Interference Items Research Articles

P3.01-109 Real-World Patient-Reported Outcome Assessment of Patients with Metastatic Non-Small Cell Lung Cancer

Patient-Reported Outcomes (PROs) provide information on patient treatment experience. We have established a real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) to understand how the advent of immunotherapy impacts treatment choice, clinical outcomes, and PROs of metastatic non-small cell lung cancer (mNSCLC). The aim of this analysis is to report early results of baseline symptom status and quality of life among mNSCLC patients using the MD Anderson Symptom Inventory lung cancer module (MDASI-LC) and EuroQol-5D 5-level version (EQ-5D-5L). During 2017, patients with mNSCLC at a single institution were enrolled in ANCHoR and completed the PRO questionnaires at clinic visits. MDASI-LC consists of thirteen core and three lung cancer-specific symptom severity questions, and six interference items rated on 0-10 scales (0 = no symptom or interference, 10 = worst imaginable symptom or complete interference). EQ-5D-5L captures five health state dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression rated on a five-level scale (1= no problems, 5= extreme problems). A single visual analogue scale (VAS) on EQ-5D-5L records patient self-rated health between ”best imaginable” (100) and “worst imaginable” (0) health state. Descriptive statistics for PRO scores at baseline are summarized. Forty-two patients completed baseline PROs before the start of therapy. Mean patient age was 63 years and 45% were males. For MDASI-LC, the mean scores for the core symptom, lung cancer-specific symptom, and interference subscales at baseline were 2.2 (standard deviation [SD] = 2.80), 2.1 (SD = 2.80), and 2.8 (SD = 3.10), respectively. Fatigue was the most severe symptom reported at baseline (mean = 4.1, SD = 3.01), followed by shortness of breath (mean = 3.2, SD = 2.81) and pain (mean = 3.19, SD = 3.00). The highest percentages of patients reporting moderate to severe symptom levels (score of ≥5) were 38% for fatigue, 33% for pain, 31% for drowsiness, 29% for shortness of breath and disturbed sleep, and 26% coughing. For EQ-5D-5L, 91% of patient reported problems with self-care, 81% with mobility, 48% with usual activity and anxiety, and 33% with pain. Mean EQ-5D VAS was 73.9 (SD = 18.2). Prior to the start of treatment, fatigue, pain, drowsiness, disturbed sleep, and coughing were the most common symptoms with fatigue, shortness of breath, and pain being the most severe. Additional follow up will confirm and expand these findings and will also allow us to examine change in PROs after first-line treatment is administered.

Improvement in pain interference after palliative radiotherapy for solid and hematologic painful tumors: a secondary analysis of a prospective observational study.

We previously demonstrated that patients with painful hematologic tumors were more likely to experience pain response after palliative radiotherapy (RT) than those with painful solid tumors. However, it is unknown whether change in pain interference differs between these two tumor types. In the present study, we carried out a secondary analysis of our previous prospective observational study to investigate this matter. From patients undergoing palliative RT to treat painful tumors, Brief Pain Inventory data were collected at the start of RT and at the 1-, 2-, and 3- month follow-ups. The Mann-Whitney U test was used to compare changes in pain interference score from baseline between the two groups. Of the 237 patients, 203 (86%) had solid and 34 (14%) had hematologic index tumors planned to receive RT. At baseline, the groups did not differ significantly in terms of pain score, analgesic use, or pain interference score. At the 1-, 2-, and 3-month follow-ups, the changes in pain interference score from baseline did not differ significantly between the two groups. In both groups, all seven pain interference items, other than sleep in patients with hematologic tumors at the 2-month follow-up, were significantly improved (P < 0.05). The two groups showed comparable benefit from RT in terms of improvement in pain interference. Patients with tumor-related pain should be offered the option of palliative RT, irrespective of whether the painful tumor is solid or hematologic.

Development and content validity of a hemodialysis symptom patient-reported outcome measure.

To describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms. Experienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings. Forty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by > 10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item "nausea/vomiting" into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes. Symptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring.

Measuring the interference of pain on daily life in persons with spinal cord injury: A Rasch-validated subset of items from the Brief Pain Inventory interference scale.

