scholarly journals Toxicity Index, Patient-Reported Outcomes, and Early Discontinuation of Endocrine Therapy for Breast Cancer Risk Reduction in NRG Oncology/NSABP B-35

2021 ◽  
pp. JCO.21.00910
Author(s):  
N. Lynn Henry ◽  
Sungjin Kim ◽  
Ron D. Hays ◽  
Marcio A. Diniz ◽  
Michael Luu ◽  
...  
Keyword(s):  
Endocrine Therapy ◽  
Cox Regression ◽  
Hot Flashes ◽  
Multivariable Analysis ◽  
Treatment Discontinuation ◽  
Pain Interference ◽  
Time To Treatment ◽  
Toxicity Index ◽  
C Statistic ◽  
Patient Reported

PURPOSE The US National Cancer Institute Moonshot initiative calls for improving analysis and reporting of toxicity to inform treatment tolerability. We used existing clinician-reported adverse event (AE) and patient-reported outcome (PRO) questionnaire data from the randomized, double-blind NSABP B-35 clinical trial to explore reasons for anastrozole and tamoxifen discontinuation. METHODS Postmenopausal women with ductal carcinoma in situ treated with breast-conserving therapy were randomly assigned to anastrozole or tamoxifen for 5 years. The primary outcome for this analysis was time to treatment discontinuation. AEs were collected every 6 months post–random assignment from all 3,104 participants and summarized using the Toxicity Index (TI). PRO data were collected at baseline and every 6 months from 1,194 participants. Univariate and multivariable analyses of time to treatment discontinuation were performed using Cox regression models with TIs and PROs as time-dependent covariates. RESULTS Of 3,046 analyzed participants, 869 (28.5%) discontinued treatment prematurely. In multivariable analysis, when both baseline PROs and on-treatment AEs were considered, thrombosis and arthralgia AEs were associated with discontinuation of both tamoxifen and anastrozole; additional AEs associated with discontinuation varied by drug. In addition, baseline pain interference, hot flashes, and unhappiness were associated with tamoxifen discontinuation (n = 589; overall Harrell's C-statistic 0.686 [95% CI, 0.640 to 0.732]); no baseline PROs were associated with anastrozole discontinuation (n = 589; overall Harrell's C-statistic 0.656 [95% CI, 0.630 to 0.681]). When only baseline PROs were examined, pain interference, hot flashes, and unhappiness were associated with shorter time to discontinuation of tamoxifen; only hot flashes were associated with discontinuation of anastrozole. CONCLUSION Analysis of AEs using the TI yielded important insights into reasons for discontinuation of endocrine therapy that was enhanced by the addition of PRO baseline and treatment-emergent symptoms.

SF3B1 Mutations Have Adverse Impact On Time to Treatment Especially in Patients with 13q Deletions: A Study On 1,124 Chronic Lymphocytic Leukemia (CLL) Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 709-709 ◽  
Author(s):  
Sabine Jeromin ◽  
Claudia Haferlach ◽  
Katharina Bayer ◽  
Frank Dicker ◽  
Sandra Weissmann ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Normal Karyotype ◽  
Lymphocytic Leukemia ◽  
Prognostic Impact ◽  
Complex Karyotype ◽  
Time To Treatment ◽  
Cox Regression Analysis ◽  
Equity Ownership

