To examine partner involvement in treatment decision making for localized prostate cancer, congru... more To examine partner involvement in treatment decision making for localized prostate cancer, congruence between partner involvement and patient preference, reasons for partner noninvolvement, and partner satisfaction with patient treatment. . Cross-sectional exploratory study. . 100 counties in North Carolina. . 281 partners of men with newly diagnosed localized prostate cancer. . Participants completed a phone survey. Logistic regression analyses were used. . Partners' involvement in treatment decision making, partner satisfaction with treatment, activities of partner involvement, and reasons for noninvolvement. . Of the 228 partners (81%) related to decision making, 205 (73%) were very satisfied with the treatment the patients received, and partner involvement was congruent with patient preference in 242 partners (86%). Partners reported several reasons for noninvolvement. Most partners engaged in multiple activities during treatment decision making for localized prostate cancer...
Decisions regarding how to treat patients who have 1 to 3 brain metastases require important trad... more Decisions regarding how to treat patients who have 1 to 3 brain metastases require important tradeoffs between controlling recurrences, side effects, and costs. In this analysis, the authors compared novel treatments versus usual care to determine the incremental cost-effectiveness ratio from a payer's (Medicare) perspective. Cost-effectiveness was evaluated using a microsimulation of a Markov model for 60 one-month cycles. The model used 4 simulated cohorts of patients aged 65 years with 1 to 3 brain metastases. The 4 cohorts had a median survival of 3, 6, 12, and 24 months to test the sensitivity of the model to different prognoses. The treatment alternatives evaluated included stereotactic radiosurgery (SRS) with 3 variants of salvage after recurrence (whole-brain radiotherapy [WBRT], hippocampal avoidance WBRT [HA-WBRT], SRS plus WBRT, and SRS plus HA-WBRT). The findings were tested for robustness using probabilistic and deterministic sensitivity analyses. Traditional radiat...
Neoadjuvant chemotherapy (NAC) before radical cystectomy is the standard of care for muscle-invas... more Neoadjuvant chemotherapy (NAC) before radical cystectomy is the standard of care for muscle-invasive bladder cancer (MIBC). Many patients are referred to an academic medical center (AMC) for cystectomy but receive NAC in the community setting. This study examines if administration of NAC in the community is associated with differences in type of NAC received, pathologic response rate (pT0), and time to cystectomy as compared to NAC administered at an AMC. We performed a retrospective study of patients with MIBC (cT2a-T4-Nx-M0) referred to a single AMC between 1/2012 and 1/2014 who received NAC. We analyzed chemotherapy received, time to cystectomy, pT0, and survival in patients who received NAC in our AMC compared to those treated in the community. In all, 47 patients were analyzed. A similar total dose of cisplatin (median: 280mg/m(2) for both groups, P = 0.82) and pT0 rate (25% vs. 29%, P = 0.72) were seen in patients treated in our AMC and the community. However, administration o...
Journal of the National Comprehensive Cancer Network : JNCCN, 2013
Potentially curative treatments for patients with muscle-invasive bladder cancer (MIBC) are under... more Potentially curative treatments for patients with muscle-invasive bladder cancer (MIBC) are underused, especially in the elderly. Trimodality bladder preservation therapy, which includes a maximally safe transurethral resection of the bladder tumor, followed by concurrent chemoradiation, fulfills this currently unmet need. In multiple prospective clinical trials and large institutional series, trimodality therapy has demonstrated excellent 5-year overall survival rates of 48% to 65%, comparable to those reported in cystectomy studies. Approximately 75% to 80% of long-term survivors maintain their native bladders, which tend to function well and allow patients to maintain excellent quality of life. Salvage cystectomy for patients who develop a local invasive recurrence can be performed with acceptable operative complication rates, and results in excellent long-term disease control and survival outcomes. For patients with MIBC who are noncystectomy candidates, or select patients who a...
The combination of radiation treatment and long-term androgen deprivation therapy (ADT) has been ... more The combination of radiation treatment and long-term androgen deprivation therapy (ADT) has been shown in multiple clinical trials to prolong overall survival in men with high-risk prostate cancer compared with either treatment alone. New radiation technologies enable the safe delivery of high radiation doses that improve cancer control compared with lower radiation doses. Based on the results of multiple randomized trials, clinical practice guidelines for high-risk prostate cancer recommend total radiation doses of at least 75.6 Gy, with long-term (2-3 years) ADT. Ongoing research into hypofractionated radiation treatment, whole-pelvic radiation, and combinations of radiation with novel hormonal agents could further improve cancer control and survival outcomes for patients with high-risk prostate cancer.
