Health Care Provider Characteristics Associated With Colorectal Cancer Screening Preferences and Use.

OBJECTIVE: To assess health care provider (HCP) preferences related to colorectal cancer (CRC) screening overall, and by HCP and patient characteristics. PARTICIPANTS AND METHODS: We developed a survey based on the Theoretical Domains Framework to assess factors associated with CRC screening preferences in clinical practice. The survey was administered online November 6 through December 6, 2019, to a validated panel of HCPs drawn from US national databases and professional organizations. The final analysis sample included 779 primary care clinicians (PCCs) and 159 gastroenterologists (GIs). RESULTS: HCPs chose colonoscopy as their preferred screening method for average-risk patients (96.9% (154/159) for GIs, 75.7% (590/779) for PCCs). Among PCCs, 12.2% (95/779) preferred multi-target stool DNA (mt-sDNA), followed by fecal immunochemical test (FIT), (7.3%; 57/779) and guaiac-based fecal occult blood test (gFOBT) (4.8%; 37/779). Preference among PCCs and GIs generally shifted toward noninvasive screening options for patients who were unable to undergo invasive procedures; concerned about taking time from work; unconvinced about need for screening; and refusing other screening recommendations. Among PCCs, preference for mt-sDNA over FIT and gFOBT was less frequent in larger compared with smaller clinical practices. Additionally, preference for mt-sDNA over FIT was more likely among PCCs with more years of clinical experience, higher patient volumes (> 25/day), and practice locations in suburban and rural settings (compared to urban). CONCLUSION: Both PCCs and GIs preferred colonoscopy for CRC screening of average-risk patients, although PCCs did so less frequently and with approximately a quarter preferring stool-based tests (particularly mt-sDNA). PCCs' preference varied by provider and patient characteristics. Our findings underscore the importance of informed choice and shared decision-making about CRC screening options.

The impact of increasing multitarget stool DNA use among colorectal cancer screeners in a self-insured US employer population.

Background: In the United States (US), colorectal cancer (CRC) is the second leading cause of cancer-related deaths. With the majority of the US population covered by employer-based health plans, employers can play a critical role in increasing CRC screening adherence, which may help avert CRC-related deaths. Therefore, it is important for self-insured employers to consider the impact of appropriate utilization of CRC screening options. Objective: To evaluate the impact of increasing multitarget stool DNA [mt-sDNA (Cologuard®)] use among CRC screeners from the perspective of a US self-insured employer. Methods:A 5-year Markov model was developed to quantify the budget impact of increasing mt-sDNA from 6% to 15% among average-risk screeners using colonoscopy, fecal immunological test, and mt-sDNA. Data on direct medical costs were obtained from published literature, Medicare CPT codes, and the Healthcare cost and Utilization project. Indirect costs included productivity loss due to workplace absenteeism for CRC screening and treatment. Results: With a hypothetical population of 100,000 employees with screeners aged 50-64 years, compared to status quo, increased mt-sDNA utilization resulted in no differences in the numbers of cancers detected and the overall direct and indirect cost savings were ~$214,000 ($0.04 per-employee-per-month) over 5 years. Most of the savings were due to a reduction in the direct medical expenditure related to CRC screening, adverse events, and productivity loss due to colonoscopy screening. Similar results were observed in the model simulation among screeners aged 45-64 years. Conclusion: Increased utilization of mt-sDNA for CRC screening averts direct and indirect medical costs from a self-insured US employer perspective.

Barriers to utilization of three colorectal cancer screening options - Data from a national survey.

Colorectal cancer (CRC) screening continues to be underutilized in the United States. A better understanding of existing barriers is critical for improving uptake of, and adherence to, CRC screening. Using data from a population-based panel survey, we examined barriers to utilization of three commonly used screening options (FIT/gFOBT, mt-sDNA, and screening colonoscopy) and assessed differences by socio-demographic characteristics, healthcare access, and health status. Data were obtained from a questionnaire developed by the authors and implemented through a U.S. national panel survey conducted in November 2019. Among 5,097 invited panelists, 1,595 completed the survey (31.3%). Analyses were focused on individuals ages 50-75 at average risk for CRC. Results showed that among respondents who reported no prior CRC screening with FIT/gFOBT, mt-sDNA, or colonoscopy, the top barriers were lack of knowledge (FIT/gFOBT: 42.1%, mt-sDNA: 44.9%, colonoscopy: 34.7%), lack of provider recommendation (FIT/gFOBT: 32.1%, mt-sDNA: 27.3%, colonoscopy: 18.6%), and suboptimal access (FIT/gFOBT: 20.8%, mt-sDNA: 17.8%, colonoscopy: 26%). Among participants who had used one or two of the screening options, the top barriers to FIT/gFOBT and mt-sDNA were lack of provider recommendation (31.6% & 37.5%) and lack of knowledge (24.6% & 25.6%), while for colonoscopy top barriers were psychosocial barriers (31%) and lack of provider recommendation (22.7%). Differences by sex, race/ethnicity, income level, and health status were observed. Our research identified primary barriers to the utilization of three endorsed CRC screening options and differences by patient characteristics, highlighting the importance of improving CRC screening education and considering patient preferences in screening recommendations.

