[Show abstract][Hide abstract] ABSTRACT: Background:
In 2016, the cancer registry community will directly assign T, N and M components of stage. The Surveillance, Epidemiology, and End Results program implemented a field study to determine how often T, N and M were not available in the medical record, requiring the registrar to directly assign clinical or pathologic TNM stage components. The field study also identified specific training needs.
T, N and M status were collected from multiple sources within medical records for a total of 280 cases, 56 each from breast, prostate, colon, lung, and ovarian cancer. TNM data elements were also directly assigned by a series of reviewers and by study participants using the medical records with TNM information redacted. Availability of physician-assigned TNM was estimated from the medical record. Also, participant responses were compared to preferred answers.
Pathologic T, N and M were available more often in the medical records than were clinical values and varied by site. Pathologic T and N were available for about two-thirds of the cases, but the clinical elements were available for only about 20% of cases. The agreement between participant responses and review panel assignments varied by data element and cancer site. Agreement was modest for most data elements and cancer sites, ranging from 54% for clinical T to 92% for clinical M for all cancer sites combined.
The data elements for TNM staging and stage group were often missing from the medical records, so registrars in the field will need to assign TNM frequently. Furthermore, the results of this study strongly suggest that more training is required, even among those who currently assign TNM.
[Show abstract][Hide abstract] ABSTRACT: Although opioid prescribing in sickle cell disease (SCD) can be controversial, little is published about patterns of opioid use.
To report on home opioid use among adults with SCD.
Adults with SCD (n = 219) who completed daily pain diaries for up to 6 months and had at least one home pain day.
Use of long-acting or short-acting opioids, other analgesics, or adjuvants; the proportion of home days, home pain days, and home crisis days with opioid use; these two outcomes according to patient characteristics.
Patients used opioids on 12,311 (78 percent) of 15,778 home pain days. Eighty-five patients (38.8 percent) used long-acting opioids with or without short-acting opioids and 103 (47.0 percent) used only short-acting opioids. Twenty-one (9.6 percent) patients used only non-opioid analgesics and 10 (4.6 percent) used no analgesics. Both pain intensity and pain frequency were higher among opioid users (analysis of variance [ANOVA], p < 0.0001). Opioid users used hydroxyurea more often than nonusers, even when controlling for mean pain on pain days. Among all patients, significant relationships were found between any opioid use and somatic symptom burden, SCD stress, negative coping, and physical and mental quality of life (QOL); the relationship with SCD stress and physical QOL remained when controlled for mean pain. Among opioid users, similar associations were found between frequency of opioid use and some disease-related and psychosocial variables.
In this adult SCD sample, opioids were used by the majority of patients. Pain was the overwhelming characteristic associated with use, but disease-related and psychosocial variables were also associated.
No preview · Article · May 2015 · Journal of opioid management
[Show abstract][Hide abstract] ABSTRACT: The National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) registries have been a source of biospecimens for cancer research for decades. Recently, registry-based biospecimen studies have become more practical, with the expansion of electronic networks for pathology and medical record reporting. Formalin-fixed paraffin-embedded specimens are now used for next-generation sequencing and other molecular techniques. These developments create new opportunities for SEER biospecimen research. We evaluated 31 research articles published during 2005 to 2013 based on authors' confirmation that these studies involved linkage of SEER data to biospecimens. Rather than providing an exhaustive review of all possible articles, ourintent wastoindicate the breadth of research madepossibleby suchare source. Wealsosummarize responses to a 2012 questionnaire that was broadly distributed to the NCI intra- and extramural biospecimen research community. This included responses from 30 investigators who had used SEER biospecimens intheir research. The survey was not intended to be a systematic sample, but instead to provide anecdotal insight on strengths, limitations, and the future of SEER biospecimen research. Identified strengths of this research resource include biospecimen availability, cost, and annotation of data, including demographic information, stage, and survival. Shortcomings include limited annotation of clinical attributes such as detailed chemotherapy history and recurrence, and timeliness of turnaround following biospecimen requests. A review of selected SEERbiospecimen articles, investigator feedback, and technological advances reinforced our viewthat SEER biospecimen resources should be developed. This would advance cancer biology, etiology, and personalized therapy research.
Full-text · Article · Dec 2014 · Cancer Epidemiology Biomarkers & Prevention
[Show abstract][Hide abstract] ABSTRACT: Background:
Cancer treatment information is often underreported in cancer registries due to the shift in cancer care to ambulatory settings. Incomplete treatment information for central registries limits the usefulness of these data for understanding disparities in outcomes. The objective of this study was to evaluate the added value and validity of medical billing data to supplement treatment for incident cases within a central cancer registry.
