Severity of cardiovascular disease and health-related quality of life in men with prostate cancer: a longitudinal analysis from CaPSURE.

ObjectiveTo evaluate the influence of comorbid cardiovascular disease severity on health-related quality of life (HRQL) in men treated with radical prostatectomy (RP) or radiotherapy (RT) for early stage prostate cancer.MethodsSubjects (n=830) with non-metastatic disease who had been diagnosed in 2000-2002 were drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE). We evaluated the influence of cardiovascular disease (CVD) severity on generic and disease-specific HRQL before and 6, 12, 18, and 24 months after treatment with RP or RT. HRQL was measured with the SF-36 and the UCLA Prostate Cancer Index.ResultsMen with moderate (n=193) or severe (n=51) cardiovascular disease had worse pre-treatment HRQL than did men without CVD (n=293) (P<0.01); HRQL scores were worse in men referred for RT. During 24 months of follow-up, men with moderate or severe CVD had worse SF-36 physical and mental component summaries and worse bowel function at all time points (P<0.05). Men with severe CVD also experienced a slower recovery in physical function (P=0.03) and sexual functioning (P=0.02) than did men without CVD.ConclusionsProstate cancer patients with moderate to severe CVD have worse HRQL during follow-up. Those with severe CVD recover their physical and sexual functioning more slowly after treatment

Sexual well-being and diurnal cortisol after prostate cancer treatment.

Sexual dysfunction and psychological distress are common after prostate cancer. Research has not examined the role of neuroendocrine markers of stress (e.g. cortisol). This study examines whether sexual functioning or sexual bother is associated with diurnal cortisol. Men treated for prostate cancer completed the University of California-Los Angeles Prostate Cancer Index and provided saliva samples four times daily for cortisol assessment. Higher sexual bother, but not sexual functioning, was associated with steeper cortisol slope. Better sexual functioning, and not sexual bother, was significantly associated with the cortisol awakening response. Assessment of stress and stress-reducing interventions might be warranted in sexual rehabilitation after prostate cancer

The Mechanistic Basis of Myxococcus xanthus Rippling Behavior and Its Physiological Role during Predation

Myxococcus xanthus cells self-organize into periodic bands of traveling waves, termed ripples, during multicellular fruiting body development and predation on other bacteria. To investigate the mechanistic basis of rippling behavior and its physiological role during predation by this Gram-negative soil bacterium, we have used an approach that combines mathematical modeling with experimental observations. Specifically, we developed an agent-based model (ABM) to simulate rippling behavior that employs a new signaling mechanism to trigger cellular reversals. The ABM has demonstrated that three ingredients are sufficient to generate rippling behavior: (i) side-to-side signaling between two cells that causes one of the cells to reverse, (ii) a minimal refractory time period after each reversal during which cells cannot reverse again, and (iii) physical interactions that cause the cells to locally align. To explain why rippling behavior appears as a consequence of the presence of prey, we postulate that prey-associated macromolecules indirectly induce ripples by stimulating side-toside contact-mediated signaling. In parallel to the simulations, M. xanthus predatory rippling behavior was experimentally observed and analyzed using time-lapse microscopy. A formalized relationship between the wavelength, reversal time, and cell velocity has been predicted by the simulations and confirmed by the experimental data. Furthermore, the results suggest that the physiological role of rippling behavior during M. xanthus predation is to increase the rate of spreading over prey cells due to increased side-to-side contact-mediated signaling and to allow predatory cells to remain on the prey longer as a result of more periodic cell motility

Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A phase 2, randomized, sham-controlled trial

Background -In non-randomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), less symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and mid-range or preserved ejection fraction (EF ≥ 40%). We conducted the first randomized, sham-controlled trial to evaluate the IASD in HF with EF ≥ 40%. Methods -REDUCE LAP-HF I was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, EF ≥ 40%, exercise PCWP ≥ 25 mmHg, and PCWP-right atrial pressure gradient ≥ 5 mmHg. Participants were randomized (1:1) to the IASD vs. a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness endpoint was exercise PCWP at 1 month. The primary safety endpoint was major adverse cardiac, cerebrovascular, and renal events (MACCRE) at 1 month. PCWP during exercise was compared between treatment groups using a mixed effects repeated measures model analysis of covariance that included data from all available stages of exercise. Results -A total of 94 patients were enrolled, of which n=44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared to sham-control (P=0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mmHg in the treatment group vs. 0.5±5.0 mmHg in the control group (P=0.14). There were no peri-procedural or 1-month MACCRE in the IASD group and 1 event (worsening renal function) in the control group (P=1.0). Conclusions -In patients with HF and EF ≥ 40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation. Clinical Trial Registration -URL: http://clinicaltrials.gov. Unique identifier: NCT02600234

The quality of surgical pathology care for men undergoing radical prostatectomy in the U.S.

BACKGROUND. The authors assessed adherence with the College of American Pathologists (CAP) radical prostatectomy (RP) practice protocol in a national sample of men who underwent RP for early-stage prostate cancer. METHODS. Using the National Cancer Data Base, the authors identified a nationally representative sample of 1240 men (unweighted) who underwent RP. For each patient, local cancer registrars performed an explicit medical record review to assess patient-level compliance with surgical pathology report documentation of 7 morphologic criteria (ie, quality indicators). Applying the CAP prognostic factor classification framework, composite measures and all-or-none measures of quality indicator compliance were calculated for the following analytic categories: 1) a strict subset of CAP category I prognostic factors (3 indicators), 2) a broad subset of CAP category I factors (6 indicators), and 3) the full set of 7 indicators. RESULTS. Among a weighted sample of 24,420 patients who underwent RP, compliance with documentation of the CAP category I factors varied from 54% (95% confidence interval [95% CI], 50–58%) for pathologic tumor, lymph node, metastases classification (according to the American Joint Committee on Cancer staging system) to 97% (95% CI, 96–99%) for Gleason score. In composite, RP pathology reports contained 83% (95% CI, 81–84%), 85% (95% CI, 84–87%), and 79% (95% CI, 78–80%) of the recommended data elements measured by the strict CAP category I subset, the broad CAP category I subset, and the full set of 7 indicators, respectively. In contrast to the generally higher composite scores, only 52% (95% CI, 48–56%) and 41% (95% CI, 37–45%) of men who underwent RP had complete documentation in their pathology reports for the strict and broad CAP category I subsets, respectively. CONCLUSIONS. RP surgical pathology reports contained most of the recommended data elements; however, the frequent absence of pathologic stage provides an opportunity for quality improvement. Cancer 2007. © 2007 American Cancer Society.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/56046/1/22698_ftp.pd

