clinical outcomes measurement: different aspects of daily diary symptom ratings predict clinic...

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G04 - Clinical Outcomes Measurement (1010) Patients’ success criteria predicted by distress and ex- pectations for treatment P. Edwards, J. Riley, J. Brown, S. George, R. Fillingim, L. Waxenberg, J. Atchison, V. Wittmer, M. Robinson; University of Florida, Gainesville, FL Despite multiple treatment options for chronic pain, patients still do not receive pain relief and continue to seek care. This suggests they do not meet their criteria for successful treatment outcome. Traditional meth- ods of pain assessment and treatment outcome from the physician‘s perspective are different than assessment and outcomes from the pa- tient‘s perspective. Patient Centered Outcome (PCO), referring to the multidimensional assessment of patient‘s success criteria and expecta- tions for treatment, has been investigated only to a limited extent. The focus of the current study was to build on previous research using our Patient Centered Outcomes Questionnaire, which includes the four do- mains of pain, fatigue, emotional distress, and interference with daily activities. These were used to develop an exploratory model of how patients’ usual levels of distress in the four domains predict their success criteria and expectations for treatment. In addition to descriptive statis- tics of these patients, Structural Equation Modeling was used to analyze the proposed model, allowing for a more precise type of evaluation of the interaction between these constructs. Data collected from 110 pa- tients from chronic pain clinics revealed that the proposed model sup- ported the hypothesis that usual levels of distress predict patients’ suc- cess criteria and expectations for treatment. Furthermore, the model was a good fit for our data (Chi-Square (df, 38) 64.4, p.05; RMSEA.08; GFI.91), and by extension for the internal constructs of the PCO Questionnaire. In addition, analyses suggested the inclusion of another variable to more clearly describe what is involved when patients rate their success criteria and expectations. Possibilities for the addi- tional variable or variables are explored. Further development of PCO would allow for calibration of existing multidimensional measures of pain to incorporate the patients’ perspective of successful treatment. (1011) Different aspects of daily diary symptom ratings pre- dict clinic ratings for patients and healthy controls D. Williams, P. Biswas, J. Kalbfleisch, R. Gracely, S. Chriscinske, D. Clauw; University of Michigan, Ann Arbor, MI Daily diary symptom ratings tend to provide a richer and potentially more accurate representation of symptom experiences than question- naires given at one point in time. Differences in these two methods can provide discrepant clinical impressions; thus this study sought to identify which aspects of the data-rich diary method is captured in traditional one-time clinic assessments. 67 patients diagnosed with a chronic multi- symptom illness (CMI (e.g. Fibromyalgia, Chronic Fatigue Syndrome, and Gulf War illnesses) and 43 age and sex matched healthy control subjects were asked to complete a daily diary of symptoms that included pain and fatigue 5 times each day for 3 days. Values for average, peak, and most recent ratings were summarized for the diary ratings. All subjects then visited a clinic where they completed standardized ratings of pain, fatigue, and function (i.e. McGill Pain Questionnaire, Multidimensional Fatigue Inventory, SF-36). Clinic ratings were used as dependent vari- ables in multiple linear regression models with the summary diary mea- sures as predictors. Identical models were run for CMI patients and con- trols. The CMI sample contained patients with FM (10), CFS (12), GWI (20) and mixed FM/CFS (25). For patients, the McGill sensory pain score was best predicted by the last diary entry (p 0.0001). The McGill affective score reflected the peak pain (p 0.001). These findings were the same for the controls (p‘s 0.001). For patients, clinic-based fatigue and SF-36 measures of physical function were best predicted by peak fatigue; whereas for controls, these same domains were best predicted by the most recent diary value (all p‘s 0.05). Patient reports of pain, fatigue, and physical function obtained in a single visit are likely to reflect a recent peak exacerbation of that symptom; whereas healthy controls tend to report the intensity of the most recent experience of each symp- tom. (1012) Interpretation of pain intensity: How does the commu- nity perceive of mild, moderate, and severe pain? G. Palos, T. Mendoza, G. Mobley, S. Cantor, C. Cleeland; The University of Texas MD Anderson Cancer Center, Houston, TX Clinicians depend on the subjective interpretation of the pain experi- ence and more importantly, on the individual‘s self-report of the inten- sity of their pain. To better understand the meaning and assessment of pain intensity in community-dwelling adults, it is important to know how the public numerically interprets mild, moderate, and severe pain. As part of a countywide, population-based, cross-sectional telephone study on community preferences toward cancer pain outcomes, we con- ducted a sub-analysis to determine the public‘s perceptions of the boundaries for mild, moderate, and severe when using an 11-point nu- merical rating scale (0 no pain; 10 pain as bad as you can imagine). The study sample consisted of 302 community members who were 18 years and older and were English/Spanish speaking. The main outcome variables were the ranges reported by respondents for mild, moderate, and severe pain, which were obtained by asking the respondent to give an upper and lower boundary for each level of pain severity. We exam- ined the differences between the mean scores of the upper and lower bounds of mild, moderate, and severe pain. Our preliminary findings indicate that the range for each category of pain intensity when asked to use a 0 – 10 numerical rating scale were: mild (1.34 – 3.66), moderate (4.27 – 6.50), and severe (7.46 – 9.76). These boundaries closely resemble those reported in patients experiencing pain related to cancer, mild (1-4), moderate (5-6), and severe (7-10). These findings suggest a high degree of consistency in the way pain intensity is interpreted by both the general public as well as by patients when using a numerical rating scale. Future community-based studies will need to examine the relationship between pain intensity and interference with activities of daily living. Supported by the National Cancer Institute Under Grant Number CA 25582. (1013) Validation of screener and opioid assessment for pa- tients with pain S. Butler, S. Budman, K. Fernandez, C. Benoit, R. Jamison; Inflexxion, Inc., Newton, MA There has been a need for a brief assessment tool for providers treating chronic pain patients to determine potential risk of abuse when pre- scribed opioids for pain. The purpose of this study was to develop and begin the validation of a self-administered, brief screening tool (Screener and Opioid Assessment for Patients with Pain; SOAPP) for chronic pain patients considered for long-term opioid therapy. A con- sensus of 26 pain and addiction experts was obtained on important characteristics of chronic pain patients that predict future medication misuse using concept mapping. Eight conceptual clusters were defined: (1) psychosocial problems, (2) psychiatric history, (3) substance abuse history, (4) antisocial behaviors/history, (5) doctor-patient relationship factors, (6) medication-related behaviors, (7) emotional attachment to pain medication, and (8) personal care and lifestyle issues. A 24-item SOAPP (version 1.0) was developed based on this consensus and was administered to 154 patients who were taking opioids for chronic pain. After six months, one hundred of these patients were re-administered the SOAPP and interviewed using the Prescription Drug Use Question- naire (PDUQ). Patients below the lower cutoff on the PDUQ do not show medication misuse problems, while those above the higher cutoff are likely to have such problems. Of the original 24 items, 16 items appeared to predict subsequent PDUQ scores. Coefficient a ´ for these 16 items was acceptable for a short scale (.73). Preliminary receiver operating charac- teristics (ROC) curve analyses yielded an area under the curve (AUC) for the lower cutoff of .92 (p 0.001), while the AUC for the higher cutoff was .84 (p 0.05). Further refinement and testing of the scale are planned. These reliability and predictive validity figures suggest that the SOAPP is a promising step toward determining risk potential for sub- stance misuse among persons with chronic pain. 111 Abstracts