Up to 60% of individuals report chronic pain after traumatic spinal cord injury (SCI). Measurement of the degree to which pain interferes with activities and emotions can provide valuable clinical insights with implications for pain management interventions. One questionnaire that can be used to quantify the impact of pain is the Brief Pain Inventory (BPI) interference scale, a seven-item self-report assessment. Our objective was to examine the Rasch measurement properties of the BPI interference scale for measuring pain interference in persons with SCI. A secondary analysis of cross-sectional, population-based, self-report data was conducted. Participants were adults with traumatic SCI with residual effects who were at least one year post-injury and 18years of age (n=876). Rasch analysis was used to evaluate the measurement properties of the BPI interference items for persons with SCI. Two BPI interference scale items were excluded from analysis due to high rates of missing data. Of the remaining five items, four items demonstrated acceptable measurement properties in the SCI population. Four of the original seven BPI interference items provide acceptable measurements of pain interference in the SCI population.

Pain interference with physical functioning is associated with physical activity level in patients with chronic musculoskeletal pain

In case of musculoskeletal pain, a decreased physical activity (PA) could favor deconditioning and chronicity. However, several studies have failed to highlight low PA in people suffering chronic pain. To explore this issue further, we analyzed PA level of patients with chronic musculoskeletal pain (CMP) with an inertial sensor. The objective was to assess whether pain interference (PI) with physical functioning correlated with PA level. We studied 267 CMP patients [age: 44 years (SD: 12)]. Pain sites were upper limbs (43%), spine (23%), and lower limbs (34%). The participants wore an accelerometer during two consecutive days. We assessed the daily duration of moderate-to-vigorous PA (MVPA), that is, all movements with an intensity above slow walking. We used the average score of the three interference items related to physical functioning in the brief pain inventory (BPI) questionnaire (0–10). We fitted a generalized linear mixed model (GLMM) with MVPA as the dependent variable. We defined PI as a continuous predictor, and pain site as a 3-level categorical covariate. Main effects and interaction (PI × Pain site) were included in the model. The average duration of MVPA was 76 min (SD: 51), that is, 10% as high as the accelerometer wear time (13 h, SD: 2.6). Average PI score was 5.3 (SD: 2.2). GLMM shows that PI was significantly and negatively associated with MVPA. The interaction result shows that the percent change for each PI point was upper limbs: −2%; spine: −10%; and lower limbs −3%. The results show that PA level correlates to how CMP patients perceived the interference between pain and physical functioning. The association is particularly strong in patients with back pain. This finding supports the hypothesis that chronic pain impairs PA through the interference with daily physical activities.

Quality of life after spinal cord injury: The impact of pain.

Pain is a common complication after spinal cord injury (SCI). A mixture of nociceptive and neuropathic pain (NP) can present. Limited studies have investigated the impact of different pain phenotypes on quality of life (QoL) post-SCI. Members registered to a national support group for those with SCIs were surveyed (n=1574). The survey comprised questions relating to demographics and SCI characteristics, The Douleur Neuropathique 4 (DN4) (interview), the International SCI Pain Basic Data Set recording the worst pain and the World Health Organisation Quality of Life BREF (WHOQOL-BREF). An ANCOVA model with post hoc analysis explored between group factors of pain type and intensity of pain categories on QoL, controlling for additional confounding variables. Significance was set p<0.05. A linear regression explored whether pain intensity, type or interference best predicted QoL. The response rate was 41% (n=643), 70% (n=447) were male. The mean age of respondents was 52years (SD 14.2) and mean time from SCI was 17years (SD 12.4). In the previous week, 71% (n=458) experienced pain, 37% (n=236) of which had NP as defined in the study. Respondents experiencing NP demonstrated significantly poorer QoL than those without pain (p<0.001) or nociceptive pain (p<0.05). Those reporting high pain intensity had significantly lower QoL than those with moderate or no pain (p<0.001). Pain interference consistently and best-predicted domains of QoL (p<0.001). High-intensity pain and NP negatively impacts QoL post-SCI. However pain interference more than intensity or type best explains the variance in QoL reported. Neuropathic pain type and severe pain intensities negatively impact QoL after SCI. Pain interference items better predict reported QoL than either pain type or intensity, suggesting better pain management strategies are warranted.

