The aim of this study was to determine the frequency and reasons for long-term opioid prescriptions (rxs) after surgery in the setting of guideline-directed prescribing and a high rate of excess ...opioid disposal.
Although previous studies have demonstrated that 5% to 10% of opioid-naïve patients prescribed opioids after surgery will receive long-term (3-12 months after surgery) opioid rxs, little is known about the reasons why long-term opioids are prescribed.
We studied 221 opioid-naïve surgical patients enrolled in a previously reported prospective clinical trial which used a patient-centric guideline for discharge opioid prescribing and achieved a high rate of excess opioid disposal. Patients were treated on a wide variety of services; 88% of individuals underwent cancer-related surgery. Long-term opioid rxs were identified using a Prescription Drug Monitoring Program search and reasons for rxs and opioid adverse events were ascertained by medical record review. We used a consensus definition for persistent opioid use: opioid rx 3 to 12 months after surgery and >60day supply.
15.3% (34/221) filled an opioid rx 3 to 12 months after surgery, with 5.4% and 12.2% filling an rx 3 to 6 and 6 to 12 months after surgery, respectively. The median opioid rx days supply per patient was 7, interquartile range 5 to 27, range 1 to 447 days. The reasons for long-term opioid rxs were: 51% new painful medical condition, 40% new surgery, 6% related to the index operation; only 1 patient on 1 occasion was given an opioid rx for a nonspecific reason. Five patients (2.3%) developed persistent opioid use, 2 due to pain from recurrent cancer, 2 for new medical conditions, and 1 for a chronic abscess.
In a group of prospectively studied opioid-naïve surgical patients discharged with guideline-directed opioid rxs and who achieved high rates of excess opioid disposal, no patients became persistent opioid users solely as a result of the opioid rx given after their index surgery. Long-term opioid use did occur for other, well-defined, medical or surgical reasons.
BackgroundSipuleucel-T (sip-T) is a Food and Drug Administration (FDA)-approved autologous cellular immunotherapy for metastatic castration-resistant prostate cancer (mCRPC). We hypothesized that ...combining sip-T with interleukin (IL)-7, a homeostatic cytokine that enhances both B and T cell development and proliferation, would augment and prolong antigen-specific immune responses against both PA2024 (the immunogen for sip-T) and prostatic acid phosphatase (PAP).MethodsFifty-four patients with mCRPC treated with sip-T were subsequently enrolled and randomized 1:1 into observation (n=26) or IL-7 (n=28) arms of a phase II clinical trial (NCT01881867). Recombinant human (rh) IL-7 (CYT107) was given weekly×4. Immune responses were evaluated using flow cytometry, mass cytometry (CyTOF), interferon (IFN)-γ ELISpot, 3H-thymidine incorporation, and ELISA.ResultsTreatment with rhIL-7 was well tolerated. For the rhIL-7-treated, but not observation group, statistically significant lymphocyte subset expansion was found, with 2.3–2.6-fold increases in CD4+T, CD8+T, and CD56bright NK cells at week 6 compared with baseline. No significant differences in PA2024 or PAP-specific T cell responses measured by IFN-γ ELISpot assay were found between rhIL-7 and observation groups. However, antigen-specific T cell proliferative responses and humoral IgG and IgG/IgM responses significantly increased over time in the rhIL-7-treated group only. CyTOF analyses revealed pleiotropic effects of rhIL-7 on lymphocyte subsets, including increases in CD137 and intracellular IL-2 and IFN-γ expression. While not powered to detect clinical outcomes, we found that 31% of patients in the rhIL-7 group had prostate specific antigen (PSA) doubling times of >6 months, compared with 14% in the observation group.ConclusionsTreatment with rhIL-7 led to a significant expansion of CD4+ and CD8+ T cells, and CD56bright natural killer (NK) cells compared with observation after treatment with sip-T. The rhIL-7 treatment also led to improved antigen-specific humoral and T cell proliferative responses over time as well as to increased expression of activation markers and beneficial cytokines. This is the first study to evaluate the use of rhIL-7 after sip-T in patients with mCRPC and demonstrates encouraging results for combination approaches to augment beneficial immune responses.
Abstract Objective To evaluate trends in prostate biopsy and prostate cancer diagnosis at a center with conservative baseline screening practices in the pre- and post-2012 era. More restrictive ...prostate-specific antigen (PSA) screening guidelines have led to lower rates of screening, biopsy and diagnosis of prostate cancer post-2012. It is not clear, however, how regions with low baseline screening rates (e.g. the Lebanon, NH hospital referral region centered on Dartmouth-Hitchcock Medical Center, with the lowest rate of screening among Medicare patients in 2012) have responded these guidelines. Methods Using data warehouse query and chart review, we retrospectively analyzed patients who underwent prostate biopsy 1/2011-3/2016. Demographic/clinical characteristics were analyzed by time. Multivariable analysis assessed for factors associated with higher grade cancer. Results 614 prostate biopsies were performed. PSA at biopsy increased with time (7.2 in 2011 vs 10.1 in 2015 p=0.0085);age did not. There was a stable proportion of benign findings;proportions of low-grade disease decreased while intermediate/high grade disease increased (2011 vs 2015: 21.1% vs 10.8% Gleason 3+3, 32.9% vs 43.3% ≥Gleason 3+4, p=0.0454). Factors predictive of higher grade disease included abnormal digital exam (OR 2.19, p=0.0076), higher PSA (OR 1.09, p=0.0040), and later biopsy date (OR 1.01, p=0.0469). Conclusions In an environment of conservative baseline screening practices, there has been a shift in prostate biopsy criteria and outcomes, namely a rising PSA threshold for biopsy and a 50% decrease in the diagnosis of low grade disease. Additional study is needed to ensure these trends are favorably impacting the quality of care.
