Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R)

Screener and Opioid Assessment for Patients 

with Pain Revised 

(SOAPP-R) 

Questionnaire Supplement to the Study Data 

Tabulation Model Implementation Guide 

for Human Clinical Trials 

Prepared by 

CDISC and Analgesic Clinical Trial Translations, Innovations, Opportunities, and 

Networks (ACTTION) 

Notes to Readers 

This implementation guide is intended to be used with other CDISC User Guides for specific 

Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model 

Implementation Guide for Human Clinical trials. 

Revision History 

Date Version Summary of Changes 

2012-03-03 0.1 Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R) 

Draft 

2012-08-07 1.0 Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R)

CDISC SDTM SOAPP-R Questionnaire Supplement (Version 1.0) 

existing procedures for licensing fees and using the instrument will remain exactly as they have 

been. Please follow the instrument owners own mechanisms for permissions and licenses if you 

have a need to use this questionnaire. 

3 The QS Domain Model 

3.1 Assumptions for Questionnaire Domain Model 

All assumptions for the QS domain from the SDTMIG apply for this supplemental 

implementation guide including those referenced in the CDISC notes. Additionally, the 

following assumptions apply to the SCREENER AND OPIOID ASSESSMENT FOR 

PATIENTS WITH PAIN REVISED Questionnaire: 

• Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R): SOAPP-R 

is a tool for clinicians to help determine how much monitoring a patient on long-term 

opioid therapy might require. This is an updated and revised version of SOAPP V.1 

released in 2003. It is a quick and easy-to-use questionnaire designed to help providers 

evaluate the patient’s relative risk for developing problems when placed on long-term 

opioid therapy. 

• The evaluator of the questionnaire is stored in QSEVAL and for the SOAPP-R form the 

SUBJECT provides the evaluation. 

• Terminology 

a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. 

b. Additional standardization of the QSORRES, QSSTRESC and QSSTRESN fields 

can be found in Section 4: Mapping Strategy. 

3.2 Example for Screener and Opioid Assessment for Patients with Pain Revised 

Domain Model 

The SOAPP-R example below shows the CDISC controlled terminology for QSCAT, QSTEST 

and QSTESTCD. Additional standardization for QSORRES, QSTRESC and QSTRESN can be 

found in Section 4: Mapping Strategy for this scale. Values for QSORRES are for prospective 

data collection. Sponsors mapping legacy data should retain legacy values for QSORRES. A full 

list of value sets for QSORRES, QSSTRESC and QSSTRESN fields are provided in Section 4: 

Mapping Strategy. 

© 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 

August 7, 2012


Example: Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R) 

This example shows data from one subject collected at one visit for a SOAPP-R questionnaire. The example uses standard controlled 

terminology for QSTESTCD, QSTEST, QSCAT and QSSORRES for the SOAPP-R measure. 

Rows 1-24: Represent the 24 questions from the SOAPP-R form. All original results are represented with the standard terminology in 

QSORRES. This result is then transformed into a Standard Numeric score in QSSTRESN. 

Row 25: Represents the textual question to include any additional information about the answers provided and is shown as a row for 

illustrative purposes in order to display the QSTESTCD/QSTEST values and contains the value of XXX, the actual missing record 

would not be created in the QS domain. 

Row 26: Represents the SOAPP-R score derived from the detailed questions 1-24 on the SOAPP-R Form. The QSDRVFL is set to “Y”. 

QS.XPT 

Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSDRVFL QSEVAL 

2324- 

SOAPR1-How Often 

1 STUDYX QS 1 SOAPR101 

P0001 

Mood Swings 

SOAPP-R Never 0 0 SUBJECT 

2324- 

SOAPR1-Need Higher 


P0001 

Doses of Medication 

SOAPP-R Seldom 1 1 SUBJECT 

2324- 

SOAPR1-Felt Impatient 


P0001 

With Doctors 

SOAPP-R Sometimes 2 2 SUBJECT 

4 STUDYX QS 

SOAPR1-Felt That 

2324- 

4 SOAPR104 Things Are 

P0001 

Overwhelming 

SOAPP-R Often 3 3 SUBJECT 

2324- 



P0001 

Tension at Home 

SOAPP-R Very Often 4 4 SUBJECT 

2324- 



P0001 

Counted Pain Pills 


2324- 

SOAPR1-Concerned 


P0001 

People Will Judge You 


2324- 

SOAPR1-How Often Feel 


P0001 

Bored 


2324- 



P0001 

Taken More Pain Med 


2324- 

SOAPR1-Worried About 


P0001 

Being Left Alone 


2324- 

SOAPR1-Felt Craving for 


P0001 

Medication 


12 STUDYX QS 

2324- 

P0001 

12 SOAPR112 

SOAPR1-Expressed 

Concern Over Med Use 



August 7, 2012


Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSDRVFL QSEVAL 

2324- 



P0001 

Friends Had Problem 


2324- 

SOAPR1-Others Told 


P0001 

You Bad Temper 


2324- 

SOAPR1-Felt Consumed 


P0001 

to Get Pain Med 


2324- 

SOAPR1-Run Out of 


P0001 

Pain Med Early 


2324- 

SOAPR1-Kept From 


P0001 

What You Deserve 


2324- 

SOAPR1-Legal Problems 


P0001 

or Arrested 


2324- 

SOAPR1-Attended AA or 


P0001 

NA Meeting 


2324- 

SOAPR1-Argument 


P0001 

Someone Got Hurt 


2324- 



P0001 

Sexually Abused 


2324- 

SOAPR1-Suggested Drug 


P0001 

or Alcohol Problem 


2324- 



P0001 

Borrowed Pain Meds 


2324- 

SOAPR1-Treated for 


P0001 

Alcohol or Drug Prob 


2324- 

SOAPR1-Any Additional 


P0001 

Information 

SOAPP-R XXX SUBJECT 

2324- 

26 STUDYX QS 

P0001 

26 SOAPR126 SOAPR1-Score SOAPP-R + 50 50 Y SUBJECT 


August 7, 2012


4 SDTM Mapping Strategy 

SOAPP-R specific mapping strategy: This section is used for reference with the annotated CRF 

for further details on the CRF data capture and to understand the alignment of the questionnaire 

to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, 

QSORRESU, QSSTRESC, QSSTRESN, and QSSTRESU) should be populated for each 

questionnaire. If a result variable is not included in the table for a questionnaire, it should not be 

populated. 

QSTESTCD= SOAPR101 - SOAPR124 

QSORRES QSSTRESC QSSTRESN 

Never 0 0 

Seldom 1 1 

Sometimes 2 2 

Often 3 3 

Very Often 4 4 

QSTESTCD= SOAPR126 QSTEST=SOAPR1-Score The numeric score is stored in 

QSSTRESN and QSSTRESC with the decode stored in QSORRES as indicated in the CRF 

instructions. 

QSORRES QSSTRESC QSSTRESN 

- 0…17 0…17 

+ 18…96 18…96 

End of Document 


August 7, 2012

Screener and Opioid Assessment for Patients with Pain Revised (SOAPP-R)

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