Pain Items Research Articles

Safety And Clinical Outcomes Of Radium-223 With Concomitant Radiotherapy Or Subsequent Treatment With The Investigational Agent 177Lu-PSMA In Patients With Metastatic Castration-Resistant Prostate Cancer: An Interim Analysis Of The REASSURE Study

Radium-223 (Ra-223) improved overall survival (OS) and demonstrated a favorable safety profile in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 ALSYMPCA trial. REASSURE (NCT02141438) is a global, prospective, single-arm, observational study investigating the safety of Ra-223 in routine clinical practice in pts with mCRPC over 7 years. The objective of this investigation, using data from the second prespecified interim analysis, was to assess safety and clinical outcomes in pts from REASSURE, including the subgroups who received radiotherapy concomitant with Ra-223, or investigational 177Lu-PSMA subsequent to Ra-223. Results of this analysis may help to inform future treatment decisions in pts with mCRPC. This analysis (data cut-off: March 20, 2019) was conducted for the entire cohort and two subsets of pts treated with either concomitant radiotherapy or with subsequent 177Lu-PSMA. Incidence of second primary malignancy (SPM), pain response, incidence of adverse events (AEs), and OS are described. In total, 1465 pts with mCRPC were included. Median follow-up was 11.5 months, and a median of 6 Ra-223 injections was received. Overall, 14 pts (1%) developed a SPM. At Cycle 6, 222/657 pts (34%) had a clinically meaningful pain response (decrease ≥2 points from baseline) in the Brief Pain Inventory worst pain item. Overall, median OS was 15.6 months (95% CI 14.6, 16.5). The most frequent treatment-emergent serious AEs (any grade; ≤30 days after Ra-223) were anemia (n = 27; 2%), physical health deterioration (n = 14; 1%), and pneumonia (n = 13; 1%). Grade 3–4 hematologic AEs occurred in 214 pts (15%); 70 pts (5%) had fractures. 160/1465 pts (11%) had concomitant radiotherapy, mainly external beam radiation therapy (n = 117; 73%), brachytherapy (n = 14; 9%), and gamma knife or stereotactic therapy (n = 8; 5% for each). Of these 160 pts, 1 (<1%) developed a SPM. Safety, including hematologic toxicity fracture rate, and pain response in this pt group was acceptable and will be presented. 26/1465 pts (2%) received 177Lu-PSMA treatment after Ra-223. Median duration of 177Lu-PSMA was 3.5 months. 3/26 pts (12%) had drug-related serious AEs; 9/26 pts (35%) had grade 3–4 hematologic AEs. 2/26 pts (8%) had fractures. Median OS was 28.0 months (95% CI 19.5, 32.7) from start of Ra-223 and 13.2 months (8.4, 16.2) from start of 177Lu-PSMA. There was a low incidence of SPM, low rate of grade 3–4 hematologic AEs, and low incidence of fractures in this second interim analysis of REASSURE, in a real-life clinical practice setting. A pain response was observed in about one-third of pts. Treatment with 177Lu-PSMA in pts who had prior Ra-223 may be feasible in selected pts based on the subset analyzed.

Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study

PurposeIn the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). MethodsPatients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. ResultsDeterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62–1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61–1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60–1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57–1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58–1.12]) trended in favor of ribociclib vs placebo. ConclusionsIn addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.

Antenatal pain, intimate partner violence, and maternal bonding disorder: data from the Japan Environment and Children's Study.

