HIPAA Compliance with Mobile Devices Among ACGME Programs.

PubMed

McKnight, Randall; Franko, Orrin

2016-05-01

To analyze self-reported HIPAA compliance with mobile technologies among residents, fellows, and attendings at ACGME training programs. A digital survey was sent to 678 academic institutions over a 1-month period. 2427 responses were analyzed using Chi-squared tests for independence. Post-hoc Bonferroni correction was applied for all comparisons between training levels, clinical setting, and specialty. 58 % of all residents self-report violating HIPAA by sharing protected health information (PHI) via text messaging with 27 % reporting they do it "often" or "routinely" compared to 15-19 % of attendings. For all specialties, 35 % of residents use text messaging photo or video sharing with PHI. Overall, 5 % of respondents "often" or "routinely" used HIPAA compliant (HCApps) with no significant differences related to training level. 20 % of residents admitted to using non-encrypted email at some point. 53 % of attendings and 41 % of residents utilized encrypted email routinely. Physicians from surgical specialties compared to non-surgical specialties demonstrated higher rates of HIPAA violations with SMS use (35 % vs. 17.7 %), standard photo/video messages (16.3 % vs. 4.7 %), HCApps (10.9 % vs. 4.9 %), and non-HCApps (5.6 % vs 1.5 %). The most significant barriers to complying with HIPAA were inconvenience (58 %), lack of knowledge (37 %), unfamiliarity (34 %), inaccessible (29 %) and habit (24 %). Medical professionals must acknowledge that despite laws to protect patient confidentiality in the era of mobile technology, over 50 % of current medical trainees knowingly violate these rules regularly despite the threat of severe consequences. The medical community must further examine the reason for these inconsistencies and work towards possible solutions.

Storing and using health data in a virtual private cloud.

PubMed

Regola, Nathan; Chawla, Nitesh V

2013-03-13

Electronic health records are being adopted at a rapid rate due to increased funding from the US federal government. Health data provide the opportunity to identify possible improvements in health care delivery by applying data mining and statistical methods to the data and will also enable a wide variety of new applications that will be meaningful to patients and medical professionals. Researchers are often granted access to health care data to assist in the data mining process, but HIPAA regulations mandate comprehensive safeguards to protect the data. Often universities (and presumably other research organizations) have an enterprise information technology infrastructure and a research infrastructure. Unfortunately, both of these infrastructures are generally not appropriate for sensitive research data such as HIPAA, as they require special accommodations on the part of the enterprise information technology (or increased security on the part of the research computing environment). Cloud computing, which is a concept that allows organizations to build complex infrastructures on leased resources, is rapidly evolving to the point that it is possible to build sophisticated network architectures with advanced security capabilities. We present a prototype infrastructure in Amazon's Virtual Private Cloud to allow researchers and practitioners to utilize the data in a HIPAA-compliant environment.

An audit of dental prescriptions between clinics and dental laboratories.

PubMed

Stewart, C A

2011-08-12

To discover the quality of written instructions from dentists to dental technicians and the nature of non-compliant prescriptions. An audit of laboratory prescription compliance was conducted within an NHS Trust Dental Teaching Hospital to determine the level of communication between dentists and dental technicians. One hundred and fifty prescriptions were audited from dental undergraduates and qualified dentists throughout the different departments. A total of two-thirds of prescriptions were considered non-compliant and failed to meet relevant ethical and legal guidelines. This problem was seen throughout all departments and at all professional levels. A breakdown in communication between dentists and technicians through the use of prescriptions is evident even within a close working environment.

HIPAA Compliant Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma

PubMed Central

Hosseini, Anahita; Buonocore, Chris M.; Hashemzadeh, Sepideh; Hojaiji, Hannaneh; Kalantarian, Haik; Sideris, Costas; Bui, Alex A.T.; King, Christine E.; Sarrafzadeh, Majid

2018-01-01

Asthma is the most prevalent chronic disease among pediatrics, as it is the leading cause of student absenteeism and hospitalization for those under the age of 15. To address the significant need to manage this disease in children, the authors present a mobile health (mHealth) system that determines the risk of an asthma attack through physiological and environmental wireless sensors and representational state transfer application program interfaces (RESTful APIs). The data is sent from wireless sensors to a smartwatch application (app) via a Health Insurance Portability and Accountability Act (HIPAA) compliant cryptography framework, which then sends data to a cloud for real-time analytics. The asthma risk is then sent to the smartwatch and provided to the user via simple graphics for easy interpretation by children. After testing the safety and feasibility of the system in an adult with moderate asthma prior to testing in children, it was found that the analytics model is able to determine the overall asthma risk (high, medium, or low risk) with an accuracy of 80.10±14.13%. Furthermore, the features most important for assessing the risk of an asthma attack were multifaceted, highlighting the importance of continuously monitoring different wireless sensors and RESTful APIs. Future testing this asthma attack risk prediction system in pediatric asthma individuals may lead to an effective self-management asthma program. PMID:29354688

SU-F-T-485: Independent Remote Audits for TG51 NonCompliant Photon Beams Performed by the IROC Houston QA Center

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alvarez, P; Molineu, A; Lowenstein, J

Purpose: IROC-H conducts external audits for output check verification of photon and electron beams. Many of these beams can meet the geometric requirements of the TG 51 calibration protocol. For those photon beams that are non TG 51 compliant like Elekta GammaKnife, Accuray CyberKnife and TomoTherapy, IROC-H has specific audit tools to monitor the reference calibration. Methods: IROC-H used its TLD and OSLD remote monitoring systems to verify the output of machines with TG 51 non compliant beams. Acrylic OSLD miniphantoms are used for the CyberKnife. Special TLD phantoms are used for TomoTherapy and GammaKnife machines to accommodate the specificmore » geometry of each machine. These remote audit tools are sent to institutions to be irradiated and returned to IROC-H for analysis. Results: The average IROC-H/institution ratios for 480 GammaKnife, 660 CyberKnife and 907 rotational TomoTherapy beams are 1.000±0.021, 1.008±0.019, 0.974±0.023, respectively. In the particular case of TomoTherapy, the overall ratio is 0.977±0.022 for HD units. The standard deviations of all results are consistent with values determined for TG 51 compliant photon beams. These ratios have shown some changes compared to values presented in 2008. The GammaKnife results were corrected by an experimentally determined scatter factor of 1.025 in 2013. The TomoTherapy helical beam results are now from a rotational beam whereas in 2008 the results were from a static beam. The decision to change modality was based on recommendations from the users. Conclusion: External audits of beam outputs is a valuable tool to confirm the calibrations of photon beams regardless of whether the machine is TG 51 or TG 51 non compliant. The difference found for TomoTherapy units is under investigation. This investigation was supported by IROC grant CA180803 awarded by the NCI.« less

Storing and Using Health Data in a Virtual Private Cloud

PubMed Central

Regola, Nathan

2013-01-01

Electronic health records are being adopted at a rapid rate due to increased funding from the US federal government. Health data provide the opportunity to identify possible improvements in health care delivery by applying data mining and statistical methods to the data and will also enable a wide variety of new applications that will be meaningful to patients and medical professionals. Researchers are often granted access to health care data to assist in the data mining process, but HIPAA regulations mandate comprehensive safeguards to protect the data. Often universities (and presumably other research organizations) have an enterprise information technology infrastructure and a research infrastructure. Unfortunately, both of these infrastructures are generally not appropriate for sensitive research data such as HIPAA, as they require special accommodations on the part of the enterprise information technology (or increased security on the part of the research computing environment). Cloud computing, which is a concept that allows organizations to build complex infrastructures on leased resources, is rapidly evolving to the point that it is possible to build sophisticated network architectures with advanced security capabilities. We present a prototype infrastructure in Amazon’s Virtual Private Cloud to allow researchers and practitioners to utilize the data in a HIPAA-compliant environment. PMID:23485880

Relational databases for rare disease study: application to vascular anomalies.

PubMed

Perkins, Jonathan A; Coltrera, Marc D

2008-01-01

To design a relational database integrating clinical and basic science data needed for multidisciplinary treatment and research in the field of vascular anomalies. Based on data points agreed on by the American Society of Pediatric Otolaryngology (ASPO) Vascular Anomalies Task Force. The database design enables sharing of data subsets in a Health Insurance Portability and Accountability Act (HIPAA)-compliant manner for multisite collaborative trials. Vascular anomalies pose diagnostic and therapeutic challenges. Our understanding of these lesions and treatment improvement is limited by nonstandard terminology, severity assessment, and measures of treatment efficacy. The rarity of these lesions places a premium on coordinated studies among multiple participant sites. The relational database design is conceptually centered on subjects having 1 or more lesions. Each anomaly can be tracked individually along with their treatment outcomes. This design allows for differentiation between treatment responses and untreated lesions' natural course. The relational database design eliminates data entry redundancy and results in extremely flexible search and data export functionality. Vascular anomaly programs in the United States. A relational database correlating clinical findings and photographic, radiologic, histologic, and treatment data for vascular anomalies was created for stand-alone and multiuser networked systems. Proof of concept for independent site data gathering and HIPAA-compliant sharing of data subsets was demonstrated. The collaborative effort by the ASPO Vascular Anomalies Task Force to create the database helped define a common vascular anomaly data set. The resulting relational database software is a powerful tool to further the study of vascular anomalies and the development of evidence-based treatment innovation.

Smartphone-coupled rhinolaryngoscopy at the point of care

NASA Astrophysics Data System (ADS)

Mink, Jonah; Bolton, Frank J.; Sebag, Cathy M.; Peterson, Curtis W.; Assia, Shai; Levitz, David

2018-02-01

Rhinolaryngoscopy remains difficult to perform in resource-limited settings due to the high cost of purchasing and maintaining equipment as well as the need for specialists to interpret exam findings. While the lack of expertise can be obviated by adopting telemedicine-based approaches, the capture, storage, and sharing of images/video is not a common native functionality of medical devices. Most rhinolaryngoscopy systems consist of an endoscope that interfaces with the patient's naso/oropharynx, and a tower of modules that record video/images. However, these expensive and bulky modules can be replaced by a smartphone that can fulfill the same functions but at a lower cost. To demonstrate this, a commercially available rhinolaryngoscope was coupled to a smartphone using a 3D-printed adapter. Software developed for other clinical applications was repurposed for ENT use, including an application that controls image and video capture, a HIPAA-compliant image/video storage and transfer cloud database, and customized software features developed to improve practitioner competency. Audio recording capabilities to assess speech pathology were also integrated into the smartphone rhinolaryngoscope system. The illumination module coupled onto the endoscope remained unchanged. The spatial resolution of the rhinolaryngoscope system was defined by the fiber diameter of endoscope fiber bundle, rather than the smartphone camera. The mobile rhinolaryngoscope system was used with appropriate patients by a general practitioner in an office setting. The general practitioner then consulted with an ENT specialist via the HIPAA compliant cloud database and workflow modules on difficult cases. These results suggest the smartphone-based rhinolaryngoscope holds promise for use in low-resource settings.

A tracking and verification system implemented in a clinical environment for partial HIPAA compliance

NASA Astrophysics Data System (ADS)

Guo, Bing; Documet, Jorge; Liu, Brent; King, Nelson; Shrestha, Rasu; Wang, Kevin; Huang, H. K.; Grant, Edward G.

2006-03-01

The paper describes the methodology for the clinical design and implementation of a Location Tracking and Verification System (LTVS) that has distinct benefits for the Imaging Department at the Healthcare Consultation Center II (HCCII), an outpatient imaging facility located on the USC Health Science Campus. A novel system for tracking and verification of patients and staff in a clinical environment using wireless and facial biometric technology to monitor and automatically identify patients and staff was developed in order to streamline patient workflow, protect against erroneous examinations and create a security zone to prevent and audit unauthorized access to patient healthcare data under the HIPAA mandate. This paper describes the system design and integration methodology based on initial clinical workflow studies within a clinical environment. An outpatient center was chosen as an initial first step for the development and implementation of this system.

Are we following an algorithm for managing chronic anal fissure? A completed audit cycle☆

PubMed Central

Farkas, Nicholas; Solanki, Kohmal; Frampton, Adam E.; Black, John; Gupta, Ashish; West, Nicholas J.

2015-01-01

Background Anal fissure is one of the commonest proctological diseases with considerable national variation in sequential treatment. We aimed to audit our compliance of chronic anal fissure (CAF) management with national guidance provided by the Association of Coloproctology of Great Britain and Ireland (ACPGBI). Methods We retrospectively audited patients presenting to outpatient clinics with CAF over a 6-month period. Using electronic patient records, notes and clinic letters, we compared their management with ACPGBI algorithm. A prospective re-audit was then performed. Results Forty-one patients were included in the analysis (59% male). Sixty-eight percent (n = 28/41) of patients were appropriately started on conservative dietary therapy, of whom only 7.1% (n = 2/28) had treatment success. Eighty-nine percent (n = 25/28) were then appropriately treated with either topical diltiazem 2% or GTN 0.4%. Overall, 43.9% (n = 18/41) of all patients' entire management strategy adhered to the ACPGBI guidelines. In total, 48.8% (n = 20/41) patients had surgical treatment (excluding Botox), of which only 15% (n = 3/20) had undergone ACPGBI-compliant management. After local dissemination of results and education, the re-audit of 20 patients showed significant improvement in adherence to the guidelines (43.9% vs. 95%; P = 0.0001). Conclusions Topical creams were the most successful treatments (50%; n = 9/18) in ACPGBI-compliant strategies. Importantly, these data suggests that compliance with the ACPGBI algorithm leads to healing without surgery in 83.3% (n = 15/18) of patients, compared to 26.1% (n = 6/23) with non-compliant methods (P = 0.0004). This highlights the benefit of early conservative and medical management of CAF, before attempting surgery. PMID:26858833

Toward Proper Authentication Methods in Electronic Medical Record Access Compliant to HIPAA and C.I.A. Triangle.

PubMed

Tipton, Stephen J; Forkey, Sara; Choi, Young B

2016-04-01

This paper examines various methods encompassing the authentication of users in accessing Electronic Medical Records (EMRs). From a methodological perspective, multiple authentication methods have been researched from both a desktop and mobile accessibility perspective. Each method is investigated at a high level, along with comparative analyses, as well as real world examples. The projected outcome of this examination is a better understanding of the sophistication required in protecting the vital privacy constraints of an individual's Protected Health Information (PHI). In understanding the implications of protecting healthcare data in today's technological world, the scope of this paper is to grasp an overview of confidentiality as it pertains to information security. In addressing this topic, a high level overview of the three goals of information security are examined; in particular, the goal of confidentiality is the primary focus. Expanding upon the goal of confidentiality, healthcare accessibility legal aspects are considered, with a focus upon the Health Insurance Portability and Accountability Act of 1996 (HIPAA). With the primary focus of this examination being access to EMRs, the paper will consider two types of accessibility of concern: access from a physician, or group of physicians; and access from an individual patient.

Mount Sinai leverages smartphone technology, aiming to boost care, coordination of ED patients while also trimming costs.

PubMed

2015-05-01

Mount Sinai Hospital in New York, NY, is using smartphone technology to enhance follow-up calls to senior patients who have visited the ED, and to help provide acute-level care to select patients in their own homes. Investigators are hoping to show that these approaches can improve care and coordination while trimming costs, and they expect that patients will approve of these new approaches as well. While senior patients are still in the ED, nurse coordinators will work with them to load a HIPAA-compliant application to their smartphones so they can conduct face-to-face follow-up calls that meet HIPAA standards. Nurses say the face-to-face communications enhance their ability to assess how patients are doing following their ED visit. The hospital is also testing a program that enables some ED patients who meet inpatient criteria to receive this care in the home setting through the use of a mobile acute care team (MACT). In the case of emergencies, the MACT team relies on community paramedics who will visit the patients' homes and provide care under the direction of MACT physicians who are linked in to these visits via smartphone technology.

A store cohort study of compliance with a point-of-sale cigarette display ban in Melbourne, Australia.

PubMed

Zacher, Meghan; Germain, Daniella; Durkin, Sarah; Hayes, Linda; Scollo, Michelle; Wakefield, Melanie

2013-02-01

This study aimed to evaluate compliance with legislation which restricted cigarette displays in retail outlets, and to assess prevalence of pro- and anti-tobacco elements in stores pre- and post-legislation. METHODS Three audits of 302 stores in Melbourne, Australia by trained observers who gathered information on point-of-sale tobacco displays 2-3 months before and 3-4 and 11-12 months after the enactment of new restrictions. Between the first and second audits, nine stores stopped selling tobacco and three stores had either shut down or were closed for renovations. Of the remaining 290 stores, 94.1% observed the full ban on cigarette package visibility, while new restrictions on price board size and new requirements for graphic health warnings were followed in 85.9% and 67.2% of stores, respectively. Between the second and third audits, another seven stores ended tobacco sales and two stores closed. In Audit 3, 89.7% of the remaining 281 stores complied with price board restrictions, and 82.2% of stores followed requirements for graphic health warnings. Overall, the prevalence of anti-tobacco signage increased and pro-tobacco features decreased between audits for every store type and neighborhood socio-economic status. Tobacco retailers were almost universally compliant with placing cigarettes out of sight and a substantial majority were compliant with regulations on price board size and display of graphic health warnings, demonstrating that such legislation can be implemented successfully.

Breast MRI BI-RADS Assessments and Abnormal Interpretation Rates by Clinical Indication in U.S. Community Practices

PubMed Central

Ichikawa, Laura; Rochelle, Michele C.; Kerlikowske, Karla; Miglioretti, Diana L.; Sprague, Brian L.; DeMartini, Wendy B.; Wernli, Karen J.; Joe, Bonnie N.; Yankaskas, Bonnie C.; Lehman, Constance D.

2014-01-01

Rationale and Objectives As breast MRI use grows, benchmark performance parameters are needed for auditing and quality assurance purposes. We describe the variation in breast MRI abnormal interpretation rates (AIRs) by clinical indication among a large sample of U.S. community practices. Materials and Methods We analyzed data from 41 facilities across five Breast Cancer Surveillance Consortium imaging registries. Each registry obtained IRB approval for this HIPAA compliant analysis. We included 11,654 breast MRI exams conducted in 2005–2010 among women aged 18–79 years. We categorized clinical indications as: 1) screening; 2) extent of disease; 3) diagnostic (e.g., breast symptoms); and 4) other (e.g., short-interval follow-up). We characterized assessments as positive (i.e., BI-RADS 0, 4, and 5) or negative (i.e., BI-RADS 1, 2, 6), and provide results with BI-RADS 3 categorized as positive and as negative. We tested for differences in AIRs across clinical indications both unadjusted and adjusted for patient characteristics and registry, and assessed for changes in AIRs by indication over time. Results When categorizing BI-RADS 3 as positive, AIRs were 21.0% (95% CI: 19.8, 22.3) for screening, 31.7% (95% CI: 29.6, 33.8) for extent of disease, 29.7% (95% CI: 28.3, 31.1) for diagnostic, and 27.4% (95% CI: 25.0, 29.8) for other indications (p<0.0001). When categorizing BI-RADS 3 as negative, AIRs were 10.5% (95% CI: 9.5, 11.4) for screening, 21.8% (95% CI: 19.9, 23.6) for extent of disease, 17.7% (95% CI: 16.5, 18.8) for diagnostic, and 13.3% (95% CI: 11.6, 15.2) for other indications (p<0.0001). The significant differences in AIRs by indication persisted even after adjusting for patient characteristics and registry (p<0.0001). In addition, for most indications, there were no significant changes in AIRs over time. Conclusion Breast MRI AIRs differ significantly by clinical indication. Practices should stratify breast MRI exams by indication for quality assurance and auditing purposes. PMID:25126973

Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients.

PubMed

Chang, Helena C; Tzou, David T; Usawachintachit, Manint; Duty, Brian D; Hsi, Ryan S; Harper, Jonathan D; Sorensen, Mathew D; Stoller, Marshall L; Sur, Roger L; Chi, Thomas

2016-12-01

Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database-the Registry for Stones of the Kidney and Ureter (ReSKU™)-was developed, and herein we describe our implementation outcomes. Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU. The number of variables within each instrument includes the following: New patient-60, Surgery-80, Postoperative-64, and Follow-up-64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient-12.06 ± 2.30, Postoperative-7.18 ± 1.02, and Follow-up-8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient-4.09 ± 1.73, Postoperative-1.41 ± 0.41, and Follow-up-0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated. ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease.

Managing Written Directives: A Software Solution to Streamline Workflow.

PubMed

Wagner, Robert H; Savir-Baruch, Bital; Gabriel, Medhat S; Halama, James R; Bova, Davide

2017-06-01

A written directive is required by the U.S. Nuclear Regulatory Commission for any use of 131 I above 1.11 MBq (30 μCi) and for patients receiving radiopharmaceutical therapy. This requirement has also been adopted and must be enforced by the agreement states. As the introduction of new radiopharmaceuticals increases therapeutic options in nuclear medicine, time spent on regulatory paperwork also increases. The pressure of managing these time-consuming regulatory requirements may heighten the potential for inaccurate or incomplete directive data and subsequent regulatory violations. To improve on the paper-trail method of directive management, we created a software tool using a Health Insurance Portability and Accountability Act (HIPAA)-compliant database. This software allows for secure data-sharing among physicians, technologists, and managers while saving time, reducing errors, and eliminating the possibility of loss and duplication. Methods: The software tool was developed using Visual Basic, which is part of the Visual Studio development environment for the Windows platform. Patient data are deposited in an Access database on a local HIPAA-compliant secure server or hard disk. Once a working version had been developed, it was installed at our institution and used to manage directives. Updates and modifications of the software were released regularly until no more significant problems were found with its operation. Results: The software has been used at our institution for over 2 y and has reliably kept track of all directives. All physicians and technologists use the software daily and find it superior to paper directives. They can retrieve active directives at any stage of completion, as well as completed directives. Conclusion: We have developed a software solution for the management of written directives that streamlines and structures the departmental workflow. This solution saves time, centralizes the information for all staff to share, and decreases confusion about the creation, completion, filing, and retrieval of directives. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients

PubMed Central

Chang, Helena C.; Tzou, David T.; Usawachintachit, Manint; Duty, Brian D.; Hsi, Ryan S.; Harper, Jonathan D.; Sorensen, Mathew D.; Stoller, Marshall L.; Sur, Roger L.

2016-01-01

Abstract Objectives: Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database—the Registry for Stones of the Kidney and Ureter (ReSKU™)—was developed, and herein we describe our implementation outcomes. Materials and Methods: Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU. Results: The number of variables within each instrument includes the following: New patient—60, Surgery—80, Postoperative—64, and Follow-up—64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient—12.06 ± 2.30, Postoperative—7.18 ± 1.02, and Follow-up—8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient—4.09 ± 1.73, Postoperative—1.41 ± 0.41, and Follow-up—0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated. Conclusions: ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease. PMID:27758162

Development of CPR security using impact analysis.

PubMed Central

Salazar-Kish, J.; Tate, D.; Hall, P. D.; Homa, K.

2000-01-01

The HIPAA regulations will require that institutions ensure the prevention of unauthorized access to electronically stored or transmitted patient records. This paper discusses a process for analyzing the impact of security mechanisms on users of computerized patient records through "behind the scenes" electronic access audits. In this way, those impacts can be assessed and refined to an acceptable standard prior to implementation. Through an iterative process of design and evaluation, we develop security algorithms that will protect electronic health information from improper access, alteration or loss, while minimally affecting the flow of work of the user population as a whole. PMID:11079984

Optimising calcium monitoring post thyroid and parathyroid surgery

PubMed Central

Rayner, Eleanor; Williams, Nerida; Dunn, Julie

2014-01-01

There is a risk of hypocalcaemia following total thyroidectomy and parathyroidectomy surgery, with the nadir being two to five days post operatively.[1] This project examined and improved the post-operative monitoring of serum calcium in patients undergoing these procedures at the Royal Devon and Exeter (RD&E) Hospital over a ten month period in 2013. A retrospective audit was undertaken, identifying whether serum calcium was monitored according to guideline; ie measured within the first 24 hours of surgery and daily thereafter until the patient was normocalcaemic.[2–3] The audit showed an overall compliance in 79% (n = 34) of cases. Of the non-compliant cases (n=9), seven also suffered hypocalcaemia. The current process was mapped by a flow chart and used as a basis for discussing experiences and identifying areas for improvement. Interventions implemented included a patient leaflet, a process flow chart displayed in the team office and in the weekend handover book, standard text for use in discharge summaries describing the process to GPs, the issuing of prescriptions or actual supplements for patients felt to be at high risk of hypocalcaemia, and finally education to the wider surgical junior doctor team. Percentage compliance with guidelines was compared before and after intervention with a re-audit undertaken in April 2014. Significant improvement was shown, with 100% of re-audit cases compliant (n=41), and all seven cases of hypocalcaemia were managed in full compliance with guideline. PMID:26732097

New HIPAA rules: a guide for radiology providers.

PubMed

Dresevic, Adrienne; Mikel, Clinton

2013-01-01

The Office for Civil Rights issued its long awaited final regulations modifying the HIPAA privacy, security, enforcement, and breach notification rules--the HIPAA Megarule. The new HIPAA rules will require revisions to Notice of Privacy Practices, changes to business associate agreements, revisions to HIPAA privacy and security policies and procedures, and an overall assessment of HIPAA compliance. The HIPAA Megarule formalizes the HITECH Act requirements, and makes it clear that the OCRs ramp up of HIPAA enforcement is not merely a passing trend. The new rules underscore that both covered entities and business associates must reassess and strengthen HIPAA compliance.

HIPAA costs and patient perceptions privacy safeguards Mayo Clinic.