The health economic impact of varying levels of adherence to colorectal screening on providers and payers.

AIMS: To examine the impact of increasing multi-target stool DNA test (mt-sDNA [Cologuard]) utilization for colorectal cancer (CRC) screening in cohorts aged 50-75 and 45-75 years old with varying levels of adherence from the perspectives of integrated delivery networks (IDNs) and payers. MATERIALS AND METHODS: We developed a budget impact model that simulates CRC screening with colonoscopy over a 10-year time horizon, fecal immunochemical test (FIT), and mt-sDNA according to the United States Preventive Services Task Force and American Cancer Society guidelines for average risk adults. We evaluated varying levels of screening adherence for a status quo scenario and for an increased mt-sDNA utilization scenario, from the IDN and payer perspectives. The IDN perspective included CRC screening program costs, whereas the payer perspective did not. Conversely, stool-based screening test and bowel preparation costs were unique to the payer perspective. RESULTS: The increased mt-sDNA scenarios yielded cost savings relative to the status quo under all adherence scenarios due to a decrease in screening and surveillance colonoscopies. For ages 50-75, in high and low adherence scenarios, savings were $19.8 M ($0.16 per-person-per-month (PPPM)) and $33.3 M ($0.28 PPPM) from the IDN perspective. From the payer perspective, savings were $4.2 M ($0.03 PPPM) and $6.7 M ($0.06 PPPM). For ages 45-75, in high and low adherence scenarios, cost savings were $19.3 M ($0.16 PPPM) and $33.0 M ($0.28 PPPM) from the IDN perspective and $3.9 M ($0.03 PPPM) and $6.2 M ($0.05 PPPM) from the payer perspective. In all imperfect adherence scenarios, the degree of cost-savings with increased mt-sDNA utilization correlated with the aggregate decrease in screening and surveillance colonoscopies. LIMITATIONS: Estimates of real-world adherence levels were based on cross-sectional screening data from the literature, and assumptions were applied to individual screening modalities and screening scenarios. CONCLUSIONS: Among all adherence scenarios, perspectives, and age ranges, increased mt-sDNA utilization yielded cost-savings.

An examination of socioeconomic and racial/ethnic disparities in the awareness, knowledge and utilization of three colorectal cancer screening modalities.

While colorectal cancer (CRC) mortality rates have been decreasing, disparities by socioeconomic status (SES) and race/ethnicity persist. CRC screening rates remain suboptimal among low SES and racial/ethnic minority populations, despite the availability of multiple screening modalities. Understanding awareness, knowledge, and utilization of common screening modalities within different racial/ethnic and SES groups is critical to inform efforts to improve population screening uptake and reduce disparities in CRC-related health outcomes. Through the theoretical lenses of diffusion of innovation and fundamental cause theory, we examined the associations of race/ethnicity and SES with awareness, knowledge, and utilization of three guideline recommended CRC screening strategies among individuals at average risk for CRC. Data were obtained from a survey of a nationally representative panel of US adults conducted in November 2019. The survey was completed by 31.3% of invited panelists (1595 of 5097). Analyses were focused on individuals at average risk for CRC, aged 45-75 for awareness and knowledge outcomes (n = 1062) and aged 50-75 for utilization outcomes (n = 858). Analyses revealed racial/ethnic and SES disparities among the three CRC screening modalities, with more racial/ethnic and SES differences observed in the awareness, knowledge, and utilization of screening colonoscopy and mt-sDNA than FIT/gFOBT. Patterns of disparities are consistent with previous research showing that inequities in social and economic resources are associated with an imbalanced adoption of medical innovations. Our findings demonstrate a need to increase awareness, knowledge, and access of various CRC screening modalities in specific populations defined by race/ethnicity or SES indicators. Efforts to increase CRC screening should be tailored to the needs and social-cultural context of populations. Interventions addressing inequalities in social and economic resources are also needed to achieve more equitable adoption of CRC screening modalities and reduce disparities in CRC-related health outcomes.

