

0

normal

1

very mild decrease in facial expressiveness

2

mild decrease in facial expressiveness

3

rare spontaneous smile, decrease blinking, voice slightly monotonous

|__|

4

no spontaneous smile, staring gaze, low monotonous speech, mumbling

5

marked facial mask, unable to frown, slurred speech

6

extremely severe facial mask with unintelligible speech

7. Akathisia

0

absent

1

looks restless, nervous, impatient, uncomfortable

2

needs to move at least one extremity

3

often needs to move one extremity or to change position

|__|

4

moves one extremity almost constantly if sitting, or stamps feet while standing

5

unable to sit down for more than a short period of time

6

moves or walks constantly

III. Examination: DYSTONIA

Based on examination and observation

Acute torsion, and non-acute or chronic or tardive dystonia

0

absent

Right upper limb

|__|

1

very mild

Left upper limb

|__|

2

mild

Right lower limb

|__|

3

moderate

Left lower limb

|__|

4

moderately severe

Head |__|

Jaw/chin |__|

5

severe

Tongue |__|

Lips |__|

6

extremely severe

Eyes |__|

Trunk |__|

IV. EXAMINATION: DYSKINETIC MOVEMENT

Based on examination and observation

Occasional*

Frequent**

Constant or Almost So

1. Lingual movements (slow lateral or torsion movement of tongue)

none:

0

borderline:

1

clearly present, within oral cavity:

2

3

4

with occasional partial protrusion:

3

4

5

with complete protrusion:

4

5

6

|__|

2. Jaw movements (lateral movement, chewing, biting, clenching)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

3

4

5

but without mouth opening:

large amplitude:

4

5

6

|__|

with mouth opening:

3. Bucco-labial movements (puckering, pouting, smacking, etc.)

none:

0

borderline:

1

clearly present, small amplitude:

3

3

4

moderate amplitude, forward movement of lips:

4

4

5

large amplitude; marked, noisy smacking of lips:

5

5

6

|__|

4. Truncal movements (involuntary rocking, twisting, pelvic gyrations)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

3

4

5

greater amplitude:

4

5

6

|__|

5. Upper extremities (choreoathetoid movements only: arms, wrists, hands, fingers)

0

none:

0

borderline:

1

clearly present, small amplitude, movement of one limb:

2

3

4

moderate amplitude, movement of one limb or movement of small amplitude involving two limbs:

3

4

5

greater amplitude, movement involving two limbs:

4

5

6

|__|

6. Lower extremities (choreoathetoid movements only: legs, knees, ankles, toes):

none:

0

borderline:

1

clearly present, small amplitude, movement of one limb:

2

3

4

moderate amplitude, movement of one limb or movement of small amplitude involving two limbs:

3

4

5

greater amplitude, movement involving two limbs:

4

5

6

|__|

7. Other involuntary movements (swallowing, irregular respiration, frowning, blinking, grimacing, sighing, etc.)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

4

4

5

greater amplitude:

5

5

6

|__|

Specify...……………………………………………………………………………………………………………..

* when activated or rarely spontaneous

** frequently spontaneous and present when activated

V. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF DYSKINESIA

Considering your clinical experience, how severe is the dyskinesia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VI. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF PARKINSONISM

Considering your clinical experience, how severe is the parkinsonism at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VII. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF DYSTONIA

Considering your clinical experience, how severe is the dystonia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VIII. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF AKATHISIA

Considering your clinical experience, how severe is the akathisia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

Scoring:

Questionnaire for Parkinsonism, akathisia, dystonia and dyskinesia:

  • Each item is rated on a four point scale (0 = absent; 3 = severe). For subjective extra-pyramidal symptoms, severity is assessed over the last seven days and persistent symptoms are rated for the most typical day over the last seven.

Examination for Parkinsonism and akathisia (subscale II):

  • Tremors and rigidity are scored on a seven-point scale (0 = none; 6 = severe) for each body part. Ratings for tremors account for amplitude and number of times the movement occurs during the interview.
  • Total scores range from 0-102.
  • A score of 3 or greater on any of the items is required to establish Parkinsonism for initiation of anti-Parkinsonism treatment.
  • A score of 2 on 2 items or a score of 3 or greater on one item is required to establish the presence of Parkinsonism.
  • Hypokinesia subscale scores (ranging from 0-42) are calculated from gait and posture, rigidity, expressive automatic movements, and bradykinesia.
  • Hyperkinesia subscale scores (ranging from 0-54) are calculated from tremor and akathisia items.