PubMed

Williams, Arthur R; Herman, David C; Moriarty, James P; Beebe, Timothy J; Bruggeman, Sandra K; Klavetter, Eric W; Steger, Paul H; Bartz, Janet K

2008-01-01

A study was conducted to assess the costs of implementation of the Health Insurance Portability and Accountability Act (HIPAA) and to report patient awareness of Notices of Privacy Practices (NPP) content and HIPAA privacy protections. All HIPAA start-up and implementation costs were collected prospectively. A random sample of 2,000 patients receiving services at the Mayo Clinic after HIPAA implementation (April 14, 2003) was surveyed about HIPAA knowledge, HIPAA content, and privacy concerns. Comprehensive measures of total HIPAA costs and costs related only to privacy practices were amortized over 7, 15, and 20 years. Patient knowledge of privacy protections and attitudes toward HIPAA were obtained from 1,309 (65.5%) respondents. The total HIPAA startup costs were $4,663,672. Fully amortized costs (annual plus start-up costs) were $1 per patient visit or $5 per patient per year. Costs for the privacy portion were $2,734,855. These costs were about $.90 per patient visit or about $4 per patient per year. Patients indicated high levels of awareness of HIPAA (71%), reading the NPP (79%), knowledge about HIPAA (80% with 6+ correct answers on a 10-item quiz), and improved feelings of privacy (44% versus 55% the same). Patients reported high levels of knowledge about HIPAA and confidence in privacy protections. HIPAA costs were modest per patient or per visit.

Advertising Content, Platform Characteristics and the Appeal of Beer Advertising on a Social Networking Site.

PubMed

Noel, Jonathan K; Babor, Thomas F; Grady, James J

2018-03-15

The current study was conducted to investigate how changes in the content of a social media ad, user engagement values associated with the ad and user-generated comments (UGCs) associated with the ad can influence the appeal (i.e. source appeal, informational appeal and emotional appeal) of a social media ad. Facebook beer ads that violated the guidelines of a relevant marketing code were rated as more emotionally appealing compared to Facebook beer ads that did not violated the guidelines. Increased emotional appeal in beer advertising increases the probability that the ad will be remembered and influence future drinking occasions. A 2 (ad regulatory compliance: compliant vs. non-compliant) × 2 (user engagement: low vs. high) × 2 (UGC congruence: pro- vs anti-alcohol) mixed factorial experiment was conducted with 120 young adults, 21-24 years old. Each participant viewed four Facebook beer ads that were previously evaluated for thematic content and regulatory compliance. Participants were randomized to view either high or low user engagement values and either pro- or anti-drinking user-generated comments. After each ad exposure, ad appeal was assessed. Statistical analysis was conducted using hierarchical linear modeling. Models were adjusted for demographics, Alcohol Use Disorders Identification Test (AUDIT) scores and Facebook involvement. Source appeal (P = 0.034) and informational appeal (P < 0.001) were significantly higher among ads that were compliant with existing advertising regulations. Emotional appeal was significantly higher among ads that were non-compliant (P = 0.004). The effect of user engagement and UGCs were non-significant (p's > 0.05). Additionally, AUDIT scores (p's < 0.01) and Facebook involvement scores (p's < 0.01) were positively associated with all forms of ad appeal. The appeal of Facebook beer ads may be primarily determined by ad content. Increased emotional appeal in advertising caused by non-compliant advertising may increase the probability that the ad will be remembered and influence future drinking occasions.

Development and evaluation of an open source software tool for deidentification of pathology reports

PubMed Central

Beckwith, Bruce A; Mahaadevan, Rajeshwarri; Balis, Ulysses J; Kuo, Frank

2006-01-01

Background Electronic medical records, including pathology reports, are often used for research purposes. Currently, there are few programs freely available to remove identifiers while leaving the remainder of the pathology report text intact. Our goal was to produce an open source, Health Insurance Portability and Accountability Act (HIPAA) compliant, deidentification tool tailored for pathology reports. We designed a three-step process for removing potential identifiers. The first step is to look for identifiers known to be associated with the patient, such as name, medical record number, pathology accession number, etc. Next, a series of pattern matches look for predictable patterns likely to represent identifying data; such as dates, accession numbers and addresses as well as patient, institution and physician names. Finally, individual words are compared with a database of proper names and geographic locations. Pathology reports from three institutions were used to design and test the algorithms. The software was improved iteratively on training sets until it exhibited good performance. 1800 new pathology reports were then processed. Each report was reviewed manually before and after deidentification to catalog all identifiers and note those that were not removed. Results 1254 (69.7 %) of 1800 pathology reports contained identifiers in the body of the report. 3439 (98.3%) of 3499 unique identifiers in the test set were removed. Only 19 HIPAA-specified identifiers (mainly consult accession numbers and misspelled names) were missed. Of 41 non-HIPAA identifiers missed, the majority were partial institutional addresses and ages. Outside consultation case reports typically contain numerous identifiers and were the most challenging to deidentify comprehensively. There was variation in performance among reports from the three institutions, highlighting the need for site-specific customization, which is easily accomplished with our tool. Conclusion We have demonstrated that it is possible to create an open-source deidentification program which performs well on free-text pathology reports. PMID:16515714

Protection detail. Protecting against breach of electronic protected health information.

PubMed

Blass, Gerry; Miller, Susan A

2010-01-01

Covered entities need to conduct risk assessments that cover the requirements of HIPAA, HITECH and Meaningful use, and create a process for steady and consistent mitigation of known gaps and vulnerabilities based on risk. Reducing risk of vulnerabilities of unauthorized access to your ePHI can be done via safeguards and controls, plus audits and monitoring. When reducing risk is outside of a covered entities control, audits and monitoring are required in order to demonstrate due diligence. Know where your ePHI is stored, where it is at risk, and take steps now to reduce or eliminate the risk. Encrypt vulnerable locations. Encrypt sensitive data. By doing so, you will be protecting your organization by reducing risk of breach of ePHI. Finally, don't forget what is sometimes considered to be the hardest part--documenting your compliance activities in order to demonstrate evidence of due diligence in and avoid major $$$$ penalties for negligence under the HITECH Act of 2009.

The management of epilepsy in pregnancy at the Whittington Hospital: a retrospective audit 2004–2006 and 2007–2010

PubMed Central

Allen, Rebecca; Grosu, Liliana; Das, Ishita; Kyei-Mensah, Amma

2013-01-01

Background: In the last maternal death enquiries report there were 14 indirect deaths due to epilepsy. Methods: Retrospective case-note analysis of epileptic women seen antenatally over two separate time periods were examined. Care in the routine antenatal clinic (ANC) was compared with that in the obstetric medicine clinic (OMC). Results: 1st audit, 65 epileptic women seen. In OMC 14% had documented preconception counselling, 58% were on anti-epileptic drugs (AEDs). In ANC 0% had documented preconception counselling, 34% were on AEDs. 2nd audit, 88 epileptic women seen. In OMC 37.5% of women had preconception counselling, 84% were on AEDs. In ANC, 4.2% had preconception counselling, 31% were on AEDs. Conclusions: Women seen in OMC received care more compliant with Scottish Obstetric Group and Audit Project recommendations. All women with epilepsy should be reviewed in an OMC. PMID:27757160

DOE Office of Scientific and Technical Information (OSTI.GOV)

Joseph, A.; Seuntjens, J.; Parker, W.

We describe development of automated, web-based, electronic health record (EHR) auditing software for use within our paperless radiation oncology clinic. By facilitating access to multiple databases within the clinic, each patient's EHR is audited prior to treatment, regularly during treatment, and post treatment. Anomalies such as missing documentation, non-compliant workflow and treatment parameters that differ significantly from the norm may be monitored, flagged and brought to the attention of clinicians. By determining historical trends using existing patient data and by comparing new patient data with the historical, we expect our software to provide a measurable improvement in the quality ofmore » radiotherapy at our centre.« less

Extended outlook: description, utilization, and daily applications of cloud technology in radiology.

PubMed

Gerard, Perry; Kapadia, Neil; Chang, Patricia T; Acharya, Jay; Seiler, Michael; Lefkovitz, Zvi

2013-12-01

The purpose of this article is to discuss the concept of cloud technology, its role in medical applications and radiology, the role of the radiologist in using and accessing these vast resources of information, and privacy concerns and HIPAA compliance strategies. Cloud computing is the delivery of shared resources, software, and information to computers and other devices as a metered service. This technology has a promising role in the sharing of patient medical information and appears to be particularly suited for application in radiology, given the field's inherent need for storage and access to large amounts of data. The radiology cloud has significant strengths, such as providing centralized storage and access, reducing unnecessary repeat radiologic studies, and potentially allowing radiologic second opinions more easily. There are significant cost advantages to cloud computing because of a decreased need for infrastructure and equipment by the institution. Private clouds may be used to ensure secure storage of data and compliance with HIPAA. In choosing a cloud service, there are important aspects, such as disaster recovery plans, uptime, and security audits, that must be considered. Given that the field of radiology has become almost exclusively digital in recent years, the future of secure storage and easy access to imaging studies lies within cloud computing technology.

Comparison Between Manual Auditing and a Natural Language Process With Machine Learning Algorithm to Evaluate Faculty Use of Standardized Reports in Radiology.

PubMed

Guimaraes, Carolina V; Grzeszczuk, Robert; Bisset, George S; Donnelly, Lane F

2018-03-01

When implementing or monitoring department-sanctioned standardized radiology reports, feedback about individual faculty performance has been shown to be a useful driver of faculty compliance. Most commonly, these data are derived from manual audit, which can be both time-consuming and subject to sampling error. The purpose of this study was to evaluate whether a software program using natural language processing and machine learning could accurately audit radiologist compliance with the use of standardized reports compared with performed manual audits. Radiology reports from a 1-month period were loaded into such a software program, and faculty compliance with use of standardized reports was calculated. For that same period, manual audits were performed (25 reports audited for each of 42 faculty members). The mean compliance rates calculated by automated auditing were then compared with the confidence interval of the mean rate by manual audit. The mean compliance rate for use of standardized reports as determined by manual audit was 91.2% with a confidence interval between 89.3% and 92.8%. The mean compliance rate calculated by automated auditing was 92.0%, within that confidence interval. This study shows that by use of natural language processing and machine learning algorithms, an automated analysis can accurately define whether reports are compliant with use of standardized report templates and language, compared with manual audits. This may avoid significant labor costs related to conducting the manual auditing process. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

What litigators need to know about HIPAA.

PubMed

Stein, Scott D

2003-01-01

HIPAA's Privacy Regulations impose a number of new requirements on Covered Entities concerning disclosure of an individual's personal health information. This Article briefly outlines the primary function of HIPAA's general nondisclosure rule and discusses the exceptions under which HIPAA permits disclosure in the course of litigation or government investigations.

78 FR 34264 - Technical Corrections to the HIPAA Privacy, Security, and Enforcement Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...-AA03 Technical Corrections to the HIPAA Privacy, Security, and Enforcement Rules AGENCY: Office for... corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement... (HHS or ``the Department'') published a final rule to implement changes to the HIPAA Privacy, Security...

Healthcare Blockchain System Using Smart Contracts for Secure Automated Remote Patient Monitoring.

PubMed

Griggs, Kristen N; Ossipova, Olya; Kohlios, Christopher P; Baccarini, Alessandro N; Howson, Emily A; Hayajneh, Thaier

2018-06-06

As Internet of Things (IoT) devices and other remote patient monitoring systems increase in popularity, security concerns about the transfer and logging of data transactions arise. In order to handle the protected health information (PHI) generated by these devices, we propose utilizing blockchain-based smart contracts to facilitate secure analysis and management of medical sensors. Using a private blockchain based on the Ethereum protocol, we created a system where the sensors communicate with a smart device that calls smart contracts and writes records of all events on the blockchain. This smart contract system would support real-time patient monitoring and medical interventions by sending notifications to patients and medical professionals, while also maintaining a secure record of who has initiated these activities. This would resolve many security vulnerabilities associated with remote patient monitoring and automate the delivery of notifications to all involved parties in a HIPAA compliant manner.

HIPAA Readiness Collaborative in Hawaii.

PubMed

Chun, Marva; Forbes, Susan; Gose, Steven; Kumabe, Brenda; Loo, Jeffrey; Nichols, Lorraine; Rosa, Luis; Sherrill, Laura; Turner, Jim

2002-01-01

The vision of Hawaii's HIPAA Readiness Collaborative (HRC) effort is to realize the positive potential of HIPAA through a collaborative process that engages the entire healthcare delivery system. Goals include reducing the cost of healthcare through streamlining, reducing the cost of HIPAA implementation for HRC participants, and improving the interoperability between facilities through use of standard technologies.

HIPAA Privacy 101: essentials for case management practice.

PubMed

DiBenedetto, Deborah V

2003-01-01

The Health Insurance Portability and Accountability Act (HIPAA) has significant impact on the delivery of healthcare in the United States. The Administrative Simplification (AS) requirements of HIPAA are aimed at reducing administrative costs and burdens in the healthcare industry. The core components of HIPAA's AS requirements address healthcare transactions, code sets, security, unique identifiers, and privacy of health information. HIPAA's privacy standard limits the nonconsensual use and release of private health information, gives patients new rights to access their medical records and to know who else has accessed them, restricts most disclosure of health information to the minimum needed for the intended purpose, establishes new criminal and civil sanctions for improper use or disclosure, and establishes new requirements for access to records by researchers and others. This article focuses on HIPAA's privacy requirements as related to case management of workers compensation populations, the treatment of protected health information, and how case managers can ensure they provide appropriate services while navigating the requirements of HIPAA's privacy standard.

Development of a Google-based search engine for data mining radiology reports.

PubMed

Erinjeri, Joseph P; Picus, Daniel; Prior, Fred W; Rubin, David A; Koppel, Paul

2009-08-01

The aim of this study is to develop a secure, Google-based data-mining tool for radiology reports using free and open source technologies and to explore its use within an academic radiology department. A Health Insurance Portability and Accountability Act (HIPAA)-compliant data repository, search engine and user interface were created to facilitate treatment, operations, and reviews preparatory to research. The Institutional Review Board waived review of the project, and informed consent was not required. Comprising 7.9 GB of disk space, 2.9 million text reports were downloaded from our radiology information system to a fileserver. Extensible markup language (XML) representations of the reports were indexed using Google Desktop Enterprise search engine software. A hypertext markup language (HTML) form allowed users to submit queries to Google Desktop, and Google's XML response was interpreted by a practical extraction and report language (PERL) script, presenting ranked results in a web browser window. The query, reason for search, results, and documents visited were logged to maintain HIPAA compliance. Indexing averaged approximately 25,000 reports per hour. Keyword search of a common term like "pneumothorax" yielded the first ten most relevant results of 705,550 total results in 1.36 s. Keyword search of a rare term like "hemangioendothelioma" yielded the first ten most relevant results of 167 total results in 0.23 s; retrieval of all 167 results took 0.26 s. Data mining tools for radiology reports will improve the productivity of academic radiologists in clinical, educational, research, and administrative tasks. By leveraging existing knowledge of Google's interface, radiologists can quickly perform useful searches.

Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries.

PubMed

Van Assche, Kerlijn; Nebot Giralt, Ariadna; Caudron, Jean Michel; Schiavetti, Benedetta; Pouget, Corinne; Tsoumanis, Achilleas; Meessen, Bruno; Ravinetto, Raffaella

2018-01-01

The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors' compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines 'Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.

HIPAA Compliance and Training: A Perfect Storm for Professionalism Education?

PubMed

Agris, Julie L; Spandorfer, John M

2016-12-01

The HIPAA Rules continue to support and bolster the importance of protecting the privacy and security of patients' protected health information. The HIPAA training requirements are at the cornerstone of meaningful implementation and provide a ripe opportunity for critical education.

Security measures required for HIPAA privacy.

PubMed

Amatayakul, M

2000-01-01

HIPAA security requirements include administrative, physical, and technical services and mechanisms to safeguard confidentiality, availability, and integrity of health information. Security measures, however, must be implemented in the context of an organization's privacy policies. Because HIPAA's proposed privacy rules are flexible and scalable to account for the nature of each organization's business, size, and resources, each organization will be determining its own privacy policies within the context of the HIPAA requirements and its security capabilities. Security measures cannot be implemented in a vacuum.

Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

PubMed

Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

2014-01-01

EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Security of electronic medical information and patient privacy: what you need to know.

PubMed

Andriole, Katherine P

2014-12-01

The responsibility that physicians have to protect their patients from harm extends to protecting the privacy and confidentiality of patient health information including that contained within radiological images. The intent of HIPAA and subsequent HIPAA Privacy and Security Rules is to keep patients' private information confidential while allowing providers access to and maintaining the integrity of relevant information needed to provide care. Failure to comply with electronic protected health information (ePHI) regulations could result in financial or criminal penalties or both. Protected health information refers to anything that can reasonably be used to identify a patient (eg, name, age, date of birth, social security number, radiology examination accession number). The basic tools and techniques used to maintain medical information security and patient privacy described in this article include physical safeguards such as computer device isolation and data backup, technical safeguards such as firewalls and secure transmission modes, and administrative safeguards including documentation of security policies, training of staff, and audit tracking through system logs. Other important concepts related to privacy and security are explained, including user authentication, authorization, availability, confidentiality, data integrity, and nonrepudiation. Patient privacy and security of medical information are critical elements in today's electronic health care environment. Radiology has led the way in adopting digital systems to make possible the availability of medical information anywhere anytime, and in identifying and working to eliminate any risks to patients. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

High-Resolution 3-T Magnetic Resonance Imaging of the Shoulder in Nonsymptomatic Professional Baseball Pitcher Draft Picks.

PubMed

Del Grande, Filippo; Aro, Michael; Jalali Farahani, Sahar; Cosgarea, Andrew; Wilckens, John; Carrino, John A

2016-01-01

To retrospectively assess the qualitative and quantitative high-resolution 3-T magnetic resonance imaging (MRI) findings in nonsymptomatic baseball pitcher draft picks. Institutional review board-approved and HIPAA compliant study. Three-Tesla MRI of the dominant shoulder of 19 asymptomatic baseball pitcher draft picks and detailed clinical examination was performed before contract signing. Two radiologists performed independently qualitative and quantitative evaluation of shoulder structures. Descriptive statistics were performed. Sixty-eight percent (13/19), 32% (6/19), and 21% (4/19) of the baseball pitcher draft picks showed tendinopathy, partial thickness tendon tear of the supraspinatus, and acromioclavicular joint osteoarthritis, respectively. Glenohumeral subluxation, glenoid remodeling, and Bennett lesion were present in 53% (10/19), 79% (15/19), and 21% (4/19) of the subjects, respectively. Interclass coefficient was 0.633 to 0.863 and κ was 0.27 to 1. In asymptomatic baseball pitcher draft picks, 3-T MRI frequently shows abnormalities involving rotator cuff tendons, the coracohumeral, inferior glenohumeral, labrum, and osseous structures.

Designing an Educational Website to Improve Quality of Supportive Oncology Care for Women with Ovarian Cancer: An Expert Usability Review and Analysis.

PubMed

McClellan, Molly A; Karumur, Raghav Pavan; Vogel, Rachel Isaksson; Petzel, Sue V; Cragg, Julie; Chan, Daniel; Jacko, Julie A; Sainfort, François; Geller, Melissa A

A broad-based research team developed a Health Insurance Portability and Accountability Act (HIPAA)-compliant educational website for women with ovarian cancer to improve the quality of supportive oncology care. Prior to a randomized clinical trial of the website, initial usability testing was implemented to evaluate the website. The initial review found that 165/247 checklist items had sufficient information to allow for evaluation with the website achieving an overall score of 63%. By category, lowest scores were for the Home Page, Task Orientation, Page Layout & Visual Design, and Help, Feedback & Error Tolerance. Major issues thought to potentially impede actual usage were prioritized in redevelopment and the second usability review, conducted by the same expert, saw an improvement in scores. Incorporating usability concepts from the start of development, fulfilling the positive expectations of end-users and identifying technical and personal factors that optimize use may greatly enhance usage of health websites.

A Framework for Privacy-preserving Classification of Next-generation PHR data.

PubMed

Koufi, Vassiliki; Malamateniou, Flora; Prentza, Andriana; Vassilacopoulos, George

2014-01-01

Personal Health Records (PHRs), integrated with data from various sources, such as social care data, Electronic Health Record data and genetic information, are envisaged as having a pivotal role in transforming healthcare. These data, lumped under the term 'big data', are usually complex, noisy, heterogeneous, longitudinal and voluminous thus prohibiting their meaningful use by clinicians. Deriving value from these data requires the utilization of innovative data analysis techniques, which, however, may be hindered due to potential security and privacy breaches that may arise from improper release of personal health information. This paper presents a HIPAA-compliant machine learning framework that enables privacy-preserving classification of next-generation PHR data. The predictive models acquired can act as supporting tools to clinical practice by enabling more effective prevention, diagnosis and treatment of new incidents. The proposed framework has a huge potential for complementing medical staff expertise as it outperforms the manual inspection of PHR data while protecting patient privacy.

Designing an Educational Website to Improve Quality of Supportive Oncology Care for Women with Ovarian Cancer: An Expert Usability Review and Analysis

PubMed Central

McClellan, Molly A.; Karumur, Raghav Pavan; Vogel, Rachel Isaksson; Petzel, Sue V.; Cragg, Julie; Chan, Daniel; Jacko, Julie A.; Sainfort, François; Geller, Melissa A.

2016-01-01

A broad-based research team developed a Health Insurance Portability and Accountability Act (HIPAA)-compliant educational website for women with ovarian cancer to improve the quality of supportive oncology care. Prior to a randomized clinical trial of the website, initial usability testing was implemented to evaluate the website. The initial review found that 165/247 checklist items had sufficient information to allow for evaluation with the website achieving an overall score of 63%. By category, lowest scores were for the Home Page, Task Orientation, Page Layout & Visual Design, and Help, Feedback & Error Tolerance. Major issues thought to potentially impede actual usage were prioritized in redevelopment and the second usability review, conducted by the same expert, saw an improvement in scores. Incorporating usability concepts from the start of development, fulfilling the positive expectations of end-users and identifying technical and personal factors that optimize use may greatly enhance usage of health websites. PMID:27110082

Development of a HIPAA-compliant environment for translational research data and analytics.

PubMed

Bradford, Wayne; Hurdle, John F; LaSalle, Bernie; Facelli, Julio C

2014-01-01

High-performance computing centers (HPC) traditionally have far less restrictive privacy management policies than those encountered in healthcare. We show how an HPC can be re-engineered to accommodate clinical data while retaining its utility in computationally intensive tasks such as data mining, machine learning, and statistics. We also discuss deploying protected virtual machines. A critical planning step was to engage the university's information security operations and the information security and privacy office. Access to the environment requires a double authentication mechanism. The first level of authentication requires access to the university's virtual private network and the second requires that the users be listed in the HPC network information service directory. The physical hardware resides in a data center with controlled room access. All employees of the HPC and its users take the university's local Health Insurance Portability and Accountability Act training series. In the first 3 years, researcher count has increased from 6 to 58.

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

42 CFR 403.812 - HIPAA privacy, security, administrative data standards, and national identifiers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false HIPAA privacy, security, administrative data standards, and national identifiers. 403.812 Section 403.812 Public Health CENTERS FOR MEDICARE & MEDICAID... Prescription Drug Discount Card and Transitional Assistance Program § 403.812 HIPAA privacy, security...

78 FR 5565 - Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... certain health information, such as standards for certain health care transactions conducted electronically and code sets and unique identifiers for health care providers and employers. The HIPAA... HIPAA apply to three types of entities, which are known as ``covered entities'': health care providers...

The Relationship of HIPAA to Special Education

ERIC Educational Resources Information Center

Benitz, Catherine, Comp.

2006-01-01

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) includes important, but limited, protections for millions of working Americans and their families around the ability to obtain and keep health coverage. Among its specific protections, HIPAA: (1) Limits the use of preexisting condition exclusions; (2) Prohibits group health…

HIPAA and talking with family caregivers: what does the law really say?

PubMed

Levine, Carol

2006-08-01

The Health Insurance Portability and Accountability Act of 1996 (PL 104-191), known as HIPAA, has confused and unnecessarily alarmed many conscientious health care providers. Nurses in particular are likely to be on the front line of family caregivers' inquiries, because physicians are often difficult to reach and because family caregivers look to nurses as sources of reliable information. A major retraining of health care providers at all levels is needed to dampen the "HIPAA scare" and clarify what HIPAA does and does not say about communication with family caregivers.

Family Caregiver Research and the HIPAA Factor

ERIC Educational Resources Information Center

Albert, Steven M.; Levine, Carol

2005-01-01

Research in family caregiving recently has become more challenging because of the strict protection of privacy mandated in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. We ask when should Institutional Review Boards (IRBs) follow HIPAA rules to the letter and when might they use the waiver option? What is the appropriate…

Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; other modifications to the HIPAA rules.

PubMed

2013-01-25

The Department of Health and Human Services (HHS or ``the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities.

United States Marine Corps 2012 Financial Report. Schedule of Budgetary Activity for Fiscal Year 2012 Appropriations

DTIC Science & Technology

2012-01-01

activity schedule for current year appropriations that is also compliant with Generally Accepted Accounting Principles ( GAAP ). The audit of this financial...are not only fighters, but also who can serve as trainers, mentors and advisers. Marine Corps Value to the Nation For a remarkably small investment ...who are interested in and could use the information in the statements to help them make resource allocation and other decisions and hold the entity

The application of telemedicine in orthopedic surgery in singapore: a pilot study on a secure, mobile telehealth application and messaging platform.