National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences.

Recommended colorectal cancer screening modalities vary with respect to safety, efficacy, and cost. Better understanding of the factors that influence patient preference is, therefore, critical for improving population adherence to colorectal cancer screening. To address this knowledge gap, we conducted a panel survey focused on three commonly utilized colorectal cancer screening options [fecal immunochemical test or guaiac-based fecal occult blood test (FIT/gFOBT), multi-target stool DNA (mt-sDNA) test, and colonoscopy] with a national sample of U.S. adults, ages 40-75 years and at average risk of colorectal cancer, in November 2019. Of 5,097 panelists invited to participate, 1,595 completed the survey (completion rate, 31.3%). Our results showed that when presented a choice between two colorectal cancer screening modalities, more respondents preferred mt-sDNA (65.4%) over colonoscopy, FIT/gFOBT (61%) over colonoscopy, and mt-sDNA (66.9%) over FIT/gFOBT. Certain demographic characteristics and awareness of and/or experience with various screening modalities influenced preferences. For example, uninsured people were more likely to prefer stool-based tests over colonoscopy [OR, 2.53; 95% confidence interval (CI), 1.22-5.65 and OR, 2.73; 95% CI, 1.13-7.47]. People who had heard of stool-based screening were more likely to prefer mt-sDNA over FIT/gFOBT (OR, 2.07; 95% CI, 1.26-3.40). People who previously had a stool-based test were more likely to prefer FIT/gFOBT over colonoscopy (OR, 2.75; 95% CI, 1.74-4.41), while people who previously had a colonoscopy were less likely to prefer mt-sDNA or FIT/gFOBT over colonoscopy (OR, 0.39; 95% CI, 0.24-0.63 and OR, 0.40; 95% CI, 0.26-0.62). Our survey demonstrated broad patient preference for stool-based tests over colonoscopy, contrasting the heavy reliance on colonoscopy for colorectal cancer screening in clinical practice and highlighting the importance of considering patient preference in colorectal cancer screening recommendations. PREVENTION RELEVANCE: Our national survey demonstrated broad patient preference for stool-based tests over colonoscopy, contrasting the heavy reliance on colonoscopy for colorectal cancer screening in clinical practice and highlighting the importance of considering patient preference in colorectal screening recommendations.

Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: Real-world data from a large cohort of older adults.

OBJECTIVE: To determine cross-sectional adherence with the multi-target stool DNA test used for colorectal cancer screening in a large, fully insured Medicare population. METHODS: All patients aged 65-85 with a valid multi-target stool DNA test order from 1 September 2016 to 31 August 2017 identified from the Exact Sciences Laboratories (Madison, WI; sole-source national multi-target stool DNA test provider) database were evaluated for test adherence. Cross-sectional adherence, defined as multi-target stool DNA test completion within 365 days from order date, was analyzed overall and by time to adherence, as well as by available patient (age, sex, test order date, Medicare coverage type) and provider (specialty, year of first multi-target stool DNA test order, multi-target stool DNA test order frequency, and practice location) factors. RESULTS: Among 368,494 Medicare beneficiaries (64% female), overall cross-sectional adherence was 71%. Cumulative adherence rates increased more rapidly at 30 (44%) and 60 (65%) days, followed by more gradual increases at 90 (67%), 180 (70%), and 365 (71%) days. By provider specialty, primary care clinicians represented a higher percentage of multi-target stool DNA orders than gastroenterologists (88% vs. 6%), but had a lower associated patient adherence rate (71% vs. 78%). CONCLUSIONS: In this large, national sample of Medicare insured older adults, nearly three-quarters of patients adhered with a multi-target stool DNA order for colorectal cancer screening. These real-world data should inform further clinical and population health applications, reimbursement model simulations, and guideline-endorsed colorectal cancer screening strategies adherence.

Projecting total costs and health consequences of increasing mt-sDNA utilization for colorectal cancer screening from the payer and integrated delivery network perspectives.

