Effect of abiraterone acetate (AA) on patient-reported pain in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel: Results of longitudinal sensitivity analyses.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9618-9618 ◽  
Author(s):  
Yanni Hao ◽  
Charles S. Cleeland ◽  
Dennis Gagnon ◽  
Derek Espindle ◽  
Arturo Molina ◽  
...  
Keyword(s):  
Missing Data ◽  
Pain Intensity ◽  
Short Form ◽  
Mixed Effects ◽  
Pain Interference ◽  
Sensitivity Analyses ◽  
Repeated Measure ◽  
Patient Reported ◽  
Pain Outcomes ◽  
The Impact

9618 Background: The COU-AA-301 phase 3 trial showed that AA + prednisone (P) improved overall survival in mCRPC patients (pts) post-docetaxel. Compared with P alone, AA + P also had significant benefits on patient-reported pain. Here we describe post hoc sensitivity analyses of pain data from that trial, using different methods to compensate for the potential impact of missing data. Methods: Pts with mCRPC progressing after docetaxel-based chemotherapy were randomized 2:1 to AA + P or placebo + P. Pain intensity and interference of pain with daily activities were assessed with the Brief Pain Inventory-Short Form (BPI-SF) questionnaire at baseline, Day 15 of Cycle 1, and Day 1 of each 28-day treatment cycle thereafter until treatment discontinuation. The effect of treatment on BPI-SF scores was analyzed using repeated measure mixed-effects (RMM) models, piecewise linear mixed-effects (PWLME) models, and joint mixed-effects and log time-to-dropout (JMEL) models. RMM and PWMLE models assumed missing data (due to death, study dropout, or administrative issues) to be missing at random, the JMEL model to be missing not at random. Model results were compared between treatment arms. Results: 797 pts were randomized to AA + P, and 398 to P only. RMM model estimates suggested statistically significant (p < 0.05) differences in change from baseline for pain intensity and pain interference scores in favor of AA + P at the majority of study visits through cycle 11. PWLME models yielded significantly smaller areas under the curve (AUCs) for AA + P vs P for pain intensity (p = 0.0031) and pain interference (p = 0.0006); smaller AUCs reflect better pain outcomes. Results using JMEL models were nearly identical to those with PWLME models, with AUCs for AA + P significantly smaller than for P alone for pain intensity (p = 0.0031) and pain interference (p = 0.0007). Conclusions: Using various modeling methods that assess the impact of missing data, AA + P showed superior patterns of pain outcomes over time compared with P only in mCRPC pts refractory to docetaxel. These results support the previously reported pain benefits of AA + P over P alone from the same trial. Clinical trial information: NCT00638690.

The problem of pain in lupus: an explication of the role of biopsychosocial mechanisms

2020 ◽  
pp. jrheum.200595
Author(s):  
Titilola Falasinnu ◽  
Cristina Drenkard ◽  
Gaobin Bao ◽  
Sean Mackey ◽  
S. Sam Lim
Keyword(s):  
Disease Activity ◽  
Pain Intensity ◽  
Lupus Erythematosus ◽  
Negative Impact ◽  
Organ Damage ◽  
Sensitivity Analyses ◽  
Behavioral Factors ◽  
Patient Reported ◽  
Pain Outcomes ◽  
The Relationship

Objective To define biopsychosocial mechanisms of pain that go above and beyond disease activity and organ damage in systemic lupus erythematosus (SLE). Methods We conducted a cross-sectional analysis of patient-reported data in a population-based registry of 766 people with SLE. Predictors of pain intensity and interference were examined using hierarchical linear regression. We built two main hierarchical regression models: pain intensity regressed on disease activity and organ damage; and pain interference regressed on disease activity and organ damage. For each model, we sought to establish the relationship between pain outcomes and the primary exposures using sequential steps comprising the inclusion of each construct in six stages: demographic, socioeconomic, physical, psychological, behavioral and social factors. We also conducted sensivity analyses eliminating all overt aspects of pain in the disease activity measure and reestimated the models. Results Disease activity and organ damage explained 32-33% of the variance in pain intensity and interference. Sociodemographic factors accounted for an additional 4-9% of variance in pain outcomes, while psychosocial/behavioral factors accounted for the final 4% of variance. In the sensitivity analyses, we found that disease activity and organ damage explained 25% of the variance in pain outcomes. Conclusion Disease activity only explained 33% of the variance of pain outcomes. However, there was an attenuation in these associations after accounting for psychosocial/behavioral factors, highlighting their roles in modifying the relationship between disease activity and pain. These findings suggest that multilevel interventions may be needed to tackle the negative impact of pain in SLE.