Comparison of EORTC QLQ-C30 and PRO-CTCAE™ Questionnaires on Six Symptom Items

ContextClinical studies have over the past decade paid increasing attention to health-related quality of life data. Multiple questionnaires are often administered resulting in overlapping questions increasing patient burden. ObjectivesTo examine the correlations between the commonly used European Organization for Research and Treatment of Cancer Quality of Life Questionnnaire-C30 (QLQ-C30) and the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) on six coinciding items to determine consistency between overlapping items. MethodsData were prospectively collected from patients attending two cancer centers in the U.K. Participants completed the QLQ-C30 version 3.0 every four weeks and the PRO-CTCAE at least once a week for 12 weeks. Data were collected via the Internet or an interactive voice response. For the six coinciding items in QLQ-C30 and PRO-CTCAE: pain, nausea, vomiting, constipation, diarrhea, and fatigue, comparisons were made between all possible related responses by aligning the four responses in the QLQ-C30 with two condensed versions of the five responses in the PRO-CTCAE. Consistency and reliability was determined with the intraclass correlation coefficient (ICC) and Cronbach's α. ResultsAbout 247 patients completed 785 QLQ-C30 and 2501 PRO-CTCAE questionnaires. Moderate (ICC >0.5) to good (ICC >0.75) reliability and Cronbach's α >0.7 were found on all coinciding questions except for questions concerning the severity of nausea and vomiting as a result of relatively few patients responding to these questions. Items on frequency showed better correlations than the severity and interference items. ConclusionThe good reliability and consistency between the QLQ-C30 and PRO-CTCAE support future attempts to minimize patient burden by shortening health-related quality of life questionnaires.

Using PROMIS Pain Interference Items to Improve Quality Measurement in Inpatient Rehabilitation Facilities

ObjectiveTo evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference items for use in a quality measure and to compare the resulting quality score, along with internal reliability and validity, to a similar item set in the Minimum Data Set Version 3.0 (MDS). DesignCross-sectional, observational study. SettingOne freestanding inpatient rehabilitation facility (IRF) and one large hospital-based IRF. ParticipantsPatients with neurologic disorders. Of 1055 consecutive admissions, 26% were excluded based on clinician-determined cognitive impairment or emotional distress. Of the remainder, 50% consented and completed the survey near the end of their IRF stay (N = 391). Of these, more than half (57%) reported pain over the last day (n = 224). MeasurementsPsychometric statistics and quality scores were computed from a 55-question survey, including the MDS and PROMIS pain interference items. ResultsEstimates for internal reliability were higher for the PROMIS 2-item scale compared to the MDS: Cronbach α (0.86 vs 0.48) and interitem correlations (0.75 vs 0.31). The PROMIS-2 items were better able to detect differences in patients with mild and severe pain intensity (Cohen d = 1.57) relative to the corresponding MDS items (Cohen d = 0.81). Two quality scores based on the PROMIS-2 items, reflecting low and high levels of pain interference, showed 46% or 12% of patients meeting these thresholds. This compared to a 30% rate when patients were classified by the MDS as experiencing pain interference. ConclusionsPROMIS pain interference items appear to be more internally consistent than similar MDS items. The graded PROMIS items permit the creation of multiple quality scores, showing predictable overlap with corresponding MDS quality scores. Because PROMIS items provide finer distinctions, they allow greater latitude in reporting quality scores. We recommend further study of pain interference scores across IRFs to improve their reliability and validity.

Validation and application of a module of the M. D. Anderson symptom inventory for measuring symptom burden in patients with gynecologic cancer (MDASI-PERI-GYN) for perioperative care

Objectives: Collecting patient reported outcomes (PROs) in perioperative care is increasingly common. We report the development and validation of a module of MDASI for use in patients with gynecologic (GYN) cancer for perioperative care. Methods: Patients who underwent GYN surgery participated in module development and validation. The process included: (1) generating Peri-GYN-specific candidate items with input from GYN oncologists and from qualitative interviews, and adding these to the core MDASI for testing; (2) dropping candidate GYN items that lacked sensitivity; (3) validating the psychometric properties (reliability, validity) of the resulting MDASI-GYN; and (4) conducting cognitive debriefing interviews with patients to confirm the questionnaire’s ease of comprehension, relevance, and acceptability. Results: Eleven GYN-module symptom items were generated from the first two steps, and added to the original 19 MDASI symptom and interference items to form the MDASI-Peri-GYN for validation. There were 147 patients (Minimally-invasive surgery (MIS)=69, open surgery=78) who participated with 122 also providing retest data. Cognitive debriefing in 20 patients demonstrated that, to patients, the MDASI-Peri-GYN is an easy-to-use and understandable tool. Two items were dropped based on the psychometric analysis and patients’ debriefing. The module symptom by severity included: bloating, abdominal cramp, constipation, hot flash, dizziness, groggy or confusion, urinary pain, difficult urinating and diarrhea. Cronbach alphas were 0.89 and 0.86 for 22 symptom severity items and 6 interference items, respectively. Test-retest reliability (intra-class correlation) was 0.88 for 22 symptom severity items. Known-group validity (sensitivity) was supported by the MDASI-GYN’s detection of significant differences in symptom and interference levels according to performance status (P < .001) and MDASI core by open surgery or MIS (P<.01). There were no observed significant differences of severity on module items between open and MIS during hospitalization. Conclusion: The MDASI-GYN is a valid, reliable, and concise tool for measuring symptom severity and interference with function in patients with GYN cancers during the perioperative period and can be useful in assessing the impact of ERAS. Disclosure of Interest: None Declared

