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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.

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.

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.

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

The 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 Name Variable IDVariable DescriptiondbGaP Mapping
PX130202_Autonomic_Assessment_Adult_Difficulty_Obtaining_Erection
PX130202120100 Have you had any of the following health more
symptoms during the past 6 months? Do you have difficulty obtaining an erection (men)? show less
N/A
PX130202_Autonomic_Assessment_Adult_Difficulty_Obtaining_Erection_Symptoms_Discomfort
PX130202120200 If you answered yes in Q12a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Dry_Mouth_Dry_Eyes
PX130202020100 Have you had any of the following health more
symptoms during the past 6 months? Do you have a dry mouth or dry eyes? show less
N/A
PX130202_Autonomic_Assessment_Adult_Dry_Mouth_Dry_Eyes_Symptoms_Discomfort
PX130202020200 If you answered yes in Q2a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Feet_Colder
PX130202040100 Have you had any of the following health more
symptoms during the past 6 months? Are your feet colder than the rest of your body? show less
N/A
PX130202_Autonomic_Assessment_Adult_Feet_Colder_Symptoms_Discomfort
PX130202040200 If you answered yes in Q4a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Feet_Pale_Blue
PX130202030100 Have you had any of the following health more
symptoms during the past 6 months? Are your feet pale or blue? show less
N/A
PX130202_Autonomic_Assessment_Adult_Feet_Pale_Blue_Symptoms_Discomfort
PX130202030200 If you answered yes in Q3a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Leaking_Urine
PX130202110100 Have you had any of the following health more
symptoms during the past 6 months? Do you have leaking of urine? show less
N/A
PX130202_Autonomic_Assessment_Adult_Leaking_Urine_Symptoms_Discomfort
PX130202110200 If you answered yes in Q11a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Lightheadedness
PX130202010100 Have you had any of the following health more
symptoms during the past 6 months? Do you have lightheadedness? show less
N/A
PX130202_Autonomic_Assessment_Adult_Lightheadedness_Symptoms_Discomfort
PX130202010200 If you answered yes in Q1a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Nausea_Vomiting_Bloating_Small_Meal
PX130202080100 Have you had any of the following health more
symptoms during the past 6 months? Do you have nausea, vomiting, or bloating after eating a small meal? show less
N/A
PX130202_Autonomic_Assessment_Adult_Nausea_Vomiting_Bloating_Small_Meal_Symptoms_Discomfort
PX130202080200 If you answered yes in Q8a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Persistent_Constipation
PX130202100100 Have you had any of the following health more
symptoms during the past 6 months? Do you have persistent constipation (less than 1 bowel movement every other day)? show less
N/A
PX130202_Autonomic_Assessment_Adult_Persistent_Constipation_Symptoms_Discomfort
PX130202100200 If you answered yes in Q10a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Persistent_Diarrhea
PX130202090100 Have you had any of the following health more
symptoms during the past 6 months? Do you have persistent diarrhea (more than 3 loose bowel movements per day)? show less
N/A
PX130202_Autonomic_Assessment_Adult_Persistent_Diarrhea_Symptoms_Discomfort
PX130202090200 If you answered yes in Q9a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Feet_Decreased
PX130202050100 Have you had any of the following health more
symptoms during the past 6 months? Is sweating in your feet decreased compared to the rest of your body? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Feet_Decreased_Absent
PX130202060100 Have you had any of the following health more
symptoms during the past 6 months? Is sweating in your feet decreased or absent (for example, after exercise or during hot weather)? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Feet_Decreased_Absent_Symptoms_Discomfort
PX130202060200 If you answered yes in Q6a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Feet_Decreased_Symptoms_Discomfort
PX130202050200 If you answered yes in Q5a, how much would more
you say the symptom bothers you? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Hands_Increased
PX130202070100 Have you had any of the following health more
symptoms during the past 6 months? Is sweating in your hands increased compared to the rest of your body? show less
N/A
PX130202_Autonomic_Assessment_Adult_Sweating_Hands_Increased_Symptoms_Discomfort
PX130202070200 If you answered yes in Q7a, how much would more
you say the symptom bothers you? show less
N/A
Neurology
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