Aims: To evaluate total costs and health consequences of a colorectal cancer (CRC) screening program with colonoscopy, fecal immunochemical tests (FIT), and expanded use of multitarget stool DNA (mt-sDNA) from the perspectives of Integrated Delivery Networks (IDNs) and payers in the United States.Materials and methods: We developed a budget impact and cost-consequence model that simulates CRC screening for eligible 50- to 75-year-old adults. A status quo scenario and an increased mt-sDNA scenario were modeled. The status quo includes the current screening mix of colonoscopy (83%), FIT (11%), and mt-sDNA (6%) modalities. The increased mt-sDNA scenario increases mt-sDNA utilization to 28% over 10 years. Costs for both the IDN and the payer perspectives incorporated diagnostic and surveillance colonoscopies, adverse events (AEs), and CRC treatment. The IDN perspective included screening program costs, composed of direct nonmedical (e.g. patient navigation) and indirect (e.g. administration) costs. It was assumed that IDNs do not incur the costs for stool-based screening tests or bowel preparation for colonoscopies.Results: In a population of one million covered lives, the 10-year incremental cost savings incurred by increasing mt-sDNA utilization was $16.2 M for the IDN and $3.3 M for the payer. The incremental savings per-person-per-month were $0.14 and $0.03 for the IDN and payer, respectively. For both perspectives, increased diagnostic colonoscopy costs were offset by reductions in screening colonoscopies, surveillance colonoscopies, and AEs. Extending screening eligibility to 45- to 75-year-olds slightly decreased the overall cost savings.Limitations: The natural history of CRC was not simulated; however, many of the utilized parameters were extracted from highly vetted natural history models or published literature. Direct nonmedical and indirect costs for CRC screening programs are applied on a per-person-per modality basis, whereas in reality some of these costs may be fixed.Conclusions: Increased mt-sDNA utilization leads to fewer colonoscopies, less AEs, and lower overall costs for both IDNs and payers, reducing overall screening program costs and increasing the number of cancers detected while maintaining screening adherence rates over 10 years.

Predicting local field potentials with recurrent neural networks.

We present a Recurrent Neural Network using LSTM (Long Short Term Memory) that is capable of modeling and predicting Local Field Potentials. We train and test the network on real data recorded from epilepsy patients. We construct networks that predict multi-channel LFPs for 1, 10, and 100 milliseconds forward in time. Our results show that prediction using LSTM outperforms regression when predicting 10 and 100 millisecond forward in time.

An implantable, designed-for-human-use peripheral nerve stimulation and recording system for advanced prosthetics.

Complex suture prostheses that deliver sensory and position feedback require a more sophisticated integration with the human user. Here a micro-size active implantable system that provides many-degree-of-freedom neural feedback in both sensory stimulation and motor control is shown, as one potential human-use solution in DARPA's HAPTIX program. Various electrical and mechanical challenge and solutions in meeting both sensory /motor performance as well as ISO 14708 FDA-acceptable human use in an aspirin-size active implementation are discussed.

Package architecture and component design for an implanted neural stimulator with closed loop control.

An implanted neural stimulator with closed loop control requires electrodes for stimulation pulses and recording neuron activity. Our system features arrays of 64 electrodes. Each electrode can be addressed through a cross bar switch, to enable it to be used for stimulation or recording. This electrode switch, a bank of low noise amplifiers with an integrated analog to digital converter, power conditioning electronics, and a communications and control gate array are co-located with the electrode array in a 14 millimeter diameter satellite package that is designed to be flush mounted in a skull burr hole. Our system features five satellite packages connected to a central hub processor-controller via ten conductor cables that terminate in a custom designed, miniaturized connector. The connector incorporates features of high reliability, military grade devices and utilizes three distinct seals to isolate the contacts from fluid permeation. The hub system is comprised of a connector header, hermetic electronics package, and rechargeable battery pack, which are mounted on and electrically interconnected by a flexible circuit board. The assembly is over molded with a compliant silicone rubber. The electronics package contains two antennas, a large coil, used for recharging the battery and a high bandwidth antenna that is used to download data and update software. The package is assembled from two machined alumina pieces, a flat base with brazed in, electrical feed through pins and a rectangular cover with rounded corners. Titanium seal rings are brazed onto these two pieces so that they can be sealed by laser welding. A third system antenna is incorporated in the flexible circuit board. It is used to communicate with an externally worn control package, which monitors the health of the system and allows both the user and clinician to control or modify various system function parameters.

Neural signal processing and closed-loop control algorithm design for an implanted neural recording and stimulation system.