PubMed

Daruwalla, Zubin Jimmy; Wong, Keng Lin; Thambiah, Joseph

2014-06-05

The application of telemedicine has been described for its use in medical training and education, management of stroke patients, urologic surgeries, pediatric laparoscopic surgeries, clinical outreach, and the field of orthopedics. However, the usefulness of a secure, mobile telehealth application, and messaging platform has not been well described. A pilot study was conducted to implement a health insurance portability and accountability act (HIPAA) compliant form of communication between doctors in an orthopedic clinical setting and determine their reactions to MyDoc, a secure, mobile telehealth application, and messaging platform. By replacing current methods of communication through various mobile applications and text messaging services with MyDoc over a six week period, we gained feedback and determined user satisfaction with this innovative system from questionnaires handed to the program director, program coordinator, one trauma consultant, all orthopedic residents, and six non-orthopedic residents at the National University Hospital in Singapore. Almost everyone who completed the questionnaire strongly agreed that MyDoc should replace current systems of peer to peer communication in the hospital. The majority also felt that the quality of images, videos, and sound were excellent. Almost everyone agreed that they could communicate easily with each other and would feel comfortable doing so routinely. The majority felt that virtual consults through MyDoc should be made available to inpatients as well as outpatients to potentially lessen clinic loads and provide a secure manner in which patients can communicate with their primary teams any time convenient to both. It was also agreed by most that the potential of telerounding had advantages, especially on weekends as a supplement to normal rounds. Potential uses of MyDoc in an orthopedic clinical setting include HIPAA-compliant peer to peer communication, clinical outreach in the setting of trauma, supervision in the operating room or watching procedures being performed remotely, providing both patient and parent reassurance in pediatric orthopedic patients, and finally in the setting of outpatient clinics. With our pilot study having excellent results in terms of acceptance and satisfaction, the integration of a secure, mobile telehealth application, and messaging platform, not only in the orthopedic department but also the hospital in general, has an exciting and limitless potential. More so in this era where downsizing hospital costs is beneficial, doing so may also be mandatory in order to comply with the soon to be introduced personal data protection act.

The complexities of HIPAA and administration simplification.

PubMed

Mozlin, R

2000-11-01

The Health Insurance Portability and Accessibility Act (HIPAA) was signed into law in 1996. Although focused on information technology issues, HIPAA will ultimately impact day-to-day operations at multiple levels within any clinical setting. Optometrists must begin to familiarize themselves with HIPAA in order to prepare themselves to practice in a technology-enriched environment. Title II of HIPAA, entitled "Administration Simplification," is intended to reduce the costs and administrative burden of healthcare by standardizing the electronic transmission of administrative and financial transactions. The Department of Health and Human Services is expected to publish the final rules and regulations that will govern HIPAA's implementation this year. The rules and regulations will cover three key aspects of healthcare delivery: electronic data interchange (EDI), security and privacy. EDI will standardize the format for healthcare transactions. Health plans must accept and respond to all transactions in the EDI format. Security refers to policies and procedures that protect the accuracy and integrity of information and limit access. Privacy focuses on how the information is used and disclosure of identifiable health information. Security and privacy regulations apply to all information that is maintained and transmitted in a digital format and require administrative, physical, and technical safeguards. HIPAA will force the healthcare industry to adopt an e-commerce paradigm and provide opportunities to improve patient care processes. Optometrists should take advantage of the opportunity to develop more efficient and profitable practices.

45 CFR 150.207 - Procedure for determining that a State fails to substantially enforce HIPAA requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Procedure for determining that a State fails to... MARKETS CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce HIPAA Requirements § 150.207 Procedure for determining that a State fails to substantially enforce HIPAA...

45 CFR 150.207 - Procedure for determining that a State fails to substantially enforce HIPAA requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Procedure for determining that a State fails to... MARKETS CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce HIPAA Requirements § 150.207 Procedure for determining that a State fails to substantially enforce HIPAA...

45 CFR 150.207 - Procedure for determining that a State fails to substantially enforce HIPAA requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Procedure for determining that a State fails to... MARKETS CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce HIPAA Requirements § 150.207 Procedure for determining that a State fails to substantially enforce HIPAA...

HIPAA the Health Care Hippo: Despite the Rhetoric, Is Privacy Still an Issue?

ERIC Educational Resources Information Center

Kuczynski, Kay; Gibbs-Wahlberg, Patty

2005-01-01

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (PL. 104-191) is a multitiered, comprehensive, convoluted, and controversial federal law for sweeping health care reform. Although HIPAA is dramatically broader in scope than privacy protections for health care information, a provision for privacy in the form of a Privacy Rule…

Cosmetic surgery in the NHS: Applying local and national guidelines.

PubMed

Breuning, Eleonore E; Oikonomou, Dimitris; Singh, Pritam; Rai, Jagdeep K; Mendonca, Derick Amith

2010-09-01

There is no worldwide consensus, as to how healthcare should be funded, in a modern society. Limited resources in the UK, have led to restrictions on cosmetic surgery in the NHS. Guidelines governing access to cosmetic surgery have been formulated. A retrospective audit has been undertaken, to assess adherence to local and national guidelines, in an NHS trust. Ninety-nine casenotes were reviewed over 1 year. Data on complications were collected. Compliance to local guidelines was 44% and to national guidelines was 22%. Complication rate was 23% in guideline compliant patients and 55% in non-compliant patients (P<0.005). Guidelines are difficult to follow in practice. Total adherence to guidelines would reduce waiting lists and complications, but some needy patients could be denied treatment. In practice, rigid adherence to guidelines is not possible. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries

PubMed Central

Caudron, Jean Michel; Schiavetti, Benedetta; Pouget, Corinne; Tsoumanis, Achilleas; Meessen, Bruno; Ravinetto, Raffaella

2018-01-01

Introduction The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes. PMID:29915671

HIPAA--a real world perspective.

PubMed

Nulan, C

2001-01-01

An effective and realistic approach to HIPAA compliance requires healthcare organizations to achieve a fundamental shift in attitude, awareness, habits and capabilities in the areas of privacy and security. They must create a sense of accountability among staff, and even patients, for the safeguarding of patient information. Only when this culture shift has occurred, along with the required technological advancements, can HIPAA compliance be realistically achieved. There is still ample time to create the organizational shift necessary, along with technological enhancements, to meet HIPAA requirements. Beyond compliance, HIPAA will benefit the healthcare industry by promoting administrative simplification--the original intention of the Act. And it will require the healthcare industry, in an abbreviated timeframe, to upgrade its level of sophistication in managing information. HIPAA certification springs from an organizational compliance method that has been underway in government for the past two decades. The HIPAA playbook is taken lock, stock and barrel from other Federal guidelines. HIPAA's legislative lineage includes the Healthcare Reform Act of 1993, Paperwork Reduction Act of 1980, Computer Security Act of 1987 and the Privacy Act of 1974. HIPAA means that public and private sector healthcare organizations are going to be required by law to adopt the same information-handling practices that have been in effect in the Federal government for years. That boils down to two things: Standardized formatting of data electronically exchanged between providers, payers and business partners (EDI) Federalization of security and privacy practices within private-sector healthcare information management The key to making HIPAA compliance achievable within a practical timeframe, as well as instituting the culture changes that go with enhanced privacy and security standards, is a process that is largely unfamiliar in the private sector, called administrative certification and accreditation. Certification is an organizational change-management methodology that drives accountability for security down to that level in the organization where it will concretely and tangibly get done. It is a comprehensive managerial assessment of the technical and non-technical security features and other safeguards of a system associated with its use and environment. The assessment seeks to establish and document the extent to which a particular system meets a set of specified security requirements. HIPAA accreditation occurs when all functional managers in an organization have completed reports of what they know they need to do in their areas. They submit that information to an executive official within the organization who functions as the accrediting official for the organization. Accreditation is the formal declaration that an information system is approved to operate in a particular security mode using a prescribed set of safeguards and should be strongly based on the solvable vulnerabilities and residual risks identified during certification. Institutionalizing a practical and formal HIPAA certification program is important to support business activities and can provide several benefits including increased communication within an organization.

'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

PubMed

Park, Sinyoung; Nam, Chung Mo; Park, Sejung; Noh, Yang Hee; Ahn, Cho Rong; Yu, Wan Sun; Kim, Bo Kyung; Kim, Seung Min; Kim, Jin Seok; Rha, Sun Young

2018-04-25

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, < 0.0001, < 0.0001, respectively). Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants' personal information were associated with higher audit grade (p < 0.0001, p = 0.0001, p < 0.0001, p = 0.003). We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits.

How automated access verification can help organizations demonstrate HIPAA compliance: A case study.

PubMed

Hill, Linda

2006-01-01

This case study of Sharp HealthCare takes an in depth look at how the organization has embedded security policies into its business process and automated workflow to ensure users are granted only the IT access that is necessary for them to perform their jobs and to ensure patient privacy Some of the most pressing audit and compliance concerns in healthcare organizations today revolve around the need to constantly review and give an account for users' IT access. The need for this at Sharp is exacerbated because of the high rate of change within the organization and the large percentage of non-employee staff such as traveling nurses moving throughout hospital departments on their rotations. By implementing a software solution to verify the accuracy of user access rights or automatically initiate appropriate corrective actions, Sharp is now able to extend the responsibility and accountability for compliance to the most appropriate resources.

Applying your corporate compliance skills to the HIPAA security standard.

PubMed

Carter, P I

2000-01-01

Compliance programs are an increasingly hot topic among healthcare providers. These programs establish policies and procedures covering billing, referrals, gifts, confidentiality of patient records, and many other areas. The purpose is to help providers prevent and detect violations of the law. These programs are voluntary, but are also simply good business practice. Any compliance program should now incorporate the Health Insurance Portability and Accountability Act (HIPAA) security standard. Several sets of guidelines for development of compliance programs have been issued by the federal government, and each is directed toward a different type of healthcare provider. These guidelines share certain key features with the HIPAA security standard. This article examines the common areas between compliance programs and the HIPAA security standard to help you to do two very important things: (1) Leverage your resources by combining compliance with the security standard with other legal and regulatory compliance efforts, and (2) apply the lessons learned in developing your corporate compliance program to developing strategies for compliance with the HIPAA security standard.

Compliance with HIPAA security standards in U.S. Hospitals.

PubMed

Davis, Diane; Having, Karen

2006-01-01

With the widespread use of computer networks, the amount of information stored electronically has grown exponentially, resulting in increased concern for privacy and security of information. The healthcare industry has been put to the test with the federally mandated Health Insurance Portability and Accountability Act (HIPAA) of 1996. To assess the compliance status of HIPAA security standards, a random sample of 1,000 U.S. hospitals was surveyed in January 2004, yielding a return rate of 29 percent. One year later, a follow-up survey was sent to all previous respondents, with 50 percent replying. HIPAA officers'perceptions of security compliance in 2004 and 2005 are compared in this article. The security standards achieving the highest level of compliance in both 2004 and 2005 were obtaining required business associate agreements and physical safeguards to limit access to electronic information systems. Respondents indicated least compliance both years in performing periodic evaluation of security practices governed by the Security Rule. Roadblocks, threats, problems and solutions regarding HIPAA compliance are discussed. This information may be applied to current and future strategies toward maintaining security of information systems throughout the healthcare industry.

HIPAA privacy rules and compliance with federal and state employment laws: the participant authorization form.

PubMed

Brislin, Joseph A

2003-03-01

Although HIPAA privacy rules do not apply directly to employers or to employment records, they do apply indirectly to employers because employer-sponsored group health plans and all health care providers are covered. HIPAA privacy regulations overlap with federal and state employment laws, and liabilities for breach of confidentiality can be substantial. Employers can use a participant's authorization form to comply with employment laws and company policies. Sample authorization forms are provided at the end of this article.

Do you know your business associates?

PubMed

Hinkley, Gerald M; Glitz, Rachel; Hirsch, W Reece

2003-01-01

HIPAA's business associate rules require covered entities to identify their business associates and enter into contracts with them to safeguard the privacy of individually identifiable health information. Covered entities need to determine who their business associates are and whether exceptions apply. Covered entities need to examine their business associate contracts to ensure that the contracts contain provisions required by HIPAA. Covered entities should not enter into business associate contracts unnecessarily. Existing business associate contracts are subject to a transition period for compliance with HIPAA.

Electronic Communication of Protected Health Information: Privacy, Security, and HIPAA Compliance.

PubMed

Drolet, Brian C; Marwaha, Jayson S; Hyatt, Brad; Blazar, Phillip E; Lifchez, Scott D

2017-06-01

Technology has enhanced modern health care delivery, particularly through accessibility to health information and ease of communication with tools like mobile device messaging (texting). However, text messaging has created new risks for breach of protected health information (PHI). In the current study, we sought to evaluate hand surgeons' knowledge and compliance with privacy and security standards for electronic communication by text message. A cross-sectional survey of the American Society for Surgery of the Hand membership was conducted in March and April 2016. Descriptive and inferential statistical analyses were performed of composite results as well as relevant subgroup analyses. A total of 409 responses were obtained (11% response rate). Although 63% of surgeons reported that they believe that text messaging does not meet Health Insurance Portability and Accountability Act of 1996 security standards, only 37% reported they do not use text messages to communicate PHI. Younger surgeons and respondents who believed that their texting was compliant were statistically significantly more like to report messaging of PHI (odds ratio, 1.59 and 1.22, respectively). A majority of hand surgeons in this study reported the use of text messaging to communicate PHI. Of note, neither the Health Insurance Portability and Accountability Act of 1996 statute nor US Department of Health and Human Services specifically prohibits this form of electronic communication. To be compliant, surgeons, practices, and institutions need to take reasonable security precautions to prevent breach of privacy with electronic communication. Communication of clinical information by text message is not prohibited under Health Insurance Portability and Accountability Act of 1996, but surgeons should use appropriate safeguards to prevent breach when using this form of communication. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Building public trust in uses of Health Insurance Portability and Accountability Act de-identified data.

PubMed

McGraw, Deven

2013-01-01

The aim of this paper is to summarize concerns with the de-identification standard and methodologies established under the Health Insurance Portability and Accountability Act (HIPAA) regulations, and report some potential policies to address those concerns that were discussed at a recent workshop attended by industry, consumer, academic and research stakeholders. The target audience includes researchers, industry stakeholders, policy makers and consumer advocates concerned about preserving the ability to use HIPAA de-identified data for a range of important secondary uses. HIPAA sets forth methodologies for de-identifying health data; once such data are de-identified, they are no longer subject to HIPAA regulations and can be used for any purpose. Concerns have been raised about the sufficiency of HIPAA de-identification methodologies, the lack of legal accountability for unauthorized re-identification of de-identified data, and insufficient public transparency about de-identified data uses. Although there is little published evidence of the re-identification of properly de-identified datasets, such concerns appear to be increasing. This article discusses policy proposals intended to address de-identification concerns while maintaining de-identification as an effective tool for protecting privacy and preserving the ability to leverage health data for secondary purposes.

Impact of HIPAA's minimum necessary standard on genomic data sharing.

PubMed

Evans, Barbara J; Jarvik, Gail P

2018-04-01

This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

Compliance with clinical pathways for inpatient care in Chinese public hospitals.

PubMed

He, Xiao Yan; Bundorf, M Kate; Gu, Jian Jun; Zhou, Ping; Xue, Di

2015-10-06

The National Health and Family Planning Commission of China has issued more than 400 clinical pathways to improve the effectiveness and efficiency of medical care delivered by public hospitals in China. The aim of our study is to determine whether patient care is compliant with national clinical pathways in public general hospitals of Pudong New Area in Shanghai. We identified the clinical pathways established by the National Health and Family Planning Commission of China for 5 common conditions (community-acquired pneumonia, acute myocardial infarction (AMI), heart failure, cesarean section, type-2 diabetes). We randomly selected patients with each condition admitted to one of 7 public general hospitals in Pudong New Area in China in January, 2013. We identified key process indicators (KPIs) for each pathway and, based on chart review for each patient, determined whether the patient's care was compliant for each indicator. We calculated the proportion of care which was compliant with clinical pathways for each indicator, the average proportion of indicators that were met for each patient, and the proportion of patients whose care was compliant for all measures. For selected indicators, we compared compliance rates among hospitals in our study with those from other countries. Average compliance rates across the KPIs for each condition ranged from 61 % for AMI to 89 % for pneumonia. The percent of patient receiving fully compliant care ranged from 0 for AMI and heart failure to 39 % for pneumonia. Compared to the compliance rate for process indicators in the hospitals of other countries, some rates in the hospitals that we audited were higher, but some were lower. Few patients received care that complied with all the pathways for each condition. The reasons for low compliance with national clinical pathways and how to improve clinical quality in public hospitals of China need to be further explored.

Update on HIPAA privacy: are you ready?

PubMed

Cole, Laura J; Fleisher, Lynn D

2003-01-01

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) created new requirements for health care providers to protect the privacy and security of individually identifiable health information. Regulations to implement HIPAA's privacy provisions were published by the Department of Health and Human Services (HHS) in "final" form in December 2000 (the Privacy Rules). In March, 2002, HHS proposed modifications to the Privacy Rules, which were published on August 14, 2002. The modified final regulations differed from the 2000 regulations in a number of important respects. Most recently, on December 4, 2002, the Office of Civil Rights (OCR), which is charged with enforcement of HIPAA, published "Guidance Explaining Significant Aspects of the Privacy Rule." The Privacy Rules went into effect on April 14, 2003. This article provides a summary of the modified Privacy Rules, discusses some interesting aspects of OCR's "guidance," and highlights the requirements that are most likely to impact the practice of medical genetics.

75 FR 8363 - Office for Civil Rights; Workshop on the HIPAA Privacy Rule's De-Identification Standard; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... Recovery and Reinvestment Act of 2009 (ARRA),\\1\\ requires HHS to issue guidance on methods for de...). --Methodological Issues Associated with HIPAA Privacy Rule De- Identification. --Statistical Disclosure Control and...

International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials

PubMed Central

Todd, Christopher A.; Greene, Kelli M.; Montefiori, David C.; Sarzotti-Kelsoe, Marcella

2012-01-01

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody – Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials. PMID:22303476

International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials.

PubMed

Ozaki, Daniel A; Gao, Hongmei; Todd, Christopher A; Greene, Kelli M; Montefiori, David C; Sarzotti-Kelsoe, Marcella

2012-01-01

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.

What if? The one question every administrator should ask. Use HIPAA rules as a blueprint for broader safety, security.

PubMed

Redling, Bob

2007-08-01

Are you doing enough to control security and privacy at your practice? Could you cope if your organization suffered a disaster that destroyed facilities, business documents and patient records? Although Health Insurance Portability and Accountability Act (HIPAA) security and privacy rules focus on patient health information, they also point the way to a more comprehensive approach to managing risk. By using HIPAA rules as a blueprint, you can design policies and procedures to address everything from safeguarding financial information to protecting the personal safety of patients, physicians and staff.

Building public trust in uses of Health Insurance Portability and Accountability Act de-identified data

PubMed Central

2013-01-01

Objectives The aim of this paper is to summarize concerns with the de-identification standard and methodologies established under the Health Insurance Portability and Accountability Act (HIPAA) regulations, and report some potential policies to address those concerns that were discussed at a recent workshop attended by industry, consumer, academic and research stakeholders. Target audience The target audience includes researchers, industry stakeholders, policy makers and consumer advocates concerned about preserving the ability to use HIPAA de-identified data for a range of important secondary uses. Scope HIPAA sets forth methodologies for de-identifying health data; once such data are de-identified, they are no longer subject to HIPAA regulations and can be used for any purpose. Concerns have been raised about the sufficiency of HIPAA de-identification methodologies, the lack of legal accountability for unauthorized re-identification of de-identified data, and insufficient public transparency about de-identified data uses. Although there is little published evidence of the re-identification of properly de-identified datasets, such concerns appear to be increasing. This article discusses policy proposals intended to address de-identification concerns while maintaining de-identification as an effective tool for protecting privacy and preserving the ability to leverage health data for secondary purposes. PMID:22735615

Acute oxygen therapy: an audit of prescribing and delivery practices in a tertiary hospital in Perth, Western Australia.

PubMed

Kamran, Anam; Chia, Elisa; Tobin, Claire

2018-02-01

Oxygen is a widely used drug in the hospital setting. However, international audits suggest that oxygen administration practices are often not compliant with prescribed standards. This can place patients at risk and cause serious adverse events. To analyse data related to recent practices of oxygen prescription and administration at Royal Perth Hospital (RPH), Western Australia. The results of this audit aim to guide further research on possible interventional studies implementing key solutions. All patients who received care in the Acute Medical Unit at RPH between 1 September and 14 September 2015 were included in this audit. Patients who were given supplemental oxygen during their admission were selected for further review of records. Appropriate medically indicated target oxygen saturations for each patient were judged under consultation with a respiratory specialist. A total of 65 patients received oxygen supplementation within the study period; 36 of these patients (55.4%) had target oxygen saturations prescribed by doctors, and 25% of the prescribed targets were judged to be inappropriate. In total, 49 patients (75.4%) were exposed to a potential risk from oxygen therapy due to prescription error and/or delivery error. A real risk was identified in 19 patients (29.2%) as they received oxygen at levels outside their appropriate medically indicated target range. The current practices of oxygen prescription and administration within RPH are suboptimal. Patients are placed at risk of oxygen toxicity due to deviation from oxygen prescription guidelines. © 2017 Royal Australasian College of Physicians.

[Audit of management of arterial hypertension in primary health care in Sousse].

PubMed

Ben Abdelaziz, Ahmed; Ben Othman, Aicha; Mandhouj, Olfa; Gaha, Rafika; Bouabid, Zouhour; Ghannem, Hassen

2006-03-01

A medical audit has been carried out on a representative sample of 456 hypertensive patients followed in the health care facilities of Sousse during 2002, to evaluate the quality of management of hypertension in primary health care. The study yielded the following results: the patients selected for a first line follow-up did not represent more than 79% of the studied population. The minimal recommended balance was achieved in 8% of cases only. Adequate drug therapy was prescribed in 64% of cases. 59% of patients were considered compliant. Controls of blood pressure was achieved in 5,5% of patients. The quality of management of hypertension in primary health care was considered satis factory in 28,7% of patents with a significant difference between urban and rural areas (24,9% versus 40,5%). These results indicate that increased attention should be paid by the national program of Struggle against the Chronic Diseases to the quality of management of hypertension in primary health care institutions.

High standards. A decade after the law went into effect, there is still debate about the pros and cons of the HIPAA privacy and electronic transaction regulations.

PubMed

Edlin, Mari; Johns, Stephanie

2006-01-01

When congress passed the Health Insurance Portability and Accountability act in 1996, the goal was to create a simpler, more standardized system that would eventually lower health care costs; reduce errors through safe, universally accepted electronic communication of health care transactions; and eliminate paper claims. Ten years later, the jury is still out on whether HIPAA has been worth the time, energy, and financial investment for insurers. That's not to say, however, that HIPAA hasn't generated benefits while also creating new challenges. "Standards made sense," says Tom Fitzpatrick, Horizon Blue Cross Blue Shield of New Jersey's director of enterprise strategic planning, "but no one ever said it would be fast, cheap, or easy. It was challenging to integrate proprietary claims systems and legacy software with the new standards that took effect in October 2003. But that wasn't the end of the story. HIPAA's privacy and security rules and the standard identifiers have meant even more upgrades and improvements and have required payers to spend millions of additional dollars over the past three years on HIPAA compliance." According to a set of quarterly surveys conducted by HIMSS/Phoenix Health Systems, progress has actually been fairly rapid. On the other hand, some things have remained much the same. In 2003, payers cited "understanding/interpreting the legal requirements" as the most difficult aspect of the HIPAA remediation process, followed by "achieving successful integration of new policies and procedures" and "resolving issues with third parties". In 2006, the barriers are similar, with users citing the same top two struggles.

Resource Planning in Glaucoma: A Tool to Evaluate Glaucoma Service Capacity.

PubMed

Batra, Ruchika; Sharma, Hannah E; Elaraoud, Ibrahim; Mohamed, Shabbir

2017-12-28

The National Patient Safety Agency (2009) publication advising timely follow-up of patients with established glaucoma followed several reported instances of visual loss due to postponed appointments and patients lost to follow-up. The Royal College of Ophthalmologists Quality Standards Development Group stated that all hospital appointments should occur within 15% of the intended follow-up period. To determine whether: 1. Glaucoma follow-up appointments at a teaching hospital occur within the requested time 2. Appointments are requested at appropriate intervals based on the NICE Guidelines 3. The capacity of the glaucoma service is adequate Methods: A two-part audit was undertaken of 98 and 99 consecutive patients respectively attending specialist glaucoma clinics. In the first part, the reasons for delayed appointments were recorded. In the second part the requested follow-up was compared with NICE guidelines where applicable. Based on the findings, changes were implemented and a re-audit of 100 patients was carried out. The initial audit found that although clinical decisions regarding follow-up intervals were 100% compliant with NICE guidelines where applicable, 24% of appointments were delayed beyond 15% of the requested period, due to administrative errors and inadequate capacity, leading to significant clinical deterioration in two patients. Following the introduction of an electronic appointment tracker and increased clinical capacity created by extra clinics and clinicians, the re-audit found a marked decrease in the percentage of appointments being delayed (9%). This audit is a useful tool to evaluate glaucoma service provision, assist in resource planning for the service and bring about change in a non-confrontational way. It can be widely applied and adapted for use in other medical specialities.

Utilizing Telehealth to deliver family-based treatment for adolescent anorexia nervosa.

PubMed

Anderson, Kristen E; Byrne, Catherine E; Crosby, Ross D; Le Grange, Daniel

2017-10-01

The purpose of this study was to test the feasibility and preliminary effect size on the main outcome measure (weight gain) of family-based treatment (FBT) for adolescents with anorexia nervosa (AN) and their families delivered via a Telehealth platform (i.e., an HIPAA compliant videoconferencing format). Ten adolescents, mean age of 16.08 years (SD = 1.99), meeting DSM-5 criteria for AN or atypical AN, were enrolled in the study and offered FBT via a Telehealth platform. Feasibility and acceptability were evaluated by rates of recruitment and retention. Treatment outcome was determined utilizing percent median body mass index (%mBMI), the eating disorder examination (EDE), and measures for depression and self-esteem. Recruitment target was achieved within allotted time, and all participants were retained for the course of treatment. Percent mBMI improved significantly from baseline to the end-of-treatment (p = .013) and from baseline to the 6-month follow-up (p = .032). Similar results were achieved for the EDE Global Score (p = .002 and .001, respectively). These findings provide preliminary evidence that it is feasible to deliver FBT via Telehealth and that satisfactory clinical outcomes are achievable. © 2017 Wiley Periodicals, Inc.

Privacy in the digital world: medical and health data outside of HIPAA protections.

