Patient-reported Pain Severity Research Articles

Comparing the clinical outcomes of lumbar transforaminal vs interlaminar epidural steroid injections in a registry cohort

BackgroundTransforaminal and interlaminar approaches are both common means of performing epidural steroid injection. Comparative effectiveness data on outcomes of these approaches is available but has yielded mixed results. ObjectiveCompare the effect of transforaminal vs interlaminar delivery of epidural steroids on patient-reported pain severity. DesignRetrospective Cohort Study. MethodsA retrospective review of prospectively collected interventional spine procedure registry data between December 2011 and July 2017 from a single academic medical center. Those who received epidural steroid injections and had prospectively collected index pain data (11-point Numeric Rating Scale [NRS]) recorded in the patient's chart prior to the procedure and at a 3 month follow up appointment were included. The outcome of interest was ≥50% reduction in pain as measured using a NRS for back and/or leg pain. To evaluate true predictive odds of success, multivariable logistic regression modeling was used to determine the odds of achieving improved pain. ResultsOf the 73 patients included in the study, 61 (84%) reported radicular pain, 49 (67%) reported back pain, and eleven (15%) had symptoms consistent with claudication, pain characteristics were not mutually exclusive. Fifty-one (70%) underwent transforaminal epidural steroid injection, while 22 (30%) underwent interlaminar injection. When claudication and radicular pain groups were combined into a single “leg pain” category (n = 66), 26/46 (57% 95% CI 41–71%) patients undergoing transforaminal and 6/20 (30% 95% CI 12–54%) patients undergoing interlaminar injections achieved ≥50% leg pain reduction on NRS (p = 0.048). Transforaminal epidural steroid injections were associated with higher odds of ≥50% reduction in leg pain in both the unadjusted model (OR 3.2, p = 00.034) and after adjustment for presence of radicular pain on presentation and the type of steroid used (OR 3.6, p = 0.042). ConclusionIn this clinical practice registry, patients treated with transforaminal epidural steroid injection were more likely to achieve ≥50% reduction in radicular or neurogenic/claudicatory leg pain compared to those treated with interlaminar epidural steroid injection.

Patient-reported orofacial-dental pain severity and tele-triage decisions during COVID-19 pandemic: Does the severity of pain drive tele-triage decisions?

BackgroundGlobally, with the COVID-19 pandemic, dental services were limited to emergency/ urgent conditions and were provided only after tele-triage referral for face-to-face management. However, no previous research explored whether the pain severity (PS) drives the tele-triage decisions. The current study examined the association between PS and tele-triage decision of whether to manage the condition remotely or refer the caller for face-to-face management.MethodsThis retrospective cross-sectional study analyzed the PS reported by hotline callers, using numerical rating scale (NRS-11), during the first wave of COVID-19 lockdown (23 March–31 August 2020) and its association with tele-triage decision controlling for age, sex, history of chronic illness, and dental discipline needed. Binomial logistic regression assessed the association between the PS (exposure) and tele-triage decision (outcome). ANOVA compared PS across tele-triage categories, dental history and tentative diagnosis.ResultsPS was significantly associated with tele-triage decisions (p < 0.05). An increase in pain score by 1 unit was associated with 1.4 times increased odds of face-face referral (95% CI: 1.26–1.54). Pediatric/ adolescent patients (9–18 years) (odds ratio (OR) = 2.07; 95% CI: 1.07–4.02), history of chronic illness (OR = 2.12; 95% CI:1.28–3.51), need for surgical specialty (OR = 1.93; 95% CI: 1.22–3.04) and orthodontic specialty (OR = 7.02; 95% CI: 3.54–13.87) were independently associated with tele-triage decision. PS was highest for the emergency triage category (8.00 ± 2.83, P < 0.0001), dental history of tooth with cavity or filling (6.65 ± 2.024, P < 0.0001), and the tentative tele-diagnosis of cellulitis (7.75 ± 2.872, P < 0.0001).ConclusionsDuring COVID-19 pandemic, tele-triage decisions were significantly influenced by patient-reported PS, adjusting for a range of variables. Despite this, referral for face-to-face management was individualized and driven by the tripartite considerations of the reported pain, clinical judgement, and the high transmission characteristics of COVID-19.