Use of quality indicators to evaluate the care of patients with localized prostate carcinoma

BACKGROUND The goal of quality assurance in health care is to preserve and improve patient care. Recently, RAND developed a set of evidence-based candidate indicators for evaluating the quality of care for patients with localized prostate carcinoma; however, the feasibility and sensitivity of these indicators have not been tested in a clinical setting. The objectives of this study were to evaluate the feasibility of measuring these quality indicators and to determine their sensitivity to change in practice patterns over time. METHODS One hundred sixty-eight men who presented in either 1995 or in 2000 and were treated for localized prostate carcinoma were selected randomly from the University of Michigan tumor registry. A combination of electronic data base review and explicit chart review was used to assess the feasibility of measuring compliance for each indicator. For each indicator in which assessment was feasible, compliance with the RAND indicators was determined for patients in both years. Multivariate regression analysis was used to adjust for potential confounding effects of disease stage, tumor grade, prostate specific antigen (PSA) level, patient age, and therapy. RESULTS Based on review of available clinical data, measurement of compliance was feasible for 19 of 22 RAND candidate quality indicators (86%). For five indicators, significant differences in documentation (compliance) were detected between 1995 and 2000 ( P < 0.05). Treatment received and higher PSA levels were associated independently with documentation of compliance for several indicators ( P < 0.05). CONCLUSIONS Measurement of the majority of the RAND quality indicators for the treatment of patients with localized prostate carcinoma was feasible, and improvements in several indicators were observed between 1995 and 2000. Demonstration of such variation, even within a single institution, suggests that the indicators are sufficiently sensitive to detect differences in practice patterns. Cancer 2003;97:1428–35. © 2003 American Cancer Society. DOI 10.1002/cncr.11216Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/34367/1/11216_ftp.pd

External validation of a claims-based algorithm for classifying kidney-cancer surgeries

<p>Abstract</p> <p>Background</p> <p>Unlike other malignancies, there is no literature supporting the accuracy of medical claims data for identifying surgical treatments among patients with kidney cancer. We sought to validate externally a previously published Medicare-claims-based algorithm for classifying surgical treatments among patients with early-stage kidney cancer. To achieve this aim, we compared procedure assignments based on Medicare claims with the type of surgery specified in SEER registry data and clinical operative reports.</p> <p>Methods</p> <p>Using linked SEER-Medicare data, we calculated the agreement between Medicare claims and SEER data for identification of cancer-directed surgery among 6,515 patients diagnosed with early-stage kidney cancer. Next, for a subset of 120 cases, we determined the agreement between the claims algorithm and the medical record. Finally, using the medical record as the reference-standard, we calculated the sensitivity, specificity, and positive and negative predictive values of the claims algorithm.</p> <p>Results</p> <p>Among 6,515 cases, Medicare claims and SEER data identified 5,483 (84.1%) and 5,774 (88.6%) patients, respectively, who underwent cancer-directed surgery (observed agreement = 93%, κ = 0.69, 95% CI 0.66 – 0.71). The two data sources demonstrated 97% agreement for classification of partial versus radical nephrectomy (κ = 0.83, 95% CI 0.81 – 0.86). We observed 97% agreement between the claims algorithm and clinical operative reports; the positive predictive value of the claims algorithm exceeded 90% for identification of both partial nephrectomy and laparoscopic surgery.</p> <p>Conclusion</p> <p>Medicare claims represent an accurate data source for ascertainment of population-based patterns of surgical care among patients with early-stage kidney cancer.</p

Spirituality and end-of-life care in disadvantaged men dying of prostate cancer

Despite the positive influence of spiritual coping on the acceptance of a cancer diagnosis, higher spirituality is associated with receipt of more high intensity care at the end of life. The purpose of our study was to assess the association between spirituality and type of end-of-life care received by disadvantaged men with prostate cancer. We studied low-income, uninsured men in IMPACT, a state-funded public assistance program, who had died since its inception in 2001. Of the 60 men who died, we included the 35 who completed a spirituality questionnaire at program enrollment. We abstracted sociodemographic and clinical information as well as treatment within IMPACT, including zolendroic acid, chemotherapy, hospice use, and palliative radiation therapy. We measured spirituality with the Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being questionnaire (FACIT-Sp) and compared end-of-life care received between subjects with low and high FACIT-Sp scores using chi-squared analyses. A higher proportion of men with high (33%) versus low (13%) spirituality scores enrolled in hospice, although our analysis was not adequately powered to demonstrate statistical significance. Likewise, we saw a trend toward increased receipt of palliative radiation among those with higher spirituality (37% vs. 25%, P = 0.69). The differences in end-of-life care received among those with low and high spirituality varied little by the FACIT-Sp peace and faith subscales. End-of-life care was similar between men with lower and higher spirituality. Men with higher spirituality trended toward greater hospice use, suggesting that they redirected the focus of their care from curative to palliative goals