PubMed

Glenn, Tasha; Monteith, Scott

2014-11-01

Increasing quantities of medical and health data are being created outside of HIPAA protection, primarily by patients. Data sources are varied, including the use of credit cards for physician visit and medication co-pays, Internet searches, email content, social media, support groups, and mobile health apps. Most medical and health data not covered by HIPAA are controlled by third party data brokers and Internet companies. These companies combine this data with a wide range of personal information about consumer daily activities, transactions, movements, and demographics. The combined data are used for predictive profiling of individual health status, and often sold for advertising and other purposes. The rapid expansion of medical and health data outside of HIPAA protection is encroaching on privacy and the doctor-patient relationship, and is of particular concern for psychiatry. Detailed discussion of the appropriate handling of this medical and health data is needed by individuals with a wide variety of expertise.

HIPAA brings new requirements, new opportunities.

PubMed

Moynihan, J J; McLure, M L

2000-03-01

The passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) brought with it the need for Federal rules to implement the act's simplification and cost-reduction efforts. HHS has published proposed rules related to security for the electronic transmission of health information, privacy of individually identifiable health information, transactions and code sets, and national provider and employer identifiers. Additional proposed rules will be published this year for claims attachments and health plan identifiers. Although HIPAA does not require providers to conduct business electronically, the new standards give providers the opportunity to reduce healthcare administrative costs significantly and undertake electronic commerce efficiently and cost-effectively.

The End of the HIPAA Privacy Rule? Currents in Contemporary Bioethics.

PubMed

Rothstein, Mark A

2016-06-01

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden. © 2016 American Society of Law, Medicine & Ethics.

An analysis of the management and leadership roles of nurses relative to the health insurance portability and accountability act.

PubMed

Kiel, Joan M

2015-01-01

Nurses have a great deal of interaction with patients. Given this, nurses play a vital role in conveying to patients knowledge of their privacy, security, and confidentiality of patient health information rights under the Health Insurance Portability and Accountability Act (HIPAA). Nurses also can be "at the head of the table" in their own organization and professional organizations in regard to facilitating the implementation of the HIPAA and making access to patient information more "consumer friendly." This article discusses the role that nurses can develop into concerning HIPAA implementation in an ever-burgeoning arena of consumer advocacy and consumer information.

Application of HIPAA group market portability rules to health flexible spending arrangements--HCFA. Clarification of regulations.

PubMed

1997-12-29

This document clarifies that it is appropriate to treat benefits under certain health flexible spending arrangements as excepted benefits for purposes of the group market portability provisions added by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

78 FR 63567 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... health insurance portability for group health plans and group health insurance issuers under HIPAA Titles... Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers Under HIPAA Titles... insurance coverage offered in connection with a group health plan. The rules contained in this document...

HIPAA Compliance in U.S. Hospitals: A Self-Report of Progress Toward the Security Rule

PubMed Central

Having, Karen; Davis, Diane C

2005-01-01

In January 2004, a random sampling of 1,000 U.S. hospitals was surveyed by researchers at a midwestern university to determine perceived level of compliance with the security requirements of the federal Health Insurance Portability and Accountability Act (HIPAA). Exactly one year later, a follow-up survey was sent to the 286 respondents of the 2004 survey, yielding a 50 percent return rate (n = 144). There was an overall trend in increased HIPAA security compliance from 2004 to 2005. There was no significant difference in perceived level of compliance based on the size of the hospital for the majority of security standards. PMID:18066377

Recognizing and reducing risks: HIPAA privacy and security enforcement.

PubMed

Wachler, Andrew B; Fehn, Amy K

2003-01-01

With the passing of the Health Insurance Portability and Accountability Act (HIPAA) privacy rule deadline and the security rule deadline looming, many covered entities are left wondering if they are doing enough to prevent privacy and security breaches and what type of exposure their organization could face in the event of a breach.

Technology in Counselor Education: HIPAA and HITECH as Best Practice

ERIC Educational Resources Information Center

Wilkinson, Tyler; Reinhardt, Rob

2015-01-01

The use of technology in counseling is expanding. Ethical use of technology in counseling practice is now a stand-alone section in the 2014 American Counseling Association "Code of Ethics." The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act…

76 FR 31425 - HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... 164 HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic... accounting of disclosures of protected health information. The purpose of these modifications is, in part, to...) provides that an accounting must include all disclosures of protected health information, except for...

75 FR 23214 - HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-03

...-AB62 HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic... disclosures, the administrative burden on covered entities and business associates of accounting for such...: HITECH Accounting of Disclosures, Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, SW...

HIPAA: update on rule revisions and compliance requirements.

PubMed

Maddox, P J

2002-01-01

Due to the highly technical requirements for HIPAA compliance and the numerous administrative and clinical functions and processes involved, guidance from experts who are knowledgeable about systems design and use to secure private data is necessary. In health care organizations, this will require individuals who are knowledgeable about clinical processes and those who understand health information technology, security, and privacy to work together to establish an entity's compliance plans and revise operations and practices accordingly. As a precondition of designing such systems, it is essential that covered entities understand the HIPAA's statutory requirements and timeline for compliance. An organization's success in preparing for HIPAA will depend upon an active program of assessment, planning, and implementation. Compliance with security and privacy standards can be expected to increase costs initially. However, greater use of EDI is expected to reduce costs and enhance revenues in the long run if processes and systems are improved. NOTE: Special protection for psychotherapy notes holds them to a higher standard of protection. Notes used only by a psychotherapist are not intended to be shared with anyone and are not considered part of the medical record.

Implementing HIPAA security in a membership organization.

PubMed

Hillabrant, L P; Gaignard, K E

2000-01-01

The upcoming HIPAA security regulations are forcing a change in business and operating procedures that many, if not most, healthcare organizations are ill-prepared to tackle. Of all healthcare organizational structures, membership organizations will most likely face the greatest number of obstacles in preparing for and implementing the HIPAA security regulations. This is because the membership organization as a whole must find a way to accommodate the disparate technologies, business and operating methodologies and processes, and available, limited resources of its individual member organizations, and integrate these into a uniform implementation plan. Compounding these obvious difficulties is the unique challenge of enforcement authority. The individual member organizations are autonomous business entities, whereas the membership organization as a whole merely acts as an advisor or consultant, and has only limited enforcement authority over any individual member organization. This article explores this unique situation in depth. We focus on PROMINA Health System, a nonprofit healthcare membership organization that consists of five disparate member healthcare organizations. We examine the challenges PROMINA has encountered in its quest to institute an organization-wide HIPAA security program and its methodology for accomplishing program implementation.

HIPPA privacy regulations: practical information for physicians.

PubMed

McMahon, E B; Lee-Huber, T

2001-07-01

After much debate and controversy, the Bush administration announced on April 12, 2001, that it would implement the Health Insurance Portability and Accountability Act (HIPAA) privacy regulations issued by the Clinton administration in December of 2000. The privacy regulations became effective on April 14, 2001. Although the regulations are considered final, the Secretary of the Department of Health and Human Services has the power to modify the regulations at any time during the first year of implementation. These regulations affect how a patient's health information is used and disclosed, as well as how patients are informed of their privacy rights. As "covered entities," physicians have until April 14, 2003, to comply fully with the HIPAA privacy regulations, which are more than 1,500 pages in length. This article presents a basic overview of the new and complex regulations and highlights practical information about physicians' compliance with the regulations. However, this summary of the HIPAA privacy regulations should not be construed as legal advice or an opinion on specific situations. Please consult an attorney concerning your compliance with HIPAA and the regulations promulgated thereunder.

Privacy and security of patient data in the pathology laboratory.

PubMed

Cucoranu, Ioan C; Parwani, Anil V; West, Andrew J; Romero-Lauro, Gonzalo; Nauman, Kevin; Carter, Alexis B; Balis, Ulysses J; Tuthill, Mark J; Pantanowitz, Liron

2013-01-01

Data protection and security are critical components of routine pathology practice because laboratories are legally required to securely store and transmit electronic patient data. With increasing connectivity of information systems, laboratory work-stations, and instruments themselves to the Internet, the demand to continuously protect and secure laboratory information can become a daunting task. This review addresses informatics security issues in the pathology laboratory related to passwords, biometric devices, data encryption, internet security, virtual private networks, firewalls, anti-viral software, and emergency security situations, as well as the potential impact that newer technologies such as mobile devices have on the privacy and security of electronic protected health information (ePHI). In the United States, the Health Insurance Portability and Accountability Act (HIPAA) govern the privacy and protection of medical information and health records. The HIPAA security standards final rule mandate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of ePHI. Importantly, security failures often lead to privacy breaches, invoking the HIPAA privacy rule as well. Therefore, this review also highlights key aspects of HIPAA and its impact on the pathology laboratory in the United States.

How to apply Y2K lessons to patient confidentiality.

PubMed

2001-04-01

Despite current debate over the details of implementing the privacy portion of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, experts say quality managers should continue their planning to comply with the new law. One way to prepare for the sweeping new mandates is to apply the lessons of Y2K to HIPAA.

Counterfeit Compliance with the HIPAA Security Rule: A Study of Information System Success

ERIC Educational Resources Information Center

Johnson, James R.

2013-01-01

The intent of the security standards adopted by the Department of Health and Human Services (DHS) implementing some of the requirements of the Administrative Simplification (AS) subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) was to improve Federal and private health care programs and to improve the…

A cryptographic key management solution for HIPAA privacy/security regulations.

PubMed

Lee, W-B; Lee, C-D

2008-01-01

The Health Insurance Portability and Accountability Act (HIPAA) privacy and security regulations are two crucial provisions in the protection of healthcare privacy. Privacy regulations create a principle to assure that patients have more control over their health information and set limits on the use and disclosure of health information. The security regulations stipulate the provisions implemented to guard data integrity, confidentiality, and availability. Undoubtedly, the cryptographic mechanisms are well defined to provide suitable solutions. In this paper, to comply with the HIPAA regulations, a flexible cryptographic key management solution is proposed to facilitate interoperations among the applied cryptographic mechanisms. In addition, case of consent exceptions intended to facilitate emergency applications and other possible exceptions can also be handled easily.

Mattress cleanliness: the role of monitoring and maintenance.

PubMed

Aziz, Ann-Marie

A clean and tidy environment provides the right setting for good patient care. It is fundamental in preventing and/or controlling the spread of healthcare-associated infections (HCAI). Cleanliness is an essential component for the comfort and dignity of patients, particularly those for whom a hospital is home for any length of time. Patients spend a lot of their time in bed so it is important for them to be provided with well maintained and clean mattresses. Beds, and especially the mattresses, should be cleaned and inspected regularly so patients know they are being cared for in a clean and safe environment. To prolong the life of the mattress and reduce infection risks, inspections for damage and contamination must take place on a regular basis. Assessment criteria for the audit of a mattress can include a visual inspection, a cover permeability test and a foam support surface test. These assessments will ensure the mattress is compliant with current standards and identify whether or not they require condemning. Mattress care can be improved by adopting unified good practices that can be standardized and audited regularly.

Implementation of the hepatitis C guidelines in UK health care workers.

PubMed

Gibson, Kirstie; Kennedy, Ioana

2007-12-01

The UK Health Department circular HSC 2002/010 requires health care employers to test certain groups of health care workers (HCWs) for hepatitis C, without additional funding. Little is known about the consistency of implementation of such guidelines. This study audited the process, completeness and problems of implementation of circular HSC 2002/010 in acute and ambulance trusts in London and the Southeast of England. Telephone questionnaire survey of 51 National Health Service trusts between July and October 2005. The response rate was 92% (47/51). Eighty-five per cent (40/47) of the trusts reported partial or full implementation of the guidance. All compliant trusts reported testing HCWs entering exposure prone procedure specialities, although 40% (16/40) were testing more staff than specified in the guidance. Most trusts (85%) in this audit reported having implemented the guidance 3 years after publication and 90% claimed not to have needed additional funding. Implementation may be improved by greater clarity about which staff should be tested, frequency of testing and by raising HCWs awareness about hepatitis C infection and treatment. Newly published health clearance guidance addresses some of these points.

Security model for picture archiving and communication systems.

PubMed

Harding, D B; Gac, R J; Reynolds, C T; Romlein, J; Chacko, A K

2000-05-01

The modern information revolution has facilitated a metamorphosis of health care delivery wrought with the challenges of securing patient sensitive data. To accommodate this reality, Congress passed the Health Insurance Portability and Accountability Act (HIPAA). While final guidance has not fully been resolved at this time, it is up to the health care community to develop and implement comprehensive security strategies founded on procedural, hardware and software solutions in preparation for future controls. The Virtual Radiology Environment (VRE) Project, a landmark US Army picture archiving and communications system (PACS) implemented across 10 geographically dispersed medical facilities, has addressed that challenge by planning for the secure transmission of medical images and reports over their local (LAN) and wide area network (WAN) infrastructure. Their model, which is transferable to general PACS implementations, encompasses a strategy of application risk and dataflow identification, data auditing, security policy definition, and procedural controls. When combined with hardware and software solutions that are both non-performance limiting and scalable, the comprehensive approach will not only sufficiently address the current security requirements, but also accommodate the natural evolution of the enterprise security model.

HIPAA security standards: is your facility ready?

PubMed

2000-05-01

Now that final rules are emerging related to the Health Insurance Portability and Accountability Act of 1996, it's more important than ever to make sure your facility's data security standards measure up. The best advice? 'Forget HIPAA for the moment and look at what you have in place,' says William Spooner, senior vice president and chief information officer for Sharp Healthcare in San Diego.

Privacy and security of patient data in the pathology laboratory

PubMed Central

Cucoranu, Ioan C.; Parwani, Anil V.; West, Andrew J.; Romero-Lauro, Gonzalo; Nauman, Kevin; Carter, Alexis B.; Balis, Ulysses J.; Tuthill, Mark J.; Pantanowitz, Liron

2013-01-01

Data protection and security are critical components of routine pathology practice because laboratories are legally required to securely store and transmit electronic patient data. With increasing connectivity of information systems, laboratory work-stations, and instruments themselves to the Internet, the demand to continuously protect and secure laboratory information can become a daunting task. This review addresses informatics security issues in the pathology laboratory related to passwords, biometric devices, data encryption, internet security, virtual private networks, firewalls, anti-viral software, and emergency security situations, as well as the potential impact that newer technologies such as mobile devices have on the privacy and security of electronic protected health information (ePHI). In the United States, the Health Insurance Portability and Accountability Act (HIPAA) govern the privacy and protection of medical information and health records. The HIPAA security standards final rule mandate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of ePHI. Importantly, security failures often lead to privacy breaches, invoking the HIPAA privacy rule as well. Therefore, this review also highlights key aspects of HIPAA and its impact on the pathology laboratory in the United States. PMID:23599904

HIPAA is larger and more complex than Y2K.

PubMed

Tempesco, J W

2000-07-01

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a larger and more complex problem than Y2K ever was. According to the author, the costs associated with a project of such unending scope and in support of intrusion into both information and operational systems of every health care transaction will be incalculable. Some estimate that the administrative simplification policies implemented through HIPAA will save billions of dollars annually, but it remains to be seen whether the savings will outweigh implementation and ongoing expenses associated with systemwide application of the regulations. This article addresses the rules established for electronic data interchange, data set standards for diagnostic and procedure codes, unique identifiers, coordination of benefits, privacy of individual health care information, electronic signatures, and security requirements.

Text messaging to communicate with public health audiences: how the HIPAA Security Rule affects practice.

PubMed

Karasz, Hilary N; Eiden, Amy; Bogan, Sharon

2013-04-01

Text messaging is a powerful communication tool for public health purposes, particularly because of the potential to customize messages to meet individuals' needs. However, using text messaging to send personal health information requires analysis of laws addressing the protection of electronic health information. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule is written with flexibility to account for changing technologies. In practice, however, the rule leads to uncertainty about how to make text messaging policy decisions. Text messaging to send health information can be implemented in a public health setting through 2 possible approaches: restructuring text messages to remove personal health information and retaining limited personal health information in the message but conducting a risk analysis and satisfying other requirements to meet the HIPAA Security Rule.

Compliance With Point-of-Sale Tobacco Control Policies in School-Adjacent Neighborhoods in Mumbai, India.

PubMed

Mistry, Ritesh; Pimple, Sharmila; Mishra, Gauravi; Gupta, Prakash C; Pednekar, Mangesh; Ranz-Schleifer, Naomi; Shastri, Surendra

2015-09-21

Purpose . We assessed factors associated with tobacco vendor compliance with India's Cigarettes and Other Tobacco Products Act (COTPA) provisions regulating tobacco sales and point-of-sale (POS) environments. Design . Study design was a cross-sectional random sample of tobacco vendors in Mumbai, India (2010). Setting . School-adjacent neighborhoods were the study setting. Subjects . Study subjects were tobacco vendors (n = 436). Measures . Face-to-face interviews, and audits of POS environments were used to assess compliance. Analysis . Factors associated with compliance were identified using logistic regression. Results . About 4% of vendors were fully compliant. Although 80% reported compliance with the ban on tobacco sales to minors, only 10% displayed signage about the ban. About 84% were compliant with the two-tobacco advertisement limit; of those displaying advertisements, 67% were compliant with size limits, 68% with content restrictions, and 8% with health warning requirements. Knowledge about fines for noncompliance was associated with compliance with the ban on sales to minors (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.26, 3.56) and signage requirement (OR, 4.42; 95% CI, 1.76, 11.13). Greater compliance with the two-advertisement limit was associated with higher store income from tobacco (OR, .26; 95% CI, .09, .73) and lower neighborhood socioeconomic status (p < .01); the latter was associated with advertisement size limits compliance (p < .05). Conclusions . Compliance with COTPA provisions was low. Interventions modifying vendor knowledge about provisions and fines may increase compliance, and they should target stores that are reliant on tobacco sales.

MedCast: a discussion support system for cooperative work

NASA Astrophysics Data System (ADS)

Moreno, Ramon A.; Lima, Vinícius; Lopes, Isidro; Gutierrez, Marco A.

2012-02-01

The availability of low cost Internet connections and specialized hardware, like webcams and headsets, makes possible the development of solutions for remote collaborative work. These solutions can provide advantages compared to presential meetings, such as: availability of experts on remote locations; lower price compared to presential meetings; creation of online didactic material (e.g. video-classes); richer forms of interaction between participants. These technologies are particularly interesting for continent-sized countries where typically there is a short number of skilled people in remote areas. However, the application of these technologies in medical field represents a special challenge due to the more complex requirements of this area, such as: Provide confidentiality (patient de-identification) and integrity of patient data; Guarantee availability of the system; Guarantee authenticity of data and users; Provide simple and effective user interface; Be compliant with medical standards such as DICOM and HL7. In order to satisfy those requirements a prototype called MedCast is under development whose architecture allows the integration of the Hospital Information System (HIS) with a collaborative tool in compliance with the HIPAA rules. Some of the MedCast features are: videoconferencing, chat, recording of the sessions, sharing of documents and reports and still and dynamic images presentation. Its current version allows the remote discussion of clinical cases and the remote ECG evaluation.

Coronary Artery Anomalies and Variants: Technical Feasibility of Assessment with Coronary MR Angiography at 3 T1

PubMed Central

Gharib, Ahmed M.; Ho, Vincent B.; Rosing, Douglas R.; Herzka, Daniel A.; Stuber, Matthias; Arai, Andrew E.; Pettigrew, Roderic I.

2008-01-01

The purpose of this study was to prospectively use a whole-heart three-dimensional (3D) coronary magnetic resonance (MR) angiography technique specifically adapted for use at 3 T and a parallel imaging technique (sensitivity encoding) to evaluate coronary arterial anomalies and variants (CAAV). This HIPAA-compliant study was approved by the local institutional review board, and informed consent was obtained from all participants. Twenty-two participants (11 men, 11 women; age range, 18–62 years) were included. Ten participants were healthy volunteers, whereas 12 participants were patients suspected of having CAAV. Coronary MR angiography was performed with a 3-T MR imager. A 3D free-breathing navigator-gated and vector electrocardiographically–gated segmented k-space gradient-echo sequence with adiabatic T2 preparation pulse and parallel imaging (sensitivity encoding) was used. Whole-heart acquisitions (repetition time msec/echo time msec, 4/1.35; 20° flip angle; 1 × 1 × 2-mm acquired voxel size) lasted 10–12 minutes. Mean examination time was 41 minutes ± 14 (standard deviation). Findings included aneurysms, ectasia, arteriovenous fistulas, and anomalous origins. The 3D whole-heart acquisitions developed for use with 3 T are feasible for use in the assessment of CAAV. © RSNA, 2008 PMID:18372470

Congenital portosystemic shunts: imaging findings and clinical presentations in 11 patients.

PubMed

Konstas, Angelos A; Digumarthy, Subba R; Avery, Laura L; Wallace, Karen L; Lisovsky, Mikhail; Misdraji, Joseph; Hahn, Peter F

2011-11-01

To evaluate the clinical anatomy and presentations of congenital portosystemic shunts, and determine features that promote recognition on imaging. Institutional review board approval was obtained for this HIPAA-compliant study. The requirement for written informed consent was waived. Radiology reports were retrospectively reviewed from non-cirrhotic patients who underwent imaging studies from January 1999 through February 2009. Clinical sources reviewed included electronic medical records, archived images and histopathological material. Eleven patients with congenital portosystemic shunts were identified (six male and five female; age range 20 days to 84 years). Seven patients had extrahepatic and four patients had intrahepatic shunts. All 11 patients had absent or hypoplastic intrahepatic portal veins, a feature detected by CT and MRI, but not by US. Seven patients presented with shunt complications and four with presentations unrelated to shunt pathophysiology. Three adult patients had four splenic artery aneurysms. Prospective radiological evaluation of five adult patients with cross-sectional imaging had failed prospectively to recognize the presence of congenital portosystemic shunts on one or more imaging examinations. Congenital portosystemic shunts are associated with splenic artery aneurysms, a previously unrecognized association. Portosystemic shunts were undetected during prospective radiologic evaluation in the majority of adult patients, highlighting the need to alert radiologists to this congenital anomaly. Copyright © 2010. Published by Elsevier Ireland Ltd.

An Algorithm for Building an Electronic Database.

PubMed

Cohen, Wess A; Gayle, Lloyd B; Patel, Nima P

2016-01-01

We propose an algorithm on how to create a prospectively maintained database, which can then be used to analyze prospective data in a retrospective fashion. Our algorithm provides future researchers a road map on how to set up, maintain, and use an electronic database to improve evidence-based care and future clinical outcomes. The database was created using Microsoft Access and included demographic information, socioeconomic information, and intraoperative and postoperative details via standardized drop-down menus. A printed out form from the Microsoft Access template was given to each surgeon to be completed after each case and a member of the health care team then entered the case information into the database. By utilizing straightforward, HIPAA-compliant data input fields, we permitted data collection and transcription to be easy and efficient. Collecting a wide variety of data allowed us the freedom to evolve our clinical interests, while the platform also permitted new categories to be added at will. We have proposed a reproducible method for institutions to create a database, which will then allow senior and junior surgeons to analyze their outcomes and compare them with others in an effort to improve patient care and outcomes. This is a cost-efficient way to create and maintain a database without additional software.

International inter-rater agreement in scoring acne severity utilizing cloud-based image sharing of mobile phone photographs.

PubMed

Foolad, Negar; Ornelas, Jennifer N; Clark, Ashley K; Ali, Ifrah; Sharon, Victoria R; Al Mubarak, Luluah; Lopez, Andrés; Alikhan, Ali; Al Dabagh, Bishr; Firooz, Alireza; Awasthi, Smita; Liu, Yu; Li, Chin-Shang; Sivamani, Raja K

2017-09-01

Cloud-based image sharing technology allows facilitated sharing of images. Cloud-based image sharing technology has not been well-studied for acne assessments or treatment preferences, among international evaluators. We evaluated inter-rater variability of acne grading and treatment recommendations among an international group of dermatologists that assessed photographs. This is a prospective, single visit photographic study to assess inter-rater agreement of acne photographs shared through an integrated mobile device, cloud-based, and HIPAA-compliant platform. Inter-rater agreements for global acne assessment and acne lesion counts were evaluated by the Kendall's coefficient of concordance while correlations between treatment recommendations and acne severity were calculated by Spearman's rank correlation coefficient. There was good agreement for the evaluation of inflammatory lesions (KCC = 0.62, P < 0.0001), noninflammatory lesions (KCC = 0.62, P < 0.0001), and the global acne grading system score (KCC = 0.69, P < 0.0001). Topical retinoid, oral antibiotic, and isotretinoin treatment preferences correlated with photographic based acne severity. Our study supports the use of mobile phone based photography and cloud-based image sharing for acne assessment. Cloud-based sharing may facilitate acne care and research among international collaborators. © 2017 The International Society of Dermatology.

Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma

PubMed Central

Hosseini, Anahita; Buonocore, Chris M.; Hashemzadeh, Sepideh; Hojaiji, Hannaneh; Kalantarian, Haik; Sideris, Costas; Bui, Alex A.T.; Sarrafzadeh, Majid

2017-01-01

To address the need for asthma self-management in pediatrics, the authors present the feasibility of a mobile health (mHealth) platform built on their prior work in an asthmatic adult and child. Real-time asthma attack risk was assessed through physiological and environmental sensors. Data were sent to a cloud via a smartwatch application (app) using Health Insurance Portability and Accountability Act (HIPAA)-compliant cryptography and combined with online source data. A risk level (high, medium or low) was determined using a random forest classifier and then sent to the app to be visualized as animated dragon graphics for easy interpretation by children. The feasibility of the system was first tested on an adult with moderate asthma, then usability was examined on a child with mild asthma over several weeks. It was found during feasibility testing that the system is able to assess asthma risk with 80.10 ± 14.13% accuracy. During usability testing, it was able to continuously collect sensor data, and the child was able to wear, easily understand and enjoy the use of the system. If tested in more individuals, this system may lead to an effective self-management program that can reduce hospitalization in those who suffer from asthma. PMID:28771168

Mum's the Word: Feds Are Serious About Protecting Patients' Privacy.

PubMed

Conde, Crystal

2010-08-01

The Health Information Technology for Economic and Clinical Health (HITECH) Act significantly changes HIPAA privacy and security policies that affect physicians. Chief among the changes are the new breach notification regulations, developed by the U.S. Department of Health and Human Services Office for Civil Rights. The Texas Medical Association has developed resources to help physicians comply with the new HIPAA regulations.