Correlation of the I-HaND Scale with Other Musculoskeletal Patient-Reported Outcome Measurement Scores

2021 ◽  
Author(s):  
Joost T.P. Kortlever ◽  
S. Ryan Pierson ◽  
David Ring ◽  
Lee M. Reichel ◽  
Gregg A. Vagner
Keyword(s):  
Pain Intensity ◽  
Upper Extremity ◽  
Short Form ◽  
Multivariable Analysis ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Symptoms Of Depression ◽  
Patient Reported ◽  
The Impact ◽  
Hand Scale

Abstract Background Experiments can determine if nerve-specific patient-reported outcome measures (PROMs) can outperform regional or condition-specific PROMs. We compared a nerve-specific PROM of the upper extremity, the Impact of Hand Nerve Disorders (I-HaND) scale, to other validated measures quantifying activity intolerance and sought to assess interquestionnaire correlations and factors independently associated with activity intolerance and pain intensity. Methods One hundred and thirty patients with any upper extremity nerve-related condition completed measures of demographics, psychological limitations, quality of life, activity intolerance, and pain intensity. To quantify activity intolerance, we used the I-HaND, Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity, and Disabilities of the Arm, Shoulder and Hand short form. Results Strong interquestionnaire correlations were found between the activity intolerance measures (r between 0.70 and 0.91). Multivariable analysis revealed that greater activity intolerance and greater pain intensity correlated most with greater symptoms of depression on all scales, with symptoms of depression accounting for 53 to 84% of the variability in the PROMs. Conclusion There is no clear advantage of the nerve-specific I-HaND over shorter, regional PROMs, perhaps because they are all so closely tied to mental health. Unless an advantage relating to responsiveness to treatment is demonstrated, we support using a brief arm-specific PROM for all upper extremity conditions. Level of Evidence Level II; Prognostic.

Missing repeated measures data in clinical trials

2021 ◽  
Author(s):  
Stephanie L Pugh ◽  
Paul D Brown ◽  
Danielle Enserro
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Repeated Measures ◽  
Drop Out ◽  
Sensitivity Analyses ◽  
Analysis Methods ◽  
Patient Reported ◽  
The Impact ◽  
Proper Interpretation

Abstract Clinical trials typically collect longitudinal data, data that is collected repeated over time, such as labs, scans, or patient-reported outcomes. Due to a variety of reasons, this data can be missing, whether a patient stops attending clinical visits (i.e., drop-out), or misses assessments intermittently. Understanding the reasons for missing data as well as predictors of missing data can aid in determination of the missing data mechanism. The analysis methods employed are dependent on the missing data mechanism and may make certain assumptions about the missing data itself. Methods for non-ignorable missing data, which assumes that the missing data depends on the missing data itself, make stronger assumptions and include pattern mixture-models and shared parameter models. Missing data that is ignorable after adjusting for other covariates, can be analyzed using methods that adjust for covariates, such as mixed effects models or multiple imputation. Missing data that is ignorable can be analyzed using standard approaches that require complete case data, such as change from baseline or proportion of patients who declined at a specified time point. In clinical trials, truly ignorable data is rare, resulting in additional analysis methods required for proper interpretation of the results. Conducting several analyses under different assumptions, called sensitivity analyses, can determine the extent of the impact of the missing data.

scholarly journals Pain Intensity and Pain Interference in Older Adults: Role of Gender, Obesity and High-Sensitivity C-Reactive Protein

Gerontology ◽  
2016 ◽  
Vol 63 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Vahid Eslami ◽  
Mindy J. Katz ◽  
Robert S. White ◽  
Erin Sundermann ◽  
Julie M. Jiang ◽  
...  
Keyword(s):  
Older Adults ◽  
Pain Intensity ◽  
Short Form ◽  
High Sensitivity ◽  
Pain Interference ◽  
C Reactive Protein ◽  
Medical Outcomes ◽  
Cross Sectional ◽  
Reactive Protein ◽  
Aging Study