Abstract Abstract 709 Introduction: Mutations in the spliceosome gene SF3B1 (splicing factor 3b, subunit 1; SF3B1mut) have recently been described in CLL and occur in 5–15% of CLL patients. They are suggested to be associated with a more aggressive course of disease, reflected by a shorter time to treatment (TTT) and overall survival. However, validation in a larger cohort is lacking. Aims: 1. Determine the frequency of SF3B1mut in a large CLL cohort. 2. Evaluate the association of SF3B1mut with established prognostic markers and its prognostic impact in relation to these parameters. Patients and Methods: 1,124 newly diagnosed CLL patients were included. The cohort comprised 64.4% (724/1124) males and 35.6% (400/1124) females with a median age of 66.8 years (range: 29.6 – 90.5 years). In all cases, the coding region of SF3B1 (exon 11 – 16) was analyzed by Sanger sequencing. Low mutation/wildtype ratios (<10%) were confirmed by an amplicon next-generation deep-sequencing assay (454 Life Sciences, Branford, CT). Additionally, TP53 (n= 83 mut/1,098 screened, 7.4%) and IGHV mutation status were analyzed. IGHV status was unmutated in 37.6% (423/1,124) and mutated in 62.4% (701/1,124).The IGHV3-21 gene was present in 63 patients, 41 of whom had a mutated status and were assigned together with the cases with unmutated IGHV (unfavorable IGHV). For all cases data on immunophenotype, FISH and chromosome banding analyses (CBA) were available. FISH categories were defined according to Döhner et al. (NEJM, 2000): del(17p) (48/1,124, 4.3%), del(11q) (123/1,124, 10.9%), +12 (139/1,124, 12.4%), normal karyotype (NK) according to FISH (273/1,124, 24.3%) and del(13q) as sole abnormality (324/1,124, 28.8%). According to CBA normal karyotype was present in 19.2% (216/1,124) and complex karyotype (at least 3 chromosomal abnormalities) in 16.2% (182/1,124). Clinical follow-up data were available in 56 SF3B1mut and 505 SF3B1 wt patients. Results: The frequency of SF3B1mut was 9.3% (105/1,124) with a median mutation/wildtype ratio of 35% (range: 5 – 60%). In 105 patients 110 SF3B1mut were detected. The most frequent mutation was Lys700Glu (47/110, 42.7%) followed by Gly742Asp (12/110, 10.9%) and Lys666Asn/Glu/Ser/Thr (11/110, 10.0%). SF3B1mut showed a strong association with prognostic unfavorable IGHV status (unfavorable vs favorable: 76/464, 16.4% vs 29/660, 4.4%, p<0.0001). They were more frequent in cases with IGHV3-21 (19.0% vs 8.7%, p=0.012) and IGHV1-69 (19.7% vs 7.9%, p<0.0001), but were mutually exclusive of IGHV1-2 (0% vs 9.7%, p=0.027). However, SF3B1mut were evenly distributed between patients with TP53mut and TP53 wt. Furthermore, SF3B1mut were associated with NK according to FISH (NK vs aberrant by FISH: 40/273, 14.7% vs 65/851, 7.6%, p=0.001) or CBA (NK vs aberrant: 29/216, 13.4% vs 76/908, 8.4%, p=0.027) and were less frequent in +12 (2/139, 1.4% vs 103/985, 10.5%, p<0.0001) and homozygous del(13q) cases (12/224, 5.4% vs 93/900, 10.3%, p=0.021). SF3B1mut were rarely detected in cases with IGH translocations identified by FISH and/or CBA (2/55, 3.6% vs. 103/1069, 9.6%, p=0.159). In contrast, SF3B1mut were very frequent in patients with del(11q) (25/123, 20.3% vs. 80/1,001, 8.0%, p<0.0001). Patients with SF3B1mut had a significantly shorter TTT than SF3B1wt patients (median TTT: 4.8 vs. 7.5 years, p<0.0001). Particularly in the subgroup with del(13q) sole the adverse effect of SF3B1mut was very prominent (median TTT: 1.1 vs 7.6 years, p<0.0001). In univariable cox regression analysis parameters associated with a shorter TTT were SF3B1mut (relative risk (RR): 2.05, p=0.001), complex karyotype (RR: 1.47, p=0.026), aberrant karyotype (RR: 1.66, p=0.036), and del(11q) (RR: 2.54, p<0.0001). Parameters associated with a longer TTT had favorable IGHV status (RR: 0.31, p<0.0001) and del(13q) sole (RR: 0.60, p=0.005). Multivariable analysis revealed an independent impact for SF3B1mut (RR: 1.54, p=0.048) besides aberrant karyotype (RR: 1.91, p=0.012), favorable IGHV status (RR: 0.35, p<0.0001) and del(13q) sole (RR: 0.63, p=0.017). Conclusions: 1. SF3B1mut are associated with unfavorable IGHV status (unmutated, IGHV3-21) and del(11q), which are known to have adverse effect on outcome in CLL. 2. Besides, SF3B1mut is an independent prognostic parameter associated with shorter TTT, with an especially striking impact in the prognostically favorable subgroup of patients with del(13q) as sole abnormality. Disclosures: Jeromin: MLL Munich Leukemia Laboratory: Employment. Haferlach:MLL Munich Leukemia Laboratory: Equity Ownership. Bayer:MLL Munich Leukemia Laboratory: Employment. Dicker:MLL Munich Leukemia Laboratory: Employment. Weissmann:MLL Munich Leukemia Laboratory: Employment. Grossmann:MLL Munich Leukemia Laboratory: Employment. Alpermann:MLL Munich Leukemia Laboratory: Employment. Kohlmann:MLL Munich Leukemia Laboratory: Employment. Haferlach:MLL Munich Leukemia Laboratory: Equity Ownership. Kern:MLL Munich Leukemia Laboratory: Equity Ownership. Schnittger:MLL Munich Leukemia Laboratory: Equity Ownership.

Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer

2017 ◽  
pp. 1-10 ◽  
Author(s):  
Sarah S. Mougalian ◽  
Lianne N. Epstein ◽  
Ami P. Jhaveri ◽  
Gang Han ◽  
Maysa Abu-Khalaf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Endocrine Therapy ◽  
Text Messaging ◽  
Hot Flashes ◽  
Text Message ◽  
Primary Objective ◽  
Text Messages ◽  
Patient Acceptance ◽  
Patient Reported

Introduction Up to 40% of patients with breast cancer may not adhere to adjuvant endocrine therapy. Therapy-related adverse effects (AEs) are important contributors to nonadherence. We developed a bidirectional text-message application, BETA-Text, that simultaneously tracks adherence, records symptoms, and alerts the clinical team. Patients and Methods We piloted our intervention in 100 patients. The intervention consisted of text messages to which patients responded for 3 months: daily, evaluating adherence; weekly, evaluating medication-related AEs; and monthly, regarding barriers to adherence. Concerning responses prompted a telephone call from a clinic nurse. The primary objective was to assess patient acceptance of this intervention using self-reported surveys. To compare participants with the general population at our institution, we assessed 100 consecutively treated patients as historical controls using medical record review. Results We approached 141 consecutive patients, 100 (71%) of whom agreed to participate and 89 of whom completed the intervention. A majority of patients reported that the intervention was easy to use (98%) and helpful in taking their medication (96%). Four patients discontinued therapy before 3 months, and 93% of patients who continued therapy took ≥ 80% of their medication. The frequency of AEs reported by participants via text was higher than that reported in clinical trials: hot flashes (72%), arthralgias (53%), and vaginal symptoms (35%). Approximately 39% of patients reported one or more severe AE that prompted an alert to the provider team to call the patient. Conclusion A daily bidirectional text-messaging system can monitor adherence and identify AEs and other barriers to adherence in real time without inconveniencing patients. AEs of endocrine therapy, as detected using this texting approach, are more prevalent than reported in clinical trials.

scholarly journals Predictive value of cardiopulmonary fitness parameters in the prognosis of patients with acute coronary syndrome after percutaneous coronary intervention

2020 ◽  
Vol 48 (8) ◽  
pp. 030006052094908
Author(s):  
Suping Niu ◽  
Fei Wang ◽  
Shenghua Yang ◽  
Zongxue Jin ◽  
Xuejie Han ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Predictive Value ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Cardiopulmonary Exercise Testing ◽  
Coronary Intervention ◽  
Coronary Syndrome ◽  
C Statistic ◽  
Percutaneous Coronary