Billing data using standardized structure and nomenclature as submitted by all practices was evaluated using an automated software (MDoffice, MDO) process that captures and processes these data and submits the information in a standardized format. A validation of the billing reported treatment was performed using data from 3 community oncology practices.
The accuracy of treatment data captured was 100 percent for both chemotherapy and radiation therapy among the 313 cases validated. Chemotherapy (36 percent and 5 percent respectively for solid tumors and hematologic cancers) and radiation therapy (46 percent and 20 percent respectively for solid tumors and hematologic cancers) information was added to 738 known incident cases using billing data.
Automated reporting based on billing data from community specialty providers is likely to markedly enhance the completeness of treatment data among known cancer cases as these community providers render significant amounts of treatment for cancer patients.
No preview · Article · Aug 2014 · J Registry Manag
[Show abstract][Hide abstract] ABSTRACT: Enrolling adequate numbers of patients that meet protocol eligibility criteria in a timely manner is critical, yet clinical trial accrual continues to be problematic. One approach to meet these accrual challenges is to utilize technology to automatically screen patients for clinical trial eligibility. This manuscript reports on the evaluation of different automated approaches to determine the metastatic status from unstructured radiology reports using the Clinical Trials Eligibility Database Integrated System (CTED). The study sample included all patients (N = 5,523) with radiologic diagnostic studies (N = 10,492) completed in a two-week period. Eight search algorithms (queries) within CTED were developed and applied to radiology reports. The performance of each algorithm was compared to a reference standard which consisted of a physician's review of the radiology reports. Sensitivity, specificity, positive, and negative predicted values were calculated for each algorithm. The number of patients identified by each algorithm varied from 187 to 330 and the number of true positive cases confirmed by physician review ranged from 171 to 199 across the algorithms. The best performing algorithm had sensitivity 94%, specificity 100%, positive predictive value 90%, negative predictive value 100%, and accuracy of 99%. Our evaluation process identified the optimal method for rapid identification of patients with metastatic disease through automated screening of unstructured radiology reports. The methods developed using the CTED system could be readily implemented at other institutions to enhance the efficiency of research staff in the clinical trials eligibility screening process.
No preview · Article · Oct 2013 · Experimental Biology and Medicine
[Show abstract][Hide abstract] ABSTRACT: Determining eligibility for a clinical trial (CT) typically requires a lengthy manual review of data for a single evaluation. The cost associated with eligibility screening is typically not compensated through contracts supporting CTs.
We used a real-time tracking system that captures CT evaluations and provides information on evaluation outcomes and time spent on each eligibility screening by research staff. Using these data, we describe the effort and costs of eligibility screening overall and per enrolled patient for cancer CTs. The study sample included all completed eligibility assessment (evaluation) records for the 18-month study period. We used generalized multinomial modeling to predict evaluation outcomes and then used the resulting parameter coefficients to estimate the effort associated with each participant, adjusted for probability of being enrolled. From these data, we calculated cost associated with eligibility screening.
We found substantial variation in attributed cost by study type and phase. The cost of eligibility screening ranged by study phase from $129.15 to $336.48 per enrolled patient. The estimated annual cost of screening was more than $90,000.
This study provides results based on prospectively captured effort to estimate the largely nonreimbursed costs of eligibility screening and suggests that screening can be a significant financial burden to an institution. Centers performing CTs may need to acknowledge the differences in screening costs for different study types when negotiating contracts with funding organizations. Information such as that captured here could support such negotiations to reduce the gap between reimbursed and nonreimbursed costs.
Full-text · Article · Nov 2012 · Journal of Oncology Practice
[Show abstract][Hide abstract] ABSTRACT: Background:
Clinical trials (CTs) are the mechanism by which research is translated into standards of care. Low recruitment among underserved and minority populations may result in inequity in access to the latest technology and treatments, compromise the generalizability, and lead to failure in identification of important positive or negative treatment effects among under-represented populations.
Data were collected over a 39-month period on patient eligibility for available therapeutic cancer CTs. Reasons for ineligibility and refusal were collected. The data were captured using an automated software tool for tracking eligibility pre-enrollment. We examined characteristics associated with being evaluated for a trial, and reasons for ineligibility and refusal, overall and by patient race.