Locoregional anesthesia for post-operative pain management in microsurgical reconstruction of the lower extremities: A retrospective study

ObjectiveOpioid-based analgesia is often used in the management of postoperative pain in arthroplasty cases. This article analyses the safety of single-shot peripheral nerve block (PNB) and potential analgesic benefits in patients undergoing lower limb free flap reconstruction. MethodsA retrospective review including all patients undergoing lower limb reconstruction with free flaps between October 2017 and April 2020 was performed. Patients were divided into two groups based on PNB utilization. The use of oral opioids, post-operative pain scores, flap-related outcomes, patient morbidity, and length of hospital stay (LOS) were compared between groups. ResultsThirty-one patients who underwent lower limb reconstruction with free flaps, were finally included in the study. Preoperative PNB was performed on 14 patients, while 17 patients received general anesthesia (GA) alone. Pain at rest, measured using the visual analog scale (VAS) score, was significantly lower (2.2 ± 1.7 vs. 4.9 ± 1.7) in the PNB group on postoperative day 1 (POD). The mean [median]±SD amounts of opioids consumed in morphine milligram equivalent (MME) were significantly lower in the PNB group on both POD1 (33.5 [22.5] ± 33.9 vs. 61.6 [48.0] ± 39.0), POD2 (29.0 [15.0] ± 29.2 vs. 58.0 [52.5] ± 37.0) and cumulatively over 7 days (164.0 [197.0] ± 132.8 vs. 315.4 [225] ± 203.2). Complication rates and LOS were not statistically different between groups, although trending toward lower take-back procedures and major complications in the PNB group. ConclusionPreoperative single-shot PNB significantly reduced postoperative opioid use and patient-reported pain severity and was not associated with an increase in complication rates.

In vivo topical gene therapy for recessive dystrophic epidermolysis bullosa: a phase 1 and 2 trial

Recessive dystrophic epidermolysis bullosa (RDEB) is a lifelong genodermatosis associated with blistering, wounding, and scarring caused by mutations in COL7A1, the gene encoding the anchoring fibril component, collagen VII (C7). Here, we evaluated beremagene geperpavec (B-VEC), an engineered, non-replicating COL7A1 containing herpes simplex virus type 1 (HSV-1) vector, to treat RDEB skin. B-VEC restored C7 expression in RDEB keratinocytes, fibroblasts, RDEB mice and human RDEB xenografts. Subsequently, a randomized, placebo-controlled, phase 1 and 2 clinical trial (NCT03536143) evaluated matched wounds from nine RDEB patients receiving topical B-VEC or placebo repeatedly over 12 weeks. No grade 2 or above B-VEC-related adverse events or vector shedding or tissue-bound skin immunoreactants were noted. HSV-1 and C7 antibodies sometimes presented at baseline or increased after B-VEC treatment without an apparent impact on safety or efficacy. Primary and secondary objectives of C7 expression, anchoring fibril assembly, wound surface area reduction, duration of wound closure, and time to wound closure following B-VEC treatment were met. A patient-reported pain–severity secondary outcome was not assessed given the small proportion of wounds treated. A global assessment secondary endpoint was not pursued due to redundancy with regard to other endpoints. These studies show that B-VEC is an easily administered, safely tolerated, topical molecular corrective therapy promoting wound healing in patients with RDEB.

P-P18 Thoracic epidural VS intrapleural analgesia for pancreaticoduodenectomy – a study on analgesic and non-analgesic outcomes