Validation of the Amharic Version of the Brief Fatigue Inventory for Assessment of Cancer-Related Fatigue in Ethiopian Cancer Patients

BackgroundAlthough cancer-related fatigue (CRF) is a highly prevalent and distressing symptom associated with cancer and its treatment, it is mostly underscreened, underassessed, and undertreated. The Brief Fatigue Inventory (BFI) is a reliable and valid instrument to assess CRF. ObjectiveTo validate the Amharic version of the BFI (BFI-Am) for assessment of CRF in Ethiopian cancer patients. MethodsThe BFI-Am was developed from its original English version through standard forward-backward translation approach. Two hundred eight consented cancer patients filled the questionnaires, along with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, version 3. In addition, sociodemographic and clinical information were collected. Psychometric properties of the BFI-Am were evaluated in terms of acceptability, internal consistency, construct validity, concurrent validity, and known group validity. Linear regression analysis was performed to identify possible predictors of fatigue severity. ResultsTwo hundred two cancer patients completed the questionnaires and included in the data analysis. The BFI-Am had an overall Cronbach's alpha of 0.97. The results of the principal axis factor analysis suggested a one-factor solution explaining 78.4% of the variance, supporting the hypothesis of unidimensionality of the BFI-Am. The global BFI-Am interference items score was highly correlated with fatigue subscale score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 than single items, showing an inverse correlation between the BFI-Am and the global health status/quality of life (r = −0.324; P = 0.000). The BFI-Am significantly detected the differences in fatigue severity in patients with poor performance status (P < 0.001), indicating known group validity. ConclusionThe BFI-Am is an excellent assessment tool with adequate psychometric properties for use in both clinical management and symptom research of CRF in Ethiopian cancer patients.

Interpreting the Effectiveness of Opioids and Pregabalin for Pain Severity, Pain Interference, and Fatigue in Fibromyalgia Patients.

To evaluate the effectiveness of opioids and/or pregabalin on patient-reported outcomes among fibromyalgia (FM) patients based on levels of improvement. A total of 1,421 FM patients were identified, with 3,082 observational periods of opioids with or without pregabalin use between April 2008 and February 2015. Patients were categorized by opioids, and pregabalin with and without opioids; opioids were designated by morphine equivalent dose (MED) of ≤20 (low MED), >20 to <100 (moderate MED), ≥100 (high MED), and pregabalin doses of ≤150mg, 151 to 300mg, and 301 to 450mg. Proportions of patients meeting clinically relevant thresholds of ≥30% and ≥50% improvement for pain interference (ability to enjoy life; activity; mood; relationships; sleep), pain severity, and fatigue were compared among treatments, and area under the curve (AUC) for improvement and worsening of effects was determined, enabling ranking of treatments. Further analysis compared pregabalin doses. Pregabalin without opioids resulted in the highest proportions of patients with ≥30% improvement on all pain items and pain interference with "ability to enjoy life," "activity" "mood," and "sleep." For the ≥50% threshold, pregabalin alone was highest for all pain interference items and for "average pain" and "worst pain." Pregabalin was consistently lowest across thresholds for fatigue, but showed better results combined with moderate MED opioids. Pregabalin doses recommended for treatment of FM (151 to 450mg) generally resulted in the highest proportion of patients achieving thresholds relative to opioids. The AUC results were consistent with thresholds; pregabalin without opioids resulted in the greatest benefits with regard to improvement, with the highest ranking for overall improvement and overall effects. Pregabalin without opioids provided the most favorable outcomes overall based on ≥30% and ≥50% improvement thresholds and AUC, with support for moderate MED opioids+pregabalin in patients suffering from fatigue. While most patients took less than recommended pregabalin doses, higher doses may lead to improved outcomes.

