Brief Pain Inventory Worst Research Articles

Abstract P5-15-03: Baseline joint pain predicts severity of subsequent joint symptoms in women initiating aromatase inhibitors for early stage breast cancer

Abstract Background: Aromatase inhibitors (AIs) are the standard adjuvant treatment of hormone-sensitive breast cancer (BC) in postmenopausal women. However, these therapies are associated with musculoskeletal complaints which may lead to non-adherence and early discontinuation. The aim of this study was to characterize the natural history of the AI-induced arthralgia. Methods: Postmenopausal women with stage I-III BC were prospectively enrolled at the onset of adjuvant AI therapy. Subjects completed the Brief Pain Inventory (BPI) questionnaire at baseline, 3, 6, 9, and 12 months. BPI worst pain scores were categorized as 0-3, 4-6 and 7-8. Multiple logistic regression analysis was used to evaluate the association between baseline factors and having a 2-point worsening in BPI worst pain score. A Cox-proportional hazards model was used to evaluate factors that influenced the time to first 2-point worsening in pain score. Clinically significant change was defined as ≥2-point increase from baseline. Those with a baseline BPI worst pain score of ≥9 were removed from analysis. Results: Among 180 consented subjects, 1 was found to be ineligible due to being perimenopausal, 42 subjects were lost to follow up, 17 subjects came off their AI and 8 subjects dropped out. Mean age was 61; 60% were white, 32% Black, 10%, Asian and 31% were Hispanic; 86% started on anastrazole; 24% had a change in AI. At baseline, 76 women had a BPI worst pain score between 0-3; 28 between 4-6; and 18 had 7+. Seventy subjects (64%) experienced at least a 2-point worsening of BPI from baseline and women who developed a 2-point worsening had a lower mean baseline BPI (2.57 vs. 3.75) compared to those who did not. Those experiencing an initial worsening in the first 6 months of therapy improved over time; while the patients experiencing BPI worsening at 9 months, continued to have progressive increase in BPI. In a multiple logistic regression model adjusting for AI switching, BMI, age, baseline score, prior chemotherapy, osteoarthritis, and prior hormone replacement therapy, those who had a baseline worst pain score between 4-6 (p=0.04) or 7+ (p=0.005) were less likely to develop a 2-point worsening in BPI at 12 months from baseline. Similarly, those with a baseline worst pain categorization of 7+ had a hazard ratio of 0.34 for time to 2-point worsening. Conclusions: Women with low baseline BPI score are more likely to develop worsening BPI score over time. Women who develop symptoms later in the course of their therapy are at greatest risk for persistent symptoms. This has implications for studies evaluating interventions for prevention of AI arthralgias. BPI mean scorePatients with >2 point increase in BPI at any timePatients with >2 point increase in BPI at 3 monthsPatients with >2 point increase in BPI at 6 monthsPatients with >2 point increase in BPI at 9 monthsPatients with >2 point increase in BPI at 12 monthsBaseline score3.752.57*2.592.302.11*1.85*Three month score4.254.526.08*4.684.133.87Six month score4.504.83*5.32*6.37*5.074.22Nine month score4.005.105.115.135.75*5.04Twelve month score4.255.37*5.484.865.666.21**p value <0.05 compared to baseline Citation Format: Lea Baer, Katherine D Crew, Danielle Awad, Kevin Kalinsky, Matt Maurer, Dawn L Hershman. Baseline joint pain predicts severity of subsequent joint symptoms in women initiating aromatase inhibitors for early stage breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-03.

Comparing and Validating Simple Measures of Patient-Reported Peripheral Neuropathy for Oncology Clinical Trials: NCCTG N0897 (Alliance) A Pooled Analysis of 2440 Patients.