This prospective study examined (1) whether antenatal pain is associated with postnatal maternal bonding disorder (MBD) through postnatal depression and (2) whether intimate partner violence (IPV) has a moderating effect on the association between antenatal pain and postnatal MBD. We analyzed 77,326 pregnancies of women who completed self-report questionnaires including the SF-8 bodily pain item, the Edinburgh Postnatal Depression Scale, the Mother-to-Infant Bonding Scale, and an assessment of IPV. We conducted a mediation analysis to assess whether postnatal depression mediated the association between antenatal pain and MBD 1 year after delivery. A moderated mediation model was used to examine the conditional effect of IPV during pregnancy on the association between antenatal pain and postnatal MBD, operating through postnatal depression. All analyses were adjusted for demographic factors, socioeconomic factors, perinatal and infant factors, medical history, and psychological status. Of the 77,326 pregnancies, 5420 (7.0%) were characterized by persistent moderate-to-severe pain. The total effect of antenatal pain on MBD was significant (standardized path coefficient = 0.06, 95% confidence interval, 0.05-0.06) and postnatal depression dominantly mediated the association between antenatal pain and postnatal MBD (70.8% mediation). Contrary to our hypothesis, IPV during pregnancy did not moderate the association between antenatal pain and postnatal MBD. However, IPV during pregnancy did have independent negative effects on both postnatal depression and MBD. Our findings suggest that antenatal pain and postnatal depression should be assessed and treated with consideration of the presence of IPV during pregnancy to better monitor and prevent the development of MBD.

The Concerns About Pain (CAP) Scale: A Patient-Reported Outcome Measure of Pain Catastrophizing

Pain catastrophizing has been recognized as an important and consistent psychosocial predictor of nearly every key pain-related outcome. The purpose of this study was to develop a new measure of pain catastrophizing using modern psychometric methodology. People with chronic pain (N = 795) responded to thirty items. Data were analyzed using item response theory, including assessment of differential item functioning and reliability. Sensitivity to change and validity were examined using data collected from patients undergoing spinal fusion surgery (n = 184) and participating in an ongoing longitudinal aging with a disability survey study (n = 1,388). The final 24-item bank had no items with significant local dependence, misfit, or differential item functioning. Results provided strong evidence of reliability and validity. Six- and 2-item short forms were developed for use when computer adaptive testing is not feasible or desirable. The item bank was named the University of Washington Concerns About Pain scale because the term “catastrophizing” was considered stigmatizing by people with chronic pain. Guidance for score interpretation was developed with extensive feedback from individuals with chronic pain. The Concerns About Pain item bank, short forms, and user manuals are free and publicly available to all users and can be accessed online at https://uwcorr.washington.edu/measures/. PerspectiveThis article presents the development of the University of Washington Concerns About Pain scale, the first item response theory-based item bank of pain catastrophizing. The measure is intended for clinicians interested in improving outcomes of patients with chronic pain and for researchers who study impact of and treatment interventions aimed at reducing pain catastrophizing.

Impact of olaparib vs physician’s choice of new hormonal agent (pcNHA) on burden of pain in metastatic castration-resistant prostate cancer (mCRPC): PROfound.

5538 Background: In the Phase III PROfound study (NCT02987543) olaparib significantly improved radiographic progression-free survival (primary endpoint) vs pcNHA (enzalutamide or abiraterone) in patients (pts) with mCRPC and homologous recombination repair (HRR) gene alterations. In pts with alterations in BRCA1, BRCA2 and/or ATM (cohort A), time to pain progression was also significantly improved by olaparib vs pcNHA. We report additional pain analyses evaluated in the overall study population (cohort A and B). Methods: Pts were randomized to olaparib tablets (300 mg bid; n=256) or pcNHA (n=131). Pts completed the Brief Pain Inventory-Short Form (BPI–SF) questionnaire (electronic administration) every 4 weeks up to 6 months after progression or treatment crossover. Responses were analysed to determine time to progression to worst pain, pain severity and first opiate use for cancer-related pain (Kaplan-Meier), and also pain interference in daily activity (mixed model for repeated measures). Results: 85% and 76% of olaparib pts were free of pain progression (worst pain item) compared with 75% and 51% in the pcNHA arm, respectively at 6 and 12 months. The proportion of pts without pain progression (overall pain severity) also favoured olaparib (Table). Median time to first opiate use was significantly prolonged in olaparib arm compared with pcNHA arm; 18 months for olaparib vs 9 months for pcNHA (Table). BPI-SF pain interference scores were also more favourable for olaparib than pcNHA; difference in overall adjusted mean change from baseline score −0.75 (95% CI: −1.14, −0.36) P=0.0002. Further pain burden results for cohort A will also be presented. Conclusions: Olaparib reduced the burden of pain and time to first opiate use in pts with mCRPC and HRR gene alterations vs pcNHA, demonstrating a clinical and symptomatic patient benefit. Clinical trial information: NCT02987543 . [Table: see text]