Abstract Background Thoracic epidural analgesia (TEA) has been the traditional option for post-operative pain management for Kausch-Whipple pancreaticoduodenectomy (KWPD) via a ‘reverse L’ incision. An alternative option with inter-pleural analgesia (IPA) has become popular. However, the superior form of analgesia for KWPD regarding analgesic and non-analgesic outcomes is unclear. This study aims to establish if IPA is equivalent to TEA. Methods Retrospective study of all patients who underwent KWPD with ‘reverse L’ incision by a single surgeon between February 2014 to June 2016. All received either IPA or TEA post-operatively; patients who had rectus sheath catheter and spinal anaesthesia were excluded. To reduce bias, the Anaesthetist, rather than Surgeon, decided the choice of analgesia based on personal skill. Efficacy regarding analgesia were collected by nursing staff as patient-reported pain severity (mild, moderate or severe). Data were collected from patient case notes and electronic records. This study analysed analgesia efficacy, complications, inotrope use, and intensive treatment unit (ITU) stay. Results A total of 40 included in the study. Twenty-two patients had TEA (45% female, median age 68 years) and 18 had IPA (44% female, median age 67 years). Median Charleson Comorbidity Index (CCI) was 5 for both. Patient-reported pain was not statistically different (p = 0.15). We noted more analgesia complications with TEA (not working=4, leakage=2, haemodynamic instability=1, lower limb anaesthesia=1) than IPA (leakage=1; p = 0.027). Eleven (50%) TEA and eight (44%) IPA patients required inotropes. TEA patients required significantly longer duration (median duration 35 VS 18 hours, p = 0.047). Median ITU stay was 3 and 2 days for TEA and IPA patients, respectively. Conclusions Both TEA and IPA provide adequate pain relief for KWPD performed via a ‘reversed L’ incision. However, evidence suggests TEA was associated with significantly more analgesia-related complications and longer inotropic requirements. Furthermore, there was also a trend towards ITU stays with TEA. Therefore, we would recommend the use of inter-pleural analgesia over thoracic epidural.

Evaluation of Prescribing and Administering As-Needed Pain Medications Based on Pain Severity Scores.

Pain is a common symptom reported by patients admitted to hospitals in both medical and surgical units. Due to the subjective and multidimensional nature of pain, it should be assessed regularly to ensure patient pain control. Suboptimal prescribing of opioids and other pain medications contribute to the inadequate treatment of pain. To combat the wide variability and response to pain medications, many providers prescribe as-needed range orders of pain medications to cover each pain severity. These range orders enable necessary and safe adjustments in dose based on individual responses to treatment. Currently, there are no studies analyzing the prescribing of pain medications based on pain severity, leaving a gap in literature in inpatient pain management. The purpose of this retrospective cohort study was to evaluate the appropriateness of prescribing as-needed pain medications based on the patient's pain severity scores throughout their hospital stay at a 125-bed community hospital in Northeast Ohio on the general medicine floor. Secondarily, this study also evaluated the administration of pain medications by nursing staff based on patient-reported pain severity scores. Statistical analyses including Chi-square tests, t-tests, Fisher's Exact tests and descriptive statistics were utilized to determine the significance of the data collected. This study found that there was a statistically significant difference between appropriately (47.4%) and inappropriately (52.6%) prescribed pain medications (P<0.001). There was also a statistically significant difference between appropriately (40.5%) and inappropriately (59.5%) administered pain medications (P<0.001). Pharmacists hope to improve pain management practices by providing education to both providers and nurses to prevent poor patient outcomes and uncontrolled pain.

Patient-reported pain severity and health-related quality of life in patients with multiple myeloma in real world clinical practice.

BackgroundThe association between patient self‐reported pain severity and health‐related quality‐of‐life (HRQoL) is poorly understood.AimsThis real‐world study of symptomatic multiple myeloma (MM) patients sought to determine how pain severity from a single question asked during routine clinical consultation was associated with HRQoL.Methods and resultsPoint‐in‐time data on HRQoL of 330 patients with MM (median age 70 years) receiving anti‐myeloma therapy in Germany and Italy from November 2017 through February 2018 were analyzed. HRQoL was assessed using validated questionnaires (Work Productivity and Activity Impairment [WPAI], European Organization for Research and Treatment of Cancer Quality of Life Questionnaire ‐C30 and ‐MY20). Physical pain severity was assessed during clinical consultation by a single question, asking patients to describe their pain as “no pain,” “mild,” “moderate,” or “severe.” Associations between patient‐reported pain severity and HRQoL scores were assessed by analysis of variance or χ 2 tests. Ninety‐six of the 330 patients (29.1%) reported moderate to severe pain. Increase in pain severity, from “no” to “severe” pain, was associated with significantly decreased overall HRQoL (mean score 70.2 to 33.3); significant decreases in levels of physical (82.7 to 35.1), social (81.1 to 44.4), emotional (78.1 to 48.3), and role functioning (79.5 to 38.9); and increased levels of WPAI usual activity impairment (35.4 to 71.4), and fatigue burden (26.0 to 68.9) (all p < .001).ConclusionHigher pain severity, based on a single self‐report question, was associated with poorer HRQoL in patients with MM, thereby supporting the clinical relevance of directly asking patients to self‐evaluate their pain severity.