It has been demonstrated that treatment decisional regret affects quality of life in patients wit... more It has been demonstrated that treatment decisional regret affects quality of life in patients with prostate cancer (CaP); however, there are limited studies that identify factors associated with treatment decisional regret, particularly within a racially diverse patient population that has extended follow-up. Logistic regression analysis was used to determine associations between decisional regret and potential predictors in a population-based cohort of 348 African American men and 446 Caucasian American men approximately 3 years after CaP diagnosis. Of 794 research participants, 12% experienced treatment decisional regret. Decisional regret was associated with androgen-deprivation therapy (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.1-4.0), recent urinary bother (OR, 3.4; 95% CI, 1.6-7.3), satisfaction with understanding potential treatment side effects (very unsatisfied: OR, 13.3; 95% CI, 5.5-32.2; somewhat unsatisfied: OR, 5.0; 95% CI, 2.3-11.2; neutral: OR, 3.8; 95% CI...
International Journal of Radiation Oncology*Biology*Physics, 2014
Large randomized trials have established the noninferiority of shorter courses of &am... more Large randomized trials have established the noninferiority of shorter courses of "hypofractionated" radiation therapy (RT) to the whole breast compared to conventional courses using smaller daily doses in the adjuvant treatment of selected breast cancer patients undergoing lumpectomy. Hypofractionation is more convenient and less costly. Therefore, we sought to determine uptake of hypofractionated breast RT over time. In the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database, we identified 16,096 women with node-negative breast cancer and 4269 with ductal carcinoma in situ (DCIS) who received lumpectomy followed by more than 12 fractions of RT between 2004 and 2010. Based on Medicare claims, we determined the number of RT treatments given and grouped patients into those receiving hypofractionation (13-24) or those receiving conventional fractionation (≥25). We also determined RT technique (intensity modulated RT or not) using Medicare claims. We evaluated patterns and correlates of hypofractionation receipt using bivariate and multivariable analyses. Hypofractionation use was similar in patients with DCIS and those with invasive disease. Overall, the use of hypofractionation increased from 3.8% in 2006 to 5.4% in 2007, to 9.4% in 2008, and to 13.6% in 2009 and 2010. Multivariable analysis showed increased use of hypofractionation in recent years and in patients with older age, smaller tumors, increased comorbidity, higher regional education, and Western SEER regions. However, even in patients over the age of 80, the hypofractionation rate in 2009 to 2010 was only 25%. Use of intensity modulated RT (IMRT) also increased over time (from 9.4% in 2004 to 22.7% in 2009-2010) and did not vary significantly between patients receiving hypofractionation and those receiving traditional fractionation. Hypofractionation use increased among low-risk older US breast cancer patients with publication and maturation of evidence from randomized trials, but overall use of this cost-saving approach remained low. This contrasts with the more rapid rate of adoption of IMRT in the same time period, a costly innovation supported by less strong evidence of benefit.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 20, 2014
To provide treatment recommendations for men with metastatic castration-resistant prostate cancer... more To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 ((223)Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefi...
Image-guided radiotherapy (IGRT), adaptive radiotherapy (ART), and online reoptimization rely on ... more Image-guided radiotherapy (IGRT), adaptive radiotherapy (ART), and online reoptimization rely on accurate mapping of the radiation beam isocenter(s) from planning to treatment space. This mapping involves rigid and/or nonrigid registration of planning (pCT) and intratreatment (tCT) CT images. The purpose of this study was to retrospectively compare a fully automatic approach, including a non-rigid step, against a user-directed rigid method implemented in a clinical IGRT protocol for prostate cancer. Isocenters resulting from automatic and clinical mappings were compared to reference isocenters carefully determined in each tCT. Comparison was based on displacements from the reference isocenters and prostate dose-volume histograms (DVHs). Ten patients with a total of 243 tCTs were investigated. Fully automatic registration was found to be as accurate as the clinical protocol but more precise for all patients. The average of the unsigned , , and offsets and the standard deviations ( ) of the signed offsets computed over all images were (avg. ± (mm)): 1.1 ± 1.4, 1.8 ± 2.3, 2.5 ± 3.5 for the clinical protocol and 0.6 ± 0.8, 1.1 ± 1.5 and 1.1 ± 1.4 for the automatic method. No failures or outliers from automatic mapping were observed, while 8 outliers occurred for the clinical protocol.