Text Messaging to Communicate With Public Health Audiences: How the HIPAA Security Rule Affects Practice

PubMed Central

Karasz, Hilary N.; Eiden, Amy; Bogan, Sharon

2013-01-01

Text messaging is a powerful communication tool for public health purposes, particularly because of the potential to customize messages to meet individuals’ needs. However, using text messaging to send personal health information requires analysis of laws addressing the protection of electronic health information. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule is written with flexibility to account for changing technologies. In practice, however, the rule leads to uncertainty about how to make text messaging policy decisions. Text messaging to send health information can be implemented in a public health setting through 2 possible approaches: restructuring text messages to remove personal health information and retaining limited personal health information in the message but conducting a risk analysis and satisfying other requirements to meet the HIPAA Security Rule. PMID:23409902

A novel key management solution for reinforcing compliance with HIPAA privacy/security regulations.

PubMed

Lee, Chien-Ding; Ho, Kevin I-J; Lee, Wei-Bin

2011-07-01

Digitizing medical records facilitates the healthcare process. However, it can also cause serious security and privacy problems, which are the major concern in the Health Insurance Portability and Accountability Act (HIPAA). While various conventional encryption mechanisms can solve some aspects of these problems, they cannot address the illegal distribution of decrypted medical images, which violates the regulations defined in the HIPAA. To protect decrypted medical images from being illegally distributed by an authorized staff member, the model proposed in this paper provides a way to integrate several cryptographic mechanisms. In this model, the malicious staff member can be tracked by a watermarked clue. By combining several well-designed cryptographic mechanisms and developing a key management scheme to facilitate the interoperation among these mechanisms, the risk of illegal distribution can be reduced.

Balancing between two goods: Health Insurance Portability and Accountability Act and ethical compliancy considerations for privacy-sensitive materials in health sciences archival and historical special collections.

PubMed

Wiener, Judith A; Gilliland, Anne T

2011-01-01

The investigation provides recommendations for establishing institutional collection guidelines and policies that protect the integrity of the historical record, while upholding the privacy and confidentiality of those who are protected by Health Insurance Portability and Accountability Act (HIPAA) or professional ethical standards. The authors completed a systematic historical investigation of the concepts of collection integrity, privacy, and confidentiality in the formal and informal legal and professional ethics literature and applied these standards to create best practices for institutional policies in these areas. Through an in-depth examination of the historical concepts of privacy and confidentiality in the legal and professional ethics literature, the authors were able to create recommendations that would allow institutions to provide access to important, yet sensitive, materials, while complying with the standards set by HIPAA regulations and professional ethical expectations. With thoughtful planning, it is possible to balance the integrity of and access to the historical record of sensitive documents, while supporting the privacy protections of HIPAA and professional ethical standards. Although it is theorized that collection development policies of institutions have changed due to HIPAA legislation, additional research is suggested to see how various legal interpretations have affected the integrity of the historical record in actuality.

The Health Insurance Portability and Accountability Act: security and privacy requirements.

PubMed

Tribble, D A

2001-05-01

The security and privacy requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their implications for pharmacy are discussed. HIPAA was enacted to improve the portability of health care insurance for persons leaving jobs. A section of the act encourages the use of electronic communications for health care claims adjudication, mandates the use of new standard code sets and transaction sets, and establishes the need for regulations to protect the security and privacy of individually identifiable health care information. Creating these regulations became the task of the Department of Health and Human Services. Regulations on security have been published for comment. Regulations on privacy and the definition of standard transaction sets and code sets are complete. National identifiers for patients, providers, and payers have not yet been established. The HIPAA regulations on security and privacy will require that pharmacies adopt policies and procedures that limit access to health care information. Existing pharmacy information systems may require upgrading or replacement. Costs of implementation nationwide are estimated to exceed $8 billion. The health care community has two years from the finalization of each regulation to comply with that regulation. The security and privacy requirements of HIPAA will require pharmacies to review their practices regarding the storage, use, and disclosure of protected health care information.

Cutting to the chase: what physician executives need to know about HIPAA.

PubMed

Fitzmaurice, J M; Rose, J S

2000-01-01

All health care providers, plans, and clearinghouses will be affected by the federally mandated uniform standards for administrative transactions. This article presents distilled core information about the Health Insurance Portability and Accountability Act (HIPAA) legislation--the standards, penalties for violations, and status of final rules. It also raises several key unsolved issues of which clinicians, executives, and health care providers must be aware so they can prepare and plan for the upcoming changes. HIPAA is intended to improve the efficiency and effectiveness of the health care system, as well as to increase the protection and confidentiality of individually identifiable health information. The costs of making the transition to the legislated standards and processes remain a worrisome factor. Although there are two years before these standards must be implemented, and cost and compliance issues resolved, work has already begun in many health institutions to identify and address them.

'Second generation' Internet e-health: the gladiator for HIPAA compliance?

PubMed

Korpman, R A; Rose, J S

2001-01-01

The Health Insurance Portability and Accountability Act (HIPAA) is intended to simplify administrative processes and improve health information security. There are a number of traditional ways to address the expense and complexities of simplification, but none of them are bargains or beauties to behold: (1) Do-it-yourself encryption; (2) new back-end system purchases; (3) legacy system re-programming; or (4) onerous paper documentation. The good news is that 'second generation' e-health solutions are emerging that act as internal "wrappers" for health plan or provider data systems. They provide both an interface for end-users and a layer of security for organizational information and allow detailed patient-related data to remain at the system owner's physical location. These second generation solutions don't just 'connect,' data, they actually 'understand' the information, and can use data elements to invoke necessary rules, processing pathways, or personalization for specific stakeholders as required by HIPAA.

Pagers, Smartphones, and HIPAA: Finding the Best Solution for Electronic Communication of Protected Health Information.

PubMed

Freundlich, Robert E; Freundlich, Katherine L; Drolet, Brian C

2017-11-25

Electronic communication is a topic that applies broadly to the professional activities of every physician and the pager has been the gold standard of communication for decades. We believe that this is a dated technology that is holding clinicians back from better, more efficient alternatives, particularly smartphones. In this manuscript, we examine the paradoxical reliance on pagers in academic medicine, at a time when the use of smartphones and text messaging is the subject of intense scrutiny with respect to its standing under the Health Insurance Portability and Accountability Act (HIPAA). We provide previously unreported data regarding the electronic communication practices of academic medical centers in the United States, which we obtained through a survey of Designated Institutional Officials. These data highlight both the controversy around text messaging and HIPAA and a puzzling widespread reliance on pagers as an alternative.

Implementing Patient Access to Electronic Health Records Under HIPAA: Lessons Learned

PubMed Central

Wang, Tiffany; Pizziferri, Lisa; Volk, Lynn A; Mikels, Debra A; Grant, Karen G; Wald, Jonathan S; Bates, David W

2004-01-01

In 2001, the Institute of Medicine (IOM) and the Health Insurance Portability and Accountability Act (HIPAA) emphasized the need for patients to have greater control over their health information. We describe a Boston healthcare system's approach to providing patients access to their electronic health records (EHRs) via Patient Gateway, a secure, Web-based portal. Implemented in 19 clinic sites to date, Patient Gateway allows patients to access information from their medical charts via the Internet in a secure manner. Since 2002, over 19,000 patients have enrolled in Patient Gateway, more than 125,000 patients have logged into the system, and over 37,000 messages have been sent by patients to their practices. There have been no major security concerns. By providing access to EHR data, secure systems like Patient Gateway allow patients a greater role in their healthcare process, as envisioned by the IOM and HIPAA. PMID:18066391

National education program for energy efficient illumination engineering

NASA Astrophysics Data System (ADS)

Walker, Constance E.; Pompea, Stephen M.

2011-05-01

About one-third of outdoor lighting escapes unused into the sky, wasting energy and causing sky glow. Because of excessive sky glow around astronomical facilities, the National Optical Astronomy Observatory has a strong motivation to lead light pollution education efforts. While our original motivation of preserving the dark skies near observatories is still important, energy conservation is a critical problem that needs to be addressed nationwide. To address this problem we have created an extensive educational program on understanding and measuring light pollution. A set of four learning experiences introduces school students at all grade levels to basic energy-responsive illumination engineering design principles that can minimize light pollution. We created and utilize the GLOBE at Night citizen science light pollution assessment campaign as a cornerstone activity. We also utilize educational activities on light shielding that are introduced through a teaching kit. These two components provide vocabulary, concepts, and visual illustrations of the causes of light pollution. The third, more advanced component is the school outdoor lighting audit, which has students perform an audit and produce a revised master plan for compliant lighting. These learning experiences provide an integrated learning unit that is highly adaptable for U.S. and international education efforts in this area.

Logical Specification of the GLBA and HIPAA Privacy Laws

DTIC Science & Technology

2010-04-29

a credit card account, deposit account, or transaction account of a consumer to any nonaffiliated third party for use in telemarketing, direct mail...the consumer’s account with the financial institution, or with another entity as part of a private label credit card program or other extension of...T dii ). Since we ensure that this class is distinct from phi , we have no norm here. All other norms that we have in HIPAA will include the constraint

Banking on privacy. Hospitals must protect patient information--and their own liability--as banks balk at HIPAA.

PubMed

Haugh, Richard

2004-02-01

Thanks to HIPAA, banks stand to earn billions of dollars in new business by processing electronic claims for health care providers and payers. And the health care industry could realize $35 billion a year in efficiency gains and cost savings. But overshadowing it all is the question of how protected patient information will be--and how liable hospitals will be for any breach of that information by their business partners.

Balancing between two goods: Health Insurance Portability and Accountability Act and ethical compliancy considerations for privacy-sensitive materials in health sciences archival and historical special collections

PubMed Central

Gilliland, Anne T

2011-01-01

Objective: The investigation provides recommendations for establishing institutional collection guidelines and policies that protect the integrity of the historical record, while upholding the privacy and confidentiality of those who are protected by Health Insurance Portability and Accountability Act (HIPAA) or professional ethical standards. Methods: The authors completed a systematic historical investigation of the concepts of collection integrity, privacy, and confidentiality in the formal and informal legal and professional ethics literature and applied these standards to create best practices for institutional policies in these areas. Results: Through an in-depth examination of the historical concepts of privacy and confidentiality in the legal and professional ethics literature, the authors were able to create recommendations that would allow institutions to provide access to important, yet sensitive, materials, while complying with the standards set by HIPAA regulations and professional ethical expectations. Conclusion: With thoughtful planning, it is possible to balance the integrity of and access to the historical record of sensitive documents, while supporting the privacy protections of HIPAA and professional ethical standards. Although it is theorized that collection development polices of institutions have changed due to HIPAA legislation, additional research is suggested to see how various legal interpretations have affected the integrity of the historical record in actuality. PMID:21243051

Stimulated echo diffusion tensor imaging and SPAIR T2-weighted imaging in Chronic Exertional Compartment Syndrome of the lower leg muscles

PubMed Central

Sigmund, Eric E.; Sui, Dabang; Ukpebor, Obehi; Baete, Steven; Fieremans, Els; Babb, James S.; Mechlin, Michael; Liu, Kecheng; Kwon, Jane; Mcgorty, KellyAnne; Hodnett, Phil; Bencardino, Jenny

2013-01-01

Purpose To evaluate the performance of diffusion tensor imaging (DTI) in the evaluation of chronic exertional compartment syndrome (CECS) as compared to T2-weighted imaging. Materials and Methods Using an IRB-approved HIPAA-compliant protocol, spectral adiabatic inversion recovery (SPAIR) T2-weighted imaging (T2w) and stimulated echo DTI were applied to 8 healthy volunteers and 14 suspected CECS patients before and after exertion. Longitudinal and transverse diffusion eigenvalues, mean diffusivity (MD), and fractional anisotropy (FA) were measured in 7 calf muscle compartments, which in patients were classified by their response on T2w: normal (<20% change), and CECS (>20% change). Mixed model analysis of variance compared subject groups and compartments in terms of response factors (post-/pre-exercise ratios) of DTI parameters. Results All diffusivities significantly increased (p<0.0001) and FA decreased (p=.0014) with exercise. Longitudinal diffusion responses were significantly smaller than transversal diffusion responses (p<0.0001). 19 of 98 patient compartments were classified as CECS on T2w. MD increased by 3.8±3.4% (volunteer), 7.4±4.2 % (normal), and 9.1±7.0% (CECS) with exercise. Conclusion DTI shows promise as an ancillary imaging method in the diagnosis and understanding of the pathophysiology in CECS. Future studies may explore its utility in predicting response to treatment. PMID:23440764

Development of a Mobile Tool That Semiautomatically Screens Patients for Stroke Clinical Trials.

PubMed

Spokoyny, Ilana; Lansberg, Maarten; Thiessen, Rosita; Kemp, Stephanie M; Aksoy, Didem; Lee, YongJae; Mlynash, Michael; Hirsch, Karen G

2016-10-01

Despite several national coordinated research networks, enrollment in many cerebrovascular trials remains challenging. An electronic tool was needed that would improve the efficiency and efficacy of screening for multiple simultaneous acute clinical stroke trials by automating the evaluation of inclusion and exclusion criteria, improving screening procedures and streamlining the communication process between the stroke research coordinators and the stroke clinicians. A multidisciplinary group consisting of physicians, study coordinators, and biostatisticians designed and developed an electronic clinical trial screening tool on a HIPAA (Health Insurance Portability and Accountability Act)-compliant platform. A web-based tool was developed that uses branch logic to determine eligibility for simultaneously enrolling clinical trials and automatically notifies the study coordinator teams about eligible patients. After 12 weeks of use, 225 surveys were completed, and 51 patients were enrolled in acute stroke clinical trials. Compared with the 12 weeks before implementation of the tool, there was an increase in enrollment from 16.5% of patients screened to 23.4% of patients screened (P<0.05). Clinicians and coordinators reported increased satisfaction with the process and improved ease of screening. We created a semiautomated electronic screening tool that uses branch logic to screen patients for stroke clinical trials. The tool has improved efficiency and efficacy of screening, and it could be adapted for use at other sites and in other medical fields. © 2016 American Heart Association, Inc.

Variation in diagnostic performance among radiologists at screening CT colonography.

PubMed

Pooler, B Dustin; Kim, David H; Hassan, Cesare; Rinaldi, Antonio; Burnside, Elizabeth S; Pickhardt, Perry J

2013-07-01

To assess the variation in diagnostic performance among radiologists at screening computed tomographic (CT) colonography. In this HIPAA-compliant, institutional review board-approved study, 6866 asymptomatic adults underwent first-time CT colonographic screening at a single center between January 2005 and November 2011. Results of examinations were interpreted by one of eight board-certified abdominal radiologists (mean number of CT colonographic studies per reader, 858; range, 131-2202). Findings at CT colonography and subsequent colonoscopy were recorded, and key measures of diagnostic performance, including adenoma and advanced neoplasia detection rate, were compared among the radiologists. The overall prevalence of histopathologically confirmed advanced neoplasia was 3.6% and did not differ significantly among radiologists (range, 2.4%-4.4%; P = .067; P = .395 when one outlier was excluded). Overall, 19.5% of polyps detected at CT colonography proved to be advanced neoplasia and did not differ significantly among radiologists (range, 14.4%-23.2%; P = .223). The overall per-polyp endoscopic confirmation rate was 93.5%, ranging from 80.0% to 97.6% among radiologists (P = .585). The overall percentage of nondiagnostic CT colonographic examinations was 0.7% and was consistent among radiologists (range, 0.3%-1.1%; P = .509). Consistent performance for adenoma and advanced neoplasia detection, as well as other clinically relevant end points, were observed among radiologists at CT colonographic screening.

The patellofemoral joint: do age and gender affect skeletal maturation of the osseous morphology in children?

PubMed

Kim, Hee Kyung; Shiraj, Sahar; Anton, Christopher; Horn, Paul S

2014-02-01

The osseous morphology of the patellofemoral joint is an independent factor that affects the biomechanics of patellofemoral instability. The purpose of this study is to determine age- and gender-related differences in the osseous morphology of the patellofemoral joint in children during skeletal maturation. This study was approved by the institutional review board and was HIPAA-compliant. We included 97 children and young adults (age range 5-22 years; 51 girls and 46 boys, mean ages 14.3 years and 13.7 years, respectively). We studied 1.5-T knee MR exams, measuring the osseous morphology of the patellofemoral joint (lateral trochlear inclination, trochlear facet asymmetry, trochlear depth, patellar height ratio, tibial tubercle-trochlear groove distance, and lateral patellofemoral angle) for each MR exam. We compared measurements to published values for patellofemoral instability. Physeal patency (open or closing/closed) was determined on MR. We assessed the associations between MR osseous measurements and gender, age and physeal patency using Wilcoxon rank sum test and least square means regression models. The osseous patellofemoral joint morphology measurements were all within a normal range. There were no significant correlations between MR osseous measurements and age, gender or physeal patency. During skeletal maturation, age and gender do not affect the osseous morphology or congruency of the patellofemoral joint.

Noninvasive Classification of Hepatic Fibrosis Based on Texture Parameters From Double Contrast-Enhanced Magnetic Resonance Images

PubMed Central

Bahl, Gautam; Cruite, Irene; Wolfson, Tanya; Gamst, Anthony C.; Collins, Julie M.; Chavez, Alyssa D.; Barakat, Fatma; Hassanein, Tarek; Sirlin, Claude B.

2016-01-01

Purpose To demonstrate a proof of concept that quantitative texture feature analysis of double contrast-enhanced magnetic resonance imaging (MRI) can classify fibrosis noninvasively, using histology as a reference standard. Materials and Methods A Health Insurance Portability and Accountability Act (HIPAA)-compliant Institutional Review Board (IRB)-approved retrospective study of 68 patients with diffuse liver disease was performed at a tertiary liver center. All patients underwent double contrast-enhanced MRI, with histopathology-based staging of fibrosis obtained within 12 months of imaging. The MaZda software program was used to compute 279 texture parameters for each image. A statistical regularization technique, generalized linear model (GLM)-path, was used to develop a model based on texture features for dichotomous classification of fibrosis category (F ≤2 vs. F ≥3) of the 68 patients, with histology as the reference standard. The model's performance was assessed and cross-validated. There was no additional validation performed on an independent cohort. Results Cross-validated sensitivity, specificity, and total accuracy of the texture feature model in classifying fibrosis were 91.9%, 83.9%, and 88.2%, respectively. Conclusion This study shows proof of concept that accurate, noninvasive classification of liver fibrosis is possible by applying quantitative texture analysis to double contrast-enhanced MRI. Further studies are needed in independent cohorts of subjects. PMID:22851409

Optum Labs: building a novel node in the learning health care system.

PubMed

Wallace, Paul J; Shah, Nilay D; Dennen, Taylor; Bleicher, Paul A; Bleicher, Paul D; Crown, William H

2014-07-01

Unprecedented change in the US health care system is being driven by the rapid uptake of health information technology and national investments in multi-institution research networks comprising academic centers, health care delivery systems, and other health system components. An example of this changing landscape is Optum Labs, a novel network "node" that is bringing together new partners, data, and analytic techniques to implement research findings in health care practice. Optum Labs was founded in early 2013 by Mayo Clinic and Optum, a commercial data, infrastructure services, and care organization that is part of UnitedHealth Group. Optum Labs now has eleven collaborators and a database of deidentified information on more than 150 million people that is compliant with the Health Insurance Portability and Accountability Act (HIPAA) of 1996. This article describes the early progress of Optum Labs. The combination of the diverse collaborator perspectives with rich data, including deep patient and provider information, is intended to reveal new insights about diseases, treatments, and patients' behavior to guide changes in practice. Practitioners' involvement in agenda setting and translation of findings into practical care innovations accelerates the implementation of research results. Furthermore, feedback loops from the clinic help Optum Labs expand on successes and give quick attention to challenges as they emerge. Project HOPE—The People-to-People Health Foundation, Inc.

Challenges and Insights in Using HIPAA Privacy Rule for Clinical Text Annotation.

PubMed

Kayaalp, Mehmet; Browne, Allen C; Sagan, Pamela; McGee, Tyne; McDonald, Clement J

2015-01-01

The Privacy Rule of Health Insurance Portability and Accountability Act (HIPAA) requires that clinical documents be stripped of personally identifying information before they can be released to researchers and others. We have been manually annotating clinical text since 2008 in order to test and evaluate an algorithmic clinical text de-identification tool, NLM Scrubber, which we have been developing in parallel. Although HIPAA provides some guidance about what must be de-identified, translating those guidelines into practice is not as straightforward, especially when one deals with free text. As a result we have changed our manual annotation labels and methods six times. This paper explains why we have made those annotation choices, which have been evolved throughout seven years of practice on this field. The aim of this paper is to start a community discussion towards developing standards for clinical text annotation with the end goal of studying and comparing clinical text de-identification systems more accurately.

The law of unintended (financial) consequences: the expansion of HIPAA business associate liability.

PubMed

Tomes, Jonathan P

2013-01-01

The recent Omnibus Rule published by the Department of Health and Human Services greatly expanded liability for breaches of health information privacy and security under the HIPAA statute and regulations. This expansion could have dire financial consequences for the health care industry. The Rule expanded the definition of business associates to include subcontractors of business associates and made covered entities and business associates liable for breaches of the entities who perform a service for them involving the use of individually identifiable health information under the federal common law of agency. Thus, if a covered entity or its "do wnstream" business associate breaches security or privacy, the covered entity or "upstream" business associate may face HIPAA's civil money penalties or a lawsuit. Financial managers need to be aware of these changes both to protect against the greater liability and to plan for the compliance costs inherent in effectively, if not legally, making business associates into covered entities.

A new evidence-based model for weight management in primary care: the Counterweight Programme.

PubMed

Laws, Rachel

2004-06-01

Obesity has become a global epidemic, and a major preventable cause of morbidity and mortality. Management strategies and treatment protocols are however poorly developed and evaluated. The aim of the Counterweight Programme is to develop an evidence-based model for the management of obesity in primary care. The Counterweight Programme is based on the theoretical model of Evidence-Based Quality Assessment aimed at improving the management of obese adults (18-75 years) in primary care. The model consists of four phases: (1) practice audit and needs assessment, (2) practice support and training, (3) practice nurse-led patient intervention, and (4) evaluation. Patient intervention consisted of screening and treatment pathways incorporating evidence-based approaches, including patient-centred goal setting, prescribed eating plans, a group programme, physical activity and behavioural approaches, anti-obesity medication and weight maintenance strategies. Weight Management Advisers who are specialist obesity dietitians facilitated programme implementation. Eighty practices were recruited of which 18 practices were randomized to act as controls and receive deferred intervention 2 years after the initial audit. By February 2004, 58 of the 62 (93.5%) intervention practices had been trained to run the intervention programme, 47 (75.8%) practices were active in implementing the model and 1256 patients had been recruited (74% female, 26% male, mean age 50.6 years, SD 14). At baseline, 75% of patients had at one or more co-morbidity, and the mean body mass index (BMI) was 36.9 kg/m(2) (SD 5.4). Of the 1256 patients recruited, 91% received one of the core lifestyle interventions in the first 12 months. For all patients followed up at 12 months, 34% achieved a clinical meaningful weight loss of 5% or more. A total of 51% of patients were classed as compliant in that they attended the required level of appointments in 3, 6, and 12 months. For fully compliant patients, weight loss improved with 43% achieving a weight loss of 5% or more at 12 months. The Counterweight Programme is an evidence-based weight management model which is feasible to implement in primary care.

Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

PubMed

Crandall, Phil; Van Loo, Ellen J; O'Bryan, Corliss A; Mauromoustakos, Andy; Yiannas, Frank; Dyenson, Natalie; Berdnik, Irina

2012-09-01

International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required improved company food safety practices and increased employee training. Adoption of a GFSI benchmarked scheme resulted in fewer audits, i.e., one less per year. An educational opportunity exists to acquaint retailers and suppliers worldwide with the benefits of having an internationally recognized certification program such as that recognized by the GFSI.

The Role of HIPAA Omnibus Rules in Reducing the Frequency of Medical Data Breaches: Insights From an Empirical Study.

PubMed

Yaraghi, Niam; Gopal, Ram D

2018-03-01

Policy Points: Frequent data breaches in the US health care system undermine the privacy of millions of patients every year-a large number of which happen among business associates of the health care providers that continue to gain unprecedented access to patients' data as the US health care system becomes digitally integrated. Implementation of the HIPAA Omnibus Rules in 2013 has led to a significant decrease in the number of privacy breach incidents among business associates. Frequent data breaches in the US health care system undermine the privacy of millions of patients every year. A large number of such breaches happens among business associates of the health care providers that continue to gain unprecedented access to patients' data as the US health care system becomes digitally integrated. The Omnibus Rules of the Health Insurance Portability and Accountability Act (HIPAA), which were enacted in 2013, significantly increased the regulatory oversight and privacy protection requirements of business associates. The objective of this study is to empirically examine the effects of this shift in policy on the frequency of medical privacy breaches among business associates in the US health care system. The findings of this research shed light on how regulatory efforts can protect patients' privacy. Using publicly available data on breach incidents between October 2009 and August 2017 as reported by the Office for Civil Rights (OCR), we conducted an interrupted time-series analysis and a difference-in-differences analysis to examine the immediate and long-term effects of implementation of HIPAA omnibus rules on the frequency of medical privacy breaches. We show that implementation of the omnibus rules led to a significant reduction in the number of breaches among business associates and prevented 180 privacy breaches from happening, which could have affected nearly 18 million Americans. Implementation of HIPAA omnibus rules may have been a successful federal policy in enhancing privacy protection efforts and reducing the number of breach incidents in the US health care system. © 2018 Milbank Memorial Fund.