A Preliminary Study of Provider Burden in the Treatment of Chronic Pain: Perspectives of Physicians and People with Chronic Pain

This study compared perceptions of the burden of patient care and associated clinical judgments between physicians and people with chronic pain (PWCP) in a 2 × 3 × 2 between-subjects design that varied participant type, patient-reported pain severity (4/6–8/10), and supporting medical evidence (low/high). One hundred and nine physicians and 476 American Chronic Pain Association members were randomly assigned to 1 of 6 conditions. Respondents estimated the clinical burden they would assume as the treating physician of a hypothetical patient with chronic low back pain, and made clinical judgments regarding that patient. Physician burden ratings were significantly higher than PWCP ratings, and clinical impressions (eg, trust in pain report, medical attribution) and management concerns (eg, opioid abuse risk) were relatively less favorable. Neither pain severity nor medical evidence affected burden ratings significantly. High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports. Burden was significantly correlated with a range of clinical judgments. Results indicate that physicians and PWCP differ in their perceptions of provider burden and related clinical judgments in ways that could impact treatment collaboration. Further research is needed that examines provider burden in actual clinical practice. PerspectivePhysicians and people with chronic pain (PWCP) estimated the clinical burden of patient care and made judgments about a hypothetical patient with chronic pain. Physician burden ratings were higher and clinical judgments less favorable, relative to PWCP respondents. These differences could impact treatment collaboration and merit study in clinical practice.

Multimodal Treatment Patterns for Osteoarthritis and Their Relationship to Patient-Reported Pain Severity: A Cross-Sectional Survey in the United States

PurposeThe purpose of this study was to assess how patient-reported pain is related to osteoarthritis (OA) treatment patterns in routine clinical practice.Patients and MethodsData were collected between February and May 2017 from 153 United States (US) primary care physicians, rheumatologists, and orthopedic surgeons. Each invited up to nine consecutive patients to rate their OA pain in the last week. Physicians provided demographic, clinical, and treatment information for patients, including nonpharmacologic therapies ever recommended, currently recommended over-the-counter (OTC) medications, and currently and ever prescribed medications for the management of OA. Findings for patients with mild (0─3), moderate (4─6), and severe current pain (7─10) were compared using appropriate statistics.ResultsAmong the 841 patients (61% female; mean 65 years; 57% knee OA), 45% reported mild, 36% moderate, and 19% severe current OA pain. Current treatment modalities differed by pain severity (P<0.05). Most patients (70%) had been recommended nonpharmacologic therapy and 40% were currently recommended OTC medications. More patients with moderate (81%) or severe pain (78%) currently received prescription medications, with or without nonpharmacologic therapy, versus those with mild pain (67%). Overall, 47% of patients currently received just one prescription drug, while 49% had received one prescription drug ever. Nonsteroidal anti-inflammatory drugs (NSAIDs) were the most common current (58%) and ever received (88%) prescriptions. Current NSAID prescriptions were not associated with pain severity. Acetaminophen recommendations, opioid prescriptions (current and ever), and multiple prescription medications tried were numerically highest in the severe pain group (all P<0.05 by pain severity). In all groups, >80% of treatment switches were due to lack of efficacy.ConclusionReal-life treatment patterns for OA in the US are significantly associated with current patient-reported pain. Combining nonpharmacologic and pharmacologic treatments is common but higher pain ratings are associated with multiple failed prescription treatments. Current use of acetaminophen and opioids, but not NSAIDs, increases alongside pain severity.