Method. Symptom ratings were obtained in each schizophrenic person (n=39) prior to neuroleptic wi... more Method. Symptom ratings were obtained in each schizophrenic person (n=39) prior to neuroleptic withdrawal and after remedication. Seven individual items were selected from the Brief Psychiatric Rating Scale (BPRS) based on Liddle's three-syndrome model (Items 3, 4, 12, 15, 16, 19 and 20). For the examination of factor structures across the three clinical states, the principal-component analysis with Varimax rotation was used.
Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer,... more Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer, has rapidly diffused over the past decade. To inform our understanding of racial disparities in prostate cancer treatment and outcomes, this study compared diffusion of IMRT in African American (AA) and Caucasian American (CA) prostate cancer patients during the early years of IMRT diffusion using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. A retrospective cohort of 947 AA and 10,028 CA patients diagnosed with localized prostate cancer from 2002 through 2006, who were treated with either IMRT or non-IMRT as primary treatment within 1 year of diagnoses was constructed. Logistic regression was used to examine potential differences in diffusion of IMRT in AA and CA patients, while adjusting for socioeconomic and clinical covariates. A significantly smaller proportion of AA compared with CA patients received IMRT for localized prostate cancer (45% vs. 53%, p < .0001). Racial differences were apparent in multivariable analysis though did not achieve statistical significance, as time and factors associated with race (socioeconomic, geographic, and tumor related factors) explained the preponderance of variance in use of IMRT. Further research examining improved access to innovative cancer treatment and technologies is essential to reducing racial disparities in cancer care.
To examine the association between socio-cultural factors and patient-provider communication and ... more To examine the association between socio-cultural factors and patient-provider communication and related racial differences. Data analysis included 1854 men with prostate cancer from a population-based study. Participants completed an assessment of communication variables, physician trust, perceived racism, religious beliefs, traditional health beliefs, and health literacy. A multi-group structural equation modeling approach was used to address the research aims. Compared with African Americans, Caucasian Americans had significantly greater mean scores of interpersonal treatment (p<0.01), prostate cancer communication (p<0.001), and physician trust (p<0.001), but lower mean scores of religious beliefs, traditional health beliefs, and perceived racism (all p values <0.001). For both African and Caucasian Americans, better patient-provider communication was associated with more physician trust, less perceived racism, greater religious beliefs (all p-values <0.01), and a...
Routine cancer screening has unproven net benefit for patients with limited life expectancy. To e... more Routine cancer screening has unproven net benefit for patients with limited life expectancy. To examine the patterns of prostate, breast, cervical, and colorectal cancer screening in the United States in individuals with different life expectancies. Data from the population-based National Health Interview Survey (NHIS) from 2000 through 2010 were used and included 27 404 participants aged 65 years or older. Using a validated mortality index specific for NHIS, participants were grouped into those with low (<25%), intermediate (25%-49%), high (50%-74%), and very high (≥75%) risks of 9-year mortality. Rates of prostate, breast, cervical, and colorectal cancer screening. In participants with very high mortality risk, 31% to 55% received recent cancer screening, with prostate cancer screening being most common (55%). For women who had a hysterectomy for benign reasons, 34% to 56% had a Papanicolaou test within the past 3 years. On multivariate analysis, very high vs low mortality risk...
Urologic Oncology: Seminars and Original Investigations, 2013
The management of genitourinary malignancies requires a multidisciplinary care team composed of u... more The management of genitourinary malignancies requires a multidisciplinary care team composed of urologists, medical oncologists, and radiation oncologists. A genitourinary (GU) oncology clinical database is an invaluable resource for patient care and research. Although electronic medical records provide a single web-based record used for clinical care, billing, and scheduling, information is typically stored in a discipline-specific manner and data extraction is often not applicable to a research setting. A GU oncology database may be used for the development of multidisciplinary treatment plans, analysis of disease-specific practice patterns, and identification of patients for research studies. Despite the potential utility, there are many important considerations that must be addressed when developing and implementing a discipline-specific database. The creation of the GU oncology database including prostate, bladder, and kidney cancers with the identification of necessary variables was facilitated by meetings of stakeholders in medical oncology, urology, and radiation oncology at the University of North Carolina (UNC) at Chapel Hill with a template data dictionary provided by the Department of Urologic Surgery at Vanderbilt University Medical Center. Utilizing Research Electronic Data Capture (REDCap, version 4.14.5), the UNC Genitourinary OncoLogy Database (UNC GOLD) was designed and implemented. The process of designing and implementing a discipline-specific clinical database requires many important considerations. The primary consideration is determining the relationship between the database and the Institutional Review Board (IRB) given the potential applications for both clinical and research uses. Several other necessary steps include ensuring information technology security and federal regulation compliance; determination of a core complete dataset; creation of standard operating procedures; standardizing entry of free text fields; use of data exports, queries, and de-identification strategies; inclusion of individual investigators&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; data; and strategies for prioritizing specific projects and data entry. A discipline-specific database requires a buy-in from all stakeholders, meticulous development, and data entry resources to generate a unique platform for housing information that may be used for clinical care and research with IRB approval. The steps and issues identified in the development of UNC GOLD provide a process map for others interested in developing a GU oncology database.