Patient-reported pain and pain medication impact in patients with HR+ Her2-neg advanced breast cancer: A U.S. FDA pooled analysis.

e13027 Background: Despite the ubiquitous prescribing of pain medications (PMs) in cancer clinical trials, the impact of such prescribing patterns and reporting on the experience of pain is not often investigated. We examined patient-reported pain before initiation of PM reporting and at the next available pain assessment. Our aim was to understand change in patient-reported pain. Methods: We pooled data from 7 phase 3 randomized, controlled, registration trials of CDKI with endocrine therapy in patients with hormone receptor positive, human epidermal growth factor receptor-2 negative MBC. We restricted our analyses to patients who started therapy with no PM reported and looked at patients who had NSAID or opioid medication documented. We calculated change between 2 assessments in patient-reported pain before and after PM using the pain occurrence item (Q9) on the EORTC Quality of Life questionnaire (QLQ-C30). Results: Of the 4200 patients who received at least 1 dose of CDKI/placebo, 1488 started with no documented PM, with 48% reporting none at all when asked about pain at baseline. Subsequently, 185 patients had documented NSAID and 43 an opioid and had a pain PRO assessment before and after. NSAIDs documentation occurred on average 11 weeks into trial and opioids 5. Before documentation of NSAIDs, 45% of patients reported no pain compared to 23% of patients with an opioid. Patients who had documented NSAIDs, 29% experienced an improvement in their self-reported pain, whereas 32% of patients with documented opioids improved. On average the time between the 2 pain assessments was around 58 days for both PMs. Conclusions: In this analysis in patients who had a pain assessment before and after documentation of a PM, there is a small group whose pain improved. It is important to note that patients’ response to the pain item was not provided to the clinical care team, which may explain why there may have been suboptimal pain control. Further study is needed to examine how pain management can be achieved in patients with advanced breast cancer. Future analysis should be performed with patients whose PRO pain results are communicated with the clinical care team in real-time. [Table: see text]

Exploring the relation between the EQ-5D-5L pain/discomfort and pain and itching in a sample of burn patients

BackgroundThe EQ-5D domain pain/discomfort (PD) uses one item to capture pain and other aspects of discomfort, like itching. This study explored how pain, itching and the EQ-5D-5L PD domain relate to each other in a sample of burn patients.MethodsAdult burn patients completed the EQ-5D-5L and the Patient and Observer Scar Assessment Scale (POSAS) 5–7 years after sustaining their injury. The POSAS includes a separate pain and an itching item. Spearman’s correlation coefficient established the association between the EQ-5D-5L PD and the POSAS pain and itching item. With multivariable regression analysis the linear association between the POSAS pain and itching item and EQ-5D-5L PD domain was tested.ResultsData from 245 patients were included. Mean EQ-5D-5L index value was 0.87 and 39.2% reported at least slight problems on the EQ-5D-5L PD domain. Most patients gave corresponding answers on the EQ-5D-5L PD domain and on the POSAS pain (73%) and itching (70%) item. Spearman correlation coefficients of the EQ-5D-5L PD domain with the POSAS pain and itching were 0.468 (p < 0.001) and 0.473 (p < 0.001), respectively. Among respondents with pain and without itching and respondents with itching and without pain, Spearman correlation coefficients were 0.585 (p = 0.076) and 0.408 (p = 0.001), respectively. POSAS pain (unstandardized Beta = 0.14) and POSAS itching (unstandardized Beta = 0.08) were significantly associated with EQ-5D-5L PD domain (p < 0.001).ConclusionsOur findings indicate that, in a sample of burn patients, pain and itching are captured by the broader EQ-5D-5L PD domain. The EQ-5D-5L PD domain can thus be used to assess pain and itching in relation to HRQL, but the POSAS pain and itching items are more sensitive. The EQ-5D-5L is, however, no replacement of the POSAS when the POSAS is used for its primary aim; assessment of scar quality.Trial registrationNetherlands Trial Register (NTR6407).