Objectives We aimed to determine the predictive value of cardiopulmonary exercise testing (CPX) in the prognosis of patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). Methods We conducted a retrospective study including patients who underwent CPX within 1 year of PCI between September 2012 and October 2017. Patients were followed-up until the occurrence of a major adverse cardiac event (MACE) or administrative censoring (September 2019). A Cox regression model was used to identify significant predictors of a MACE. Model performance was evaluated in terms of discrimination (C-statistic) and calibration (calibration-in-the-large). Results In total, 184 patients were included and followed-up for a median 51 months (interquartile range: 36–67 months) and 32 events occurred. Multivariable analysis revealed that body mass index and Gensini score were significant predictors of a MACE. Four CPX-related variables were found to be predictive of a MACE: premature CPX termination, peak oxygen uptake, heart rate reserve, and ventilatory equivalent for carbon dioxide slope. The final prediction model had a C-statistic of 0.92 and calibration-in-the-large 0.58%. Conclusion CPX-related parameters may have high predictive value for poor outcomes in patients with ACS who undergo PCI, indicating a need for appropriate treatment and timely management.

scholarly journals Impact of Adjuvant Endocrine Therapy on Quality of Life and Symptoms: Observational Data Over 12 Months From the Mind-Body Study

2016 ◽  
Vol 34 (8) ◽  
pp. 816-824 ◽  
Author(s):  
Patricia A. Ganz ◽  
Laura Petersen ◽  
Julienne E. Bower ◽  
Catherine M. Crespi
Keyword(s):  
Mental Health ◽  
Endocrine Therapy ◽  
Hot Flashes ◽  
Symptom Burden ◽  
Adjuvant Endocrine Therapy ◽  
Physical And Mental Health ◽  
Patient Reported ◽  
The Mind ◽  
Cognitive Problems ◽  
Over Time

Purpose To examine patterns of health and symptoms associated with the initiation of adjuvant endocrine therapy (ET) for primary breast cancer treatment. Patients and Methods The mind-body study (MBS) observational cohort participants provided self-reported data on physical and mental health, ET-related symptoms, as well as depression, fatigue, and sleep obtained at enrollment (after primary treatment, prior to initiation of ET) and 6 and 12 months later. Longitudinal trajectories of outcome variables among three patient groups (no ET, aromatase inhibitor [AI], or tamoxifen) were compared by using linear mixed models. Results Two-thirds of the 186 women initiated ET, which was evenly split between AI and tamoxifen, and no significant differences were observed in self-reported measures among the groups at baseline or in covariate-adjusted analyses. Physical health scores were below normative levels initially and improved over time, but the AI group had a significantly lower score at 12 months (P = .05); mental health scores were within the normal range, were similar in each group, and did not change over time. The no-ET group showed either stable or declining symptom severity, whereas the ET groups often showed increased severity over time, and the AI group reported more severe musculoskeletal (P = .02), hot flash (P = .02), and cognitive problems (P = .006) at one or both of the follow-up time points compared with the no-ET group. The tamoxifen group had higher levels of hot flashes (P = .002), cognitive problems (P = .016), and bladder problems (P = .02) than the no-ET group. Conclusion Attention should be given to the increased symptom burden associated with ET, and better efforts should be made to address patient-reported outcomes.

Effect of Minimal Residual Disease (MRD) Information on Prediction of Relapse and Survival in Adult Acute Myeloid Leukemia

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2569-2569
Author(s):  
Megan Othus ◽  
Brent L. Wood ◽  
Elihu H. Estey ◽  
Stephen Petersdorf ◽  
Frederick R. Appelbaum ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Induction Chemotherapy ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Cox Regression ◽  
Residual Disease ◽  
Multivariable Analysis ◽  
Bone Marrow Blast ◽  
C Statistic ◽  
Prediction Of Relapse