Fire Recognition Based On Multi-Channel Convolutional Neural Network

In recent years, fire recognition methods have received more and more attention in the fields of academy and industry. Current sensor-based recognition methods rely heavily on the external physical signals, which will probably reduce the recognition precision if the external environment changes dramatically. With the rapid development of high-definition camera, the methods based on image feature extraction provide another solution which tries to conduct pattern recognition for the monitoring video. However, these methods couldn’t be widely and successfully applied to fire detection due to two deficiencies: (1) there are too many interference items like lamplight and car highlight in the room or tunnel, which will disturb the recognition performance largely; (2) The features depend on much prior knowledge about flame and smoke, and there lacks a universal and automatic extraction method for various fire scenes. As a breakthrough in pattern recognition, deep learning is capable of exploring the useful information from raw data, and can automatically provide accurate recognition results. Therefore, based on deep learning idea, a novel fire recognition method based on multi-channel convolutional neural network is proposed in this paper to overcome the deficiencies mentioned above. First, three channel colorful images are constructed as the input of convolutional neural network; Second, the hidden layers with multiple-layer convolution and pooling are constructed, and simultaneously, the model parameters are find tuned by using back propagation; Finally, softmax method is used to conduct the classification about fire recognition. To save the training time, we utilize GPU to construct training and test models. From public fire dataset and Internet, we collect 7000 images for training and 4494 images for test, and then run experiments with the comparison of four baseline methods including deep neural network, support vector machine based on scale-invariant feature transform feature, stack auto-encoder and deep belief network. The experimental results show that the proposed method is more capable of restoring the features of input image by means of hidden output figure, and for various flame scenes and types, the proposed method can reach 98% or more classification accuracy, getting improvement of around 2% than the traditional feature-based method. Also, the proposed method always outperforms other Deep Learning methods in terms of ROC curve, recall rate, precision rate and F1-score.

Symptom Burden of Busulfan and Melphalan Versus Melphalan Alone for Multiple Myeloma

Background: High-dose melphalan 200 mg/m2 (Mel) is the standard for autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma. Retrospective analyses suggested that a combination of busulfan and melphalan (Bu-Mel) may be associated with a longer progression-free survival (PFS). A secondary aim of a randomized, phase III trial that compared the safety and efficacy of Bu-Mel vs Mel was to compare the symptom burden of the two regimens. Symptom burden is the combined impact of disease- and therapy-related symptoms on patient functional ability.Methods: Patients were randomized to Bu-Mel (Bu 130 mg/m2 daily for 4 days, either as a fixed dose or to target an average daily area under the curve of 5000 μmol-min, followed by 2 daily doses of Mel 70 mg/m)2or Mel (Mel 100 mg/m2 daily for 2 days). A subset of patients completed the 20 symptom severity and 6 interference items of MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) prior to the start of the treatment regimen and weekly for 4 weeks post autoHSCT. Symptoms and interference are rated on 0-10 scales (0 = none or no interference, 10 = worst imaginable or complete interference). Differences in individual symptom severity and interference between the two arms were assessed by t-tests and mixed modeling.Results: As previously reported, 204 (Bu-Mel: 104, Mel: 100) were enrolled between October 2011 and March 2017. At last evaluation, 52 (51%) and 49 (49%) patients achieved a CR (p=0.88), and 69 (68%) and 67 (67%) patients achieved a CR+nCR (p=0.88) in Bu-Mel and Mel arms, respectively. Median PFS was 64.7 months and 34.4 months (p=0.013) in Bu-Mel and Mel arms, respectively. There was no difference in OS between the two arms. One hundred sixty-five of the patients (Bu-Mel: 81, Mel: 84) completed at least one MDASI-MM assessment. Median ages at autoHSCT were 57.2 and 57.0 years in Bu-Mel and Mel groups, respectively (p=0.86). At baseline, t-tests showed significantly higher mean severity of constipation (1.80, standard deviation [SD] = 2.87 vs 0.98, SD = 1.94; p=0.036), muscle weakness (2.38, SD=2.49 vs 1.44, SD=1.87; p=0.034), diarrhea (1.45, SD=2.43 vs 0.60, SD=1.10; p=0.005), and global symptom interference (2.96, SD=2.81 vs 1.77, SD=2.00; p=0.003) in the Bu-Mel arm than the Mel arm. The Bu-Mel patients had a significantly higher mean severity of pain (5.67, SD=2.65 vs 3.17, SD=3.07; p=0.0043) and mouth sores (7.35, SD=2.41 vs 1.25, SD=2.22; p <0.0001) than the Mel patients 7 days post autoHSCT. Longitudinal analysis using mixed modeling showed that the Bu-Mel arm had a significantly higher mean severity of pain (ED = 1.102, p=0.003), drowsiness (ED = 0.674, p=0.040), dry mouth (ED = 0.904, p=0.009), constipation (ED = 0.695, p=0.006), muscle weakness (ED = 0.815, p=0.006), mouth sores (ED = 1.683, p <0.0001), rash (ED = 0.362, p=0.019), and interference with physical functions (general activity: ED = 1.015, p=0.010; working: ED=1.229, p=0.006; walking: ED=0.920, p=0.009) than the Mel arm during the 4 weeks following autoHSCT.Conclusions: Patients receiving Bu-Mel vs Mel prior to autoHSCT report some differences in symptom severity, with Bu-Mel patients experiencing more severe sore mouth, pain, and symptom interference with daily functioning. The greater intensity of the double-alkylating agent conditioning regimen of Bu-Mel likely led to these differences. The increased severity of drowsiness, dry mouth, constipation, and muscle weakness may be due to an increased need for opioids to control severe pain and mouth sores. The effect of significant differences in symptom severity and interference at baseline between these two groups, despite randomization, is not clear. However, the longer time to progression of myeloma with the Bu-Mel regimen may offset the greater symptom burden early post autoHSCT. Systematic measurement of symptom burden during clinical trials can provide useful information for clinicians and patients in evaluating the full impact of different treatment regimens and enhance treatment decision making and discussion between clinicians and patients. DisclosuresNo relevant conflicts of interest to declare.

