This study attempts to create a valid and reliable self-report measure of current opioid medication misuse (COMM). The benefit of such a measure is to document the reliable use of opioids in the treatment of pain for persons with chronic pain. A 40-item questionnaire was developed using input from a panel of experts and concept mapping analyses. Seventeen of the items of the COMM were found to show good reliability and adequate validity in identifying which chronic pain patients currently on long-term opioid therapy would show evidence of medication misuse or abuse after an extensive assessment process. The questionnaire appears to be easy to understand and takes little effort to score.
Unlike other measures that were designed to identify risk potential for substance abuse (predictive validity), the COMM is designed to address ongoing medication misuse by asking patients to describe how they are currently using their medication. Each question asks the relative frequency of a thought or behavior over the past 30 days from “0 = Never” to “4 = Very Often.” Thus, instead of identifying character and personality traits based on past history, the COMM is mostly interested in current behaviors and cognition. We recognize that patients taking opioids for pain who misuse their medication are prone to be less than truthful when completing a current medication misuse questionnaire; however, many of the items are subtly related to misuse of medication and are less transparent. We have also found that patients are willing to admit to certain items if they rate them as 1 = ‘seldom’ on a 0 to 4 scale (Butler et al., 2004
), thus decreasing the chance that the patients will falsify all of their answers.
The COMM cutoff score was selected to over-identify misuse, rather than to mislabel someone as responsible when they are not. This is why a low cut-off score was accepted. Any endorsement of the COMM items would have a greater likelihood of identifying current medication misuse. We believe that it is more important to identify patients who have only a possibility of misusing their medications than to fail to identify those who are actually abusing their medication. Thus, this scale will result in false positives – patients identified as misusing their medication when they were not. Similar to past measures that help to predict substance abuse, the COMM may also be valuable as a scale to identify those who are not having problems with their use of opioids (very low scores). However, since there are no objective means by which to identify substance abusers, errors can be made. Clinicians are encouraged to practice caution when interpreting the results of the COMM and to take into consideration other extenuating circumstances. As with all screeners, the COMM is a single indicator of possible medication misuse. Additional information should be used in making a diagnosis of a substance abuse disorder (Savage, 2002
There is a risk that the COMM could be used as a “gatekeeper” for discontinuing prescription of opioids by some providers. Our past experience with the SOAPP (Screener and Opioid Assessment for Patients with Pain) has showed, however, that prescribing physicians are more willing to maintain patients on opioids for pain because of the reassurance offered by the SOAPP that there are minimal signs of opioid abuse (Butler et al., 2004
; Akbik et al., 2006
). Thus, the COMM may also be used in helping to reassure physicians about their prescription practices.
The goal of the COMM is to identify those patients with chronic pain taking opioids who have indicators of current medication misuse. We believe that the COMM will be able to assist providers in documenting compliance along with the use of other indicators such as periodic urine screens. We do not believe that the COMM should be used to deny care but rather to make appropriate decisions about the best ways to manage chronic pain. Ideally, the results of the COMM can serve as an educational tool for patients and providers. While the COMM will require additional research, the initial results suggest that this scale could be used in a pain practice or general medical setting to help document ongoing patient compliance. Patients who score higher on the COMM could be seen on a more frequent basis, with regular pill counts and urine toxicology screens.
As noted in previous studies, physicians can be unreliable in accurately identifying aberrant drug behavior within a busy pain practice. This was further supported in recent studies showing a 44.5% rate of abnormal urine results among random drug screening (Michna et al., in press
) and a high degree of unreliability of physicians to judge aberrant behavior (Wasan et al., in press
). These results reinforce the notion that the COMM is only one source of information and never should be used in isolation to determine appropriate use of opioids.
We purposely divided the experts into doctoral-level and non-doctoral-level (e.g., nurses) groups to see if there would be agreement in the way that these professionals rank-ordered the factors. We found that the two groups tended to rate the clusters in a reasonably similar manner with respect to importance, achieving a high positive correlation of 0.96. Specifically, the two highest-ranking clusters, medication misuse/noncompliance and evidence of lying and drug use, were identical for the two groups. The relative rankings of the other four concepts were somewhat different. Nurses/support staff and non-doctoral level individuals tended to see appointment patterns as more important than physicians, perhaps because they deal more directly with such patterns. Likewise, patients being more difficult in their interactions with providers may affect nurses and support staff more directly than physicians, prompting these individuals to rate such behaviors more highly. Both groups of participants rated all the concepts about a 3 on a 5-point scale, suggesting that the participants viewed all concepts as important. While these concepts require empirical validation, it is encouraging to find reasonably high correspondence of views across disciplines. Including more input from other professional groups in future validity studies of the COMM would be recommended.
The following limitations of this study deserve mention. First, this study needs to be replicated with more subjects in a variety of centers. We do not know, for instance, how useful the COMM may be in primary care settings vs. tertiary university-based pain centers. Attempts were made to include minorities, but further information on the usefulness of the COMM among different ethnic groups and pain populations is also needed.
Second, the long-term reliability of the COMM is unknown. We include the results of one-week test-retest reliability and three-month repeated administration data, which produced very promising results. However, use of the COMM repeatedly over a longer period of time has yet to be assessed.
Third, COMM items were derived by consensus and concept mapping techniques. Cross-validation of empirically-derived COMM items is needed. Also, evaluation of the COMM’s ability to detect misuse or abuse, both initially and during a three-month re-administration were based on data from the same patient sample used to develop the measurement items. We strongly believe that a balanced approach is necessary and recognition of other reasons to account for behavior need to be considered in order to avoid prejudicial thinking. A study is currently underway to cross-validate the COMM and to further examine its psychometric properties with a new population of patients. Ultimately, a revised version that would incorporate more predictive yet subtle items to reduce the risk of fabrication may be needed.