A fully autonomous intracranial device is built to continually record neural activities in different parts of the brain, process these sampled signals, decode features that correlate to behaviors and neuropsychiatric states, and use these features to deliver brain stimulation in a closed-loop fashion. In this paper, we describe the sampling and stimulation aspects of such a device. We first describe the signal processing algorithms of two unsupervised spike sorting methods. Next, we describe the LFP time-frequency analysis and feature derivation from the two spike sorting methods. Spike sorting includes a novel approach to constructing a dictionary learning algorithm in a Compressed Sensing (CS) framework. We present a joint prediction scheme to determine the class of neural spikes in the dictionary learning framework; and, the second approach is a modified OSort algorithm which is implemented in a distributed system optimized for power efficiency. Furthermore, sorted spikes and time-frequency analysis of LFP signals can be used to generate derived features (including cross-frequency coupling, spike-field coupling). We then show how these derived features can be used in the design and development of novel decode and closed-loop control algorithms that are optimized to apply deep brain stimulation based on a patient's neuropsychiatric state. For the control algorithm, we define the state vector as representative of a patient's impulsivity, avoidance, inhibition, etc. Controller parameters are optimized to apply stimulation based on the state vector's current state as well as its historical values. The overall algorithm and software design for our implantable neural recording and stimulation system uses an innovative, adaptable, and reprogrammable architecture that enables advancement of the state-of-the-art in closed-loop neural control while also meeting the challenges of system power constraints and concurrent development with ongoing scientific research designed to define brain network connectivity and neural network dynamics that vary at the individual patient level and vary over time.

An implantable 64-channel neural interface with reconfigurable recording and stimulation.

Next generation implantable medical devices will have the potential to provide more precise and effective therapies through adaptive closed-loop controllers that combine sensing and stimulation across larger numbers of electrode channels. A major challenge in the design of such devices is balancing increased functionality and channel counts with the miniaturization required for implantation within small anatomical spaces. Customized therapies will require adaptive systems capable of tuning which channels are sensed and stimulated to overcome variability in patient-specific needs, surgical placement of electrodes, and chronic physiological responses. In order to address these challenges, we have designed a miniaturized implantable fully-reconfigurable front-end system that is integrated into the distal end of an 8-wire lead, enabling up to 64 electrodes to be dynamically configured for sensing and stimulation. Full reconfigurability is enabled by two custom 32×2 cross-point switch (CPS) matrix ASICs which can route any electrode to either an amplifier with reprogrammable bandwidth and integrated ADC or to one of two independent stimulation channels that can be driven through the lead. The 8-wire circuit includes a digital interface for robust communication as well as a charge-balanced powering scheme for enhanced safety. The system is encased in a hermetic package designed to fit within a 14 mm bur-hole in the skull for neuromodulation of the brain, but could easily be adapted to enhance therapies across a broad spectrum of applications.

Psychomotor vigilance testing of professional drivers in the occupational health clinic: a potential objective screen for daytime sleepiness.

OBJECTIVE: Psychomotor vigilance testing (PVT) rapidly assesses attention, reaction time (RT), and abnormal vigilance. Thus, PVT may be an adjunct to screening drivers for high-risk obstructive sleep apnea (OSA)/excess daytime sleepiness (EDS). METHODS: Commercial drivers and emergency responders undergoing occupational examinations took a 10-minute PVT and were instructed to achieve their fastest possible RTs. Participants with maximum RT >5 seconds or ≥ 2 "super lapses" (RT ≥ 1000 ms) were categorized as "microsleepers." RESULTS: Among 193 male participants, the 15 microsleepers (8%) were significantly more obese, but not different on age or Epworth Sleepiness Score. Time of day had no effect on RT. CONCLUSION: PVT is suitable to occupational clinics and can identify otherwise unrecognized, impaired vigilance. Further studies must validate the PVT abnormalities most predictive of OSA/EDS and vehicular crashes, compared to adiposity measures alone.

Iatrogenic disability and narcotics addiction after lumbar fusion in a worker's compensation claimant.

STUDY DESIGN: Case report. OBJECTIVE: Describe a case of chronic occupational low back pain with various treatments of questionable efficacy, leading to prolonged disability, iatrogenic narcotic addiction, and opioid-induced hyperalgesia. SUMMARY OF BACKGROUND DATA: Concerns about narcotics and other questionable treatments for chronic low back pain are increasing, especially in those with work-related conditions. METHODS: Medical record review. RESULTS: The patient had significant, persistent low back symptoms, but good function at work and home. He underwent lumbar fusion to address persistent pain, and subsequently developed failed back surgery syndrome. He was prescribed increasing amounts of opioid analgesics and was recommended for an intrathecal morphine pump, without evaluation of the safety or efficacy of his current regimen. Subsequently, he was hospitalized for opioid detoxification and substance abuse treatment. CONCLUSION: Patients with chronic low back pain are at risk for receiving ineffective and potentially harmful treatment. A focus on restoring function instead of complete pain relief may lead to better outcomes in these patients.