Protocol - Frequency of Sickle Cell Pain Episodes Per Year

Description:

This protocol includes three self-administered questions from the Cooperative Study of Sickle Cell Disease (CSSCD) that capture number of painful episodes that required visits to the emergency room or hospital or interfered with daily activities.

Protocol:

PAINFUL EVENTS - Number of visits should include visits to BOTH your hospital AND outside hospitals.

1. In the last 6 months, how many times did you visit an emergency room because of a sickle cell painful event?

Number of times (_)

DATE OF VISIT	NAME OF HOSPITAL, CITY, STATE
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________

2. In the last 12 months, how many times were you admitted to a hospital because of a sickle cell painful event?

Number of times (_)

DATE OF HOSPITALIZATION	NAME OF HOSPITAL, CITY, STATE
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________
______________	_________________________________________________

3. In the last 6 months, have you had a painful episode severe enough to keep you from doing the usual daily activities, but without being seen by a doctor?

[ ] No

[ ] Yes

a. How many episodes

[ ] <4

[ ] >=4

b. How many days were missed?

[ ] <= a week

[ ] > a week

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Download PDF

Personnel and Training Required

None

Equipment Needs

None

Requirements

Requirement Category	Required
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

Participants:

Adults, ages 18 and older

Specific Instructions:

The Sickle Cell Disease Research and Scientific Panel (SRSP) notes that a pain episode is pain lasting at least two hours that requires an unscheduled emergency room visit or hospitalization or that disrupts daily activities.

The SRSP suggests that this protocol could be administered to adolescents younger than 18 and to young children via a proxy.

Selection Rationale

These self-administered questions from the Cooperative Study of Sickle Cell Disease (CSSCD) are validated, well established and easy to implement and interpret.

Language

English

Standards

Standard	Name	ID	Source
Common Data Elements (CDE)	Sickle Cell Disease Pain Episode Frequency Assessment Text	4924414	CDE Browser

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung, and Blood Institute (NHLBI). Cooperative Study of Sickle Cell Disease (CSSCD). Form 25 - Painful Episodes. Questions 7a, 7b, and 7c.

General References

Platt, O.S., Brambilla, D.J., Rosse, W.F., Milner, P.F., Castro, O., Steinberg, M.H., & Klug, P.P. (1994). Mortality in sickle cell disease. Life expectancy and risk factors for early death. New England Journal of Medicine 330(23), 1639-1644.

Platt, O.S., Thorington, B.D., Brambilla, D.J., Milner, P.F., Rosse, W.F., Vichinsky, E., & Kinney, T.R. (1991). Pain in sickle cell disease. Rates and risk factors. New England Journal of Medicine 325(1), 11-16.

Wallen, G.R., Minniti, C.P., Krumlauf, M., Eckes, E., Allen, D., Oguhebe, A., Seamon, C., Darbari, D.S., Hildesheim, M., Yang, L., Schulden, J.D., Kato, G.J., & Taylor JG 6^th. (2014). Sleep disturbance, depression and pain in adults with sickle cell disease. BMC Psychiatry 14, 207.

Protocol ID:

830101

Variables:

Export Variables

Variable Name	Variable ID	Variable Description	Version	dbGaP Mapping
PX830101_SCDPainSixMonths	PX830101010100	In the last 6 months, how many times did you visit an emergency room because of a sickle cell painful event?	4	N/A
PX830101_SCDPainSixMonths_City_Event1	PX830101010400	In the past six months, what city was the hospital (Event1) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event10	PX830101014000	In the past six months, what city was the hospital (Event10) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event2	PX830101010800	In the past six months, what city was the hospital (Event2) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event3	PX830101011200	In the past six months, what city was the hospital (Event3) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event4	PX830101011600	In the past six months, what city was the hospital (Event4) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event5	PX830101012000	In the past six months, what city was the hospital (Event5) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event6	PX830101012400	In the past six months, what city was the hospital (Event6) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event7	PX830101012800	In the past six months, what city was the hospital (Event7) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event8	PX830101013200	In the past six months, what city was the hospital (Event8) in?	4	N/A
PX830101_SCDPainSixMonths_City_Event9	PX830101013600	In the past six months, what city was the hospital (Event9) in?	4	N/A
PX830101_SCDPainSixMonths_Date_Event1	PX830101010200	In the past six months, what was the date of Event1?	4	N/A
PX830101_SCDPainSixMonths_Date_Event10	PX830101013800	In the past six months, what was the date of Event10?	4	N/A
PX830101_SCDPainSixMonths_Date_Event2	PX830101010600	In the past six months, what was the date of Event2?	4	N/A
PX830101_SCDPainSixMonths_Date_Event3	PX830101011000	In the past six months, what was the date of Event3?	4	N/A
PX830101_SCDPainSixMonths_Date_Event4	PX830101011400	In the past six months, what was the date of Event4?	4	N/A
PX830101_SCDPainSixMonths_Date_Event5	PX830101011800	In the past six months, what was the date of Event5?	4	N/A
PX830101_SCDPainSixMonths_Date_Event6	PX830101012200	In the past six months, what was the date of Event6?	4	N/A
PX830101_SCDPainSixMonths_Date_Event7	PX830101012600	In the past six months, what was the date of Event7?	4	N/A
PX830101_SCDPainSixMonths_Date_Event8	PX830101013000	In the past six months, what was the date of Event8?	4	N/A
PX830101_SCDPainSixMonths_Date_Event9	PX830101013400	In the past six months, what was the date of Event9?	4	N/A
PX830101_SCDPainSixMonths_Days	PX830101030300	How many days were missed?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event1	PX830101010300	In the past six months, which hospital did you go for Event1?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event10	PX830101013900	In the past six months, which hospital did you go for Event10?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event2	PX830101010700	In the past six months, which hospital did you go for Event2?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event3	PX830101011100	In the past six months, which hospital did you go for Event3?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event4	PX830101011500	In the past six months, which hospital did you go for Event4?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event5	PX830101011900	In the past six months, which hospital did you go for Event5?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event6	PX830101012300	In the past six months, which hospital did you go for Event6?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event7	PX830101012700	In the past six months, which hospital did you go for Event7?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event8	PX830101013100	In the past six months, which hospital did you go for Event8?	4	N/A
PX830101_SCDPainSixMonths_Hospital_Event9	PX830101013500	In the past six months, which hospital did you go for Event9?	4	N/A
PX830101_SCDPainSixMonths_Number	PX830101030200	How many episodes?	4	N/A
PX830101_SCDPainSixMonths_Severity	PX830101030100	In the last 6 months, have you had a painful episode severe enough to keep you from doing the usual daily activities, but without being seen by a doctor?	4	N/A
PX830101_SCDPainSixMonths_State_Event1	PX830101010500	In the past six months, what state was the hospital (Event1) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event10	PX830101014100	In the past six months, what state was the hospital (Event10) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event2	PX830101010900	In the past six months, what state was the hospital (Event2) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event3	PX830101011300	In the past six months, what state was the hospital (Event3) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event4	PX830101011700	In the past six months, what state was the hospital (Event4) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event5	PX830101012100	In the past six months, what state was the hospital (Event5) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event6	PX830101012500	In the past six months, what state was the hospital (Event6) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event7	PX830101012900	In the past six months, what state was the hospital (Event7) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event8	PX830101013300	In the past six months, what state was the hospital (Event8) in?	4	N/A
PX830101_SCDPainSixMonths_State_Event9	PX830101013700	In the past six months, what state was the hospital (Event9) in?	4	N/A
PX830101_SCDPainTwelveMonths	PX830101020100	In the last 12 months, how many times did you visit an emergency room because of a sickle cell painful event?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event1	PX830101020400	In the past twelve months, what city was the hospital (Event1) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event10	PX830101024000	In the past twelve months, what city was the hospital (Event10) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event2	PX830101020800	In the past twelve months, what city was the hospital (Event2) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event3	PX830101021200	In the past twelve months, what city was the hospital (Event3) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event4	PX830101021600	In the past twelve months, what city was the hospital (Event4) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event5	PX830101022000	In the past twelve months, what city was the hospital (Event5) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event6	PX830101022400	In the past twelve months, what city was the hospital (Event6) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event7	PX830101022800	In the past twelve months, what city was the hospital (Event7) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event8	PX830101023200	In the past twelve months, what city was the hospital (Event8) in?	4	N/A
PX830101_SCDPainTwelveMonths_City_Event9	PX830101023600	In the past twelve months, what city was the hospital (Event9) in?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event1	PX830101020200	In the past twelve months, what was the date of Event1?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event10	PX830101023800	In the past twelve months, what was the date of Event10?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event2	PX830101020600	In the past twelve months, what was the date of Event2?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event3	PX830101021000	In the past twelve months, what was the date of Event3?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event4	PX830101021400	In the past twelve months, what was the date of Event4?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event5	PX830101021800	In the past twelve months, what was the date of Event5?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event6	PX830101022200	In the past twelve months, what was the date of Event6?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event7	PX830101022600	In the past twelve months, what was the date of Event7?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event8	PX830101023000	In the past twelve months, what was the date of Event8?	4	N/A
PX830101_SCDPainTwelveMonths_Date_Event9	PX830101023400	In the past twelve months, what was the date of Event9?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event1	PX830101020300	In the past twelve months, which hospital did you go for Event1?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event10	PX830101023900	In the past twelve months, which hospital did you go for Event10?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event2	PX830101020700	In the past twelve months, which hospital did you go for Event2?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event3	PX830101021100	In the past twelve months, which hospital did you go for Event3?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event4	PX830101021500	In the past twelve months, which hospital did you go for Event4?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event5	PX830101021900	In the past twelve months, which hospital did you go for Event5?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event6	PX830101022300	In the past twelve months, which hospital did you go for Event6?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event7	PX830101022700	In the past twelve months, which hospital did you go for Event7?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event8	PX830101023100	In the past twelve months, which hospital did you go for Event8?	4	N/A
PX830101_SCDPainTwelveMonths_Hospital_Event9	PX830101023500	In the past twelve months, which hospital did you go for Event9?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event1	PX830101020500	In the past twelve months, what state was the hospital (Event1) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event10	PX830101024100	In the past twelve months, what state was the hospital (Event10) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event2	PX830101020900	In the past twelve months, what state was the hospital (Event2) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event3	PX830101021300	In the past twelve months, what state was the hospital (Event3) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event4	PX830101021700	In the past twelve months, what state was the hospital (Event4) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event5	PX830101022100	In the past twelve months, what state was the hospital (Event5) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event6	PX830101022500	In the past twelve months, what state was the hospital (Event6) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event7	PX830101022900	In the past twelve months, what state was the hospital (Event7) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event8	PX830101023300	In the past twelve months, what state was the hospital (Event8) in?	4	N/A
PX830101_SCDPainTwelveMonths_State_Event9	PX830101023700	In the past twelve months, what state was the hospital (Event9) in?	4	N/A

Research Domain Information

Measure Name:

Frequency of Sickle Cell Pain Episodes Per Year

Release Date:

July 30, 2015

Definition

A questionnaire to capture the frequency of acute pain episodes due to sickle cell disease (SCD).

Purpose

Frequency of acute sickle cell pain episodes is correlated with disease severity and early mortality.

Keywords

Pain, sickle cell disease, SCD, frequency of sickle cell pain episodes, work absence, school absence