Validation and Application of the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM).

The MD Anderson Symptom Inventory (MDASI) is a brief, yet thorough, patient-reported outcomes measure for assessing the severity of common cancer-related symptoms and their interference with daily functioning. We report the development of an MDASI version tailored for use with Traditional Chinese Medicine in China (the MDASI-TCM). Chinese-speaking patients with mixed cancer types (n = 317) participated in the study. The development and validation process included four steps: 1) identify candidate TCM-specific items, with input from patients, oncologists, and TCM specialists; 2) eliminate candidate TCM items lacking relevance, based on patient report; 3) psychometrically examine the MDASI-TCM's validity and reliability in cancer patients receiving TCM-based care; and 4) cognitively debrief patients to assess the MDASI-TCM's relevance, understandability, and acceptability. Seven TCM-specific symptom items (sweating, feeling cold, constipation, bitter taste, coughing, palpitations, and heat in palms/soles) were clinically and psychometrically meaningful to add to the core MDASI. Approximately 61% of patients had moderate to severe symptoms (rated ≥5 on the MDASI-TCM's 0-10 scale). Cronbach α coefficients were .90 for symptom-severity items and .93 for interference items, indicating internal consistency reliability. Known-group validity was substantiated by the MDASI-TCM's detection of differences in symptom severity according to performance status (P < .001) and interference levels by cancer stage (P < .05). Cognitive debriefing indicated that patients found the MDASI-TCM to be an understandable, easy-to-use tool. The Chinese MDASI-TCM is a valid, reliable, and concise measure of symptom severity and interference that can be used to assess Chinese cancer patients and survivors receiving TCM-based care.

Long-Term Patient Reported Outcomes Following Treatment for Locally Advanced Oropharyngeal Carcinoma: Results from a Symptom Assessment Study