Background: Among older adults, pain intensity and pain interference are more common in women than men and associated with obesity and inflammatory markers. Objective: We examined whether the obesity and pain relationship is mediated by the high-sensitivity C-reactive protein (hsCRP), a nonspecific marker of systemic inflammation, and whether this relationship differs by sex. Methods: Items from Medical Outcomes Study Short Form-36 were used to measure pain intensity and pain interference in daily life. Ordinal logistic regression was used to assess the cross-sectional association among body mass index (BMI), hsCRP levels, pain intensity and pain interference using gender-stratified models adjusted for demographic variables. Results: Participants included 667 community-residing adults over the age of 70 years, free of dementia, enrolled in the Einstein Aging Study (EAS). In women (n = 410), pain intensity was associated with obesity [BMI ≥30 vs. normal, odds ratio (OR) = 2.29, 95% confidence interval (CI) 1.43-3.68] and higher hsCRP (OR = 1.28, 95% CI 1.08-1.51). In a model with obesity and hsCRP, both remained significant, but the association between hsCRP and pain intensity was somewhat attenuated. Obesity (OR = 3.04, 95% CI 1.81-5.11) and higher hsCRP levels (OR = 1.30, 95% CI 1.08-1.56) were also independently associated with greater pain interference in women. After adjustment for pain intensity and BMI, hsCRP was no longer associated with pain interference in women. Greater pain intensity and being overweight or obese continued to be significantly associated with pain interference in women. In men (n = 257), obesity and hsCRP were not associated with pain intensity or pain interference. Conclusions: In women, the relationship between obesity and higher levels of pain intensity or interference may be accounted for by factors related to hsCRP.

scholarly journals Patient-Reported Outcomes Demonstrate The Value Of Non-Operative And Operative Orthopedic Treatments And Predict The Odds Of Improvement With Surgery

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0000
Author(s):  
Andrew Haskell ◽  
Todd S. Kim
Keyword(s):  
Pain Intensity ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Surgical Patients ◽  
Final Visit ◽  
Adaptive Tests ◽  
Item Banks ◽  
Patient Reported ◽  
Computer Adaptive Tests ◽  
Better Than

Category: Outcomes Measurement Introduction/Purpose: The importance of patient reported outcomes (PROs) has become increasingly recognized as an important tool to measure our clinical value. The National Institute of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS), a series of validated item banks, to help clinicians and researches measure key clinical domains. The PROMIS computer adaptive tests (CAT) may be administered with minimal resources or administrative burden. This study describes the results of administering computer adaptive tests (CAT) to every patient in a high volume Orthopedic Surgery practice. We test the hypotheses that both non-operative treatment and operative treatments improve PRO scores. Furthermore, we test the hypothesis that preoperative scores in these domains may be used to predict chances of improvement after surgery. Methods: The PROMIS CAT was administered prospectively for all patients as part of standard clinic intake and recorded in the patient’s electronic medical record (EMR) at each clinic visit. The PROMIS item banks are normalized to mean 50±10 for the US population. De-identified data was retrospectively extracted from the EMR including PROMIS scores, demographic information, as well as surgery specific information. As of this submission, 1688 PROMIS CATs from March 2015 to September 2016 have been analyzed. Data for initial and final clinic visits, as well as for the final preoperative visit for patients who had surgery, are compared using Wilcoxon Matched Pairs Test for paired samples and Mann-Whitney U Test for unpaired samples. Linear regression is used to assess the association of initial values to change in value after treatment. The effect of stratified initial clinic domain value on odds of improving with surgery is assessed using Analysis of Variance. Results: Non-surgical and surgical patients present with similar pain intensity (49.6±7.9 vs. 49.4±7.8). Surgical patients do not improve prior to surgery, but both improve by their final visit (45.7±7.5, 43.7±8.8, p<0.05). Non-surgical and surgical patients present with similar pain interference (60.0±8.4 vs. 60.3±8.9). Surgical patients do not improve prior to surgery, but both improve by their final visit (56.9±8.8, 54.3±9.4, p<0.05). For surgical patients, change in pain intensity and pain interference correlate with initial values (R2 0.32 and 0.27, p<0.05). The percentage whose pain intensity improves after surgery when initial value is over one SD worse than mean is 96%, within one SD worse than mean is 81%, within one SD better than mean is 56%, and over one SD better than mean is 40% (p<0.05). Conclusion: Both non-operative and operative orthopedic treatments improve patient reported pain intensity and pain interference. For patients that have surgery, patients that present with more severe symptoms tend to improve more with surgery. Furthermore, the odds of improving after surgery can be calculated based on preoperative PRO scores. This may allow surgeons to counsel patients about the potential benefits of surgery with personalized precision that is currently unavailable. Measuring PROs using PROMIS CATs demonstrates the value of both non-operative and operative Orthopedic Surgery care for our patients. Preoperative PRO scores may predict the odds of successful surgical intervention.