Social psychiatry and psychiatric epidemiology, 2005
Previous family experience of psychotic illness may play an important role in whether and when a ... more Previous family experience of psychotic illness may play an important role in whether and when a patient seeks help in first-episode psychosis. This study investigated the relationship between family experience of psychosis and the duration of untreated psychosis in a prospective sample of first-episode psychosis patients in Hong Kong. We also studied the effects of pre-morbid adjustment, educational level, living alone, and mode of onset as potential determinants of the duration of untreated psychosis (DUP). A total of 131 first-episode psychosis patients in Hong Kong were recruited in a study of the DUP and related factors. The Interview for the Retrospective Assessment of the Onset of Schizophrenia (IRAOS) was used to measure the DUP and to provide a structured assessment of family history, educational level, household arrangement, and mode of onset. Previous family experience of psychiatric illness (the presence of another family member who has been receiving psychiatric treatme...
Value-based health care has been proposed as a unifying force to drive improved outcomes and cost... more Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.
International Journal of Radiation Oncology*Biology*Physics, 2014
The radiation oncology community has witnessed growing interest in observational research conduct... more The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based data sets. With the growing emphasis on observational analyses in health care, the radiation oncology community must possess a sophisticated understanding of the methodological considerations of such studies in order to evaluate evidence appropriately to guide practice and policy. Because observational research has unique features that distinguish it from clinical trials and other forms of traditional radiation oncology research, the International Journal of Radiation Oncology, Biology, Physics assembled a panel of experts in health services research to provide a concise and well-referenced review, intended to be informative for the lay reader, as well as for scholars who wish to embark on such research without prior experience. This review begins by discussing the types of research questions relevant to radiation oncology that large-scale databases may help illuminate. It then describes major potential data sources for such endeavors, including information regarding access and insights regarding the strengths and limitations of each. Finally, it provides guidance regarding the analytical challenges that observational studies must confront, along with discussion of the techniques that have been developed to help minimize the impact of certain common analytical issues in observational analysis. Features characterizing a well-designed observational study include clearly defined research questions, careful selection of an appropriate data source, consultation with investigators with relevant methodological expertise, inclusion of sensitivity analyses, caution not to overinterpret small but significant differences, and recognition of limitations when trying to evaluate causality. This review concludes that carefully designed and executed studies using observational data that possess these qualities hold substantial promise for advancing our understanding of many unanswered questions of importance to the field of radiation oncology.
Better understanding of the error reporting culture in radiation oncology treatment facilities, a... more Better understanding of the error reporting culture in radiation oncology treatment facilities, and obstacles to reporting, can provide insight into potential areas for improvement. We conducted a survey of radiation therapists and dosimetrists to examine the error reporting cultures in radiation oncology facilities across the United States and staff comfort in reporting errors. In 2011, a national sample of 1500 radiation therapists and 528 dosimetrists was mailed a 27-item survey assessing perceptions regarding communication among staff, comfort in error reporting, and associated obstacles. Survey results were summarized using descriptive statistics, and factors associated with discomfort with error reporting analyzed using multivariate logistic regression. A total of 356 radiation therapists from 47 states (24% response rate) and 190 dosimetrists from 35 states (36% response rate) responded to the survey. Almost all (87% of therapists and 88% of dosimetrists) reported that there is an error reporting system in their treatment facility. Most feel that communication between them and physicians and dosimetrists or physicists (81% and 88% of therapists, and 89% and 88% of dosimetrists, respectively) is good, but only 65% of therapists and 66% of dosimetrists agree that communication with administrators is good. Obstacles to reporting errors included hierarchy within the treatment facility, poor communication, and fear of reprimand. On multivariate analysis, previous personal reprimand for reporting errors (odds ratio, 4.13, P = .001) and reprimand of other therapists and dosimetrists (odds ratio, 2.55, P = .03) were significantly associated with discomfort in error reporting. The majority of therapists and dosimetrists feel communication in their treatment facilities is good and that there are systems in place to report errors. A sizable minority reported experience with reprimand for error reporting that significantly reduced their comfort level with reporting errors. Obstacles identified in this study represent opportunities for future research and potential ways for improvement in radiation oncology treatment facilities.