Current standard evaluation of Peripheral Neuropathy (PN) is based on an investigator-reported classification system that is commonly unable to correctly reflect the subjective symptoms for patients. Thus more reliable methods to assess PN are needed. This study assessed alternative methods of assessing patient-reported PN in 5 North Central Cancer Treatment Group (NCCTG) clinical trials. Two single-item assessments relating to numbness and tingling were used to measure PN. Patients' Quality Of Life (QOL) was also assessed using the Uniscale, Symptom Distress Scale (SDS), Profile of Mood States (POMS), Brief Pain Inventory (BPI) and Subject Global Impression of Change (SGIC). Wilcoxon tests compared QOL scores between patients with PN (score > 50) vs. no PN (score ≤ 50). Changes from baseline in QOL were compared by Wilcoxon rank sum test with a 20-point change in PN defined as clinically meaningful. Both distribution-based and anchor-based approaches were used to derive estimates of Minimal Important Differences (MID). Standardized Response Means (SRM), Effect Sizes (ES) and Guyatt's responsiveness statistic were used to measure responsiveness. The proportion of patients reporting numbness (tingling) at baseline was 10.7% (10.0%) and 18.4% (17.8%) at last assessment. The correlation between numbness and tingling at baseline was 0.81, and at last assessment was 0.83. Patients with substantial PN reported an average of 10 points lower overall QOL, mood and worse symptom distress and 20 points lower in the BPI interference items. Patients having a ≤ 20 point worsening in PN score reported significantly worse in symptom distress and BPI worst pain, but not in POMS or overall QOL. The MID estimates were similar between numbness and tingling items but varied depending on the approach used. Responsiveness statistics indicated that the two PN assessments are sensitive and responsive instruments for cancer patients with PN. The two PN items for numbness and tingling were redundant. Evidence of criterion validity and responsiveness indicates that these simple measures of PN can be used successfully in cancer clinical trials.

The characteristics of physical activity and gait in patients receiving radiotherapy in cancer induced bone pain

Background and purposeAn objective measure of pain relief may add important information to patients’ self assessment, particularly after a treatment. The study aims were to determine whether measures of physical activity and/or gait can be used in characterizing cancer-induced bone pain (CIBP) and whether these biomarkers are sensitive to treatment response, in patients receiving radiotherapy (XRT) for CIBP. Materials and methodsPatients were assessed before (baseline) and 6–8weeks after XRT (follow up). The following assessments were done: Brief Pain Inventory (BPI), activPAL™ activity meter, and GAITRite® electronic walkway (measure of gait). Wilcoxon, Mann–Whitney and Pearson statistical analyses were done. ResultsSixty patients were assessed at baseline; median worst pain was 7 and walking interference was 5. At follow up 42 patients were assessed. BPI worst pain, average pain, walking interference and total functional interference all improved (p<0.001). An improvement in functional interference correlated with aspects of physical activity (daily hours standing r=0.469, p=0.002) and gait (cadence r=0.341, p=0.03). The activPAL and GAITRite parameters did not change following XRT (p>0.05). In responder analyses there were no differences in activPAL and GAITRite parameters (p>0.05). ConclusionAssessment of physical activity and gait allow a characterization of the functional aspects of CIBP, but not in the evaluation of XRT.