scholarly journals Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

2020 ◽  
pp. 1-9
Author(s):  
Juan Carlos Alarcon ◽  
Alfonso Bunch ◽  
Freddy Ardila ◽  
Eduardo Zuñiga ◽  
Jasmin I. Vesga ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
High Flux ◽  
Middle Molecules ◽  
Patient Reported ◽  
The Impact

<b><i>Introduction:</i></b> A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). <b><i>Objective:</i></b> The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. <b><i>Methods:</i></b> This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. <b><i>Results:</i></b> During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (<i>p</i> &#x3c; 0.0001), effects of kidney disease (<i>p</i> &#x3c; 0.0001), and burden of kidney disease (<i>p</i> &#x3c; 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (<i>p</i> &#x3c; 0.0001). No significant differences in the number of symptoms (DSI, <i>p =</i> 0.1) were observed, although their severity decreased (<i>p</i> = 0.009). <b><i>Conclusions:</i></b> In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

scholarly journals Association Between Baseline PROMIS Scores, Patient-Provider Communication Factors, and Musculoskeletal Health Literacy on Patient and Surgeon Expectations in Foot and Ankle Surgery

2020 ◽  
pp. 107110072095901
Author(s):  
Aoife MacMahon ◽  
Elizabeth A. Cody ◽  
Kristin Caolo ◽  
Jensen K. Henry ◽  
Mark C. Drakos ◽  
...  
Keyword(s):  
Health Literacy ◽  
Pain Intensity ◽  
Physical Function ◽  
Mental Status ◽  
Patient Perceptions ◽  
Pain Interference ◽  
Foot And Ankle ◽  
Musculoskeletal Health ◽  
Ankle Surgery ◽  
Patient Reported

Background: Various factors may affect differences between patient and surgeon expectations. This study aimed to assess associations between patient-reported physical and mental status, patient-surgeon communication, and musculoskeletal health literacy with differences in patient and surgeon expectations of foot and ankle surgery. Methods: Two hundred two patients scheduled to undergo foot or ankle surgery at an academic hospital were enrolled. Preoperatively, patients and surgeons completed the Hospital for Special Surgery Foot & Ankle Surgery Expectations Survey. Patients also completed Patient-Reported Outcomes Measurement Information System (PROMIS) scores in Physical Function, Pain Interference, Pain Intensity, Depression, and Global Health. Patient-surgeon communication and musculoskeletal health literacy were assessed via the modified Patients’ Perceived Involvement in Care Scale (PICS) and Literacy in Musculoskeletal Problems (LiMP) questionnaire, respectively. Results: Greater differences in patient and surgeon overall expectations scores were associated with worse scores in Physical Function ( P = .003), Pain Interference ( P = .001), Pain Intensity ( P = .009), Global Physical Health ( P < .001), and Depression ( P = .009). A greater difference in the number of expectations between patients and surgeons was associated with all of the above ( P ≤ .003) and with worse Global Mental Health ( P = .003). Patient perceptions of higher surgeons’ partnership building were associated with a greater number of patient than surgeon expectations ( P = .017). There were no associations found between musculoskeletal health literacy and differences in expectations. Conclusion: Worse baseline patient physical and mental status and higher patient perceptions of provider partnership building were associated with higher patient than surgeon expectations. It may be beneficial for surgeons to set more realistic expectations with patients who have greater disability and in those whom they have stronger partnerships with. Further studies are warranted to understand how modifications in patient and surgeon interactions and patient health literacy affect agreement in expectations of foot and ankle surgery. Level of Evidence: Level II, prospective comparative series.

scholarly journals Early Changes in Pain Acceptance Predict Pain Outcomes in Interdisciplinary Treatment for Chronic Pain