To examine partner involvement in treatment decision making for localized prostate cancer, congru... more To examine partner involvement in treatment decision making for localized prostate cancer, congruence between partner involvement and patient preference, reasons for partner noninvolvement, and partner satisfaction with patient treatment. . Cross-sectional exploratory study. . 100 counties in North Carolina. . 281 partners of men with newly diagnosed localized prostate cancer. . Participants completed a phone survey. Logistic regression analyses were used. . Partners' involvement in treatment decision making, partner satisfaction with treatment, activities of partner involvement, and reasons for noninvolvement. . Of the 228 partners (81%) related to decision making, 205 (73%) were very satisfied with the treatment the patients received, and partner involvement was congruent with patient preference in 242 partners (86%). Partners reported several reasons for noninvolvement. Most partners engaged in multiple activities during treatment decision making for localized prostate cancer...
Decisions regarding how to treat patients who have 1 to 3 brain metastases require important trad... more Decisions regarding how to treat patients who have 1 to 3 brain metastases require important tradeoffs between controlling recurrences, side effects, and costs. In this analysis, the authors compared novel treatments versus usual care to determine the incremental cost-effectiveness ratio from a payer's (Medicare) perspective. Cost-effectiveness was evaluated using a microsimulation of a Markov model for 60 one-month cycles. The model used 4 simulated cohorts of patients aged 65 years with 1 to 3 brain metastases. The 4 cohorts had a median survival of 3, 6, 12, and 24 months to test the sensitivity of the model to different prognoses. The treatment alternatives evaluated included stereotactic radiosurgery (SRS) with 3 variants of salvage after recurrence (whole-brain radiotherapy [WBRT], hippocampal avoidance WBRT [HA-WBRT], SRS plus WBRT, and SRS plus HA-WBRT). The findings were tested for robustness using probabilistic and deterministic sensitivity analyses. Traditional radiat...
Neoadjuvant chemotherapy (NAC) before radical cystectomy is the standard of care for muscle-invas... more Neoadjuvant chemotherapy (NAC) before radical cystectomy is the standard of care for muscle-invasive bladder cancer (MIBC). Many patients are referred to an academic medical center (AMC) for cystectomy but receive NAC in the community setting. This study examines if administration of NAC in the community is associated with differences in type of NAC received, pathologic response rate (pT0), and time to cystectomy as compared to NAC administered at an AMC. We performed a retrospective study of patients with MIBC (cT2a-T4-Nx-M0) referred to a single AMC between 1/2012 and 1/2014 who received NAC. We analyzed chemotherapy received, time to cystectomy, pT0, and survival in patients who received NAC in our AMC compared to those treated in the community. In all, 47 patients were analyzed. A similar total dose of cisplatin (median: 280mg/m(2) for both groups, P = 0.82) and pT0 rate (25% vs. 29%, P = 0.72) were seen in patients treated in our AMC and the community. However, administration o...
Journal of the National Comprehensive Cancer Network : JNCCN, 2013
Potentially curative treatments for patients with muscle-invasive bladder cancer (MIBC) are under... more Potentially curative treatments for patients with muscle-invasive bladder cancer (MIBC) are underused, especially in the elderly. Trimodality bladder preservation therapy, which includes a maximally safe transurethral resection of the bladder tumor, followed by concurrent chemoradiation, fulfills this currently unmet need. In multiple prospective clinical trials and large institutional series, trimodality therapy has demonstrated excellent 5-year overall survival rates of 48% to 65%, comparable to those reported in cystectomy studies. Approximately 75% to 80% of long-term survivors maintain their native bladders, which tend to function well and allow patients to maintain excellent quality of life. Salvage cystectomy for patients who develop a local invasive recurrence can be performed with acceptable operative complication rates, and results in excellent long-term disease control and survival outcomes. For patients with MIBC who are noncystectomy candidates, or select patients who a...
The combination of radiation treatment and long-term androgen deprivation therapy (ADT) has been ... more The combination of radiation treatment and long-term androgen deprivation therapy (ADT) has been shown in multiple clinical trials to prolong overall survival in men with high-risk prostate cancer compared with either treatment alone. New radiation technologies enable the safe delivery of high radiation doses that improve cancer control compared with lower radiation doses. Based on the results of multiple randomized trials, clinical practice guidelines for high-risk prostate cancer recommend total radiation doses of at least 75.6 Gy, with long-term (2-3 years) ADT. Ongoing research into hypofractionated radiation treatment, whole-pelvic radiation, and combinations of radiation with novel hormonal agents could further improve cancer control and survival outcomes for patients with high-risk prostate cancer.