Health-related quality of life among patients with metastatic melanoma

Clinical and health-related quality of life (HRQoL) information was analyzed to determine: (a) patient-reported signs, symptoms, and functioning, (b) HRQoL questionnaire psychometrics, and (c) treatment impact on HRQoL. Data from the Melanoma Subscale (MS) of the Functional Assessment of Cancer Therapy-Melanoma and the worst pain question from the Brief Pain Inventory (BPI) were taken from a clinical trial evaluating intetumumab alone or with dacarbazine in Stage IV metastatic melanoma. Descriptive statistics examined patient-reported disease burden at baseline. Correlations explored clinical endpoint and HRQoL associations. Psychometrics included Cronbach's α internal consistency and intraclass correlation coefficient (ICC). Treatment impact on HRQoL was evaluated through HRQoL maintenance and response analyses. Patients (n=127) had a mean age of 62 years, a mean±SD hemoglobin of 13.0±2.6 g/dl, and a mean±SD lactic dehydrogenase of 394±454 IU/l. Ninety-eight percent were Caucasian, 67% were men, and 64% had an Eastern Cooperative Oncology Group status of 0. Baseline BPI worst pain and MS scores (mean±SD) were 1.6±2.2 and 54.5±7.2, respectively. Top three patient-reported health decrements in the MS were appetite, fatigue, and limited physical activity. Observed HRQoL decrements were consistent with the literature. MS and BPI worst pain item demonstrated good psychometrics: Cronbach's α and ICC for the MS were 0.79 and 0.86, respectively; BPI ICC was 0.74. A trend for HRQoL response was observed 3 weeks postbaseline in the dacarbazine + 10 mg/kg intetumumab arm compared with dacarbazine + placebo: 22 versus 10%, respectively, for the MS; 23 versus 5% for the BPI. Further research on the HRQoL benefit of intetumumab in larger studies appears warranted.

Neuropathic Pain Features in Patients With Bone Metastases Referred for Palliative Radiotherapy

To estimate the prevalence of pain with neuropathic features among patients with metastatic bone pain and to assess differences between patients with and without neuropathic features by pain severity, functional interference, and quality-of-life (QOL) measures. A prospective cross-sectional survey of consecutive patients with symptomatic bone metastases was conducted between December 2006 and March 2008 at a comprehensive cancer center. Patients completed the Brief Pain Inventory (BPI), the Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). Statistical associations between pain with neuropathic features and other measures were explored. Ninety-eight patients were enrolled. Seventeen percent of patients (95% CI, 10% to 24%) had positive S-LANSS scores suggesting pain with neuropathic features. Mean worst pain and mean interference scores were 7.2 (standard deviation [SD], 2.0) and 5.8 (SD, 2.5), respectively. EORTC QLQ-C30 global QOL, function, and symptom scores were 42 (SD, 24), 52 (SD, 20), and 46 (SD, 17), respectively. Patients with neuropathic features had a higher BPI worst pain score than patients without neuropathic features (8.3 v 7.0, respectively; P = .016). Corticosteroid use, oral morphine equivalent dosing, and site of bone pain were not associated with neuropathic features. Some patients with bone metastases manifest bone pain with distinguishable neuropathic features, and these patients reported greater pain intensity. Additional work is required to validate the S-LANSS against clinical criteria for neuropathic pain in this context and to explore the unmet pain management needs in this population.

Morphine/Naltrexone

Oral morphine/naltrexone extended release capsules comprise the selective mu-opioid receptor agonist morphine in a sustained-release formulation combined with a sequestered core of the mu-opioid receptor antagonist naltrexone for use in the management of moderate to severe pain. When morphine/naltrexone is taken as intended, naltrexone exerts no clinically significant effect. However, when the capsule contents are taken after being tampered with by crushing, chewing or dissolution, naltrexone is rapidly released and absorbed, thereby mitigating the effects of morphine. Morphine/naltrexone was effective in the treatment and management of moderate to severe chronic pain in patients with pain due to osteoarthritis of the hip or knee participating in a randomized, double-blind, placebo-controlled, phase III study (n = 344). Changes in mean Brief Pain Inventory (BPI) average scores from baseline of the double-blind maintenance phase to 12 weeks were significantly better with morphine/naltrexone (20 mg/0.8 mg to 80 mg/3.2 mg twice daily) than with placebo. In a 12-month, open-label safety study, morphine/naltrexone also provided effective pain relief and sustained pain control in patients with chronic, moderate to severe, nonmalignant pain (n = 465 at baseline; 162 at study end). Furthermore, significant mean changes from baseline in BPI worst, least, average and current pain scores were seen from week 1 onwards. Morphine/naltrexone treatment was generally well tolerated in adult patients with chronic moderate to severe nonmalignant pain in clinical trials of up to 1-year duration.