Background
Surveillance recommendations for patients with low‐risk, non–muscle‐invasive bladder cancer (NMIBC) are based on limited evidence. The objective of this study was to add to the evidence by ...assessing outcomes after frequent versus recommended cystoscopic surveillance.
Methods
This was a retrospective cohort study of patients diagnosed with low‐risk (low‐grade Ta (AJCC)) NMIBC from 2005 to 2011 with follow‐up through 2014 from the Department of Veterans Affairs. Patients were classified as having undergone frequent versus recommended cystoscopic surveillance (>3 vs 1‐3 cystoscopies in the first 2 years after diagnosis). By using propensity score‐adjusted models, the authors estimated the impact of frequent cystoscopy on the number of transurethral resections, the number of resections without cancer in the specimen, and the risk of progression to muscle‐invasive cancer or bladder cancer death.
Results
Among 1042 patients, 798 (77%) had more frequent cystoscopy than recommended. In adjusted analyses, the frequent cystoscopy group had twice as many transurethral resections (55 vs 26 per 100 person‐years; P < .001) and more than 3 times as many resections without cancer in the specimen (5.7 vs 1.6 per 100 person‐years; P < .001). Frequent cystoscopy was not associated with time to progression or bladder cancer death (3% at 5 years in both groups; P = .990).
Conclusions
Frequent cystoscopy among patients with low‐risk NMIBC was associated with twice as many transurethral resections and did not decrease the risk for bladder cancer progression or death, supporting current guidelines.
Frequent cystoscopic surveillance among patients with low‐risk, non–muscle‐invasive bladder cancer is associated with twice as many transurethral resections and does not decrease the risk for bladder cancer progression or death. This supports current guideline recommendations for less frequent surveillance.
To understand cystoscopic surveillance practices among patients with low-risk non–muscle-invasive bladder cancer (NMIBC) within the Department of Veterans Affairs (VA).
Using a validated natural ...language processing algorithm, we included patients newly diagnosed with low-risk (ie low-grade Ta) NMIBC from 2005 to 2011 in the VA. Patients were followed until cancer recurrence, death, last contact, or 2 years after diagnosis. Based on guidelines, surveillance overuse was defined as >1 cystoscopy if followed <1 year, >2 cystoscopies if followed 1 to <2 years, or >3 cystoscopies if followed for 2 years. We identified patient, provider, and facility factors associated with overuse using multilevel logistic regression.
Overuse occurred in 75% of patients (852/1135) – with an excess of 1846 more cystoscopies performed than recommended. Adjusting for 14 factors, overuse was associated with patient race (odds ratio OR 0.49, 95% confidence interval CI: 0.28, 0.85 unlisted race vs White), having 2 comorbidities (OR 1.60, 95% CI: 1.00, 2.55 vs no comorbidities), and earlier year of diagnosis (OR 2.50, 95% CI: 1.29, 4.83 for 2005 vs 2011, and OR 2.03, 95% CI: 1.11, 3.69 for 2006 vs 2011). On sensitivity analyses assuming all patients were diagnosed with multifocal or large low-grade tumors (ie, intermediate-risk), overuse would have still occurred in 45% of patients.
Overuse of cystoscopy among patients with low-risk NMIBC was common, raising concerns about bladder cancer surveillance cost and quality. However, few factors were associated with overuse. Further qualitative research is needed to identify other determinants of overuse not readily captured in administrative data.
To assess geographic variation in cystoscopy rates among women vs men with suspected bladder cancer, lending insight into gender-specific differences in cystoscopic evaluation.
We conducted a ...cross-sectional study of all fee-for-service Medicare beneficiaries within 306 Hospital Referral Regions (HRRs) who received care in 2014. For each HRR, we calculated the age- and race-adjusted cystoscopy rate for women and men as our primary outcome. The rate was the number of beneficiaries who underwent cystoscopy for bladder cancer symptoms (using procedure and ICD-9 diagnosis codes) divided by all beneficiaries in the HRR. We used the coefficient of variation to compare relative variability of cystoscopy rates.
Overall, 173,551 women (n = 14.8 million) and 286,090 men (n = 11.5 million) underwent cystoscopy in 2014. While women received less cystoscopies compared to men (mean 11.0 vs 23.5 per 1000, P < .001), there was greater variation in cystoscopy rates among women (coefficient of variation 27.5 vs 23.5, P = .010). When restricting to ICD-9 codes for hematuria only, women continued to demonstrate greater variation in cystoscopy rates (coefficient of variation 27.8 vs 24.2, P = .022). Findings were robust across larger HRR sizes—thereby removing some random variation seen in smaller HRRs—as well as across years 2010, 2011, 2012, and 2013.
Cystoscopy rates are lower in women than men, likely due to their lower bladder cancer incidence. However, there is greater variation in cystoscopy rates among women with symptoms of bladder cancer. This may reflect increased provider uncertainty whether to refer and work-up women with suspected bladder cancer.
Highlights • A decision aid (DA) for newly diagnosed prostate cancer patients was investigated. • Patient knowledge of the rationale for active surveillance (AS) was assessed. • Those who viewed the ...DA were almost 3 times as likely to correctly answer questions. • Those who viewed the DA better understood the reasons AS is a viable treatment.
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