Postoperative Pain Responses in Dental Patients on Chronic Opioid Therapy

It is estimated that 5 to 8 million Americans use opioids daily for the management of chronic pain. Yet, opioid therapy for chronic pain is not an evidence-based intervention, and it is increasingly apparent that outcomes are poorer for patients taking opioids (pain severity, functionality, quality of life) (1). A theorized explanation for these poor outcomes is the phenomenon of opioid-induced hyperalgesia (OIH) (2), defined as increased sensitivity to pain related to chronic opioid use, and which may interfere with desired pain relief in the chronic pain patient. This study was designed to compare pain responses and analgesic need in a sample of dental patients on chronic opioid therapy vs. not on opioid therapy, the first study of its kind. A total of 40 adult dental surgical patients are being enrolled in the study, 20 of whom are on opioid therapy for chronic pain, all undergoing a dental surgical procedure with a similar expected trauma rating, and standardized postoperative non-opioid pain management. Those in the opioid group are taking a regular daily dose of opioids ≥ 50mg morphine equivalents/day for ≥ 3 months and those in the control group have not taken an opioid medication within 3 months. Exclusion criteria include active substance use disorder; severe psychiatric disorder; neurological or psychiatric illness that would affect pain responses; history of GI ulcers; NSAID allergy; poor liver or kidney function; or pregnancy. Prior to the surgical procedure, pain perception is measured using 2 standardized experimental pain assays (cold-pressor testing; quantitative sensory testing) to detect OIH. To determine how OIH may affect postoperative pain responses, patient-reported pain severity and documentation of all analgesic consumption for the first 72 hours are collected. If preoperative opioid use is found to result in increased postoperative pain severity, clinical implications may include anticipation of increased analgesic need or preoperative opioid taper.

(110) Impact of Pain Severity among Patients with Osteoarthritis on Healthcare Use in the United States

Osteoarthritis (OA) is the leading cause of disability in older adults. Total healthcare costs tend to rise as pain severity associated with OA increases. To understand treatment and healthcare resource utilization (HCRU) by OA pain severity, data were collected from Feb-May 2017 using US Adelphi Disease Specific Programme, a cross-sectional survey of primary care physicians, rheumatologists, orthopedists and their patients. Descriptive statistics were used and all data were analysed using SPSS v6 and Stata v14.1. A total of 841 patients seeking care for OA were included. Patient-reported pain severity (Numeric Rating Scale; 0-10) over the last week was categorized as none/mild (45.4%; 0-3), moderate (35.9%, 4-6) and severe (18.7%; 7-10) pain. The majority of patients were female (61%) and white (78%) and the average age was 64.6 years. Increased pain severity was associated with a higher Body Mass Index and increased reliance on walking aids (21%, 38%, 47%), modifications to home (9%, 19%, 31%), and need for caregivers (5%, 14%, 31%) (all p

Abstract P6-11-17: Nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy in patients receiving neoadjuvant or adjuvant chemotherapy for breast cancer