It has been demonstrated that treatment decisional regret affects quality of life in patients wit... more It has been demonstrated that treatment decisional regret affects quality of life in patients with prostate cancer (CaP); however, there are limited studies that identify factors associated with treatment decisional regret, particularly within a racially diverse patient population that has extended follow-up. Logistic regression analysis was used to determine associations between decisional regret and potential predictors in a population-based cohort of 348 African American men and 446 Caucasian American men approximately 3 years after CaP diagnosis. Of 794 research participants, 12% experienced treatment decisional regret. Decisional regret was associated with androgen-deprivation therapy (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.1-4.0), recent urinary bother (OR, 3.4; 95% CI, 1.6-7.3), satisfaction with understanding potential treatment side effects (very unsatisfied: OR, 13.3; 95% CI, 5.5-32.2; somewhat unsatisfied: OR, 5.0; 95% CI, 2.3-11.2; neutral: OR, 3.8; 95% CI...
International Journal of Radiation Oncology*Biology*Physics, 2014
Large randomized trials have established the noninferiority of shorter courses of &amp;amp;am... more Large randomized trials have established the noninferiority of shorter courses of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;hypofractionated&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; radiation therapy (RT) to the whole breast compared to conventional courses using smaller daily doses in the adjuvant treatment of selected breast cancer patients undergoing lumpectomy. Hypofractionation is more convenient and less costly. Therefore, we sought to determine uptake of hypofractionated breast RT over time. In the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database, we identified 16,096 women with node-negative breast cancer and 4269 with ductal carcinoma in situ (DCIS) who received lumpectomy followed by more than 12 fractions of RT between 2004 and 2010. Based on Medicare claims, we determined the number of RT treatments given and grouped patients into those receiving hypofractionation (13-24) or those receiving conventional fractionation (≥25). We also determined RT technique (intensity modulated RT or not) using Medicare claims. We evaluated patterns and correlates of hypofractionation receipt using bivariate and multivariable analyses. Hypofractionation use was similar in patients with DCIS and those with invasive disease. Overall, the use of hypofractionation increased from 3.8% in 2006 to 5.4% in 2007, to 9.4% in 2008, and to 13.6% in 2009 and 2010. Multivariable analysis showed increased use of hypofractionation in recent years and in patients with older age, smaller tumors, increased comorbidity, higher regional education, and Western SEER regions. However, even in patients over the age of 80, the hypofractionation rate in 2009 to 2010 was only 25%. Use of intensity modulated RT (IMRT) also increased over time (from 9.4% in 2004 to 22.7% in 2009-2010) and did not vary significantly between patients receiving hypofractionation and those receiving traditional fractionation. Hypofractionation use increased among low-risk older US breast cancer patients with publication and maturation of evidence from randomized trials, but overall use of this cost-saving approach remained low. This contrasts with the more rapid rate of adoption of IMRT in the same time period, a costly innovation supported by less strong evidence of benefit.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 20, 2014
To provide treatment recommendations for men with metastatic castration-resistant prostate cancer... more To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 ((223)Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefi...
Image-guided radiotherapy (IGRT), adaptive radiotherapy (ART), and online reoptimization rely on ... more Image-guided radiotherapy (IGRT), adaptive radiotherapy (ART), and online reoptimization rely on accurate mapping of the radiation beam isocenter(s) from planning to treatment space. This mapping involves rigid and/or nonrigid registration of planning (pCT) and intratreatment (tCT) CT images. The purpose of this study was to retrospectively compare a fully automatic approach, including a non-rigid step, against a user-directed rigid method implemented in a clinical IGRT protocol for prostate cancer. Isocenters resulting from automatic and clinical mappings were compared to reference isocenters carefully determined in each tCT. Comparison was based on displacements from the reference isocenters and prostate dose-volume histograms (DVHs). Ten patients with a total of 243 tCTs were investigated. Fully automatic registration was found to be as accurate as the clinical protocol but more precise for all patients. The average of the unsigned , , and offsets and the standard deviations ( ) of the signed offsets computed over all images were (avg. ± (mm)): 1.1 ± 1.4, 1.8 ± 2.3, 2.5 ± 3.5 for the clinical protocol and 0.6 ± 0.8, 1.1 ± 1.5 and 1.1 ± 1.4 for the automatic method. No failures or outliers from automatic mapping were observed, while 8 outliers occurred for the clinical protocol.