PMS3 LORECEVIVINT, A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS: FACTORS DRIVING WOMAC PAIN SUBSCORE CHANGES - A POST HOC ANALYSIS OF PHASE 2B DATA

Knee osteoarthritis (OA) is a heterogenous disease characterized by pain, functional loss, and deformity, which can confound patient-reported outcomes (PROs). The WOMAC Pain subscore addresses this variability by capturing ‘active’ (A1–A2) and ‘static’ (A3–A5) pain items. We hypothesize that measurement of ‘active’ versus ‘static’ pain dimensions may demonstrate differential effect sizes (ES) when assessing treatment benefit. Lorecivivint (LOR; SM04690), a small-molecule, intra-articular CLK/DYRK1A inhibitor, is in development as a potential disease-modifying treatment for knee OA.

PIT12 EXPLORING THE RELATION BETWEEN THE EQ-5D-5L PAIN/DISCOMFORT AND PAIN AND ITCHING IN A SAMPLE OF BURN PATIENTS

The EQ-5D domain pain/discomfort (PD) uses one item to capture pain and other aspects of discomfort, like itching. This study explored how pain, itching and the EQ-5D-5L PD domain relate to each other in a sample of burn patients. Adult burn patients completed the EQ-5D-5L and the Patient and Observer Scar Assessment Scale (POSAS) 5-7 years after sustaining their injury. The POSAS includes a separate pain and an itching item. Spearman’s correlation coefficient established the association between the EQ-5D PD and the POSAS pain and itching item. With multivariable regression analysis the linear association between the POSAS pain and itching item and EQ-5D-5L PD domain was tested. Data from 245 patients were included. Mean EQ-5D-5L index value was 0.87 and 39.2% reported at least slight problems on the EQ-5D PD. Most patients gave corresponding answers on the EQ-5D-5L PD domain and on the POSAS pain (73%) and itching (70%) item. Spearman correlation coefficients of the EQ-5D-5L PD domain with the POSAS pain and itching were 0.468 (p<0.001) and 0.473 (p<0.001), respectively. Among respondents with pain and without itching and respondents with itching and without pain, Spearman correlation coefficients were 0.585 (strong correlation, p=0.076) and 0.408 (moderate correlation, p=0.001), respectively. POSAS pain (unstandardized Beta=0.14) and POSAS itching (unstandardized Beta=0.08) were significantly associated with EQ-5D-5L PD domain (p<0.001). Our findings indicate that, in a sample of burn patients, pain and itching are captured by the broader EQ-5D-5L PD. The EQ-5D-5L PD domain can thus be used to assess pain and itching in relation to HRQL, but the POSAS pain and itching items are more sensitive. The EQ-5D-5L is, however, no replacement of the POSAS when the POSAS is used for its primary aim; assessment of scar quality.

Reliability, validity, and the ability to detect change of the Psoriasis Symptom Scale (PSS) in patients with plaque psoriasis

Introduction: The primary objective of the study was to evaluate the measurement properties of the patient-reported four-item Psoriasis Symptom Scale (PSS).Methods: Analysis of phase-III data on the efficacy of risankizumab to assess psychometric characteristics of the PSS in patients with moderate-to-severe psoriasis.Results: PSS items had a good range of symptom severity coverage. The PSS had good test–retest reliability (ICCs >0.90). Convergent and discriminant validity was indicated by moderate-to-strong correlations between the PSS and Dermatology Life Quality Index (DLQI), PSS pain item and EQ-5D pain/discomfort item at week 12 (0.63), and moderate negative correlation with EQ-Visual Analog Scale score at week 12 (−0.37). Known groups validity demonstrated as mean PSS total scores varied by Psoriasis Area and Severity Index (PASI) and Static Physician’s Global Assessment (sPGA) defined groups (p < .0001). PSS total scores were responsive to changes in PASI score (p < .0001) and sPGA (p < .0001). PSS minimal, clinical, and meaningful change is estimated to be 1 to 2 points; a preliminary responder definition is a total change score of 3 to 4 points.Conclusions: The PSS is a short, valid unidimensional measure of psoriasis symptom severity, well suited for use in clinical trials.

Psychometric Validation of the Danish Version of the Oswestry Disability Index in Patients With Chronic Low Back Pain.