VOIP for Telerehabilitation: A Risk Analysis for Privacy, Security and HIPAA Compliance: Part II

PubMed Central

Watzlaf, Valerie J.M.; Moeini, Sohrab; Matusow, Laura; Firouzan, Patti

2011-01-01

In a previous publication the authors developed a privacy and security checklist to evaluate Voice over Internet Protocol (VoIP) videoconferencing software used between patients and therapists to provide telerehabilitation (TR) therapy. In this paper, the privacy and security checklist that was previously developed is used to perform a risk analysis of the top ten VoIP videoconferencing software to determine if their policies provide answers to the privacy and security checklist. Sixty percent of the companies claimed they do not listen into video-therapy calls unless maintenance is needed. Only 50% of the companies assessed use some form of encryption, and some did not specify what type of encryption was used. Seventy percent of the companies assessed did not specify any form of auditing on their servers. Statistically significant differences across company websites were found for sharing information outside of the country (p=0.010), encryption (p=0.006), and security evaluation (p=0.005). Healthcare providers considering use of VoIP software for TR services may consider using this privacy and security checklist before deciding to incorporate a VoIP software system for TR. Other videoconferencing software that is specific for TR with strong encryption, good access controls, and hardware that meets privacy and security standards should be considered for use with TR. PMID:25945177

VOIP for Telerehabilitation: A Risk Analysis for Privacy, Security and HIPAA Compliance: Part II.

PubMed

Watzlaf, Valerie J M; Moeini, Sohrab; Matusow, Laura; Firouzan, Patti

2011-01-01

In a previous publication the authors developed a privacy and security checklist to evaluate Voice over Internet Protocol (VoIP) videoconferencing software used between patients and therapists to provide telerehabilitation (TR) therapy. In this paper, the privacy and security checklist that was previously developed is used to perform a risk analysis of the top ten VoIP videoconferencing software to determine if their policies provide answers to the privacy and security checklist. Sixty percent of the companies claimed they do not listen into video-therapy calls unless maintenance is needed. Only 50% of the companies assessed use some form of encryption, and some did not specify what type of encryption was used. Seventy percent of the companies assessed did not specify any form of auditing on their servers. Statistically significant differences across company websites were found for sharing information outside of the country (p=0.010), encryption (p=0.006), and security evaluation (p=0.005). Healthcare providers considering use of VoIP software for TR services may consider using this privacy and security checklist before deciding to incorporate a VoIP software system for TR. Other videoconferencing software that is specific for TR with strong encryption, good access controls, and hardware that meets privacy and security standards should be considered for use with TR.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, Xiaoqi; Yao, Lei; Xi, Lei

Purpose: To evaluate the feasibility of functional photoacoustic tomography (fPAT) for high resolution detection and characterization of breast cancer and to demonstrate for the first time quantitative hemoglobin concentration and oxygen saturation images of breasts that were formed with model-based reconstruction of tomographic photoacoustic data. Methods: The study was HIPAA compliant and was approved by the university institutional review board. Written informed consents were obtained from all the participants. Ten cases, including six cancer and four healthy (mean age = 50 yr; age range = 41–66 yr), were examined. Functional images of breast tissue including absolute total hemoglobin concentration (Hb{submore » T}) and oxygen saturation (StO{sub 2}%) were obtained by fPAT and cross validated with magnetic resonance imaging (MRI) readings and/or histopathology. Results: Hb{sub T} and StO{sub 2}% maps from all six pathology-confirmed cancer cases (60%) show clear detection of tumor, while MR images indicate clear detection of tumor for five of six cancer cases; one small tumor was read as near-complete-resolution by MRI. The average Hb{sub T} and StO{sub 2}% value of suspicious lesion area for the cancer cases was 61.6 ± 18.9 μM/l and 67.5% ± 5.2% compared to 25.6 ± 7.4 μM/l and 65.2% ± 3.8% for background normal tissue. Conclusions: fPAT has the potential to be a significant add-on in breast cancer detection and characterization as it provides submillimeter resolution functional images of breast lesions.« less

Assessing response to treatment in non--small-cell lung cancer: role of tumor volume evaluated by computed tomography.

PubMed

Knollmann, Friedrich D; Kumthekar, Rohan; Fetzer, David; Socinski, Mark A

2014-03-01

We set out to investigate whether volumetric tumor measurements allow for a prediction of treatment response, as measured by patient survival, in patients with advanced non-small-cell lung cancer (NSCLC). Patients with nonresectable NSCLC (stage III or IV, n = 100) who were repeatedly evaluated for treatment response by computed tomography (CT) were included in a Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective study. Tumor response was measured by comparing tumor volumes over time. Patient survival was compared with Response Evaluation Criteria in Solid Tumors (RECIST) using Kaplan-Meier survival statistics and Cox regression analysis. The median overall patient survival was 553 days (standard error, 146 days); for patients with stage III NSCLC, it was 822 days, and for patients with stage IV disease, 479 days. The survival differences were not statistically significant (P = .09). According to RECIST, 5 patients demonstrated complete response, 39 partial response, 44 stable disease, and 12 progressive disease. Patient survival was not significantly associated with RECIST class, the change of the sum of tumor diameters (P = .98), nor the change of the sum of volumetric tumor dimensions (P = .17). In a group of 100 patients with advanced-stage NSCLC, neither volumetric CT measurements of changes in tumor size nor RECIST class significantly predicted patient survival. This observation suggests that size response may not be a sufficiently precise surrogate marker of success to steer treatment decisions in individual patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Stimulated echo diffusion tensor imaging and SPAIR T2 -weighted imaging in chronic exertional compartment syndrome of the lower leg muscles.

PubMed

Sigmund, Eric E; Sui, Dabang; Ukpebor, Obehi; Baete, Steven; Fieremans, Els; Babb, James S; Mechlin, Michael; Liu, Kecheng; Kwon, Jane; McGorty, KellyAnne; Hodnett, Philip A; Bencardino, Jenny

2013-11-01

To evaluate the performance of diffusion tensor imaging (DTI) in the evaluation of chronic exertional compartment syndrome (CECS) as compared to T2 -weighted (T2w) imaging. Using an Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, spectral adiabatic inversion recovery (SPAIR) T2w imaging and stimulated echo DTI were applied to eight healthy volunteers and 14 suspected CECS patients before and after exertion. Longitudinal and transverse diffusion eigenvalues, mean diffusivity (MD), and fractional anisotropy (FA) were measured in seven calf muscle compartments, which in patients were classified by their response on T2w: normal (<20% change), and CECS (>20% change). Mixed model analysis of variance compared subject groups and compartments in terms of response factors (post/pre-exercise ratios) of DTI parameters. All diffusivities significantly increased (P < 0.0001) and FA decreased (P = 0.0014) with exercise. Longitudinal diffusion responses were significantly smaller than transversal diffusion responses (P < 0.0001). Nineteen of 98 patient compartments were classified as CECS on T2w. MD increased by 3.8 ± 3.4% (volunteer), 7.4 ± 4.2% (normal), and 9.1 ± 7.0% (CECS) with exercise. DTI shows promise as an ancillary imaging method in the diagnosis and understanding of the pathophysiology in CECS. Future studies may explore its utility in predicting response to treatment. Copyright © 2013 Wiley Periodicals, Inc.

Amplatzer vascular plug for arteriovenous hemodialysis access occlusion: initial experience.

PubMed

Bui, J T; Gaba, R C; Knuttinen, M G; West, D L; Owens, C A

2009-01-01

The Amplatzer Vascular Plug (AVP; AGA Medical, Golden Valley, MN) is a recently developed self-expanding metallic device indicated for peripheral vascular embolizations. Herein, we describe use of this device in the treatment of vascular complications related to arteriovenous hemodialysis fistulas and grafts. This HIPAA compliant retrospective study was approved by the institutional review board with informed consent waived. Six patients with problematic arteriovenous access underwent access occlusion using the AVP. Procedure indications included vascular steal syndrome in five patients, and enlarging vascular aneurysms in one patient. Contraindications for surgical correction were determined by the referring surgeon. AVP embolizations were performed using devices oversized by 50% introduced through vascular sheaths positioned within vein segments just beyond the arteriovenous anastomoses. Noninvasive evaluation of the involved extremity was performed pre- and post-embolization in addition to clinical follow-up examinations. Measured outcomes included success of angiographic occlusion, improvement in distal arterial flow, AVP number, AVP diameter, time to access occlusion, and clinical symptomatic improvement. Technical success was 100%, with complete arteriovenous access occlusion accomplished in all cases, with an average of 1.5 AVPs used per patient. Mean time to access occlusion was 19.3 minutes. Angiographic improvement in distal arterial flow was immediately evident and resolution of clinical symptoms occurred in all patients, with mean long-term follow-up of 16 months. No procedure-related complications were encountered. The Amplatzer Vascular Plug provides a minimally invasive and efficacious method for embolization of problematic arteriovenous hemodialysis access.

Evaluation of breast cancer using intravoxel incoherent motion (IVIM) histogram analysis: comparison with malignant status, histological subtype, and molecular prognostic factors.

PubMed

Cho, Gene Young; Moy, Linda; Kim, Sungheon G; Baete, Steven H; Moccaldi, Melanie; Babb, James S; Sodickson, Daniel K; Sigmund, Eric E

2016-08-01

To examine heterogeneous breast cancer through intravoxel incoherent motion (IVIM) histogram analysis. This HIPAA-compliant, IRB-approved retrospective study included 62 patients (age 48.44 ± 11.14 years, 50 malignant lesions and 12 benign) who underwent contrast-enhanced 3 T breast MRI and diffusion-weighted imaging. Apparent diffusion coefficient (ADC) and IVIM biomarkers of tissue diffusivity (Dt), perfusion fraction (fp), and pseudo-diffusivity (Dp) were calculated using voxel-based analysis for the whole lesion volume. Histogram analysis was performed to quantify tumour heterogeneity. Comparisons were made using Mann-Whitney tests between benign/malignant status, histological subtype, and molecular prognostic factor status while Spearman's rank correlation was used to characterize the association between imaging biomarkers and prognostic factor expression. The average values of the ADC and IVIM biomarkers, Dt and fp, showed significant differences between benign and malignant lesions. Additional significant differences were found in the histogram parameters among tumour subtypes and molecular prognostic factor status. IVIM histogram metrics, particularly fp and Dp, showed significant correlation with hormonal factor expression. Advanced diffusion imaging biomarkers show relationships with molecular prognostic factors and breast cancer malignancy. This analysis reveals novel diagnostic metrics that may explain some of the observed variability in treatment response among breast cancer patients. • Novel IVIM biomarkers characterize heterogeneous breast cancer. • Histogram analysis enables quantification of tumour heterogeneity. • IVIM biomarkers show relationships with breast cancer malignancy and molecular prognostic factors.

Association Between Visceral Adiposity and Colorectal Polyps on CT Colonography

PubMed Central

Summers, Ronald M.; Liu, Jiamin; Sussman, Daniel L.; Dwyer, Andrew J.; Rehani, Bhavya; Pickhardt, Perry J.; Choi, J. Richard; Yao, Jianhua

2012-01-01

OBJECTIVE To determine if there is an association between visceral adiposity measured on CT colonography (CTC) and colorectal polyps. MATERIALS AND METHODS The study was HIPAA-compliant and approved by our Institutional Review Board and Office of Human Subjects Research. 1186 patients who underwent CTC and same day optical colonoscopy were analyzed. Visceral adipose tissue volumes (VAV) and volume percents relative to total internal body volume (VAV%) were measured on slices in the L2–L3 regions on supine CTC scan with validated fully-automated software. Student t-test, odds ratio (OR), logistic regression and receiver operating characteristic analyses were performed. RESULTS For subjects with and without adenomatous polyps, means and s. d. of VAV% were 31.2 ± 10.8% (n=345) and 28.2% ± 11.3% (n=841) (p<0.0001), respectively. For subjects with and without hyperplastic polyps they were 31.8% ± 10.7% (n=244) and 28.3% ± 11.2% (n=942) (p<0.0001), respectively. Comparing the lowest and highest quintiles of VAV%, the ORs for having at least one adenomatous polyp or hyperplastic polyp versus no polyp were 2.06 (95% CI: 1.36–3.13) and 1.71 [1.08, 2.71] and the prevalence of having adenomatous polyps or hyperplastic polyps increased 14% and 8%, respectively. CONCLUSION Subjects with higher visceral adiposity measurements on CTC have a greater risk for the presence of colonic polyps. PMID:22733893

Retrieval of Tip-embedded Inferior Vena Cava Filters by Using the Endobronchial Forceps Technique: Experience at a Single Institution.

PubMed

Stavropoulos, S William; Ge, Benjamin H; Mondschein, Jeffrey I; Shlansky-Goldberg, Richard D; Sudheendra, Deepak; Trerotola, Scott O

2015-06-01

To evaluate the use of endobronchial forceps to retrieve tip-embedded inferior vena cava (IVC) filters. This institutional review board-approved, HIPAA-compliant retrospective study included 114 patients who presented with tip-embedded IVC filters for removal from January 2005 to April 2014. The included patients consisted of 77 women and 37 men with a mean age of 43 years (range, 18-79 years). Filters were identified as tip embedded by using rotational venography. Rigid bronchoscopy forceps were used to dissect the tip or hook of the filter from the wall of the IVC. The filter was then removed through the sheath by using the endobronchial forceps. Statistical analysis entailed calculating percentages, ranges, and means. The endobronchial forceps technique was used to successfully retrieve 109 of 114 (96%) tip-embedded IVC filters on an intention-to-treat basis. Five failures occurred in four patients in whom the technique was attempted but failed and one patient in whom retrieval was not attempted. Filters were in place for a mean of 465 days (range, 31-2976 days). The filters in this study included 10 Recovery, 33 G2, eight G2X, 11 Eclipse, one OptEase, six Option, 13 Günther Tulip, one ALN, and 31 Celect filters. Three minor complications and one major complication occurred, with no permanent sequelae. The endobronchial forceps technique can be safely used to remove tip-embedded IVC filters. © RSNA, 2014.

Skeletal development of the glenoid and glenoid-coracoid interface in the pediatric population: MRI features.

PubMed

Kothary, Shefali; Rosenberg, Zehava Sadka; Poncinelli, Leonardo L; Kwong, Steven

2014-09-01

To assess the MRI appearance of normal skeletal development of the glenoid and glenoid-coracoid interface in the pediatric population. To the best of our knowledge, this has not yet been studied in detail in the literature. An IRB-approved, HIPAA-compliant retrospective review of 105 consecutive shoulder MRI studies in children, ages 2 months to 18 years was performed. The morphology, MR signal, and development of the following were assessed: (1) scapular-coracoid bipolar growth plate, (2) glenoid and glenoid-coracoid interface secondary ossification centers, (3) glenoid advancing osseous surface. The glenoid and glenoid-coracoid interface were identified in infancy as a contiguous, cartilaginous mass. A subcoracoid secondary ossification center in the superior glenoid was identified and fused in all by age 12 and 16, respectively. In ten studies, additional secondary ossification centers were identified in the inferior two-thirds of the glenoid. The initial concavity of the glenoid osseous surface gradually transformed to convexity, matching the convex glenoid articular surface. The glenoid growth plate fused by 16 years of age. Our study, based on MRI, demonstrated a similar pattern of development of the glenoid and glenoid coracoid interface to previously reported anatomic and radiographic studies, except for an earlier development and fusion of the secondary ossification centers of the inferior glenoid. The pattern of skeletal development of the glenoid and glenoid-coracoid interface follows a chronological order, which can serve as a guideline when interpreting MRI studies in children.

Variation in Diagnostic Performance among Radiologists at Screening CT Colonography

PubMed Central

Pooler, B. Dustin; Kim, David H.; Hassan, Cesare; Rinaldi, Antonio; Burnside, Elizabeth S.

2013-01-01

Purpose: To assess the variation in diagnostic performance among radiologists at screening computed tomographic (CT) colonography. Materials and Methods: In this HIPAA-compliant, institutional review board–approved study, 6866 asymptomatic adults underwent first-time CT colonographic screening at a single center between January 2005 and November 2011. Results of examinations were interpreted by one of eight board-certified abdominal radiologists (mean number of CT colonographic studies per reader, 858; range, 131–2202). Findings at CT colonography and subsequent colonoscopy were recorded, and key measures of diagnostic performance, including adenoma and advanced neoplasia detection rate, were compared among the radiologists. Results: The overall prevalence of histopathologically confirmed advanced neoplasia was 3.6% and did not differ significantly among radiologists (range, 2.4%–4.4%; P = .067; P = .395 when one outlier was excluded). Overall, 19.5% of polyps detected at CT colonography proved to be advanced neoplasia and did not differ significantly among radiologists (range, 14.4%–23.2%; P = .223). The overall per-polyp endoscopic confirmation rate was 93.5%, ranging from 80.0% to 97.6% among radiologists (P = .585). The overall percentage of nondiagnostic CT colonographic examinations was 0.7% and was consistent among radiologists (range, 0.3%–1.1%; P = .509). Conclusion: Consistent performance for adenoma and advanced neoplasia detection, as well as other clinically relevant end points, were observed among radiologists at CT colonographic screening. © RSNA, 2013 PMID:23449954

Magnetic resonance imaging (MRI) of hormone-induced breast changes in young premenopausal women.

PubMed

Clendenen, Tess V; Kim, Sungheon; Moy, Linda; Wan, Livia; Rusinek, Henry; Stanczyk, Frank Z; Pike, Malcolm C; Zeleniuch-Jacquotte, Anne

2013-01-01

We conducted a pilot study to identify whether MRI parameters are sensitive to hormone-induced changes in the breast during the natural menstrual cycle and whether changes could also be observed during an oral contraceptive (OC) cycle. The New York University Langone Medical Center Institutional Review Board approved this HIPAA-compliant prospective study. All participants provided written informed consent. Participants were aged 24-31 years.We measured several non-contrast breast MRI parameters during each week of a single menstrual cycle (among 9 women) and OC cycle (among 8 women). Hormones were measured to confirm ovulation and classify menstrual cycle phase among naturally cycling women and to monitor OC compliance among OC users. We investigated how the non-contrast MRI parameters of breast fibroglandular tissue (FGT), apparent diffusion coefficient (ADC), magnetization transfer ratio (MTR), and transverse relaxation time (T2) varied over the natural and the OC cycles. We observed significant increases in MRI FGT% and ADC in FGT, and longer T2 in FGT in the luteal vs. follicular phase of the menstrual cycle. We did not observe any consistent pattern of change for any of the MRI parameters among women using OCs. MRI is sensitive to hormone-induced breast tissue changes during the menstrual cycle. Larger studies are needed to assess whether MRI is also sensitive to the effects of exogenous hormones, such as various OC formulations, on the breast tissue of young premenopausal women. Copyright © 2013 Elsevier Inc. All rights reserved.

Reference Levels for Patient Radiation Doses in Interventional Radiology: Proposed Initial Values for U.S. Practice1

PubMed Central

Miller, Donald L.; Kwon, Deukwoo; Bonavia, Grant H.

2009-01-01

Purpose: To propose initial values for patient reference levels for fluoroscopically guided procedures in the United States. Materials and Methods: This secondary analysis of data from the Radiation Doses in Interventional Radiology Procedures (RAD-IR) study was conducted under a protocol approved by the institutional review board and was HIPAA compliant. Dose distributions (percentiles) were calculated for each type of procedure in the RAD-IR study where there were data from at least 30 cases. Confidence intervals for the dose distributions were determined by using bootstrap resampling. Weight banding and size correction methods for normalizing dose to patient body habitus were tested. Results: The different methods for normalizing patient radiation dose according to patient weight gave results that were not significantly different (P > .05). The 75th percentile patient radiation doses normalized with weight banding were not significantly different from those that were uncorrected for body habitus. Proposed initial reference levels for various interventional procedures are provided for reference air kerma, kerma-area product, fluoroscopy time, and number of images. Conclusion: Sufficient data exist to permit an initial proposal of values for reference levels for interventional radiologic procedures in the United States. For ease of use, reference levels without correction for body habitus are recommended. A national registry of radiation-dose data for interventional radiologic procedures is a necessary next step to refine these reference levels. © RSNA, 2009 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.2533090354/-/DC1 PMID:19789226

Increasing access to care for young adults with cancer: Results of a quality-improvement project using a novel telemedicine approach to supportive group psychotherapy.

PubMed

Melton, Laura; Brewer, Benjamin; Kolva, Elissa; Joshi, Tanisha; Bunch, Michelle

2017-04-01

Young adults with cancer experience high levels of psychological distress. Group interventions for cancer patients have been effective in reducing levels of psychological distress but suffer from high levels of attrition and serve a limited geographic area. In a quality-improvement project, we converted an existing in-person support group to a telemedicine format in the hopes of improving attendance and reducing geographic disparities in access to care. Eight young adults (18-40 years) with cancer were recruited from across Colorado. Participants received a tablet equipped with Wi-Fi and downloaded an HIPAA-compliant video-conferencing application. Participants attended six weekly supportive psychotherapy sessions. Participants found the group to be beneficial: the technology worked, they enjoyed the group format, and they would recommend it to others. The novel treatment interface allowed for low attrition rates due to the flexibility of a patient's location during the intervention. It allowed for provision of services to a geographically diverse population of medically ill young adults, as participants lived an average of 148 miles from the cancer center (range = 25-406 miles). Internet-based mental health care is an area of growing interest for providers, but few studies have evaluated its efficacy in patients with cancer, and even fewer in young adults with cancer. Incorporating technological advances into clinical practice will increase access to care, reduce geographic health disparities, and provide more consistent services.

Digital mobile technology facilitates HIPAA-sensitive perioperative messaging, improves physician-patient communication, and streamlines patient care.

PubMed

Gordon, Chad R; Rezzadeh, Kameron S; Li, Andrew; Vardanian, Andrew; Zelken, Jonathan; Shores, Jamie T; Sacks, Justin M; Segovia, Andres L; Jarrahy, Reza

2015-01-01

Mobile device technology has revolutionized interpersonal communication, but the application of this technology to the physician-patient relationship remains limited due to concerns over patient confidentiality and the security of digital information. Nevertheless, there is a continued focus on improving communication between doctors and patients in all fields of medicine as a means of improving patient care. In this study, we implement a novel communications platform to demonstrate that instantaneously sharing perioperative information with surgical patients and members of their support networks can improve patient care and strengthen the physician-patient relationship. 423 consecutive patients scheduled to undergo elective surgical procedures were offered complimentary registration to a secure, web-based service designed to distribute perioperative updates to a group of recipients designated by each patient via Short Message Service (SMS) and/or email. Messages were created by attending surgeons and delivered instantaneously through the web-based platform. In the postoperative period, patients and their designated message recipients, as well as participating healthcare providers, were asked to complete a survey designed to assess their experience with the messaging system. Survey results were statistically analyzed to determine satisfaction rates. Of the qualifying 423 patients, 313 opted to enroll in the study. On average, patients selected a total of 3.5 recipients to receive perioperative updates. A total of 1,195 electronic messages were generated for distribution to designated recipients during the study period and delivered to recipients located around the world. There were no documented errors or failures in message delivery. Satisfaction surveys were completed by 190 users of the service (73 %). Respondents identified themselves as either patients (n = 48, 25.5 %), family/friends (n = 120, 63.8 %), or healthcare providers (n = 15, 12 %). Satisfaction with the service was high: 94.2 % of users "enjoyed this software" and and 94.2 % of family/friends "felt more connected to their loved ones during surgery." 92.5 % would "recommend their loved ones sign up for this service". Ninety percent of patients who completed the survey reported "an improved hospital experience". Digital communications platforms can facilitate the immediate transfer of HIPAA-compliant data to patients and their designees. Such systems can greatly improve the level of communication between physicians, patients, and patients' families and caregivers. All types of users, including healthcare professionals, patients, and their loved ones, recorded high levels of satisfaction. Based on these observations, we conclude that mobile digital communications platforms represent a way to harness the power of social media to enhance patient care.

A Formalization of HIPAA for a Medical Messaging System

NASA Astrophysics Data System (ADS)

Lam, Peifung E.; Mitchell, John C.; Sundaram, Sharada

The complexity of regulations in healthcare, financial services, and other industries makes it difficult for enterprises to design and deploy effective compliance systems. We believe that in some applications, it may be practical to support compliance by using formalized portions of applicable laws to regulate business processes that use information systems. In order to explore this possibility, we use a stratified fragment of Prolog with limited use of negation to formalize a portion of the US Health Insurance Portability and Accountability Act (HIPAA). As part of our study, we also explore the deployment of our formalization in a prototype hospital Web portal messaging system.

HIPAA and patient care: the role for professional judgment.

PubMed

Lo, Bernard; Dornbrand, Laurie; Dubler, Nancy N

2005-04-13

Federal health privacy regulations, commonly known as the Health Insurance Portability and Accountability Act (HIPAA) regulations, came into effect in April 2003. Many clinicians and institutions have relied on consultants and risk managers to tell them how to implement these regulations. Much of the controversy and confusion over the HIPAA regulations concern so-called incidental disclosures. Some interpretations of the privacy regulations would limit essential communication and compromise good patient care. This article analyzes misconceptions regarding what the regulations say about incidental disclosures and discusses the reasons for such misunderstandings. Many misconceptions arise from gaps in the regulations. These gaps are appropriately filled by professional judgment informed by ethical guidelines. The communication should be necessary and effective for good patient care, and the risks of a breach of confidentiality should be proportional to the likely benefit for the patient's care. The alternative for communication should be impractical. We offer specific recommendations to help physicians think through what incidental disclosures in patient care are ethically permissible and what safeguards ought to be taken. Physicians should work with risk managers and practice administrators to develop policies that promote good communication in patient care, while taking appropriate steps to protect patient privacy.

Impact of HIPAA’s Minimum Necessary Standard on Genomic Data Sharing

PubMed Central

Evans, Barbara J.; Jarvik, Gail P.

2017-01-01

Purpose This article provides a brief introduction to the HIPAA Privacy Rule’s minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. Methods This research used the Thomson Reuters Westlaw™ database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data-sharing. We considered relevant example cases of genomic data-sharing needs. Results In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized—whether for research, public health, or clinical interpretation and medical practice support—affects how the minimum necessary standard applies and its overall impact on data access and use. Conclusion There is no clear regulatory guidance on how to apply HIPAA’s minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy-makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows. PMID:28914268

HIPAA and the military health system: organizing technological and organizational reform in large enterprises

NASA Astrophysics Data System (ADS)

Collmann, Jeff R.