Method. Symptom ratings were obtained in each schizophrenic person (n=39) prior to neuroleptic wi... more Method. Symptom ratings were obtained in each schizophrenic person (n=39) prior to neuroleptic withdrawal and after remedication. Seven individual items were selected from the Brief Psychiatric Rating Scale (BPRS) based on Liddle's three-syndrome model (Items 3, 4, 12, 15, 16, 19 and 20). For the examination of factor structures across the three clinical states, the principal-component analysis with Varimax rotation was used.
Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer,... more Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer, has rapidly diffused over the past decade. To inform our understanding of racial disparities in prostate cancer treatment and outcomes, this study compared diffusion of IMRT in African American (AA) and Caucasian American (CA) prostate cancer patients during the early years of IMRT diffusion using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. A retrospective cohort of 947 AA and 10,028 CA patients diagnosed with localized prostate cancer from 2002 through 2006, who were treated with either IMRT or non-IMRT as primary treatment within 1 year of diagnoses was constructed. Logistic regression was used to examine potential differences in diffusion of IMRT in AA and CA patients, while adjusting for socioeconomic and clinical covariates. A significantly smaller proportion of AA compared with CA patients received IMRT for localized prostate cancer (45% vs. 53%, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .0001). Racial differences were apparent in multivariable analysis though did not achieve statistical significance, as time and factors associated with race (socioeconomic, geographic, and tumor related factors) explained the preponderance of variance in use of IMRT. Further research examining improved access to innovative cancer treatment and technologies is essential to reducing racial disparities in cancer care.
To examine the association between socio-cultural factors and patient-provider communication and ... more To examine the association between socio-cultural factors and patient-provider communication and related racial differences. Data analysis included 1854 men with prostate cancer from a population-based study. Participants completed an assessment of communication variables, physician trust, perceived racism, religious beliefs, traditional health beliefs, and health literacy. A multi-group structural equation modeling approach was used to address the research aims. Compared with African Americans, Caucasian Americans had significantly greater mean scores of interpersonal treatment (p<0.01), prostate cancer communication (p<0.001), and physician trust (p<0.001), but lower mean scores of religious beliefs, traditional health beliefs, and perceived racism (all p values <0.001). For both African and Caucasian Americans, better patient-provider communication was associated with more physician trust, less perceived racism, greater religious beliefs (all p-values <0.01), and a...
Routine cancer screening has unproven net benefit for patients with limited life expectancy. To e... more Routine cancer screening has unproven net benefit for patients with limited life expectancy. To examine the patterns of prostate, breast, cervical, and colorectal cancer screening in the United States in individuals with different life expectancies. Data from the population-based National Health Interview Survey (NHIS) from 2000 through 2010 were used and included 27 404 participants aged 65 years or older. Using a validated mortality index specific for NHIS, participants were grouped into those with low (<25%), intermediate (25%-49%), high (50%-74%), and very high (≥75%) risks of 9-year mortality. Rates of prostate, breast, cervical, and colorectal cancer screening. In participants with very high mortality risk, 31% to 55% received recent cancer screening, with prostate cancer screening being most common (55%). For women who had a hysterectomy for benign reasons, 34% to 56% had a Papanicolaou test within the past 3 years. On multivariate analysis, very high vs low mortality risk...
Urologic Oncology: Seminars and Original Investigations, 2013
The management of genitourinary malignancies requires a multidisciplinary care team composed of u... more The management of genitourinary malignancies requires a multidisciplinary care team composed of urologists, medical oncologists, and radiation oncologists. A genitourinary (GU) oncology clinical database is an invaluable resource for patient care and research. Although electronic medical records provide a single web-based record used for clinical care, billing, and scheduling, information is typically stored in a discipline-specific manner and data extraction is often not applicable to a research setting. A GU oncology database may be used for the development of multidisciplinary treatment plans, analysis of disease-specific practice patterns, and identification of patients for research studies. Despite the potential utility, there are many important considerations that must be addressed when developing and implementing a discipline-specific database. The creation of the GU oncology database including prostate, bladder, and kidney cancers with the identification of necessary variables was facilitated by meetings of stakeholders in medical oncology, urology, and radiation oncology at the University of North Carolina (UNC) at Chapel Hill with a template data dictionary provided by the Department of Urologic Surgery at Vanderbilt University Medical Center. Utilizing Research Electronic Data Capture (REDCap, version 4.14.5), the UNC Genitourinary OncoLogy Database (UNC GOLD) was designed and implemented. The process of designing and implementing a discipline-specific clinical database requires many important considerations. The primary consideration is determining the relationship between the database and the Institutional Review Board (IRB) given the potential applications for both clinical and research uses. Several other necessary steps include ensuring information technology security and federal regulation compliance; determination of a core complete dataset; creation of standard operating procedures; standardizing entry of free text fields; use of data exports, queries, and de-identification strategies; inclusion of individual investigators&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; data; and strategies for prioritizing specific projects and data entry. A discipline-specific database requires a buy-in from all stakeholders, meticulous development, and data entry resources to generate a unique platform for housing information that may be used for clinical care and research with IRB approval. The steps and issues identified in the development of UNC GOLD provide a process map for others interested in developing a GU oncology database.