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G04 - Clinical Outcomes Measurement(1010) Patients’ success criteria predicted by distress and ex-

pectations for treatmentP. Edwards, J. Riley, J. Brown, S. George, R. Fillingim, L. Waxenberg, J. Atchison,V. Wittmer, M. Robinson; University of Florida, Gainesville, FLDespite multiple treatment options for chronic pain, patients still do notreceive pain relief and continue to seek care. This suggests they do notmeet their criteria for successful treatment outcome. Traditional meth-ods of pain assessment and treatment outcome from the physician‘sperspective are different than assessment and outcomes from the pa-tient‘s perspective. Patient Centered Outcome (PCO), referring to themultidimensional assessment of patient‘s success criteria and expecta-tions for treatment, has been investigated only to a limited extent. Thefocus of the current study was to build on previous research using ourPatient Centered Outcomes Questionnaire, which includes the four do-mains of pain, fatigue, emotional distress, and interference with dailyactivities. These were used to develop an exploratory model of howpatients’ usual levels of distress in the four domains predict their successcriteria and expectations for treatment. In addition to descriptive statis-tics of these patients, Structural Equation Modeling was used to analyzethe proposed model, allowing for a more precise type of evaluation ofthe interaction between these constructs. Data collected from 110 pa-tients from chronic pain clinics revealed that the proposed model sup-ported the hypothesis that usual levels of distress predict patients’ suc-cess criteria and expectations for treatment. Furthermore, the modelwas a good fit for our data (Chi-Square (df, 38) � 64.4, p�.05;RMSEA�.08; GFI�.91), and by extension for the internal constructs ofthe PCO Questionnaire. In addition, analyses suggested the inclusion ofanother variable to more clearly describe what is involved when patientsrate their success criteria and expectations. Possibilities for the addi-tional variable or variables are explored. Further development of PCOwould allow for calibration of existing multidimensional measures ofpain to incorporate the patients’ perspective of successful treatment.