2001-08-01

The global scale, multiple units, diverse operating scenarios and complex authority structure of the Department of Defense Military Health System (MHS) create social boundaries that tend to reduce communication and collaboration about data security. Under auspices of the Defense Health Information Assurance Program (DHIAP), the Telemedicine and Advanced Technology Research Center (TATRC) is contributing to the MHS's efforts to prepare for and comply with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 through organizational and technological innovations that bridge such boundaries. Building interdisciplinary (clinical, administrative and information technology) medical information security readiness teams (MISRT) at each military treatment facility (MTF) constitutes the heart of this process. DHIAP is equipping and training MISRTs to use new tools including 'OCTAVE', a self-directed risk assessment instrument and 'RIMR', a web-enabled Risk Information Management Resource. DHIAP sponsors an interdisciplinary, triservice workgroup for review and revision of relevant DoD and service policies and participates in formal DoD health information assurance activities. These activities help promote a community of proponents across the MHS supportive of improved health information assurance. The MHS HIPAA-compliance effort teaches important general lessons about organizational reform in large civilian or military enterprises.

Leveraging the cost of HIPPA..

PubMed

Hoppszallern, Suzanna; Arges, George

2002-01-01

HIPAA's administrative simplification rule was introduced to reduce the costs of handling provider-payer transactions by standardizing them. The transaction rules are predicted to save billions of dollars. To get the biggest payoff, providers will need to overhaul their business processes as part of electronic transaction processing. By eliminating redundant and inefficient administrative processes, staff time can be focused on processes that improve financial performance and customer satisfaction. If your organization needs to have an extension beyond the original compliance date, you must file a plan before Oct. 16 to show how you'll come into compliance by Oct. 16, 2003. Check the roadmap and timetable for HIPAA compliance and see where your organization is and where it needs to be.

Nonvisualization of the ovaries on pelvic ultrasound: does MRI add anything?

PubMed

Lisanti, Christopher J; Wood, Jonathan R; Schwope, Ryan B

2014-02-01

The purpose of our study is to assess the utility of pelvic magnetic resonance imaging (MRI) in the event that either one or both ovaries are not visualized by pelvic ultrasound. This HIPAA-compliant retrospective study was approved by our local institutional review board and informed consent waived. 1926 pelvic MRI examinations between March 2007 and December 2011 were reviewed and included if a combined transabdominal and endovaginal pelvic ultrasound had been performed in the preceding 6 months with at least one ovary nonvisualized. Ovaries not visualized on pelvic ultrasound were assumed to be normal and compared with the pelvic MRI findings. MRI findings were categorized as concordant or discordant. Discordant findings were divided into malignant, non-malignant physiologic or non-malignant non-physiologic. The modified Wald, the "rule of thirds", and the binomial distribution probability tests were performed. 255 pelvic ultrasounds met inclusion criteria with 364 ovaries not visualized. 0 malignancies were detected on MRI. 6.9% (25/364) of nonvisualized ovaries had non-malignant discordant findings on MRI: 5.2% (19/364) physiologic, 1.6% (6/364) non-physiologic. Physiologic findings included: 16 functional cysts and 3 hemorrhagic cysts. Non-physiologic findings included: 3 cysts in post-menopausal women, 1 hydrosalpinx, and 2 broad ligament fibroids. The theoretical risk of detecting an ovarian carcinoma on pelvic MRI when an ovary is not visualized on ultrasound ranges from 0 to 1.3%. If an ovary is not visualized on pelvic ultrasound, it can be assumed to be without carcinoma and MRI rarely adds additional information.

Development of a Searchable Database of Cryoablation Simulations for Use in Treatment Planning.

PubMed

Boas, F Edward; Srimathveeravalli, Govindarajan; Durack, Jeremy C; Kaye, Elena A; Erinjeri, Joseph P; Ziv, Etay; Maybody, Majid; Yarmohammadi, Hooman; Solomon, Stephen B

2017-05-01

To create and validate a planning tool for multiple-probe cryoablation, using simulations of ice ball size and shape for various ablation probe configurations, ablation times, and types of tissue ablated. Ice ball size and shape was simulated using the Pennes bioheat equation. Five thousand six hundred and seventy different cryoablation procedures were simulated, using 1-6 cryoablation probes and 1-2 cm spacing between probes. The resulting ice ball was measured along three perpendicular axes and recorded in a database. Simulated ice ball sizes were compared to gel experiments (26 measurements) and clinical cryoablation cases (42 measurements). The clinical cryoablation measurements were obtained from a HIPAA-compliant retrospective review of kidney and liver cryoablation procedures between January 2015 and February 2016. Finally, we created a web-based cryoablation planning tool, which uses the cryoablation simulation database to look up the probe spacing and ablation time that produces the desired ice ball shape and dimensions. Average absolute error between the simulated and experimentally measured ice balls was 1 mm in gel experiments and 4 mm in clinical cryoablation cases. The simulations accurately predicted the degree of synergy in multiple-probe ablations. The cryoablation simulation database covers a wide range of ice ball sizes and shapes up to 9.8 cm. Cryoablation simulations accurately predict the ice ball size in multiple-probe ablations. The cryoablation database can be used to plan ablation procedures: given the desired ice ball size and shape, it will find the number and type of probes, probe configuration and spacing, and ablation time required.

Inter-examination Precision of Magnitude-based Magnetic Resonance Imaging for Estimation of Segmental Hepatic Proton Density Fat Fraction (PDFF) in Obese Subjects

PubMed Central

Negrete, Lindsey M.; Middleton, Michael S.; Clark, Lisa; Wolfson, Tanya; Gamst, Anthony C.; Lam, Jessica; Changchien, Chris; Deyoung-Dominguez, Ivan M.; Hamilton, Gavin; Loomba, Rohit; Schwimmer, Jeffrey; Sirlin, Claude B.

2013-01-01

Purpose To prospectively describe magnitude-based multi-echo gradient-echo hepatic proton density fat fraction (PDFF) inter-examination precision at 3T. Materials and Methods In this prospective, IRB approved, HIPAA compliant study, written informed consent was obtained from 29 subjects (body mass indexes > 30kg/m2). Three 3T magnetic resonance imaging (MRI) examinations were obtained over 75-90 minutes. Segmental, lobar, and whole liver PDFF were estimated (using three, four, five, or six echoes) by magnitude-based multi-echo MRI in co-localized regions of interest (ROIs). For estimate (using three, four, five, or six echoes), at each anatomic level (segmental, lobar, whole liver), three inter-examination precision metrics were computed: intra-class correlation coefficient (ICC), standard deviation (SD), and range. Results Magnitude-based PDFF estimates using each reconstruction method showed excellent inter-examination precision for each segment (ICC ≥ 0.992; SD ≤ 0.66%; range ≤ 1.24%), lobe (ICC ≥ 0.998; SD ≤ 0.34%; range ≤ 0.64%), and the whole liver (ICC = 0.999; SD ≤ 0.24%; range ≤ 0.45%). Inter-examination precision was unaffected by whether PDFF was estimated using three, four, five, or six echoes. Conclusion Magnitude-based PDFF estimation shows high inter-examination precision at segmental, lobar, and whole liver anatomic levels, supporting its use in clinical care or clinical trials. The results of this study suggest that longitudinal hepatic PDFF change greater than 1.6% is likely to represent signal rather than noise. PMID:24136736

Comparison of digital mammography and digital breast tomosynthesis in the detection of architectural distortion.

PubMed

Dibble, Elizabeth H; Lourenco, Ana P; Baird, Grayson L; Ward, Robert C; Maynard, A Stanley; Mainiero, Martha B

2018-01-01

To compare interobserver variability (IOV), reader confidence, and sensitivity/specificity in detecting architectural distortion (AD) on digital mammography (DM) versus digital breast tomosynthesis (DBT). This IRB-approved, HIPAA-compliant reader study used a counterbalanced experimental design. We searched radiology reports for AD on screening mammograms from 5 March 2012-27 November 2013. Cases were consensus-reviewed. Controls were selected from demographically matched non-AD examinations. Two radiologists and two fellows blinded to outcomes independently reviewed images from two patient groups in two sessions. Readers recorded presence/absence of AD and confidence level. Agreement and differences in confidence and sensitivity/specificity between DBT versus DM and attendings versus fellows were examined using weighted Kappa and generalised mixed modeling, respectively. There were 59 AD patients and 59 controls for 1,888 observations (59 × 2 (cases and controls) × 2 breasts × 2 imaging techniques × 4 readers). For all readers, agreement improved with DBT versus DM (0.61 vs. 0.37). Confidence was higher with DBT, p = .001. DBT achieved higher sensitivity (.59 vs. .32), p < .001; specificity remained high (>.90). DBT achieved higher positive likelihood ratio values, smaller negative likelihood ratio values, and larger ROC values. DBT decreases IOV, increases confidence, and improves sensitivity while maintaining high specificity in detecting AD. • Digital breast tomosynthesis decreases interobserver variability in the detection of architectural distortion. • Digital breast tomosynthesis increases reader confidence in the detection of architectural distortion. • Digital breast tomosynthesis improves sensitivity in the detection of architectural distortion.

A database de-identification framework to enable direct queries on medical data for secondary use.

PubMed

Erdal, B S; Liu, J; Ding, J; Chen, J; Marsh, C B; Kamal, J; Clymer, B D

2012-01-01

To qualify the use of patient clinical records as non-human-subject for research purpose, electronic medical record data must be de-identified so there is minimum risk to protected health information exposure. This study demonstrated a robust framework for structured data de-identification that can be applied to any relational data source that needs to be de-identified. Using a real world clinical data warehouse, a pilot implementation of limited subject areas were used to demonstrate and evaluate this new de-identification process. Query results and performances are compared between source and target system to validate data accuracy and usability. The combination of hashing, pseudonyms, and session dependent randomizer provides a rigorous de-identification framework to guard against 1) source identifier exposure; 2) internal data analyst manually linking to source identifiers; and 3) identifier cross-link among different researchers or multiple query sessions by the same researcher. In addition, a query rejection option is provided to refuse queries resulting in less than preset numbers of subjects and total records to prevent users from accidental subject identification due to low volume of data. This framework does not prevent subject re-identification based on prior knowledge and sequence of events. Also, it does not deal with medical free text de-identification, although text de-identification using natural language processing can be included due its modular design. We demonstrated a framework resulting in HIPAA Compliant databases that can be directly queried by researchers. This technique can be augmented to facilitate inter-institutional research data sharing through existing middleware such as caGrid.

Penetrating Colorectal Injuries: Diagnostic Performance of Multidetector CT with Trajectography.

PubMed

Dreizin, David; Boscak, Alexis R; Anstadt, Michael J; Tirada, Nikki; Chiu, William C; Munera, Felipe; Bodanapally, Uttam K; Hornick, Michael; Stein, Deborah M

2016-12-01

Purpose To determine the diagnostic performance of multidetector computed tomography (CT) with trajectography for penetrating colorectal injuries. Materials and Methods This institutional review board-approved and HIPAA-compliant study was a 6-year blinded retrospective review by two independent readers of 182 consecutive patients who preoperatively underwent 40- or 64-row multidetector CT for penetrating torso trauma below the diaphragm and had surgically confirmed findings. Colorectal perforation was present in 42 patients. Trajectory analysis with postprocessing software was used for all studies. Additional signs evaluated were rectal contrast agent leak, collections of extruded fecal material, mural defect, wall thickening, abnormal enhancement, free fluid or stranding, and free air. The quality of the colorectal contrast agent administration was recorded. Sensitivity, specificity, predictive values, areas under the receiver operating characteristic curves (AUCs), and Cohen κ were determined. Results In patients with rectal contrast agent administration (n = 151), AUCs were 0.90-0.91, which indicated excellent accuracy. Trajectory was sensitive (88%-91%). For single wounds (n = 104), sensitivity of trajectory was 96% for both readers, but was only 80% for multiple wounds (n = 47). Contrast agent leak was highly specific (96%-98%), but insensitive (42%-46%). Improved diagnostic performance was observed in patients with poor colonic distension or opacification. Accuracy remained high (AUC, 0.86-0.99) in the group without rectal contrast agent administration (n = 31). Conclusion Trajectory had excellent sensitivity, while rectal contrast agent leak was specific but insensitive. Sensitivity of trajectory was lower for multiple wounds. Accuracy remained high in patients without rectal contrast agent administration. © RSNA, 2016.

Predictive MRI correlates of lesser metatarsophalangeal joint plantar plate tear.

PubMed

Umans, Rachel L; Umans, Benjamin D; Umans, Hilary; Elsinger, Elisabeth

2016-07-01

To identify correlated signs on non-enhanced MRI that might improve diagnostic detection of plantar plate (PP) tear. We performed an IRB-approved, HIPAA-compliant retrospective analysis of 100 non-contrast MRI (50 PP tear, 50 controls). All were anonymized, randomized, and reviewed; 20 were duplicated to assess consistency. One musculoskeletal radiologist evaluated qualitative variables. A trained non-physician performed measurements. Consistency and concordance were assessed. Pearson's Chi-square test was used to test the correlation between qualitative findings and PP tear status. Correlation between measurements and PP status was assessed using t tests and Wilcoxon's rank-sum test (p values < 0.05 considered significant). Classification and regression trees were utilized to identify attributes that, taken together, would consistently distinguish PP tear from controls. Quantitative measurements were highly reproducible (concordance 0.88-0.99). Elevated 2nd MT protrusion, lesser MT supination and rotational divergence of >45° between the 1st-2nd MT axis correlated with PP tear. Pericapsular soft tissue thickening correlated most strongly with PP tear, correctly classifying 95 % of cases and controls. Excluding pericapsular soft tissue thickening, sequential assessment of 2nd toe enthesitis, 2nd flexor tendon subluxation, and splaying of the second and third toes accurately classified PP status in 92 %. Pericapsular soft tissue thickening most strongly correlated with PP tear. For cases in which it might be difficult to distinguish pericapsular fibrosis from neuroma, sequential assessment of 2nd toe enthesitis, flexor tendon subluxation and splaying of the 2nd and 3rd toe is most helpful for optimizing accurate diagnosis of PP tear.

Multimodal Randomized Functional MR Imaging of the Effects of Methylene Blue in the Human Brain.

PubMed

Rodriguez, Pavel; Zhou, Wei; Barrett, Douglas W; Altmeyer, Wilson; Gutierrez, Juan E; Li, Jinqi; Lancaster, Jack L; Gonzalez-Lima, Francisco; Duong, Timothy Q

2016-11-01

Purpose To investigate the sustained-attention and memory-enhancing neural correlates of the oral administration of methylene blue in the healthy human brain. Materials and Methods The institutional review board approved this prospective, HIPAA-compliant, randomized, double-blinded, placebo-controlled clinical trial, and all patients provided informed consent. Twenty-six subjects (age range, 22-62 years) were enrolled. Functional magnetic resonance (MR) imaging was performed with a psychomotor vigilance task (sustained attention) and delayed match-to-sample tasks (short-term memory) before and 1 hour after administration of low-dose methylene blue or a placebo. Cerebrovascular reactivity effects were also measured with the carbon dioxide challenge, in which a 2 × 2 repeated-measures analysis of variance was performed with a drug (methylene blue vs placebo) and time (before vs after administration of the drug) as factors to assess drug × time between group interactions. Multiple comparison correction was applied, with cluster-corrected P < .05 indicating a significant difference. Results Administration of methylene blue increased response in the bilateral insular cortex during a psychomotor vigilance task (Z = 2.9-3.4, P = .01-.008) and functional MR imaging response during a short-term memory task involving the prefrontal, parietal, and occipital cortex (Z = 2.9-4.2, P = .03-.0003). Methylene blue was also associated with a 7% increase in correct responses during memory retrieval (P = .01). Conclusion Low-dose methylene blue can increase functional MR imaging activity during sustained attention and short-term memory tasks and enhance memory retrieval. © RSNA, 2016 Online supplemental material is available for this article.

Age-related apparent diffusion coefficient changes in the normal brain.

PubMed

Watanabe, Memi; Sakai, Osamu; Ozonoff, Al; Kussman, Steven; Jara, Hernán

2013-02-01

To measure the mean diffusional age-related changes of the brain over the full human life span by using diffusion-weighted spin-echo single-shot echo-planar magnetic resonance (MR) imaging and sequential whole-brain apparent diffusion coefficient (ADC) histogram analysis and, secondarily, to build mathematical models of these normal age-related changes throughout human life. After obtaining institutional review board approval, a HIPAA-compliant retrospective search was conducted for brain MR imaging studies performed in 2007 for various clinical indications. Informed consent was waived. The brain data of 414 healthy subjects (189 males and 225 females; mean age, 33.7 years; age range, 2 days to 89.3 years) were obtained with diffusion-weighted spin-echo single-shot echo-planar MR imaging. ADC histograms of the whole brain were generated. ADC peak values, histogram widths, and intracranial volumes were plotted against age, and model parameters were estimated by using nonlinear regression. Four different stages were identified for aging changes in ADC peak values, as characterized by specific mathematical terms: There were age-associated exponential decays for the maturation period and the development period, a constant term for adulthood, and a linear increase for the senescence period. The age dependency of ADC peak value was simulated by using four-term six-coefficient function, including biexponential and linear terms. This model fit the data very closely (R(2) = 0.91). Brain diffusivity as a whole demonstrated age-related changes through four distinct periods of life. These results could contribute to establishing an ADC baseline of the normal brain, covering the full human life span.

Frequency Domain Ultrasound Waveform Tomography: Breast Imaging Using a Ring Transducer

PubMed Central

Sandhu, G Y; Li, C; Roy, O; Schmidt, S; Duric, N

2016-01-01

Application of the frequency domain acoustic wave equation on data acquired from ultrasound tomography scans is shown to yield high resolution sound speed images on the order of the wavelength of the highest reconstructed frequency. Using a signal bandwidth of 0.4–1 MHz and an average sound speed of 1500 m/s, the resolution is approximately 1.5 mm. The quantitative sound speed values and morphology provided by these images have the potential to inform diagnosis and classification of breast disease. In this study, we present the formalism, practical application, and in vivo results of waveform tomography applied to breast data gathered by two different ultrasound tomography scanners that utilize ring transducers. The formalism includes a review of frequency domain modeling of the wave equation using finite difference operators as well as a review of the gradient descent method for the iterative reconstruction scheme. It is shown that the practical application of waveform tomography requires an accurate starting model, careful data processing, and a method to gradually incorporate higher frequency information into the sound speed reconstruction. Following these steps resulted in high resolution quantitative sound speed images of the breast. These images show marked improvement relative to commonly used ray tomography reconstruction methods. The robustness of the method is demonstrated by obtaining similar results from two different ultrasound tomography devices. We also compare our method to MRI to demonstrate concordant findings. The clinical data used in this work was obtained from a HIPAA compliant clinical study (IRB 040912M1F). PMID:26110909

A comparison of the diagnostic accuracy of magnetic resonance imaging to axillary ultrasound in the detection of axillary nodal metastases in newly diagnosed breast cancer.

PubMed

Assing, Matthew A; Patel, Bhavika K; Karamsadkar, Neel; Weinfurtner, Jared; Usmani, Omar; Kiluk, John V; Drukteinis, Jennifer S

2017-11-01

Patients with a diagnosis of invasive breast cancer are increasingly undergoing breast magnetic resonance imaging (MRI) for preoperative staging including evaluation of axillary lymph node metastases (ALNM). This retrospective study aims to evaluate the utility of adding axillary ultrasound (AUS) in the preoperative setting when an MRI is planned or has already been performed. This IRB approved, HIPAA compliant study reviewed a total of 271 patients with a new diagnosis of invasive breast cancer at a single institution, between June 1, 2010 and June 30, 2013. The study included patients who received both AUS and MRI for preoperative staging. Data were divided into two cohorts, patients who underwent MRI prior to AUS and those who underwent AUS prior to MRI. AUS and MRI reports were categorized according to BI-RADS criteria as "suspicious" or "not suspicious" for ALNM. In the setting of a negative MRI and subsequent positive AUS, only one out of 25 cases (4%) were positive for metastases after correlating with histologic pathology. MRI detected metastatic disease in four out of 27 (15%) patients who had false-negative AUS performed prior to MRI. Our results indicate the addition of AUS after preoperative MRI does not contribute significantly to increased detection of missed disease. MRI could serve as the initial staging imaging method of the axilla in the setting that AUS is not initially performed and may be valuable in identification of lymph nodes not identified on AUS. © 2017 Wiley Periodicals, Inc.

Apparent diffusion coefficient mapping using diffusion-weighted MRI: impact of background parenchymal enhancement, amount of fibroglandular tissue and menopausal status on breast cancer diagnosis.

PubMed

Horvat, Joao V; Durando, Manuela; Milans, Soledad; Patil, Sujata; Massler, Jessica; Gibbons, Girard; Giri, Dilip; Pinker, Katja; Morris, Elizabeth A; Thakur, Sunitha B

2018-06-01

To investigate the impact of background parenchymal enhancement (BPE), amount of fibroglandular tissue (FGT) and menopausal status on apparent diffusion coefficient (ADC) values in differentiation between malignant and benign lesions. In this HIPAA-compliant study, mean ADC values of 218 malignant and 130 benign lesions from 288 patients were retrospectively evaluated. The differences in mean ADC values between benign and malignant lesions were calculated within groups stratified by BPE level (high/low), amount of FGT (dense/non-dense) and menopausal status (premenopausal/postmenopausal). Sensitivities and specificities for distinguishing malignant from benign lesions within different groups were compared for statistical significance. The mean ADC value for malignant lesions was significantly lower compared to that for benign lesions (1.07±0.21 x 10 -3 mm 2 /s vs. 1.53±0.26 x 10 -3 mm 2 /s) (p<0.0001). Using the optimal cut-off point of 1.30 x 10 -3 mm 2 /s, an area under the curve of 0.918 was obtained, with sensitivity and specificity both of 87 %. There was no statistically significant difference in sensitivities and specificities of ADC values between different groups stratified by BPE level, amount of FGT or menopausal status. Differentiation between benign and malignant lesions on ADC values is not significantly affected by BPE level, amount of FGT or menopausal status. • ADC allows differentiation between benign and malignant lesions. • ADC is useful for breast cancer diagnosis despite different patient characteristics. • BPE, FGT or menopause do not significantly affect sensitivity and specificity.

Radiation-induced liver disease as a mimic of liver metastases at serial PET/CT during neoadjuvant chemoradiation of distal esophageal cancer.

PubMed

Grant, Michael J; Didier, Ryne A; Stevens, Jeffrey S; Beyder, Dmitry D; Hunter, John G; Thomas, Charles R; Coakley, Fergus V

2014-10-01

To determine the frequency and appearance of radiation-induced liver disease on PET/CT in patients undergoing serial imaging during neoadjuvant chemoradiation of distal esophageal cancer. In this IRB-approved, HIPAA-compliant retrospective analysis, we identified 112 patients with distal esophageal cancer treated by neoadjuvant chemoradiation who had serial PET/CT imaging available for review. Two readers reviewed all studies in consensus and recorded those cases where new foci of visually detectable increased FDG avidity appeared in the liver during therapy. The etiology of such foci was determined from corresponding findings at CT or MRI, by hepatic biopsy during surgery, by characteristic evolution on post-operative imaging, or by a combination of these methods. New foci of FDG avidity developed in the liver during neoadjuvant therapy in 10 of 112 (9%) patients, of whom nine (8%) were determined to have radiation-induced liver disease based on further imaging and/or biopsy and one of whom had developed interval metastatic disease based on biopsy. In the cases of radiation-induced liver disease, the abnormal foci were found only in the caudate and left hepatic lobes, near the primary tumor, while the patient who developed interval metastatic disease had involvement of the inferior right hepatic lobe, remote from the radiation therapy field. New foci of increased FDG avidity are commonly seen in the caudate and left hepatic lobes of the liver during neoadjuvant chemoradiation of distal esophageal cancer, and these findings generally reflect radiation-induced liver disease rather than metastatic disease.

Bladder cancer diagnosis with CT urography: test characteristics and reasons for false-positive and false-negative results.

PubMed

Trinh, Tony W; Glazer, Daniel I; Sadow, Cheryl A; Sahni, V Anik; Geller, Nina L; Silverman, Stuart G

2018-03-01

To determine test characteristics of CT urography for detecting bladder cancer in patients with hematuria and those undergoing surveillance, and to analyze reasons for false-positive and false-negative results. A HIPAA-compliant, IRB-approved retrospective review of reports from 1623 CT urograms between 10/2010 and 12/31/2013 was performed. 710 examinations for hematuria or bladder cancer history were compared to cystoscopy performed within 6 months. Reference standard was surgical pathology or 1-year minimum clinical follow-up. False-positive and false-negative examinations were reviewed to determine reasons for errors. Ninety-five bladder cancers were detected. CT urography accuracy: was 91.5% (650/710), sensitivity 86.3% (82/95), specificity 92.4% (568/615), positive predictive value 63.6% (82/129), and negative predictive value was 97.8% (568/581). Of 43 false positives, the majority of interpretation errors were due to benign prostatic hyperplasia (n = 12), trabeculated bladder (n = 9), and treatment changes (n = 8). Other causes include blood clots, mistaken normal anatomy, infectious/inflammatory changes, or had no cystoscopic correlate. Of 13 false negatives, 11 were due to technique, one to a large urinary residual, one to artifact. There were no errors in perception. CT urography is an accurate test for diagnosing bladder cancer; however, in protocols relying predominantly on excretory phase images, overall sensitivity remains insufficient to obviate cystoscopy. Awareness of bladder cancer mimics may reduce false-positive results. Improvements in CTU technique may reduce false-negative results.

Dilatation of the Virchow-Robin spaces as an indicator of unilateral carotid artery stenosis: correlation with white matter lesions.