Social psychiatry and psychiatric epidemiology, 2005
Previous family experience of psychotic illness may play an important role in whether and when a ... more Previous family experience of psychotic illness may play an important role in whether and when a patient seeks help in first-episode psychosis. This study investigated the relationship between family experience of psychosis and the duration of untreated psychosis in a prospective sample of first-episode psychosis patients in Hong Kong. We also studied the effects of pre-morbid adjustment, educational level, living alone, and mode of onset as potential determinants of the duration of untreated psychosis (DUP). A total of 131 first-episode psychosis patients in Hong Kong were recruited in a study of the DUP and related factors. The Interview for the Retrospective Assessment of the Onset of Schizophrenia (IRAOS) was used to measure the DUP and to provide a structured assessment of family history, educational level, household arrangement, and mode of onset. Previous family experience of psychiatric illness (the presence of another family member who has been receiving psychiatric treatme...
Value-based health care has been proposed as a unifying force to drive improved outcomes and cost... more Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.
International Journal of Radiation Oncology*Biology*Physics, 2014
The radiation oncology community has witnessed growing interest in observational research conduct... more The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based data sets. With the growing emphasis on observational analyses in health care, the radiation oncology community must possess a sophisticated understanding of the methodological considerations of such studies in order to evaluate evidence appropriately to guide practice and policy. Because observational research has unique features that distinguish it from clinical trials and other forms of traditional radiation oncology research, the International Journal of Radiation Oncology, Biology, Physics assembled a panel of experts in health services research to provide a concise and well-referenced review, intended to be informative for the lay reader, as well as for scholars who wish to embark on such research without prior experience. This review begins by discussing the types of research questions relevant to radiation oncology that large-scale databases may help illuminate. It then describes major potential data sources for such endeavors, including information regarding access and insights regarding the strengths and limitations of each. Finally, it provides guidance regarding the analytical challenges that observational studies must confront, along with discussion of the techniques that have been developed to help minimize the impact of certain common analytical issues in observational analysis. Features characterizing a well-designed observational study include clearly defined research questions, careful selection of an appropriate data source, consultation with investigators with relevant methodological expertise, inclusion of sensitivity analyses, caution not to overinterpret small but significant differences, and recognition of limitations when trying to evaluate causality. This review concludes that carefully designed and executed studies using observational data that possess these qualities hold substantial promise for advancing our understanding of many unanswered questions of importance to the field of radiation oncology.
Better understanding of the error reporting culture in radiation oncology treatment facilities, a... more Better understanding of the error reporting culture in radiation oncology treatment facilities, and obstacles to reporting, can provide insight into potential areas for improvement. We conducted a survey of radiation therapists and dosimetrists to examine the error reporting cultures in radiation oncology facilities across the United States and staff comfort in reporting errors. In 2011, a national sample of 1500 radiation therapists and 528 dosimetrists was mailed a 27-item survey assessing perceptions regarding communication among staff, comfort in error reporting, and associated obstacles. Survey results were summarized using descriptive statistics, and factors associated with discomfort with error reporting analyzed using multivariate logistic regression. A total of 356 radiation therapists from 47 states (24% response rate) and 190 dosimetrists from 35 states (36% response rate) responded to the survey. Almost all (87% of therapists and 88% of dosimetrists) reported that there is an error reporting system in their treatment facility. Most feel that communication between them and physicians and dosimetrists or physicists (81% and 88% of therapists, and 89% and 88% of dosimetrists, respectively) is good, but only 65% of therapists and 66% of dosimetrists agree that communication with administrators is good. Obstacles to reporting errors included hierarchy within the treatment facility, poor communication, and fear of reprimand. On multivariate analysis, previous personal reprimand for reporting errors (odds ratio, 4.13, P = .001) and reprimand of other therapists and dosimetrists (odds ratio, 2.55, P = .03) were significantly associated with discomfort in error reporting. The majority of therapists and dosimetrists feel communication in their treatment facilities is good and that there are systems in place to report errors. A sizable minority reported experience with reprimand for error reporting that significantly reduced their comfort level with reporting errors. Obstacles identified in this study represent opportunities for future research and potential ways for improvement in radiation oncology treatment facilities.
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Papers by Ronald Chen