Abstract A brief background discussion. Nanoparticle albumin-bound paclitaxel (nab-PTX) has been developed under the concept of improved drug delivery. nab-PTX has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel (PTX) in metastatic breast cancer. However, the long-term outcomes of nab-PTX induced peripheral neuropathy (nPIPN) have not yet been fully elucidated. Trial design: observational cohort study (UMIN20852) Primary objective: The long-term outcome of nPIPN Secondary objectives (1)The validity of the Neuropathic Pain Screening Questionnaire (Japan–Q, Ishikawa et al. Pain Research 2016 ) (2) To evaluate the effect of frozen gloves and elastic stockings for nPIPN nPIPN was assessed by the Japan-Q (J-Q) and Common Toxicity Criteria for Adverse Events ver 4.0 (CTC). The J-Q is an assessment tool for patient-reported pain severity, which consists of seven items, each rated on a five-point scale 0-4; grade 0 (no symptoms) to grade 4 (verysevere symptoms). Pricking pain, electric shock pain, burn like pain, tingling pain with numbness, allodynia, reduced or hyper sensitivity and hand-foot syndrome. Assessment was performed every day during chemotherapy, six months and one year after completion of nab-PTX therapy. Total of 28 points for each day and 588 points for each cycle, higher point correlates with severity. Frozen gloves during administration of nab-PTX and/or elastic stockings were optionally used. Statistical methods Kruskal Wallis test was used and p&amp;lt;0.05 was considered as significant. RESULTS: Between May 2013, and April 2016, 105 patients were enrolled from 7 hospitals. In 73 patients (69.5%) nab-PTX was administered as primary and in 32 patients (30.5%) as adjuvant therapy. Forty three (41.0%) patients received nab-PTX as first line and 62 (59.0%) received after anthracycline contained regimen. Trastuzumab was administered as combination therapy with nab-PTX for Her2 positive patients. Both frozen gloves and stockings were used in 21 patients (20.0%) and frozen gloves only were used in 21 patients (20.0%) according to patient preference. One hundred patients (95.2%) completed four courses, and overall relative dose intensity was 91.4%. During chemotherapy, J-Q scores go elevated from day 1 to day 5 and gradually declined throughout the rest of the cycle. Without using frozen gloves, there was a significant increase according to courses (1st: 45.0 ± 5.7, 2nd: 76.7 ± 8.6, 3rd: 94.3 ± 11.8, 4th: 95.4 ± 11.8). Using frozen gloves, there was a significant increase from 1st course to 2nd, but no further increase was observed(1st: 37.4 ± 8.1, 2nd: 61.9 ± 12.4, 3rd: 62.9 ± 10.4, 4th: 55.3 ± 10.6). After six month and one year, the scores were significantly lower compared with the last day of the fourth cycle (4.28 ± 0.50, 2.53 ± 0.25, 2.85 ± 0.39, respectively). CTC, grade 2 or more sensory disturbance was observed in 57.9% after four cycles, but improved to 9.5% and 5.4% after six month and one year respectively. CONCLUSIONS: Patient-reported nPIPN was significantly getting worse without frozen gloves during chemotherapy, however be largely reversible within 1 year of PST or adjuvant treatment. The J-Q findings support that nab-PTX treatment is tolerable. Citation Format: Yoshidome K, Morimoto T, Matsunami N, Tsunashima R, Tsukamoto F, Ryo T, Nishida Y, Shimo T, Anno K, Shimada M, Udo M, Kagawa M, Morishima H, Oda N. Nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy in patients receiving neoadjuvant or adjuvant chemotherapy for breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-17.

Patient-reported pain severity, pain interference and health status in HR+/HER2− advanced/metastatic breast cancer

IntroductionPatient-reported pain severity and related impact in advanced/metastatic breast cancer (ABC/MBC) are not well documented. The objective of this study was to assess pain and general health status in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) ABC/MBC.MethodsData were collected in the USA and Europe in a real-world, cross-sectional study. Patients were recruited at oncology practices and completed validated questionnaires; pain severity and interference were assessed using the Brief Pain Inventory (BPI) and general health status using the EuroQoL-5D (EQ-5D-3L). Descriptive statistics were generated for the overall cohort, and stratified by type of therapy and sites of metastases. Differences between patient groups were assessed via the Mann-Whitney Wilcoxon test. The relationship between pain scores and general health status was assessed using Kruskal-Wallis tests.ResultsOverall, 173 oncologists and 739 patients participated. The majority of patients rated their worst pain, average pain and pain interference as mild (59%, 77% and 70%, respectively). Most patients (>90%) reported no problems or moderate problems for all items of the EQ-5D-3L. Current treatment had no significant associations with pain severity or interference. Patients on chemotherapy reported significantly higher proportions of moderate/extreme levels of anxiety/depression (66.7%) and significantly lower general health status (60.7) compared with those on endocrine therapy (53.1% and 64.4, respectively). Pain severity and interference, all EQ-5D-3L items except self-care and the EQ-5D-3L health utility index were also significantly associated with sites of metastases, with greater impact in patients with visceral and bone metastases than those with bone only or visceral only metastases. Significant associations were observed between pain and health status, with increased pain severity and pain interference associated with worse health utility and general health status.ConclusionThere is a clear unmet need for treatments that can reduce pain and preserve health status in patients with HR+/HER2− ABC/MBC .