2019 ◽  
Vol 8 (9) ◽  
pp. 1373 ◽  
Author(s):  
Probst ◽  
Jank ◽  
Dreyer ◽  
Seel ◽  
Wagner ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pain Intensity ◽  
Pain Perception ◽  
Rating Scale ◽  
Post Treatment ◽  
Interdisciplinary Treatment ◽  
Binary Logistic Regression Analysis ◽  
Pain Acceptance ◽  
Pain Outcomes ◽  
The Impact

Studies have shown that pain acceptance is associated with a better pain outcome. The current study explored whether changes in pain acceptance in the very early treatment phase of an interdisciplinary cognitive-behavioral therapy (CBT)-based treatment program for chronic pain predict pain outcomes. A total of 69 patients with chronic, non-malignant pain (at least 6 months) were treated in a day-clinic for four-weeks. Pain acceptance was measured with the Chronic Pain Acceptance Questionnaire (CPAQ), pain outcomes included pain intensity (Numeric Rating Scale, NRS) as well as affective and sensory pain perception (Pain Perception Scale, SES-A and SES-S). Regression analyses controlling for the pre-treatment values of the pain outcomes, age, and gender were performed. Early changes in pain acceptance predicted pain intensity at post-treatment measured with the NRS (B = −0.04 (SE = 0.02); T = −2.28; p = 0.026), affective pain perception at post-treatment assessed with the SES-A (B = −0.26 (SE = 0.10); T = −2.79; p = 0.007), and sensory pain perception at post-treatment measured with the SES-S (B = -0.19 (SE = 0.08); T = -2.44; p = 0.017) . Yet, a binary logistic regression analysis revealed that early changes in pain acceptance did not predict clinically relevant pre-post changes in pain intensity (at least 2 points on the NRS). Early changes in pain acceptance were associated with pain outcomes, however, the impact was beneath the threshold defined as clinically relevant.

scholarly journals Estudo Unicêntrico Prospetivo de Avaliação Sistemática da Dor em Doentes Portugueses com Cancro da Próstata Metastizado

2017 ◽  
Vol 30 (11) ◽  
pp. 796
Author(s):  
Maria Inês Sequeira ◽  
Nuno Sousa ◽  
Maria Fragoso ◽  
Alexandra Silva ◽  
Filipa Pereira ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Pain Intensity ◽  
Metastatic Prostate Cancer ◽  
Short Form ◽  
Brief Pain Inventory ◽  
Life Assessment ◽  
Medical Interventions ◽  
Reduction Of Pain ◽  
Prevalence Of Pain ◽  
The Impact

Introduction: Pain is one of the most common symptoms reported by cancer patients and is associated with decreased quality of life. Assessment of pain with standardized questionnaires reduces variability in its interpretation and may increase effectiveness of medical interventions. Prostate cancer is the most frequent male neoplasm in Portugal. We designed this study to evaluate the impact of a standardized pain questionnaire on pain management in patients with metastatic prostate cancer.Material and Methods: Single centre prospective observational study of patients with metastatic prostate cancer. The study was designed to evaluate the benefit of systematically evaluating pain with Brief Pain Inventory-Short Form prior to a scheduled medical oncology consult. Patients reporting pain were reassessed one week later by telephone. To assess the benefit two consecutive cohorts were established based on communication of questionnaire results to the treating physician.Results: We recruited 207 patients of which 60% reported pain. Statistically significant decrease in mean pain intensity one week after the scheduled appointment was noted (3.95 vs 3.01; p < 0.001). Patients whose Brief Pain Inventory-Short Form was provided to their oncologist experienced greater reduction in pain, which was non-significant (p = 0.227). Using Brief Pain Inventory-Short Form assessment resulted in a higher probability of pain control (43.5% vs 30.9%; p = 0.193).Discussion: The prevalence of pain founded was higher than described in the literature, probably because our sample was less selected than the published in clinical trials. After the scheduled appointment, there was a statistically significant reduction in mean pain intensity, but the explicit use of this questionnaire was not associated with a statistically significant reduction of pain.Conclusion: Patients with metastatic prostate cancer have a high prevalence of pain. Evaluation and treatment by medical oncologists is associated with a reduction of mean pain intensity. The use of Brief Pain Inventory-Short Form was associated with a non-significant increased reduction of pain.

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