Registry-based repeated-measures psychometric validation of the Danish Oswestry Disability Index (ODI). The goal was to use classical and modern psychometric validation methods to assess the measurement properties and the minimally clinical important difference (MCID) of the ODI in a Danish cohort of patients with chronic low back pain being treated with spinal surgery. Scores for the ODI, EQ-5D, SF-36, leg pain, back pain, and a general rating of pain item from 800 patients with chronic low back pain were extracted from the National Danish Spine Registry (DaneSpine) at baseline and 1-year postspine surgery. Confirmatory factor analysis and item response theory (IRT) models were used to assess the psychometric properties of the ODI. MCID was also calculated based on generic legacy PROMs (EQ-5D and SF-36) and follow-up pain scores. While ODI did not fit a Rasch model, adequate fit to a confirmatory factor analysis and a two-parameter item response theory model was found when accounting for differential item functioning across diagnostic subgroups (degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc). In addition, each group exhibited substantially different MCID values. The Danish version of the ODI is valid and responsive, but only within each of the four major diagnosis subgroups: degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc. 4.

Patellofemoral arthroplasty for the treatment of patellofemoral arthritis

To explore the clinical effect of patellofemoral joint replacement in the treatment of patellofemoral arthritis. From July 2013 to June 2017, 35 patients with 42 knees underwent patellofemoral arthroplasty, including 34 females and 1 male, aged 45 to 70 (55.0±8.2) years old, with a course of 6 to 36 (13.7±2.5) months. Before and at the end of the follow-up, the patients were assessed with Oxford knee score, satisfaction with the operation was assessed at the end of the follow-up. In addition, X-ray films of the front and side of the knee joint and axial films of the patella were taken to assess whether the prosthesis was loose, and complications such as hematoma and joint infection were recorded. Forty-two knees of 35 patients were followed up for 18 to 65 (35.0±7.2) months, and the operation time was (56.2±8.7) min. Oxford knee joint score increased from preoperative 28.14±0.36 to 37.19±0.47 at the end of the follow-up (P<0.05) . The score of pain items increased from preoperative 10.12±0.26 to 15.83±0.30 at the end of the follow-up, and the score of functional items increased from preoperative 18.02±0.13 to 21.36±0.23 at the end of the follow-up (P<0.05) , there was statistical significance (P <0.05) . In one case, there was wound suture reaction in the early postoperative period, which was improved after debridement; in the other case, there was swelling around the wound 5 weeks after operation, which was improved after antibiotic treatment; in one case, there was tear at the suture of quadriceps femoris muscle at 1 month after operation, which was improved after re suture; no loosening of prosthesis was found. The second generation of patellofemoral arthroplasty for the treatment of simple severe patellofemoral arthritis has satisfactory early clinical effect and few complications, but the indication of operation should be strictly grasped. For severe cases, CT scan of knee joint can be used to customize the patellofemoral prosthesis, so as to reduce postoperative complications and improve the clinical effect.

Self-versus Proxy-Reported Pain in Children with Cerebral Palsy: A Population-Based Registry Study of 3783 Children.

Objective: To assess how the prevalence of pain in a population-based sample of children and adolescents with cerebral palsy (CP) differ based on self- or proxy reporting. Methods: This cross-sectional registry study included 3783 children (58% boys), 1 to 18 years old, enrolled in the Swedish follow-up program for CP. Logistic regression was used to regress source of reporting (self or proxy) on the presence of general pain adjusted for age, sex, Gross Motor Function Classification System (GMFCS), and Communication Function Classification System (CFCS) levels, including marginal effects between source of reporting and adjusted covariates. Results: The pain item was self-reported in 45%, proxy-reported in 51%, and information was missing in 3%. Pain was reported in 44% of those who self-reported and in 41% of those who proxy-reported (P = .04). The logistic regression showed that the average marginal effects of proxy versus self-reported pain were lower among children at GMFCS level IV (−0.14, 95% CI −0.17 to −0.03) and CFCS level I (−0.09, CI −0.16 to −0.01) and higher at CFCS level III (0.11, CI 0.00-0.22). There were no statistically significant differences in average marginal effects related to age, sex, or the other GMFCS and CFCS levels between proxy and self-reporting. Conclusions: Pain was more often reported by those who self-reported. However, after adjusting for age, sex, CFCS level, and GMFCS level, the proportion of reported pain was almost equal between self and proxy-reporting. Assuming that the self- and proxy-reported groups were not significantly different on relevant factors not controlled for the results indicate that presence of pain is equally reported by children and parents.