Abstract Background: With the gradual improvement in treatment-related mortality over the last several decades, therapeutic resistance remains the primary challenge in adult acute myeloid leukemia (AML). Accurate prediction of treatment outcomes, including relapse, would facilitate decision-making, e.g. regarding assignment of patients to risk-stratified investigational or standard therapies. Yet, our previous studies have indicated that our ability to predict therapeutic resistance based on detailed pre-treatment information, including cytogenetic and molecular profiling data, remains relatively limited. Here, we investigated to what degree the prediction of relapse and survival can be improved for individual patients by inclusion of post-treatment data, in particular minimal residual disease (MRD) after the initiation cycle of induction chemotherapy. Patients and Methods: We used data on adults aged 18-60 years with newly diagnosed de novo AML who achieved a morphologic complete remission (CR) on a recent phase 3 intergroup trial (S0106) that investigated the value of gemtuzumab ozogamicin (GO) when added to standard induction chemotherapy (NCT00085709). MRD was prospectively assessed by multiparameter flow cytometry in bone marrow specimens obtained at CR following ANC and platelet recovery; any level of MRD was considered MRDpos. The flow cytometric method used was an early generation, 3 tube, 10-color assay performed on an LSRII and relied on identification of progenitor populations that differ from normal by visual inspection. We used Cox regression analyses to assess the association between the outcomes relapse-free survival (RFS) and overall survival (OS) and the covariates: age, gender, performance status, white blood cell (WBC) count, platelet count, bone marrow blast percentage, cytogenetic risk, FLT3-ITD and NPM1 mutational status, and MRD (present vs. absent). We then used the C-statistic to quantify a model's ability to predict outcomes; in this approach, a C-statistics of 1 indicates perfect prediction while a C-statistic of 0.5 indicates no prediction; C-statistics values of 0.6-0.7, 0.7-0.8, and 0.8-0.9 are commonly considered as poor, fair, and good, respectively. Results: Among 595 eligible patient randomly assigned to receive induction chemotherapy with or without GO, 416 patients achieved a CR; of these, MRD data was available for 170 patients: 38 (22%) were MRDpos, and 132 (78%) were MRDneg. Consistent with previous studies by others, on univariate analysis MRD status was statistically significantly associated with RFS (hazard ratio [HR]=2.28 [95% confidence interval: 1.45-3.60], p<0.001) and OS (HR=2.32 [1.42-3.77], p<0.001). In univariate Cox regression analyses, MRD status, cytogenetic risk, NPM1/FLT3-ITD status, age, platelets, and bone marrow blast percentage (C-statistics ranging from 0.55 to 0.58) were the strongest (but poor) individual predictors for RFS. For OS, the strongest individual predictors were cytogenetic risk, age, NPM1/FLT3-ITD status, bone marrow blasts percentage, and MRD status (C-statistics ranging from 0.56 to 0.59). Without inclusion of MRD data, multivariable models yielded C-statistics of 0.64 and 0.66 for the prediction of RFS and OS. Inclusion of MRD data improved the models only minimally, yielding C-statistics of 0.66 and 0.70 for the prediction of RFS and OS. On multivariable analysis, MRD was the most important predictor of both RFS and OS (as measured by Chi-squared value minus degrees of freedom). For RFS the next two most important predictors were platelets and age. For OS the next two most important predictors were platelets and NPM1/FLT3-ITD status. Conclusion: Although MRD status after induction chemotherapy is statistically significantly associated with RFS and OS and the most important predictor of both outcomes on multivariable analysis, the accuracy of multivariate models predicting these outcomes is only minimally increased when MRD information is included and remains limited. Support: NIH/NCI/NCTN grants CA180944 and CA180819, NCI grant CA182010, and in part by Wyeth (Pfizer) Pharmaceuticals Disclosures Erba: GlycoMimetics; Janssen: Other: Data Safety & Monitoring Committees; Sunesis; Pfizer; Daiichi Sankyo; Ariad: Consultancy; Millennium/Takeda; Celator; Astellas: Research Funding; Seattle Genetics; Amgen: Consultancy, Research Funding; Novartis; Incyte; Celgene: Consultancy, Patents & Royalties. Walter:Covagen AG: Consultancy; AstraZeneca, Inc.: Consultancy; Pfizer, Inc.: Consultancy; Seattle Genetics, Inc.: Research Funding; Amgen, Inc.: Research Funding; Amphivena Therapeutics, Inc.: Consultancy, Research Funding.

