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Protocol - Neuropathy - Autonomic Assessment - Adult

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Description:

The Survey of Autonomic Symptoms (SAS) is a self-administered 12-item questionnaire that measures autonomic symptoms over the past 6 months in subjects with mild neuropathy. The severity of each item is rated on 5-point Likert scale (1 is least severe; 5 is most severe). The total number of symptoms is calculated as the sum of column A. The total impact score is calculated as the total of column B.

Protocol:

Survey of Autonomic Symptoms

Q1a. Have you had any of the following health symptoms during the past 6 months?

(1 _Yes; 0 _ No)

Q1b. If you answered yes in Q1a, how much would you say the symptom bothers you? (1 _ Not at all; 2 _ A little; 3 _ Some; 4 _ A moderate amount;5 _ A lot)

Symptom/health problem

1 0

1 2 3 4 5

1. Do you have lightheadedness?

1 0

1 2 3 4 5

2. Do you have a dry mouth or dry eyes?

1 0

1 2 3 4 5

3. Are your feet pale or blue?

1 0

1 2 3 4 5

4. Are your feet colder than the rest of your body?

1 0

1 2 3 4 5

5. Is sweating in your feet decreased compared to the rest of your body?

1 0

1 2 3 4 5

6. Is sweating in your feet decreased or absent (for example, after exercise or during hot weather)?

1 0

1 2 3 4 5

7. Is sweating in your hands increased compared to the rest of your body?

1 0

1 2 3 4 5

8. Do you have nausea, vomiting, or bloating after eating a small meal?

1 0

1 2 3 4 5

9. Do you have persistent diarrhea (more than 3 loose bowel movements per day)?

1 0

1 2 3 4 5

10. Do you have persistent constipation (less than 1 bowel movement every other day)?

1 0

1 2 3 4 5

11. Do you have leaking of urine?

1 0

1 2 3 4 5

12. Do you have difficulty obtaining an erection (men)?

1 0

1 2 3 4 5

Number of symptoms reported: _________ (sum of column A, 0-12 for men and 0-11 for women); total symptom impact score: _________ (sum of column B, 0-60 for men and 0-55 for women).

Protocol Name from Source:

Survey of Autonomic Symptoms (SAS)

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

None

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

Self-administered questionnaire

Life Stage:

Adult, Senior

Participants:

Adult, aged 18 years and older.

Specific Instructions:

The External Review Panel notes that in comparison to the Michigan Neuropathy Screening Instrument (MNSI) included in the Diabetic Peripheral Neuropathy measure, the Survey of Autonomic Symptoms (SAS) is appropriate for assessing mild autonomic symptoms associated with all types of small-fiber neuropathies.

Selection Rationale

The Survey of Autonomic Symptoms (SAS) was vetted against similar protocols and chosen because it is a relatively short, validated protocol that focuses more on autonomic symptoms that characterize small-fiber neuropathies.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Neurology Autonomic Symptom Survey Assessment Score 6459276 CDE Browser
Derived Variables

None

Process and Review

Expert Review Panel 4 (ERP 4) reviewed the measures in the Neurology, Psychiatric, and Psychosocial domains.

Guidance from ERP 4 included the following:

  • Changed name of measure
  • Added new protocol
  • Created new data dictionary

Source

Zilliox, L., Peltier, A. C., Wren, P. A., Anderson, A., Smith, A. G., Singleton, J. R., Feldman, E. L., Alexander, N. B., & Russell, J. W. (2011). Assessing autonomic dysfunction in early diabetic neuropathy: The Survey of Autonomic Symptoms. Neurology, 76(12), 1099-1105.

General References

Kim, S. H., Lee, K. A., Jin, H. Y., Baek, H. S., & Park, T. S. (2014). Relationship between the Korean Version Survey of the Autonomic Symptoms Score and cardiac autonomic neuropathy parameters in patients with diabetic peripheral neuropathy. Diabetes and Metabolism Journal, 38(5), 349-355.

Protocol ID:

130202

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

Neuropathy

Release Date:

November 28, 2017

Definition

A measure to assess neuropathy.

Purpose

This measure can be used to assess the severity of symptoms and disability associated with peripheral neuropathy caused by a number of disorders including tumors, infections, autoimmune diseases, and inherited disorders such as Charcot-Marie-Tooth disease.

Keywords

Neurology, small fiber neuropathy, diabetic neuropathy, clinical neuropathy assessment, autonomic neuropathy