To describe long-term patient reported symptoms following radiation (±systemic therapy) for locally advanced oropharyngeal carcinoma (OPC). Disease-free head and neck cancer survivors (> 6 mos. since treatment) were eligible for participation in a prospective questionnaire-based study. Participants completed the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Those who had been treated with definitive RT (±systemic therapy) for T3-4 or N2c-3 OPC were included in this analysis. Individual item and overall symptom reports were analyzed. Of the 147 participants analyzed, 87% were male, 47% were never and 23% current smokers, 61% had base of tongue and 37% tonsil primaries, and 22% had T4 and 42% N2c disease. 7% had received RT alone, 51% concurrent chemoradiotherapy (CCRT), 18% induction chemotherapy followed by radiotherapy, and 25% induction chemotherapy followed by CCRT. IMRT was the chosen modality in 78% of individuals. Mean age at time of RT was 57.6 years. Mean time from treatment end to MDASI-HN completion was 63.3 mos. (82% >24 mos). Of the 48 tumors that had been tested, 83% were HPV or p16 positive. Mean (±SD) ratings (0-10 scale) for all 22 MDASI-HN symptom items was 1.36 (±1.02). Mean (±SD) symptom interference item score (0-10 scale) was 0.79 (±0.18). The top 5 MDASI-HN items rated most severe in terms of mean (±SD) ratings were dry mouth 4.37 (±3.21), chewing/swallowing 3.24 (±3.10), tasting food 2.40 (±3.02), mucus in mouth/throat 2.29 (±2.83), and choking/coughing 2.01 (±2.72), and were reported at moderate to severe levels (≥5) by 48, 33, 22, 23 and 21% respectively. Considering all 22 MDASI-HN symptom items, 5% were symptom free (0 across all items), 29% had no more than mild (≤5), 20% no more than moderate (≤7), and 46% with at least one item rated severe (>7). The long-term symptom profile in this cohort of patients treated for locally advanced OPC showed ∼50% of patients with potentially problematic xerostomia and ∼20-30% with dysphagia-related symptoms. These data provide a reference for patients treated with toxicity reduction strategies or other modalities.

Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy.

The aim of this study is to examine and compare with the validated, paper/pencil European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20), the psychometric properties of three electronically administered patient reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN): (1) the two neuropathy items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), (2) the QLQ-CIPN20, and (3) the 0-10 Neuropathy Screening Question (NSQ). We employed a descriptive, cross-sectional design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy at an academic hospital. Participants completed the paper/pencil QLQ-CIPN20 and electronic versions of the QLQ-CIPN20, PRO-CTCAE, and NSQ. Internal consistency reliability, intraclass correlation, and concurrent and discriminant validity analyses were conducted. The alpha coefficients for the electronic QLQ-CIPN20 sensory and motor subscales were 0.76 and 0.75. Comparison of the electronic and paper/pencil QLQ-CIPN20 subscales supported mode equivalence (intraclass correlation range >0.91). Participants who reported the presence of numbness/tingling via the single-item NSQ reported higher mean QLQ-CIPN20 sensory subscale scores (p<0.001). PRO-CTCAE neuropathy severity and interference items correlated well with the QLQ-CIPN20 electronic and paper/pencil sensory (r=0.76; r=0.70) and motor (r=0.55; r=0.62) subscales, and with the NSQ (r=0.72; r=0.44). These data support the validity of the electronically administered PRO-CTCAE neuropathy items, NSQ, and QLQ-CIPN20 for neuropathy screening in clinical practice. The electronic and paper/pencil versions of the QLQ-CIPN can be used interchangeably based on evidence of mode equivalence.

Dissecting the Yale-Brown Obsessive-Compulsive Scale severity scale to understand the routes for symptomatic improvement in obsessive-compulsive disorder.

We aimed to investigate which items of the Yale-Brown Obsessive-Compulsive Severity Scale best discriminate the reduction in total scores in obsessive-compulsive disorder patients after 4 and 12 weeks of pharmacological treatment. Data from 112 obsessive-compulsive disorder patients who received fluoxetine (⩽80 mg/day) for 12 weeks were included. Improvement indices were built for each Yale-Brown Obsessive-Compulsive Severity Scale item at two timeframes: from baseline to week 4 and from baseline to week 12. Indices for each item were correlated with the total scores for obsessions and compulsions and then ranked by correlation coefficient. A correlation coefficient ⩾0.7 was used to identify items that contributed significantly to reducing obsessive-compulsive disorder severity. At week 4, the distress items reached the threshold of 0.7 for improvement on the obsession and compulsion subscales although, contrary to our expectations, there was greater improvement in the control items than in the distress items. At week 12, there was greater improvement in the time, interference, and control items than in the distress items. The use of fluoxetine led first to reductions in distress and increases in control over symptoms before affecting the time spent on, and interference from, obsessions and compulsions. Resistance did not correlate with overall improvement. Understanding the pathway of improvement with pharmacological treatment in obsessive-compulsive disorder may provide clues about how to optimize the effects of medication.