Effect of hospital volume on outcome of stage IV pancreatic cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 123-123
Author(s):  
Suleyman Yasin Goksu ◽  
Muhammet Ozer ◽  
Busra N Bacik Goksu ◽  
Syed Mohammad Ali Kazmi ◽  
Nina Niu Sanford ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Hospital Volume ◽  
Treatment Initiation ◽  
Cox Regression ◽  
Private Insurance ◽  
Multivariable Analysis ◽  
Stage Iv ◽  
Time To Treatment ◽  
Stage 4 ◽  
Chemotherapy Initiation

123 Background: The effect of hospital volume on the outcome of stage 4 pancreatic cancer is not well known. We evaluated the effect of hospital volume on time to treatment and survival in patients with stage 4 pancreatic adenocarcinoma (PDAC). Methods: We used the National Cancer Database, including 1,319 hospitals to identify the study population. Adult (≥ 18 years) patients with stage 4 PDAC were included. We excluded the patients who had other histologies, unknown follow-up, and survival of less than 30 days. We categorized the hospital volume as three groups: low- (<25th centile), medium- (25th–75th centile), and high-volume hospitals (HVH) (>75th centile). Time from diagnosis to chemotherapy initiation was classified as early (≤ 6 weeks) or late (> 6 weeks). Kaplan-Meier and Cox regression methods were used to evaluate the overall survival (OS) between HVH and low-volume hospital (LVH) groups. Results: Among 72,531 patients with stage 4 PDAC; 65% received chemotherapy. Patients treated at HVH had higher rates of chemotherapy ( 73% vs. 60%, p<.001), and late chemotherapy initiation ( 27% vs. 20%, p<.001) compared to LVH. Patients at HVH were more likely to be younger, have less comorbidity score, private insurance, treated at the academic center, and need to travel more than 50 miles (all p<.001). Patients treated at HVH had better OS than LVH (6 vs. 4 months, p<.001). In multivariable analysis, HVH was independently associated with better OS versus LVH ( HR 0.79 [0.72-0.87]). In addition, HVH was associated with better OS in patients who received chemotherapy ( HR 0.78 [0.69-0.88]), while early treatment initiation, age, black race, uninsured status was not. Conclusions: Treatment at an HVH is independently associated with improved survival among patients with stage 4 PDAC. Patients seen at HVH had a higher rate of chemotherapy administration but a longer time to treatment initiation. [Table: see text]

P041 DEVELOPMENT OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOME SHORT FORMS FOR FATIGUE AND PAIN INTERFERENCE IN CHILDREN WITH CROHN’S DISEASE

2020 ◽  
Vol 158 (3) ◽  
pp. S101-S102
Author(s):  
Julia Schuchard ◽  
Michael Kappelman ◽  
Andrew Grossman ◽  
Jennifer Clegg ◽  
Christopher Forrest
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patient ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Short Forms ◽  
Patient Reported

Impact of Preoperative Opioid Use on 2-Year Patient-Reported Outcomes in Knee Surgery Patients

2020 ◽  
Author(s):  
Ali Aneizi ◽  
Patrick M. J. Sajak ◽  
Aymen Alqazzaz ◽  
Tristan Weir ◽  
Cameran I. Burt ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Knee Surgery ◽  
The Body ◽  
Pain Interference ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Met Expectations