Development and validation of the Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire.

Patients with co-occurring chronic pain and opioid use disorder (OUD) have unique needs that may present challenges for clinicians and health care systems. Primary care providers' (PCPs) capacity to deliver high quality, research-informed care for this population is unknown. The objective of this study was to develop and test a questionnaire of factors influencing PCP capacity to treat co-occurring chronic pain and OUD. Capacity to Treat Co-Occurring Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire items were developed over a 2-year process including literature review, semi-structured interviews, and expert panel review. In 2018, a national sample of 509 PCPs was recruited through email to complete a questionnaire including the initial 44-item draft CAP-POD questionnaire. CAP-POD items were analyzed for dimensionality, inter-item reliability, and construct validity. Principal component analysis resulted in a 22-item questionnaire. Twelve more items were removed for parsimony, resulting in a final 10-item questionnaire with the following 4 scales: (1) Motivation to Treat patients with chronic pain and OUD (α = .87), (2) Trust in Evidence (α = .87), (3) Assessing Risk (α = .82), and (4) Patient Access to therapies (α = .79). These scales were associated with evidence-based practice attitudes, knowledge of pain management, and self-reported behavioral adherence to best practice recommendations. We developed a brief, 10-item questionnaire that assesses factors influencing the capacity of PCPs to implement best practice recommendations for the treatment of co-occurring chronic pain and OUD. The questionnaire demonstrated good reliability and initial evidence of validity, and may prove useful in future research as well as clinical settings. Patients with co-occurring chronic pain and opioid use disorder (OUD) have unique needs that may present challenges for clinicians and health care systems. Primary care providers' (PCPs) ability to deliver high quality, research-informed care for this population is unknown. There are no validated instruments to assess factors influencing PCP capacity to implement best practices for treating these patients. The objective of this study was to develop and test a questionnaire of factors influencing PCP capacity to treat co-occurring chronic pain and OUD. We recruited 509 PCPs to participate in an online questionnaire that included 44 potential items that assess PCP capacity. Analyses resulted in a 10-item questionnaire that assesses factors influencing capacity to implement best practice recommendations for the treatment of co-occurring chronic pain and OUD. PCPs reported moderately high confidence in the strength and quality of evidence for best practices, and in their ability to identify patients at risk. However, PCPs reported low motivation to treat co-occurring chronic pain and OUD, and perceived patients' access to relevant services as suboptimal, highlighting two areas that should be targeted with tailored implementation strategies. The 10-item Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire can be used for two purposes: (1) to assess factors influencing PCP capacity before implementation and identify areas that may require improvement for implementation and (2) to evaluate implementation interventions aimed at increasing PCP capacity to treat this population.

Chronic pain and depression as factors associated with temporomandibular dysfunction in older adults with Parkinson's disease

ABSTRACT Purpose: to investigate whether chronic pain and depression are factors associated with temporomandibular dysfunction (TMD) in older adults with Parkinson's disease. Methods: a cross-sectional study using the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire. The clinical variables studied were chronic pain, depression, nonspecific physical symptoms including and excluding items of pain, and dentures use. The associations between the dependent and independent variables were evaluated by the chi-square odds ratio, with a 95% confidence interval. Results: a total of 81 older adults met the eligibility criteria - 67% were males, 74% were married or had a partner, 43% reported earning 1 to 2 minimum wages, and 47% were in the moderate stage of Parkinson's disease. TMD was identified in 22% of the sample, 12% reporting chronic pain. The statistical analysis showed an association between TMD and chronic pain (p = 0.001, OR = inf, 95% CI = 12.13 - inf) and between TMD and moderate-to-severe depression (p = 0.014, OR = 4.8, 95% CI = 1.14 - 23.51). Conclusion: it was verified that chronic pain and moderate-to-severe depression were the factors associated with TMD in older adults presented with Parkinson's disease.

Pattern of item score change in Stroke Impairment Assessment Set in comprehensive inpatient rehabilitation wards.

