The purpose of this article is to provide a brief history of the Screener and Opioid Assessment for Patients with Pain (SOAPP). It is one of the opioid risk assessment tools available for download on PainEDU.org for clinicians to use in their practice when managing patients with pain, for whom opioids may be an important part of their therapy. Understanding the history of how this tool was developed may help clinicians decide how it can be most useful to them in their clinical setting.

The beginning

The development and validation of the SOAPP has been documented in four journal articles; the first was published in 2004¹. Beginning in 2003, researchers at Inflexxion, Inc., with support from a grant from the National Institutes of Health and an unrestricted grant from Endo Pharmaceuticals, began a study to develop and begin validation of a self-administered screening tool for chronic pain patients who were being considered for long-term opioid therapy, prior to institution of therapy. At the time, there was no widely accepted or widely used assessment for screening for potential problematic use behavior. When asked, most physicians prescribing pain medications, with no training in addiction issues, wanted an assessment tool.

The researchers began with a rigorous scientific process by which expert providers (pain specialists, primary care providers treating patients with chronic pain, nurses and support staff) were recruited from five pain centers to help generate a list of potential indicators of problems, or risk factors, for patients who were being considered for opioid therapy. After this first list was generated, a separate group of experts recruited from the International Pain and Chemical Dependency Listserv, sorted and rated the list. This led to the development of the initial list of 24 items that comprised SOAPP version 1.0.

The next step in the research was to validate the SOAPP version 1.0, to determine which of the items predicted aberrant use, to establish the reliability of the tool, and establish a scoring plan that would be clinically meaningful and practical. One hundred seventy-five (175) chronic non-cancer pain patients were recruited for this study. Three measures were used to establish aberrant drug-related behaviors: 1) self report via a structured interview; 2) staff assessment; and, 3) urine toxicology reports. Of the original 24 items, 14 items appeared to be reliable and to predict aberrant behavior, suggesting that SOAPP had promise as a screening tool.

Further refinements

In 2005, Inflexxion researchers carried out a longer and larger trial of the SOAPP with 396 non-cancer pain patients from two pain centers². They used a tool made up of the 14 SOAPP items that had appeared to predict aberrant behavior in the first study. Again, the researchers found that using the SOAPP questionnaire with only the 14 items supported their previous finding that the tool had good predictive validity, and therefore would be useful as a clinical tool. However, since all 14 of the items on the tool were obviously predictive of aberrant behavior, individuals who believed their report might make them ineligible for opioid therapy, might then underreport their behavior. The researchers determined then to develop a revised SOAPP (SOAPP-R) with the addition of further more subtle items.

Validation and cross-validation of the SOAPP-R

The SOAPP-R, the Screener and Opioid Assessment for Patients with Pain-Revised Version, was developed to address some of the limitations of the original SOAPP by improving the predictive value of a low SOAPP score, in order to give a higher level of confidence to clinicians. The article describing this study was published in 2008³. The researchers used the same method of developing this tool as they had with the original SOAPP. Again, pain and addiction experts were asked to help to develop a list of items that might predict aberrant use of an opioid. An initial alpha version of the SOAPP-R was developed with 142 statements. An empirical evaluation of the first, or alpha version, was conducted, to help identify items that should be dropped from the list.

A beta version was developed and tested with 283 patients. This was used to determine items for the final version. Eight of the original items remained. Sixteen (16) new items were added reflecting content that was not obviously related to prescription opioid abuse. The result was the final 24-item SOAPP-R tool. This was tested and found to be a reliable and valid measure of predicting risk for aberrant medication-related behavior.

The SOAPP-R was further cross-validated in a study with a new sample of 302 non-cancer pain patients. This study was published in 2009⁴. The study participants were recruited from 5 pain management centers and were followed for 5 months. This cross validation study revealed similar reliability and predictability of aberrant behavior as the original study. This further supported the researchers’ belief that the SOAPP-R is a useful tool for helping clinicians identify patients at different levels of risk. The researchers have concluded that the SOAPP-R can help clinicians to be more aware of patients at high risk, who may need extra monitoring when prescribed opioids, as well as to identify patients who are at low risk, and who may require fewer monitoring resources.

In addition to assessing patients and determining when a trial of opioids may be appropriate, clinicians must make choices regarding how to initiate, adjust, monitor, and in some cases discontinue chronic opioid therapy⁵.

As the need for performing and documenting opioid risk assessment, and determining the benefit to harm ratio of opioid use becomes more commonplace prior to making the decision to prescribe, the SOAPP has the ability to provide health care professionals with a validated solution to help guide their clinical decision-making. Visit the "Tools" section of www.PainEDU.org for more information and detailed instructions and scoring guides for the SOAAP.

References

1. Butler S, Budman S, Fernandez K, Jamison R. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004; 112: 65-75.
2. Akbik H, Butler S, Budman, S, Fernandez K, Katz N, Jamison R. Validation and clinical application of the screener and opioid assessment for patients with pain (SOAPP). Journal of Pain and Symptom Management. 2006; 32 (3): 287-293.
3. Butler S, Fernandez K, Benoit C, Budman S, Jamison R. Validation of the revised screener and opioid assessment for patients with pain (SOAPP-R). Pain. 2008; 9 (4): 360-372.
4. Butler S, Budman S, Fernandez K, Fanciullo G, Jamison R. Cross-validation of a screener to predict opioid misuse in chronic pain patients (SOAPP-R). J Addict Med. 2009; 3 (2): 66-73.
5. Chou R, Ballantyne J, Fanciullo G, Fine P, Miaskowski C. Research Gaps on Use of Opioids for Chronic Noncancer Pain: Findings From a Review of the Evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline The Journal of Pain, Vol 10, No 2 (February), 2009: 147-159