Examination for dystonia:

  • Acute and chronic movements are scored on a seven point scale (0 = none; 6 = most severe). Each body part is rated separately.
  • Dystonia scores range from 0-60 and includes both acute and chronic dystonia.
  • A score of three or greater on at least one item or a score of 2 on 2 items is required for presence of dystonia.

Examination for dyskinesia:

  • Movements are scored on a seven-point scale (0 = none; 6 = severe) for each body part. Ratings account for amplitude and number of times the movement occurs during the interview.
  • Dyskinesia scores range from 0-42 and is the total of all seven items.
  • A score of three or greater on at least one item or a score of 2 on 2 items is required for presence of dyskinesia.
  • Tardive dyskinesia subscale scores for each item separately
  • Buccal-lingual-masticatory subscale is the total (0-18) from items 1, 2, 3 and an extremities score (0-12) from items 5 and 6.

Total Score:

  • A total DMID score can be derived by adding together all 41 items.

Clinical global impressions of severity of Parkinsonism, akathisia, dystonia, and tardive dyskinesia:

  • Results are rated according to results of the subjective questionnaire, examination subscales, and the evaluator’s clinical experience by applying an 8-point rating (0: absent; 1: borderline; 2: very mild; 3: mild; 4: moderate; 5: moderately severe; 6: marked; 7: severe; 8: extremely severe).
  • The 4 clinical global impressions of severity subscales are analyzed as separate items.

Chouinard © 1979

Protocol Name from Source:

Extrapyramidal Symptom Rating Scale (ESRS)

Availability:

Publicly available

Personnel and Training Required

The interviewer must be trained to and found competent to conduct motor examinations as well as be competent to recognize the impact of comorbidities (such as stroke, arthritis, psychosis, schizophrenia, etc.) on motor movements. Additionally, the interviewer must be trained and found competent in the recognition of motor movements and ratings listed in this protocol, such as the signs and degree of tremor and rigidity and the presence of bradykinesia/hypokinesia.

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training Yes
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual Yes
Mode of Administration

Clinician administered physical assessment and questionnaire

Life Stage:

Adult

Participants:

Adults, ages 18 years and older

Specific Instructions:

None

Selection Rationale

The Extrapyramidal Symptom Rating Scale (ESRS) is a widely used, reliable, and valid clinician-administered questionnaire that assess abnormalities due to drug-induced movement disorders both subjectively and objectively.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Mental Health Extrapyramidal Symptom Rating Scale-Abbreviated Clinical Classification Assessment Scale 5628152 CDE Browser
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Chouinard, G., & Margolese, H. C. (2005). Manual for the Extrapyramidal Symptom Rating Scale (ESRS). Schizophrenia Research, 76(2-3), 247-265.

General References

Chouinard, G. (2006). Interrelations between psychiatric symptoms and drug-induced movement disorder. Journal of Psychiatry and Neuroscience, 31(3), 177-180.

Kotler, M., Dilbaz, N., Rosa, F., Paterakis, P., Milanova, V., Smulevich, A. B., Lahaye, M., & Schreiner, A. (2015). A flexible-dose study of paliperidone ER in patients with nonacute schizophrenia previously treated unsuccessfully with oral olanzapine. Journal of Psychiatric Practice, 22(1), 9-21.

Protocol ID:

661601

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
Research Domain Information
Measure Name:

Antipsychotic Medication Extrapyramidal Side Effects

Release Date:

January 17, 2017

Definition

A questionnaire and a patient examination tool to assess drug-induced extrapyramidal symptoms (slowness, stiffness, tremor, and rigidity).

Purpose

This measure is designed to assess the frequency and severity of antipsychotic drug-induced movement disorders (DIMD) including parkinsonism, dyskinesia, akathisia, and dystonia. DMID interferes with cognition and social rehabilitation and is similar to symptoms of psychosis and schizophrenia.

Keywords

Early psychosis, psychosis, extrapyramidal symptom rating scale, ESRS, extrapyramidal features, drug-induced movement disorders, DIMD, drug-induced extrapyramidal symptoms, extrapyramidal side effects, EPSE