Psychometric evaluation of the pediatric and parent-proxy Patient-Reported Outcomes Measurement Information System and the Neurology and Traumatic Brain Injury Quality of Life measurement item banks in pediatric traumatic brain injury.

The primary objective is to provide evidence of convergent and discriminant validity for the pediatric and parent-proxy versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, Depression, Anger, Peer Relations, Mobility, Pain Interference, and Fatigue item banks, the Neurology Quality of Life measurement system (Neuro-QOL) Cognition-General Concerns and Stigma item banks, and the Traumatic Brain Injury Quality of Life (TBI-QOL) Executive Function and Headache item banks in a pediatric traumatic brain injury (TBI) sample. Participants were 134 parent-child (ages 8-18 years) days. Children all sustained TBI and the dyads completed outcome ratings 6 months after injury at one of six medical centers across the United States. Ratings included PROMIS, Neuro-QOL, and TBI-QOL item banks, as well as the Pediatric Quality of Life inventory (PedsQL), the Health Behavior Inventory (HBI), and the Strengths and Difficulties Questionnaire (SDQ) as legacy criterion measures against which these item banks were validated. The PROMIS, Neuro-QOL, and TBI-QOL item banks demonstrated good convergent validity, as evidenced by moderate to strong correlations with comparable scales on the legacy measures. PROMIS, Neuro-QOL, and TBI-QOL item banks showed weaker correlations with ratings of unrelated constructs on legacy measures, providing evidence of discriminant validity. Our results indicate that the constructs measured by the PROMIS, Neuro-QOL, and TBI-QOL item banks are valid in our pediatric TBI sample and that it is appropriate to use these standardized scores for our primary study analyses.

Differential item functioning of the patient-reported outcomes information system (PROMIS®) pain interference item bank by language (Spanish versus English).

About 70% of Latinos, 5years old or older, in the United States speak Spanish at home. Measurement equivalence of the PROMIS® pain interference (PI) item bank by language of administration (English versus Spanish) has not been evaluated. A sample of 527 adult Spanish-speaking Latinos completed the Spanish version of the 41-item PROMIS® pain interference item bank. We evaluate dimensionality, monotonicity and local independence of the Spanish-language items. Then we evaluate differential item functioning (DIF) using ordinal logistic regression with item response theory scores estimated from DIF-free "anchor" items. One of the 41 items in the Spanish version of the PROMIS® PI item bank was identified as having significant uniform DIF. English- and Spanish-speaking subjects with the same level of pain interference responded differently to 1 of the 41 items in the PROMIS® PI item bank. This item was not retained due to proprietary issues. The original English language item parameters can be used when estimating PROMIS® PI scores.

Measuring pain phenomena after spinal cord injury: Development and psychometric properties of the SCI-QOL Pain Interference and Pain Behavior assessment tools

Objective: To develop modern patient-reported outcome measures that assess pain interference and pain behavior after spinal cord injury (SCI). Design: Grounded-theory based qualitative item development; large-scale item calibration field-testing; confirmatory factor analyses; graded response model item response theory analyses; statistical linking techniques to transform scores to the Patient Reported Outcome Measurement Information System (PROMIS) metric. Setting: Five SCI Model Systems centers and one Department of Veterans Affairs medical center in the United States. Participants: Adults with traumatic SCI. Interventions: N/A. Outcome Measures: Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference item bank, SCI-QOL Pain Interference short form, and SCI-QOL Pain Behavior scale. Results: Seven hundred fifty-seven individuals with traumatic SCI completed 58 items addressing various aspects of pain. Items were then separated by whether they assessed pain interference or pain behavior, and poorly functioning items were removed. Confirmatory factor analyses confirmed that each set of items was unidimensional, and item response theory analyses were used to estimate slopes and thresholds for the items. Ultimately, 7 items (4 from PROMIS) comprised the Pain Behavior scale and 25 items (18 from PROMIS) comprised the Pain Interference item bank. Ten of these 25 items were selected to form the Pain Interference short form. Conclusions: The SCI-QOL Pain Interference item bank and the SCI-QOL Pain Behavior scale demonstrated robust psychometric properties. The Pain Interference item bank is available as a computer adaptive test or short form for research and clinical applications, and scores are transformed to the PROMIS metric.