African-Americans (AAs) were more likely than Whites to be ineligible (odds ratio, (OR) = 1.26, 95% confidence interval (CI) = 1.0-1.58) and if eligible, to refuse participation (OR = 1.79, 95% CI = 1.27-2.52), even after adjusting for insurance, age, gender, study phase, and cancer type. White patients were more likely to be ineligible due to study-specific or cancer characteristics. AAs were more likely to be ineligible due to mental status or perceived noncompliance. Whites were more likely to refuse due to extra burden, due to concerns with randomization and toxicity, or because they express a positive treatment preference. AAs were more likely to refuse because they were not interested in CTs, because of family pressures, or they felt overwhelmed (NS)).
This study is the first to directly compare ineligibility and refusal rates and reasons captured prospectively in AA and White cancer patients. The data are consistent with earlier studies that indicated that AA patients more often are deemed ineligible and, when eligible, more often refuse participation. However, differences in reasons for ineligibility and refusal by race have implications for a cancer center to participate in CTs appropriate for the population of patients served. On a broader scale, consideration should be given to modifying eligibility criteria and other design aspects to permit broader participation of minority and other underserved groups.
[Show abstract][Hide abstract] ABSTRACT: Reporting of hematologic malignancies is an increasingly important focus for cancer surveillance. As trends in cancer care are shifting to the outpatient setting, hospital-based data collection methods used for cancer surveillance will result in under-reporting of these cancers. This study describes the testing and validation of an automated system for capturing and reporting cancers from community oncology providers.
The system was evaluated in 5 oncology practices in two states processing claims data for a 4- or 8-month interval. Resulting cancers were matched with the state registries. A random sample of nonmatched cases was reabstracted to measure the accuracy of the claims data for reporting of hematologic malignancies.
The overall match rate for the 1,935 hematologic malignancies reported during the study period was 58.2 % (range, 37.4 % for CLL to 71.2 % for Hodgkin's Lymphoma). The overall accuracy rate for billing-reported hematologic malignancies was 95 %. Accuracy among cases that did not match with the cancer registry was 88 %. The estimated number of missed cases for the five participating practices ranged from 0.8 leukemia cases/oncologist/year to 3.4 CLL cases/oncologist/year. The estimated total number of missed cases in the five participating practices was 292 with an interquartile range of 263-323.
As cancer diagnosis and treatment continue migration into ambulatory physician practice settings unreported hematopoietic cases will become increasingly problematic. Leveraging the standardized electronic billing data for automated reporting of cancer cases from physician practices may be an efficient method to reduce this gap in cancer surveillance reporting.
Full-text · Article · Jun 2012 · Cancer Causes and Control
[Show abstract][Hide abstract] ABSTRACT: Urologic cancers represent a substantial proportion of the total cancer burden, yet the true burden of these cancers is unknown due to gaps in current cancer surveillance systems. Prostate and bladder cancers in particular may be underreported due to increased availability of outpatient care. Thus, there is a critical need to develop systems to completely and accurately capture longitudinal data to understand the true patterns of care and outcomes for these cancers.
We determined the accuracy and impact of automated software to capture and process billing data to supplement reporting of cancers diagnosed and treated in a large community urology practice. From these data, we estimated numbers of unreported cancers for an actively reporting and for a non-reporting practice and the associated impact for a central cancer registry.
The software automatically processed billing data representing 26,133 visits for 15,495 patients in the 3.5-month study period. Of these, 2,275 patients had a cancer diagnosis and 87.2% of these matched with a central registry case. The estimated annual number of prostate and bladder cancers remaining unreported from this practice was 158. If the practice were not actively reporting, the unreported cases were estimated at 1,111, representing an increase of 12% to the registry. Treatments added from billing varied by treatment type with the largest proportion of added treatments for biologic response modifiers (BRMs) (127%-166%) and chemotherapy (22%).
Automated processing of billing data from community urology practices offers an opportunity to enhance capture of missing prostate and bladder cancer surveillance data with minimal effort to a urology practice.
Broader implementation of automated reporting could have a major impact nationally considering the more than 12,000 practicing urologists listed as members of the American Urological Association.
No preview · Article · Dec 2010 · J Registry Manag
[Show abstract][Hide abstract] ABSTRACT: Research on pressing health services and policy issues requires access to complete, accurate, and timely patient and organizational data.
This paper describes how administrative and health records (including electronic medical records) can be linked for comparative effectiveness and health services research.