Although numerous studies have examined activities of daily living (ADL) in stroke rehabilitation, there has been little focus on impairment, despite its close relationship to ADL. Therefore, we evaluated the change in impairment from admission to discharge of patients with stroke in comprehensive inpatient rehabilitation wards using the Stroke Impairment Assessment Set (SIAS). Data from 3279 patients with first stroke who were admitted to comprehensive inpatient rehabilitation wards between 2004 and 2016 were analyzed. A scattergram of the items showing the percentage of the highest score on admission and the percentage of patients whose score improved during hospitalization was plotted. The items of the SIAS were grouped by their location on the scattergram. Three clusters could be discriminated on the scattergram. The upper right group, showed an improved score during hospitalization in combination with a high percentage of patients with the highest score on admission. This group consisted of the verticality, unaffected-side quadriceps, visuospatial, and pain items of the SIAS. The upper left group improved during hospitalization, but only contained a small percentage of patients with a high score on admission, and consisted of motor function items. The lower group was characterized by poor improvement during hospitalization and consisted of sensory, tone, range of motion, speech, and grip power items. Understanding the change in impairment during hospitalization using the three groups described above will facilitate design of a plan for stroke rehabilitation on admission.

Efficacy of Intra-Articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.

Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone. A randomized, double-blind, controlled clinical trial. The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections). Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment. Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group. These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

PRO154 CONFIRMATORY PSYCHOMETRIC VALIDATION OF THE BRIEF PAIN INVENTORY (BPI-SF) IN ADULT X-LINKED HYPOPHOSPHATEMIA (XLH)

XLH is a rare inherited bone disorder causing pain due to multiple factors e.g. skeletal deformity, osteoarthritis, pseudofractures, fractures and enthesopathy. A valid and reliable PRO measure is required to evaluate the impact of treatment on XLH-associated pain. This study sought to confirm an initial evaluation of the item/scale properties, reliability, validity, sensitivity to change of the BPI-SF in adult XLH patients, and to establish meaningful change/responder thresholds. Analyses were conducted using data (pooled across treatment groups) from a phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of burosumab in adults with XLH. 134 patients, 64.9% female, mean age 40.0 (range 18-65 yrs). Item response distributions were well distributed across the response scale. Item-scale correlations ranged from 0.61-0.81. In known-groups analysis the BPI-SF could discriminate between groups differing in baseline: pain medication use, use of walking device, pain severity and walking ability. There was moderate support for convergent validity with stronger correlations with the Patient Global Impression of Severity (PGI-S) than the six-minute walk test (6MWT). The BPI-SF Pain Interference dimension had very high internal consistency reliability (α=0.917). When the PGI-I was used to define stability, all ICCs were indicative of either moderate or high test-retest reliability. In responsiveness analyses, particularly when using the PGI-I to define change groups, there was strong support that the BPI-SF domain scores are able to detect changes over time in this population. For the Worst Pain item, a change score of 1.72 is recommended as a threshold for defining responders, and a change score of 1.0 for the Pain Interference score. Analyses support the reliability, validity, and responsiveness of the BPI-SF in adult XLH patients and provide responder thresholds, supporting the use of this PRO to evaluate the effects of treatment interventions in clinical studies.

Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy.

BackgroundIn the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression‐free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor‐positive (HR+), HER2‐negative advanced breast cancer (ABC). This study assessed patient‐reported pain, global health‐related quality of life (HRQoL), functioning, and symptoms.Materials and MethodsAbemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI‐sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ‐C30); and Breast Cancer Questionnaire (QLQ‐BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3–13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.ResultsOn‐treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n = 446) experienced a 4.9‐month delay in pain deterioration (mBPI‐sf), compared with the control arm (n = 223), and significantly greater TTSD on the mBPI‐sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59–0.98) and QLQ‐C30 pain item (hazard ratio, 0.62; 95% CI, 0.48–0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20–2.10).ConclusionHRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine‐resistant HR+, HER2‐negative ABC.Implications for PracticeIn MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor‐positive (HR+), HER2‐negative (−) advanced breast cancer (ABC). Impact on health‐related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient‐reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient‐reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2− ABC.