Predictive Modeling of Response to Pregabalin for the Treatment of Neuropathic Pain Using 6-Week Observational Data: A Spectrum of Modern Analytics Applications

PurposeThis post hoc analysis used 11 predictive models of data from a large observational study in Germany to evaluate potential predictors of achieving at least 50% pain reduction by week 6 after treatment initiation (50% pain response) with pregabalin (150–600 mg/d) in patients with neuropathic pain (NeP). MethodsThe potential predictors evaluated included baseline demographic and clinical characteristics, such as patient-reported pain severity (0 [no pain] to 10 [worst possible pain]) and pain-related sleep disturbance scores (0 [sleep not impaired] to 10 [severely impaired sleep]) that were collected during clinic visits (baseline and weeks 1, 3, and 6). Baseline characteristics were also evaluated combined with pain change at week 1 or weeks 1 and 3 as potential predictors of end-of-treatment 50% pain response. The 11 predictive models were linear, nonlinear, and tree based, and all predictors in the training dataset were ranked according to their variable importance and normalized to 100%. FindingsThe training dataset comprised 9187 patients, and the testing dataset had 6114 patients. To adjust for the high imbalance in the responder distribution (75% of patients were 50% responders), which can skew the parameter tuning process, the training set was balanced into sets of 1000 responders and 1000 nonresponders. The predictive modeling approaches that were used produced consistent results. Baseline characteristics alone had fair predictive value (accuracy range, 0.61–0.72; κ range, 0.17–0.30). Baseline predictors combined with pain change at week 1 had moderate predictive value (accuracy, 0.73–0.81; κ range, 0.37–0.49). Baseline predictors with pain change at weeks 1 and 3 had substantial predictive value (accuracy, 0.83–0.89; κ range, 0.54–0.71). When variable importance across the models was estimated, the best predictor of 50% responder status was pain change at week 3 (average importance 100.0%), followed by pain change at week 1 (48.1%), baseline pain score (14.1%), baseline depression (13.9%), and using pregabalin as a monotherapy (11.7%). ImplicationsThe finding that pain changes by week 1 or weeks 1 and 3 are the best predictors of pregabalin response at 6 weeks suggests that adhering to a pregabalin medication regimen is important for an optimal end-of-treatment outcome. Regarding baseline predictors alone, considerable published evidence supports the importance of high baseline pain score and presence of depression as factors that can affect treatment response. Future research would be required to elucidate why using pregabalin as a monotherapy also had more than a 10% variable importance as a potential predictor.

284P - Patient reported pain severity and interference in HR + /HER2- advanced/metastatic breast cancer in real world settings

To assess patient reported pain severity and pain interference in HR + /HER2- advanced/metastatic breast cancer (ABC/MBC) across multiple countries in a real world setting. Physicians across 5 major EU countries and the US participated in a cross-sectional study of over 2000 patients with HR + /HER2- ABC/MBC. A subset of patients (N = 739) completed validated questionnaires, including the Brief Pain Inventory (BPI), used to assess the severity and impact of pain on daily functions. Pain severity is reported at its worst on a 0-10 scale, while average pain severity is a mean of 4 items on a 0-10 scale (worst & least in past 24 hours, average and current pain). On both scales a higher score implies greater pain. Interference is a mean of 7 items on a 0-10 scale with higher scores implying greater pain interference. Mean scores are reported for the overall cohort and by sites of metastases and compared using Mann-Whitney U and Kruskal-Wallis tests. Mean (SD) scores for worst pain was 3.1 (2.4), average pain was 2.4 (1.9), and pain interference was 2.8 (2.2). The subgroup with bone and visceral metastases had significantly higher (p < 0.05) average pain severity [3.0 (1.9)], compared to those with bone disease (no visceral metastases) [2.5 (1.9)] and those with visceral (no bone) disease [2.2 (1.9)]. Pain interference was significantly higher (p < 0.05) for those with both bone and visceral metastases (3.4 [2.2]) followed by bone disease (2.9 [2.1]) and visceral disease (2.6 [2.2]). In a subset of patients receiving chemotherapy at the time of completion of the BPI, worst pain was significantly (p < 0.05) higher in patients with both metastases [3.8 (2.4)], compared to those with bone metastases [3.4 (2.3)] and those with visceral metastases [2.8 (2.3)]. No significant difference in pain interference scores were observed by type of metastatic site within the subset of patients treated with chemotherapy. Low to moderate levels of pain severity and pain interference scores observed in advanced/metastatic breast cancer patients in the real world, which vary significantly by extent and site of metastases.