We categorize the major agents (i.e., who owns and controls data and who carries out the data linkage) into three areas: (1) individual investigators; (2) government sponsored linked data bases; and (3) public-private partnerships that facilitate linkage of data owned by private organizations. We describe challenges that may be encountered in the linkage process, and the benefits of combining secondary databases with primary qualitative and quantitative sources. We use cancer care research to illustrate our points.
To fill the gaps in the existing data infrastructure, additional steps are required to foster collaboration among institutions, researchers, and public and private components of the health care sector. Without such effort, independent researchers, governmental agencies, and nonprofit organizations are likely to continue building upon a fragmented and costly system with limited access. Discussion. Without the development and support for emerging information technologies across multiple health care settings, the potential for data collected for clinical and transactional purposes to benefit the research community and, ultimately, the patient population may go unrealized.
The current environment is characterized by budget and technical challenges, but investments in data infrastructure are arguably cost-effective given the need to reform our health care system and to monitor the impact of health reform initiatives.
Preview · Article · Oct 2010 · Health Services Research
[Show abstract][Hide abstract] ABSTRACT: Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials.
This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios.
There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process.
The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer.
Full-text · Article · Mar 2010 · Contemporary clinical trials
[Show abstract][Hide abstract] ABSTRACT: Treatment options for sickle cell disease (SCD) pain could be tailored to pain locations. But few epidemiologic descriptions of SCD pain location exist; these are based on few subjects over short time periods. We examined whether SCD pain locations vary by disease genotype, gender, age, frequency of pain, depression, pain crisis or healthcare utilization. We enrolled 308 adults with SCD in 2002-2004. Subjects kept daily pain diaries for up to 6months, including a body chart. Mixed model and generalized estimating equations were employed for analyses. Two hundred and sixty subjects completed at least one body chart. An average of 3.3/16 sites (25%) were painful. The number of pain sites varied by age, depression, frequent pain days, crisis and unplanned hospital/ED utilization. Lower back, knee/shin and hip, hurt on average more than a third of pain days, while jaw and pelvis hurt on fewer than 10% of days. Odds of a crisis were increased substantially when pain was in the arm, shoulder, upper back, sternum, clavicle, chest or pelvis (OR>1.5) while the odds of unplanned utilization were substantially increased for the sternum, clavicle and chest (OR>2.0). Pain in SCD varies considerably both within and between subjects, although it occurs most commonly in the lower back and lower extremities. The number and location of pain sites vary significantly by age, frequent pain, crisis and utilization. Identification and understanding of combinations of pain location and intensity may help to understand the etiology of SCD and improve SCD management.
[Show abstract][Hide abstract] ABSTRACT: This is a pilot study designed to identify gene expression profiles able to stratify head and neck squamous cell carcinoma (HNSCC) tumors that may or may not respond to chemoradiation or radiation therapy.
We prospectively evaluated 14 HNSCC specimens, arising from patients undergoing chemoradiotherapy or radiotherapy alone with curative intent. A complete response was assessed by clinical evaluation with no evidence of gross tumor after a 2-year follow-up period.
Residual biopsy samples from eight complete responders (CR) and six nonresponders (NR) were evaluated by genome-wide gene expression profiling using HG-U133A 2.0 arrays. Univariate parametric t-tests with proportion of false discoveries controlled by multivariate permutation tests were used to identify genes with significantly different gene expression levels between CR and NR cases. Six different prediction algorithms were used to build gene predictor lists. Three representative genes showing 100% crossvalidation support after leave-one-out crossvalidation (LOOCV) were further validated using real-time QRT-PCR.
We identified 167 significant probe sets that discriminate between the two classes, which were used to build gene predictor lists. Thus, 142 probe sets showed an accuracy of prediction ranging from 93% to 100% across all six prediction algorithms. The genes represented by these 142 probe sets were further classified into different functional networks that included cellular development, cellular movement, and cancer.
The results presented herein offer encouraging preliminary data that may provide a basis for a more precise prognosis of HNSCC, as well as a molecular-based therapy decision for the management of these cancers.
No preview · Article · Jan 2009 · The Laryngoscope
[Show abstract][Hide abstract] ABSTRACT: Patients with sickle cell disease often receive a substantial amount of their health care in the emergency department (ED) and some come to the ED frequently, seeking treatment for pain. As a result, patients with sickle cell disease are often stigmatized as opioid-seeking ED overutilizers. We describe the proportion of sickle cell disease patients who are high utilizers of the ED and compare them with other sickle cell disease patients on demographics, pain characteristics, health data, psychosocial characteristics, and quality of life.