AbstractThe objectives of this study are to assess perioperative opioid use in patients undergoing knee surgery and to examine the relationship between preoperative opioid use and 2-year postoperative patient-reported outcomes (PROs). We hypothesized that preoperative opioid use and, more specifically, higher quantities of preoperative opioid use would be associated with worse PROs in knee surgery patients. We studied 192 patients undergoing knee surgery at a single urban institution. Patients completed multiple PRO measures preoperatively and 2-year postoperatively, including six patient-reported outcomes measurement information system (PROMIS) domains; the International Knee Documentation Committee (IKDC) questionnaire, numeric pain scale (NPS) scores for the operative knee and the rest of the body, Marx's knee activity rating scale, Tegner's activity scale, International Physical Activity Questionnaire, as well as measures of met expectations, overall improvement, and overall satisfaction. Total morphine equivalents (TMEs) were calculated from a regional prescription monitoring program. Eighty patients (41.7%) filled an opioid prescription preoperatively, and refill TMEs were significantly higher in this subpopulation. Opioid use was associated with unemployment, government insurance, smoking, depression, history of prior surgery, higher body mass index, greater comorbidities, and lower treatment expectations. Preoperative opioid use was associated with significantly worse 2-year scores on most PROs, including PROMIS physical function, pain interference, fatigue, social satisfaction, IKDC, NPS for the knee and rest of the body, and Marx's and Tegner's scales. There was a significant dose-dependent association between greater preoperative TMEs and worse scores for PROMIS physical function, pain interference, fatigue, social satisfaction, NPS body, and Marx's and Tegner's scales. Multivariable analysis confirmed that any preoperative opioid use, but not quantity of TMEs, was an independent predictor of worse 2-year scores for function, activity, and knee pain. Preoperative opioid use and TMEs were neither independent predictors of met expectations, satisfaction, patient-perceived improvement, nor improvement on any PROs. Our findings demonstrate that preoperative opioid use is associated with clinically relevant worse patient-reported knee function and pain after knee surgery.

scholarly journals Clinical features and prognostic analysis of patients with Aspergillus isolation during acute exacerbation of chronic obstructive pulmonary disease

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yu Gu ◽  
Xianping Ye ◽  
Yu Wang ◽  
Kunlu Shen ◽  
Jinjin Zhong ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Acute Exacerbation ◽  
Clinical Features ◽  
Antifungal Therapy ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Positive Culture ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease

Abstract Background Lower respiratory tract (LRT) specimen culture is widely performed for the identification of Aspergillus. We investigated the clinical features and prognosis of patients with Aspergillus isolation from LRT specimens during acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods This is a 6-year single-center, real-world study. 75 cases out of 1131 hospitalized AECOPD patients were positive for Aspergillus. These patients were carefully evaluated and finally diagnosed of pulmonary aspergillosis (PA, 60 cases, 80%) or colonization (15 cases, 20%). Comparisons of clinical data were performed between these two groups. A cox regression model was used to confirm prognostic factors of Aspergillus infection. Results The PA group had worse lung function and higher rates of systemic corticosteroid use and broad-spectrum antibiotic use before admission than the colonization group. The PA group had significantly higher in-hospital mortality and 180-day mortality than the colonization group (45% (27/60) vs. 0% (0/15), p = 0.001, and 52.5% (31/59) vs. 6.7% (1/15), p < 0.001, respectively). By multivariable analysis among Aspergillus infection patients, antifungal therapy (HR 0.383, 95% CI 0.163–0.899, p = 0.027) was associated with improved survival, whereas accumulated dose of systemic steroids > 700 mg (HR 2.452, 95% CI 1.134–5.300, p = 0.023) and respiratory failure at admission (HR 5.983, 95% CI 2.487–14.397, p < 0.001) were independently associated with increased mortality. Significant survival differential was observed among PA patients without antifungals and antifungals initiated before and after Aspergillus positive culture (p = 0.001). Conclusions Aspergillus isolation in hospitalized AECOPD patients largely indicated PA. AECOPD patients with PA had worse prognosis than those with Aspergillus colonization. Empirical antifungal therapy is warranted to improve the prognosis for Aspergillus infection.

Sign in / Sign up

Export Citation Format

Share Document