Prevalence and treatment of pain in EDs in the United States, 2000 to 2010

ObjectivesTo describe changes in the prevalence and severity of pain and prescribing of non-opioid analgesics in US emergency departments (EDs) from 2000 to 2010. MethodsAnalysis of serial cross-sectional data regarding ED visits from the National Hospital Ambulatory Medical Care Survey. Visits were limited to patients ≥18 years old without malignancy. Outcome measures included annual volume of visits among adults with a primary symptom or diagnosis of pain, annual rates of patient-reported pain severity, and predictors of non-opioid receipt for non-malignant pain. ResultsRates of pain remained stable, representing approximately 45% of visits from 2000 through 2010. Patients reported pain as their primary symptom twice as often as providers reported a primary pain diagnosis (40% vs 20%). The percentage of patients reporting severe pain increased from 25% (95% confidence intervals [CI] 22%-27%) in 2003 to 40% (CI 37%-42%) in 2008. From 2000 to 2010, the proportion of pain visits treated with pharmacotherapies increased from 56% (CI 53%-58%) to 71% (CI 69%-72%), although visits treated exclusively with non-opioids decreased 21% from 28% (CI 27%-30%) to 22% (CI 20%-23%). The adjusted odds of non-opioid rather than opioid receipt were greater among visits for patients 18 to 24 years old (odds ratio [OR] 1.35, CI 1.24-1.46), receiving fewer medicines (OR 2.91, CI 2.70-3.15) and those with a diagnosis of mental illness (OR 2.24, CI 1.99-2.52). ConclusionsLarge increases in opioid utilization in EDs have coincided with reductions in the use of non-opioid analgesics and an unchanging prevalence of pain among patients.

Judging pain and disability: effects of pain severity and physician specialty

While considerable evidence indicates that the assessment of pain is an exercise in social cognition, provider contributions to pain assessment have received little attention. This study compared internist versus neurosurgeon ratings of pain and pain-related disability for hypothetical patients reporting either low or high levels of low back pain. Using practice characteristics as covariates, a multivariate analysis of covariance showed that both physician groups rated pain severity, but not measures of disability, as significantly lower for the low pain severity condition. Relative to internists, neurosurgeons rated both pain severity and pain-related disability as significantly lower, regardless of patient-reported pain severity. There were no interactions between physician specialty and patient-reported pain severity. Practice characteristics accounted for relatively little variance in ratings. Results are discussed in terms of differences in comparison levels for the physician groups, as well as implications for clinical practice and disability determination systems.

Exercise and changes in health status in patients with ankylosing spondylitis.

Although exercise is a commonly recommended treatment for ankylosing spondylitis (AS), little is known about the effectiveness of unsupervised recreational and back exercises. We examined the effects of recreational exercise and back exercises on patient-reported pain severity, stiffness severity, and functional disability in a prospective longitudinal study of 220 patients with AS. Participants provided information on exercise habits and health status every 6 months using mailed questionnaires (median follow-up, 4.5 years). Pain severity and stiffness severity were measured using visual analog scales, and functional disability was measured using the Health Assessment Questionnaire (HAQ) Disability Index. Among all patients, there were no associations between either the number of exercise minutes per week or the number of days of back exercise per week and short-term (6-month) changes in pain, stiffness, or HAQ Disability Index. However, among those who had AS for 15 years or less, pain scores were 0.18 points lower (on a scale of 0-3; P =.04), and stiffness scores were 6.4 points lower (on a scale of 0-100; P =.005) during periods with more than 200 minutes per week of exercise compared with periods with 0 to 30 minutes of exercise per week. Among those who had AS for more than 15 years, pain scores were 0.11 points lower (on a scale of 0-3; P =. 03), and HAQ Disability Indexes were 0.08 points lower (on a scale of 0-3; P<.001) during periods with 5 to 7 days per week of back exercise compared with periods when back exercises were not performed. Less intense levels of exercise were not associated with improvements in health status. Unsupervised recreational exercise improves pain and stiffness, and back exercise improves pain and function in patients with AS, but these effects differ with the duration of AS. Health status is improved when patients perform recreational exercise at least 30 minutes per day and back exercises at least 5 days per week. Arch Intern Med. 2000;160:2969-2975