Estimating minimally important differences (MID) for the worst pain rating of the brief pain inventory (BPI)-short form (SF).

6112 Background: The BPI-SF is a widely used patient-reported outcome measure for assessing pain and has become the standard for use in clinical and research studies. The rating of worst pain is often selected as the primary outcome of interest; however, there are no published data available on its MID, particularly as a change score. The data presented in this analysis can help to enhance interpretation of the assessment. Methods: Patients with advanced breast cancer who enrolled in a randomized, double-blind, phase 3 study comparing denosumab vs. zoledronic acid in the treatment of bone metastases completed the BPI-SF, FACT-B, and EQ-5D questionnaires at baseline, week 5, and every 4 weeks thereafter until the end of the study. After assessing the correlation between change in the BPI worst pain rating with several potential anchors using the interval from baseline to week 25, we computed both anchor-based and distribution-based MID estimates for the BPI worst pain rating in both treatment arms combined...

Use of thermal sensation as a biomarker of response to palliative radiotherapy for cancer-induced bone pain.

9068 Background: Radiotherapy (XRT) is the gold standard treatment for cancer-induced bone pain (CIBP), but not all patients achieve adequate analgesia. The aim of this study was to identify predictors of response to XRT for CIBP, as currently no clinical biomarkers of response are known. Methods: The Brief Pain Inventory (BPI) and Quantitative Sensory Testing (QST) were completed before and 6-8 weeks after XRT for CIBP. Using warm (40°C) and cool (25°C) rollers in the CIBP and control sites, thermal sensation was tested. Analgesic response was defined as a reduction in BPI worst pain score of ≥30% at the CIBP site. Mann-Whitney test compared responders and non-responders and those with normal and abnormal sensation. Multivariate regression analysis examined potential predictors of response to XRT. Results: 42 patients were assessed pre and post XRT (16 male (38%), median (range) age 65.5 (38-88) years). Primary sites included breast (52%), prostate (29%) and lung (12%) with spine the most common site of ...

A survey of pain in patients with advanced cancer

One hundred eleven patients with advanced cancer and pain newly referred to a palliative care center completed the Brief Pain Inventory (BPI) weekly for up to 4 weeks. The aims were (a) to review the numbers and causes of pain, (b) to consider the usefulness of the BPI in the evaluation of pain in cancer patients, and (c) to determine the impact of treatment. A total of 370 pains were recorded initially, a median of 3 per patient; 85% had more than 1 pain and more than 40% had 4 or more pains. Causes of pain were cancer (46%), debility (29%), treatment (5%), concurrent disorder (8%), and no stated cause (12%). The top 10 individual causes accounted for 73% of the pains. Seventy-six (68%) of the patients completed two BPIs, but only 46 (41%) completed 5. After 4 weeks, the median number of pains had fallen to 1.5; 78% still had more than 1 pain, but only 20% had 4 or more pains. Intensity of pain also declined, particularly in the first 2 weeks. With their last BPI, 23% had become completely pain free and a further 27% achieved acceptable relief (worst pain scores 1–4), compared with none and 24% initially. Of those who completed all five BPIs, the final respective figures were 22% and 29%. In contrast, 23% of patients still had unacceptable severe pain noted on their last BPI (worst pain scores 8–10), compared with 36% initially. Of those who completed five BPIs, the final figure was 20%. Highly significant correlations were observed between all seven interference factors and present, worst, and average pain intensities. After 4 weeks, the pattern was more variable, particularly in relation to present pain, suggesting that interference factors may have a limited utility as a measure of satisfactory pain management. Many patients did not answer all the questions in the BPI. It was concluded that the BPI is not brief enough or routine clinical use, and that the short form of the BPI (BPI-SF) is too short. A pain diary card will be developed comprising mainly pain scores, a pain relief score and a satisfaction with pain management score.