(1011) Different aspects of daily diary symptom ratings pre-dict clinic ratings for patients and healthy controls

D. Williams, P. Biswas, J. Kalbfleisch, R. Gracely, S. Chriscinske, D. Clauw;University of Michigan, Ann Arbor, MIDaily diary symptom ratings tend to provide a richer and potentiallymore accurate representation of symptom experiences than question-naires given at one point in time. Differences in these two methods canprovide discrepant clinical impressions; thus this study sought to identifywhich aspects of the data-rich diary method is captured in traditionalone-time clinic assessments. 67 patients diagnosed with a chronic multi-symptom illness (CMI (e.g. Fibromyalgia, Chronic Fatigue Syndrome, andGulf War illnesses) and 43 age and sex matched healthy control subjectswere asked to complete a daily diary of symptoms that included painand fatigue 5 times each day for 3 days. Values for average, peak, andmost recent ratings were summarized for the diary ratings. All subjectsthen visited a clinic where they completed standardized ratings of pain,fatigue, and function (i.e. McGill Pain Questionnaire, MultidimensionalFatigue Inventory, SF-36). Clinic ratings were used as dependent vari-ables in multiple linear regression models with the summary diary mea-sures as predictors. Identical models were run for CMI patients and con-trols. The CMI sample contained patients with FM (10), CFS (12), GWI (20)and mixed FM/CFS (25). For patients, the McGill sensory pain score wasbest predicted by the last diary entry (p� 0.0001). The McGill affectivescore reflected the peak pain (p� 0.001). These findings were the samefor the controls (p‘s� 0.001). For patients, clinic-based fatigue and SF-36measures of physical function were best predicted by peak fatigue;whereas for controls, these same domains were best predicted by themost recent diary value (all p‘s� 0.05). Patient reports of pain, fatigue,and physical function obtained in a single visit are likely to reflect arecent peak exacerbation of that symptom; whereas healthy controlstend to report the intensity of the most recent experience of each symp-tom.

(1012) Interpretation of pain intensity: How does the commu-nity perceive of mild, moderate, and severe pain?

G. Palos, T. Mendoza, G. Mobley, S. Cantor, C. Cleeland; The University of TexasMD Anderson Cancer Center, Houston, TXClinicians depend on the subjective interpretation of the pain experi-ence and more importantly, on the individual‘s self-report of the inten-sity of their pain. To better understand the meaning and assessment ofpain intensity in community-dwelling adults, it is important to knowhow the public numerically interprets mild, moderate, and severe pain.As part of a countywide, population-based, cross-sectional telephonestudy on community preferences toward cancer pain outcomes, we con-ducted a sub-analysis to determine the public‘s perceptions of theboundaries for mild, moderate, and severe when using an 11-point nu-merical rating scale (0 � no pain; 10 � pain as bad as you can imagine).The study sample consisted of 302 community members who were 18years and older and were English/Spanish speaking. The main outcomevariables were the ranges reported by respondents for mild, moderate,and severe pain, which were obtained by asking the respondent to givean upper and lower boundary for each level of pain severity. We exam-ined the differences between the mean scores of the upper and lowerbounds of mild, moderate, and severe pain. Our preliminary findingsindicate that the range for each category of pain intensity when askedto use a 0 – 10 numerical rating scale were: mild (1.34 – 3.66), moderate(4.27 – 6.50), and severe (7.46 – 9.76). These boundaries closely resemblethose reported in patients experiencing pain related to cancer, mild(1-4), moderate (5-6), and severe (7-10). These findings suggest a highdegree of consistency in the way pain intensity is interpreted by both thegeneral public as well as by patients when using a numerical rating scale.Future community-based studies will need to examine the relationshipbetween pain intensity and interference with activities of daily living.Supported by the National Cancer Institute Under Grant Number CA25582.

(1013) Validation of screener and opioid assessment for pa-tients with pain

S. Butler, S. Budman, K. Fernandez, C. Benoit, R. Jamison; Inflexxion, Inc.,Newton, MAThere has been a need for a brief assessment tool for providers treatingchronic pain patients to determine potential risk of abuse when pre-scribed opioids for pain. The purpose of this study was to develop andbegin the validation of a self-administered, brief screening tool(Screener and Opioid Assessment for Patients with Pain; SOAPP) forchronic pain patients considered for long-term opioid therapy. A con-sensus of 26 pain and addiction experts was obtained on importantcharacteristics of chronic pain patients that predict future medicationmisuse using concept mapping. Eight conceptual clusters were defined:(1) psychosocial problems, (2) psychiatric history, (3) substance abusehistory, (4) antisocial behaviors/history, (5) doctor-patient relationshipfactors, (6) medication-related behaviors, (7) emotional attachment topain medication, and (8) personal care and lifestyle issues. A 24-itemSOAPP (version 1.0) was developed based on this consensus and wasadministered to 154 patients who were taking opioids for chronic pain.After six months, one hundred of these patients were re-administeredthe SOAPP and interviewed using the Prescription Drug Use Question-naire (PDUQ). Patients below the lower cutoff on the PDUQ do not showmedication misuse problems, while those above the higher cutoff arelikely to have such problems. Of the original 24 items, 16 items appearedto predict subsequent PDUQ scores. Coefficient a for these 16 items wasacceptable for a short scale (.73). Preliminary receiver operating charac-teristics (ROC) curve analyses yielded an area under the curve (AUC) forthe lower cutoff of .92 (p � 0.001), while the AUC for the higher cutoffwas .84 (p � 0.05). Further refinement and testing of the scale areplanned. These reliability and predictive validity figures suggest that theSOAPP is a promising step toward determining risk potential for sub-stance misuse among persons with chronic pain.

111Abstracts