Two hundred thirty-two patients completed baseline data and at least 30 days of daily diary data. Baseline data included demographics, health data, and quality of life (Medical Outcome Study 36 Item Short Form). Daily diary data included ED utilization for sickle cell pain and descriptors of pain and distress.
Eighty-two (35.5%) patients were found to be high ED utilizers. Clinically important and statistically significant differences were found between high ED utilizers and all other sickle cell disease patients: lower hematocrit level, more transfusions, more pain days, more pain crises, higher mean pain and distress, and worse quality of life on Medical Outcome Study 36 Item Short Form physical function summary scales. After controlling for severity and frequency of pain, high ED utilizers did not use opioids more frequently than other sickle cell disease patients.
A substantial minority of sickle cell disease patients are high ED utilizers. However, high ED utilizers with sickle cell disease are more severely ill as measured by laboratory variables, have more pain, more distress, and have a lower quality of life.
Full-text · Article · Nov 2008 · Annals of emergency medicine
[Show abstract][Hide abstract] ABSTRACT: Depression and anxiety are common in sickle cell disease (SCD) but relatively little is known about their impact on SCD adults. This study measured prevalence of depression and anxiety in SCD adults, and their effects on crisis and noncrisis pain, quality-of-life, opioid usage, and healthcare utilization.
The Pain in Sickle Cell Epidemiology Study is a prospective cohort study in 308 SCD adults. Baseline variables included demographics, genotype, laboratory data, health-related quality-of-life, depression, and anxiety. Subjects completed daily diaries for up to 6 months, reporting sickle cell pain intensity, distress, interference, whether they were in a sickle cell crisis, as well as health care and opioid utilization.
Two hundred thirty-two subjects who completed at least 1 month of diaries were studied; 27.6% were depressed and 6.5% had any anxiety disorder. Depressed subjects had pain on significantly more days than nondepressed subjects (mean pain days 71.1% versus 49.6%, p < .001). When in pain on noncrisis days, depressed subjects had higher mean pain, distress from pain, and interference from pain. Both depressed and anxious subjects had poorer functioning on all eight SF-36 subscales, even after controlling for demographics, hemoglobin type, and pain. The anxious subjects had more pain, distress from pain, and interference from pain, both on noncrisis pain days and on crisis days, and used opioids more often.
Depression and anxiety predicted more daily pain and poorer physical and mental quality-of-life in adults with SCD, and accounted for more of the variance in all domains of quality-of-life than hemoglobin type.
Full-text · Article · Mar 2008 · Psychosomatic Medicine
[Show abstract][Hide abstract] ABSTRACT: Researchers of sickle cell disease have traditionally used health care utilization as a proxy for pain and underlying vaso-occlusion. However, utilization may not completely reflect the amount of self-reported pain or acute, painful episodes (crises).
To examine the prevalence of self-reported pain and the relationship among pain, crises, and utilization in adults with sickle cell disease.
Prospective cohort study.
Academic and community practices in Virginia.
232 patients age 16 years or older with sickle cell disease.
Patients completed a daily diary for up to 6 months, recording their maximum pain (on a scale of 0 to 9); whether they were in a crisis (crisis day); and whether they used hospital, emergency, or unscheduled ambulatory care for pain on the previous day (utilization day). Summary measures included both simple proportions and adjusted probabilities (for repeated measures within patients) of pain days, crisis days, and utilization days, as well as mean pain intensity.
Pain (with or without crisis or utilization of care) was reported on 54.5% of 31 017 analyzed patient-days (adjusted probability, 56%). Crises without utilization were reported on 12.7% of days and utilization on only 3.5% (unadjusted). In total, 29.3% of patients reported pain in greater than 95% of diary days, whereas only 14.2% reported pain in 5% or fewer diary days (adjusted). The frequency of home opiate use varied and independently predicted pain, crises, and utilization. Mean pain intensity on crisis days, noncrisis pain days, and total pain days increased as the percentage of pain days increased (P < 0.001). Intensity was significantly higher on utilization days (P < 0.001). However, utilization was not an independent predictor of crisis, after controlling for pain intensity.
The study was done in a single state. Patients did not always send in their diaries.
Pain in adults with sickle cell disease is the rule rather than the exception and is far more prevalent and severe than previous large-scale studies have portrayed. It is mostly managed at home; therefore, its prevalence is probably underestimated by health care providers, resulting in misclassification, distorted communication, and undertreatment.
Full-text · Article · Jan 2008 · Annals of internal medicine