PubMed

Sahin, Neslin; Solak, Aynur; Genc, Berhan; Akpinar, Mehmet Besir

2015-07-01

Virchow-Robin space (VRS) dilatation is related to many pathologic conditions, mostly associated with vascular abnormalities. White matter lesions (WMLs) are commonly seen on brain magnetic resonance imaging (MRI) with advancing age and generally considered as potential markers for vascular disease. To investigate if asymmetric dilatation of VRSs and WMLs are associated with unilateral internal carotid artery stenosis (ICAS) and to test the relationship between dilated VRSs and common vascular risk factors. Twenty-nine patients (18 men, 11 women; mean age, 68.62 years) with unilateral ICAS (≥70% carotid stenosis) undergoing carotid endarterectomy were identified for this Health Insurance Portability and Accountability Act (HIPAA) compliant prospective study and assessed with brain MRI. Two experienced radiologists scored VRSs and WMLs and evaluated old infarcts, chronic lacunar infarcts, and cerebral atrophy. Asymmetry of WML and VRS scores between two cerebral hemispheres was assessed and associations between VRS scores, WML scores, and explanatory variables (e.g. age, sex, vascular risk factors, and atrophy) were tested. In this study, WMLs and basal ganglia VRSs were significantly greater in the unilateral hemisphere with ICA stenosis than contralateral hemisphere. Basal ganglia VRSs were associated with WMLs and internal cerebral atrophy. No association between the severity of VRSs and vascular risk factors was found. ICA stenosis may contribute as a factor in the development of WMLs and dilatation of VRSs by causing chronic hypoperfusion. VRS dilatation may be an additional MRI marker of ICAS. © The Foundation Acta Radiologica 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

The impact of a telehealth web-based solution on neurosurgery triage and consultation.

PubMed

Moya, Monica; Valdez, Jessica; Yonas, Howard; Alverson, Dale C

2010-11-01

To enhance the quality of neurosurgery consultations, triage, and transport decisions between a Level I trauma service neurosurgery program at the University of New Mexico Hospital and referring hospitals, a secure Health Insurance Portability and Accountability Act (HIPAA)-compliant Web-based system was developed, to which digital neurological images could be sent for review by a neurosurgeon for consultation or patient transfer. Based upon prior experience of neurosurgery, it was predicted that 25% of transfer requests would be avoided if the neurosurgeons reviewed the computerized tomography scans at the time of a transfer request. In addition, it was predicted in 25% of the case that changes in management recommendations would take place independent of the transfer decision. The program was designed to allow referring hospitals to transmit digital images to the Web site, providing consulting doctors with additional patient information. This project analyzed the neurosurgeons' responses to questions designed to determine if transport or management decisions were altered when using this telehealth program in response to a request for consultation or transfer from a rural facility. Analysis of the responses of the consulting neurosurgeons revealed that, after viewing the images, 44% of the potential transfers were avoided and 44% of consulted cases resulted in management recommendation changes independent of the transfer decision. Use of the system resulted in improved triage and changes in transfer or management recommendations. A significant number of potential transfers were avoided, resulting in transport cost avoidance, more effective use of resources, and more appropriate use of the neurosurgery service as well as improved patient preparation.

Compliant cantilevered micromold

DOEpatents

Morales, Alfredo Martin [Pleasanton, CA; Domeier, Linda A [Danville, CA; Gonzales, Marcela G [Seattle, WA; Keifer, Patrick N [Livermore, CA; Garino, Terry Joseph [Albuquerque, NM

2006-08-15

A compliant cantilevered three-dimensional micromold is provided. The compliant cantilevered micromold is suitable for use in the replication of cantilevered microparts and greatly simplifies the replication of such cantilevered parts. The compliant cantilevered micromold may be used to fabricate microparts using casting or electroforming techniques. When the compliant micromold is used to fabricate electroformed cantilevered parts, the micromold will also comprise an electrically conducting base formed by a porous metal substrate that is embedded within the compliant cantilevered micromold. Methods for fabricating the compliant cantilevered micromold as well as methods of replicating cantilevered microparts using the compliant cantilevered micromold are also provided.

Method for providing a compliant cantilevered micromold

DOEpatents

Morales, Alfredo M.; Domeier, Linda A.; Gonzales, Marcela G.; Keifer, Patrick N.; Garino, Terry J.

2008-12-16

A compliant cantilevered three-dimensional micromold is provided. The compliant cantilevered micromold is suitable for use in the replication of cantilevered microparts and greatly simplifies the replication of such cantilevered parts. The compliant cantilevered micromold may be used to fabricate microparts using casting or electroforming techniques. When the compliant micromold is used to fabricate electroformed cantilevered parts, the micromold will also comprise an electrically conducting base formed by a porous metal substrate that is embedded within the compliant cantilevered micromold. Methods for fabricating the compliant cantilevered micromold as well as methods of replicating cantilevered microparts using the compliant cantilevered micromold are also provided.

Security Concerns in Android mHealth Apps

PubMed Central

He, Dongjing; Naveed, Muhammad; Gunter, Carl A.; Nahrstedt, Klara

2014-01-01

Mobile Health (mHealth) applications lie outside of regulatory protection such as HIPAA, which requires a baseline of privacy and security protections appropriate to sensitive medical data. However, mHealth apps, particularly those in the app stores for iOS and Android, are increasingly handling sensitive data for both professionals and patients. This paper presents a series of three studies of the mHealth apps in Google Play that show that mHealth apps make widespread use of unsecured Internet communications and third party servers. Both of these practices would be considered problematic under HIPAA, suggesting that increased use of mHealth apps could lead to less secure treatment of health data unless mHealth vendors make improvements in the way they communicate and store data. PMID:25954370

Security Concerns in Android mHealth Apps.

PubMed

He, Dongjing; Naveed, Muhammad; Gunter, Carl A; Nahrstedt, Klara

2014-01-01

Mobile Health (mHealth) applications lie outside of regulatory protection such as HIPAA, which requires a baseline of privacy and security protections appropriate to sensitive medical data. However, mHealth apps, particularly those in the app stores for iOS and Android, are increasingly handling sensitive data for both professionals and patients. This paper presents a series of three studies of the mHealth apps in Google Play that show that mHealth apps make widespread use of unsecured Internet communications and third party servers. Both of these practices would be considered problematic under HIPAA, suggesting that increased use of mHealth apps could lead to less secure treatment of health data unless mHealth vendors make improvements in the way they communicate and store data.

CQUIN audit for prescription of antibiotics for urinary tract infections in an acute medical assessment unit.

PubMed

Oppenheimer, Maylin; Rezwan, Nivin

2015-01-01

Urinary tract infections (UTI) are a common presentation in a medical assessment unit, and we wanted to check compliance with hospital guidelines for antibiotic prescribing in patients presenting to hospital with urinary tract infection. The guidelines are based on local organisms and sensitivities. A retrospective audit of 40 patient records with positive urine cultures from July to August 2013 showed that 20% of patients with culture confirmed UTI were not given antibiotics at all. Of those prescribed antibiotics, 25% were non-compliant with local policy, and nearly one in two patients received more than one antibiotic. Furthermore, stop dates were not stated on 77% of the drug charts and duration of treatment ranged from one to 11 days. Interventions were then introduced in the form of group teaching sessions, proactive checks by Trust pharmacists and widely distributed posters, and the same data sets collected for April to March 2014 to assess for efficacy of the interventions. On re-auditing, 35% patients were not prescribed any antibiotics. However, compliance with local policy was 100%, including 100% drug charts having a stop/review date stated. The overall duration of treatment now ranged from one to seven days, and fewer than one in four patients had more than one antibiotic. Our results showed that improvement was needed in antibiotic stewardship, in particular with regards to compliance with the local guidelines and documentation of prescription. We have demonstrated that it is possible to improve compliance through teaching, by displaying information prominently, and vigilance by the clinical team. The outcome of this is a decreased number and duration of antibiotics prescribed, which has benefits for the patients, the hospital, and the community as a whole. Further work would include interventions to improve the number of patients who are missing antibiotic prescriptions altogether.

To what extent are national guidelines for the management of urinary incontinence in women adhered? Data from a national audit.

PubMed

Wagg, A; Duckett, J; McClurg, D; Harari, D; Lowe, D

2011-12-01

OBJECTIVE  To assess the degree of adherence to the current National Institute for Health and Clinical Excellence (NICE) guidelines on the management of urinary incontinence (UI) in women. Retrospective survey of consecutive female inpatients and outpatients with UI as part of a national audit. NHS hospital and primary care (PC) trusts. Twenty-five women <65 years old and 25 women ≥ 65 years old from each participating site. All NHS trusts in England, Wales and Northern Ireland were eligible to participate. A web-based data collection form aligned to the NICE guidelines was constructed for the study. All data submitted to the audit were anonymous and access to the web-tool was password-protected for confidentiality. Data were returned by 128 acute and 75 PC trusts on 7846 women. No diagnosis was documented in 6.8% (153/2254) of younger and 28% (571/2011) of older women in hospitals (P < 0.001), and by 8.6% (123/1435) of younger and 21% (380/1786) of older women in PC trusts. In hospitals, 26% (396/1524) of younger women and 15% (182/1231) of older women (P < 0.001) and in PC trusts 8.2% (77/934) of younger and 4.7% (46/975) of older women underwent multichannel cystometry before conservative therapy. Documentation of discussion of causes and treatment of UI occurred in 76% (1717/2254) of younger and 44% (884/2011) of older women in hospitals (P < 0.001) and in 75% (1080/1435) of younger and 53% (948/1786) of older women in PC trusts (P < 0.001). CONCLUSION Older women are less likely to receive NICE compliant management. Adherence varies according to recommendation. There needs to be concentration on evidence-based community provision of care by competent and interested clinicians before the aims of the NICE guidelines are met. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

Student-selected component in the medical curriculum: investigations and psychiatric referral for paracetamol overdose in an accident and emergency department

PubMed Central

Cowman, James G; Bakheet, Manuel

2017-01-01

Background A student-selected component (SSC) of the medical curriculum requires the student to be self-directed in locating and undertaking a placement in a clinical specialty of their choosing and completing a project. The clinical area for experience was an accident and emergency department, and our topic was a focused audit on the investigations and referral for paracetamol overdose. The purpose of this paper is twofold: to reflect on the education value to medical students of an SSC in a medical curriculum, and to highlight learning and understanding through completion of an audit. Materials and methods An audit approach was applied. The aim of the project study was to investigate the level of compliance with best-practice guidelines for investigations and psychiatric referral in paracetamol overdose. Results A total of 40 cases meeting the inclusion criteria were randomly selected. The sample had a mean age of 27 years, of whom 70.5% were female, and the ingested dose of paracetamol ranged from 0.864 to 80 g. Paracetamol abuse may present as intentional and unintentional overdose. In our study, 85% of cases were identified as intentional overdose and 76% had a history of psychiatric illness. Generally, medical management was compliant with guidelines, with some minor irregularities. The international normalized ratio was the most underperformed test. Conclusion Our choice of topic, paracetamol overdose, contributed to our understanding of the breadth of factors to be considered in the emergency medical management of a patient. In this regard, we had the benefit of understanding how the diagnostic and therapeutic factors, when applied in accordance with best-practice guidelines, work very effectively. The SSC impacted positively on our cognitive, personal, and professional development. In facilitating the student with choice, the SSC encouraged self-direction and proactivity. We gained experience in the discipline of research and acquired some skills in independent thinking and analysis. PMID:28883749

Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study.

PubMed

Manion, Frank J; Robbins, Robert J; Weems, William A; Crowley, Rebecca S

2009-06-15

Data protection is important for all information systems that deal with human-subjects data. Grid-based systems--such as the cancer Biomedical Informatics Grid (caBIG)--seek to develop new mechanisms to facilitate real-time federation of cancer-relevant data sources, including sources protected under a variety of regulatory laws, such as HIPAA and 21CFR11. These systems embody new models for data sharing, and hence pose new challenges to the regulatory community, and to those who would develop or adopt them. These challenges must be understood by both systems developers and system adopters. In this paper, we describe our work collecting policy statements, expectations, and requirements from regulatory decision makers at academic cancer centers in the United States. We use these statements to examine fundamental assumptions regarding data sharing using data federations and grid computing. An interview-based study of key stakeholders from a sample of US cancer centers. Interviews were structured, and used an instrument that was developed for the purpose of this study. The instrument included a set of problem scenarios--difficult policy situations that were derived during a full-day discussion of potentially problematic issues by a set of project participants with diverse expertise. Each problem scenario included a set of open-ended questions that were designed to elucidate stakeholder opinions and concerns. Interviews were transcribed verbatim and used for both qualitative and quantitative analysis. For quantitative analysis, data was aggregated at the individual or institutional unit of analysis, depending on the specific interview question. Thirty-one (31) individuals at six cancer centers were contacted to participate. Twenty-four out of thirty-one (24/31) individuals responded to our request- yielding a total response rate of 77%. Respondents included IRB directors and policy-makers, privacy and security officers, directors of offices of research, information security officers and university legal counsel. Nineteen total interviews were conducted over a period of 16 weeks. Respondents provided answers for all four scenarios (a total of 87 questions). Results were grouped by broad themes, including among others: governance, legal and financial issues, partnership agreements, de-identification, institutional technical infrastructure for security and privacy protection, training, risk management, auditing, IRB issues, and patient/subject consent. The findings suggest that with additional work, large scale federated sharing of data within a regulated environment is possible. A key challenge is developing suitable models for authentication and authorization practices within a federated environment. Authentication--the recognition and validation of a person's identity--is in fact a global property of such systems, while authorization - the permission to access data or resources--mimics data sharing agreements in being best served at a local level. Nine specific recommendations result from the work and are discussed in detail. These include: (1) the necessity to construct separate legal or corporate entities for governance of federated sharing initiatives on this scale; (2) consensus on the treatment of foreign and commercial partnerships; (3) the development of risk models and risk management processes; (4) development of technical infrastructure to support the credentialing process associated with research including human subjects; (5) exploring the feasibility of developing large-scale, federated honest broker approaches; (6) the development of suitable, federated identity provisioning processes to support federated authentication and authorization; (7) community development of requisite HIPAA and research ethics training modules by federation members; (8) the recognition of the need for central auditing requirements and authority, and; (9) use of two-protocol data exchange models where possible in the federation.

Audit of radiology communication systems for critical, urgent, and unexpected significant findings.

PubMed

Duncan, K A; Drinkwater, K J; Dugar, N; Howlett, D C

2016-03-01

To determine the compliance of UK radiology departments and trusts/healthcare organisations with National Patient Safety Agency and Royal College of Radiologist's published guidance on the communication of critical, urgent, and unexpected significant radiological findings. A questionnaire was sent to all UK radiology department audit leads asking for details of their current departmental policy regarding the issuing of alerts; use of automated electronic alert systems; methods of notification of clinicians of critical, urgent, and unexpected significant radiological findings; monitoring of results receipt; and examples of the more common types of serious pathologies for which alerts were issued. One hundred and fifty-four of 229 departments (67%) responded. Eighty-eight percent indicated that they had a policy in place for the communication of critical, urgent, and unexpected significant radiological findings. Only 34% had an automated electronic alert system in place and only 17% had a facility for service-wide electronic tracking of radiology reports. In only 11 departments with an electronic acknowledgement system was someone regularly monitoring the read rate. There is wide variation in practice across the UK with regard to the communication and monitoring of reports with many departments/trusts not fully compliant with published UK guidance. Despite the widespread use of electronic systems, only a minority of departments/trusts have and use electronic tracking to ensure reports have been read and acted upon. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Attitude and subjective wellbeing of non-compliant mothers to childhood oral polio vaccine supplemental immunization in Northern Nigeria.

PubMed

Umeh, Gregory C; Nomhwange, Terna Ignatius; Shamang, Anthony F; Zakari, Furera; Musa, Audu I; Dogo, Paul M; Gugong, Victor; Iliyasu, Neyu

2018-02-08

Attitude and subjective well-being are important factors in mothers accepting or rejecting Oral Polio Vaccine (OPV) supplemental immunization. The purpose of the study was to determine the role of mothers' attitude and subjective wellbeing on non-compliance to OPV supplemental immunization in Northern Nigeria. The study utilized a cross-sectional design to assess attitude and subjective well-being of mothers using previously validated VACSATC (Vaccine Safety, Attitudes, Training and Communication-10 items) & SUBI (Subjective Well-being Inventory-40 items) measures. A total of 396 participants (equal number of non-compliant and compliant mothers) from 94 non-compliant settlements were interviewed, after informed consent. T-test was run to assess difference in mean scores between the non-compliant and compliant mothers on VACSATC and SUBI measures. The research showed a significant difference in mean scores between the non-compliant and compliant groups on VACSATC measure of mothers' attitude (M = 18.9 non-compliant, compared to 26.5 compliant; p < 0.05). On subjective well-being, the study showed there was no significant difference in the mean scores of the SUBI measure (M = 77.4 non-compliant, compared to 78.0 compliant; p > 0.05). The research has shown that negative attitude is more commonly present in non-compliant mothers and may be a factor in vaccine refusal in Northern Nigeria.

Assessing the difficulty and time cost of de-identification in clinical narratives.

PubMed

Dorr, D A; Phillips, W F; Phansalkar, S; Sims, S A; Hurdle, J F

2006-01-01

To characterize the difficulty confronting investigators in removing protected health information (PHI) from cross-discipline, free-text clinical notes, an important challenge to clinical informatics research as recalibrated by the introduction of the US Health Insurance Portability and Accountability Act (HIPAA) and similar regulations. Randomized selection of clinical narratives from complete admissions written by diverse providers, reviewed using a two-tiered rater system and simple automated regular expression tools. For manual review, two independent reviewers used simple search and replace algorithms and visual scanning to find PHI as defined by HIPAA, followed by an independent second review to detect any missed PHI. Simple automated review was also performed for the "easy" PHI that are number- or date-based. From 262 notes, 2074 PHI, or 7.9 +/- 6.1 per note, were found. The average recall (or sensitivity) was 95.9% while precision was 99.6% for single reviewers. Agreement between individual reviewers was strong (ICC = 0.99), although some asymmetry in errors was seen between reviewers (p = 0.001). The automated technique had better recall (98.5%) but worse precision (88.4%) for its subset of identifiers. Manually de-identifying a note took 87.3 +/- 61 seconds on average. Manual de-identification of free-text notes is tedious and time-consuming, but even simple PHI is difficult to automatically identify with the exactitude required under HIPAA.

HIPAA Business Associate Contracts: the value of contracts for case managers.

PubMed

Muller, Lynn S

2003-01-01

Case Managers are in the middle of the upcoming HIPAA regulation changes, with the issuance of the Final Privacy Rule. Every case obliges case managers to work with Individually Identifiable Health Information (IIHI) and Protected Health Information (PHI). The purpose of this article is to provide case managers in all practice settings with a clear understanding of a "Business Associate," of a "Covered Entity," and of the specifics of a Business Associate Contract. This information will demonstrate how case managers can benefit from the use of these contracts in their business life. As an essential component of an organization's compliance plan, Business Associate Contracts can become a sword or a shield. This article is particularly helpful to case managers in independent practice, as well as those who work for Covered Entities.

Patients' and sleeping partners' experience of treatment for sleep-related breathing disorders with a mandibular repositioning splint.

PubMed

Bates, C J; McDonald, J P

2006-01-28

To determine in detail the complications associated with the use of mandibular repositioning splints (MRS) to treat sleep-related breathing disorders. This prospective cross-sectional cohort study audits the management with mandibular repositioning splints of 121 patients suffering from sleep-related breathing disorders. Investigation of patients' and sleeping partners' perspectives on treatment was undertaken with the use of a questionnaire based study. Sixty-eight per cent of respondents reported that they were compliant with treatment; various side effects were reported of which excess salivation was the most common. Investigation of sleeping partners' perspectives revealed that 70% felt that their partners' snoring was improved and 47% felt that their partner's breathing pauses during sleep were reduced. Sixty-four per cent of the sleeping partners also reported that their own sleep pattern had improved since their partner's treatment. Mandibular repositioning splints used in the manner described by this paper are demonstrated to have a good compliance rate, provide successful treatment and exhibit only minor, reversible side effects.

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The compressed breast during mammography and breast tomosynthesis: in vivo shape characterization and modeling

NASA Astrophysics Data System (ADS)

Rodríguez-Ruiz, Alejandro; Agasthya, Greeshma A.; Sechopoulos, Ioannis

2017-09-01

To characterize and develop a patient-based 3D model of the compressed breast undergoing mammography and breast tomosynthesis. During this IRB-approved, HIPAA-compliant study, 50 women were recruited to undergo 3D breast surface imaging with structured light (SL) during breast compression, along with simultaneous acquisition of a tomosynthesis image. A pair of SL systems were used to acquire 3D surface images by projecting 24 different patterns onto the compressed breast and capturing their reflection off the breast surface in approximately 12-16 s. The 3D surface was characterized and modeled via principal component analysis. The resulting surface model was combined with a previously developed 2D model of projected compressed breast shapes to generate a full 3D model. Data from ten patients were discarded due to technical problems during image acquisition. The maximum breast thickness (found at the chest-wall) had an average value of 56 mm, and decreased 13% towards the nipple (breast tilt angle of 5.2°). The portion of the breast not in contact with the compression paddle or the support table extended on average 17 mm, 18% of the chest-wall to nipple distance. The outermost point along the breast surface lies below the midline of the total thickness. A complete 3D model of compressed breast shapes was created and implemented as a software application available for download, capable of generating new random realistic 3D shapes of breasts undergoing compression. Accurate characterization and modeling of the breast curvature and shape was achieved and will be used for various image processing and clinical tasks.

Fully Automated Quantitative Estimation of Volumetric Breast Density from Digital Breast Tomosynthesis Images: Preliminary Results and Comparison with Digital Mammography and MR Imaging.

PubMed

Pertuz, Said; McDonald, Elizabeth S; Weinstein, Susan P; Conant, Emily F; Kontos, Despina

2016-04-01

To assess a fully automated method for volumetric breast density (VBD) estimation in digital breast tomosynthesis (DBT) and to compare the findings with those of full-field digital mammography (FFDM) and magnetic resonance (MR) imaging. Bilateral DBT images, FFDM images, and sagittal breast MR images were retrospectively collected from 68 women who underwent breast cancer screening from October 2011 to September 2012 with institutional review board-approved, HIPAA-compliant protocols. A fully automated computer algorithm was developed for quantitative estimation of VBD from DBT images. FFDM images were processed with U.S. Food and Drug Administration-cleared software, and the MR images were processed with a previously validated automated algorithm to obtain corresponding VBD estimates. Pearson correlation and analysis of variance with Tukey-Kramer post hoc correction were used to compare the multimodality VBD estimates. Estimates of VBD from DBT were significantly correlated with FFDM-based and MR imaging-based estimates with r = 0.83 (95% confidence interval [CI]: 0.74, 0.90) and r = 0.88 (95% CI: 0.82, 0.93), respectively (P < .001). The corresponding correlation between FFDM and MR imaging was r = 0.84 (95% CI: 0.76, 0.90). However, statistically significant differences after post hoc correction (α = 0.05) were found among VBD estimates from FFDM (mean ± standard deviation, 11.1% ± 7.0) relative to MR imaging (16.6% ± 11.2) and DBT (19.8% ± 16.2). Differences between VDB estimates from DBT and MR imaging were not significant (P = .26). Fully automated VBD estimates from DBT, FFDM, and MR imaging are strongly correlated but show statistically significant differences. Therefore, absolute differences in VBD between FFDM, DBT, and MR imaging should be considered in breast cancer risk assessment.

Patient-specific Radiation Dose and Cancer Risk for Pediatric Chest CT

PubMed Central

Samei, Ehsan; Segars, W. Paul; Sturgeon, Gregory M.; Colsher, James G.; Frush, Donald P.

2011-01-01

Purpose: To estimate patient-specific radiation dose and cancer risk for pediatric chest computed tomography (CT) and to evaluate factors affecting dose and risk, including patient size, patient age, and scanning parameters. Materials and Methods: The institutional review board approved this study and waived informed consent. This study was HIPAA compliant. The study included 30 patients (0–16 years old), for whom full-body computer models were recently created from clinical CT data. A validated Monte Carlo program was used to estimate organ dose from eight chest protocols, representing clinically relevant combinations of bow tie filter, collimation, pitch, and tube potential. Organ dose was used to calculate effective dose and risk index (an index of total cancer incidence risk). The dose and risk estimates before and after normalization by volume-weighted CT dose index (CTDIvol) or dose–length product (DLP) were correlated with patient size and age. The effect of each scanning parameter was studied. Results: Organ dose normalized by tube current–time product or CTDIvol decreased exponentially with increasing average chest diameter. Effective dose normalized by tube current–time product or DLP decreased exponentially with increasing chest diameter. Chest diameter was a stronger predictor of dose than weight and total scan length. Risk index normalized by tube current–time product or DLP decreased exponentially with both chest diameter and age. When normalized by DLP, effective dose and risk index were independent of collimation, pitch, and tube potential (<10% variation). Conclusion: The correlations of dose and risk with patient size and age can be used to estimate patient-specific dose and risk. They can further guide the design and optimization of pediatric chest CT protocols. © RSNA, 2011 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11101900/-/DC1 PMID:21467251

Patient-specific radiation dose and cancer risk for pediatric chest CT.

PubMed

Li, Xiang; Samei, Ehsan; Segars, W Paul; Sturgeon, Gregory M; Colsher, James G; Frush, Donald P

2011-06-01

To estimate patient-specific radiation dose and cancer risk for pediatric chest computed tomography (CT) and to evaluate factors affecting dose and risk, including patient size, patient age, and scanning parameters. The institutional review board approved this study and waived informed consent. This study was HIPAA compliant. The study included 30 patients (0-16 years old), for whom full-body computer models were recently created from clinical CT data. A validated Monte Carlo program was used to estimate organ dose from eight chest protocols, representing clinically relevant combinations of bow tie filter, collimation, pitch, and tube potential. Organ dose was used to calculate effective dose and risk index (an index of total cancer incidence risk). The dose and risk estimates before and after normalization by volume-weighted CT dose index (CTDI(vol)) or dose-length product (DLP) were correlated with patient size and age. The effect of each scanning parameter was studied. Organ dose normalized by tube current-time product or CTDI(vol) decreased exponentially with increasing average chest diameter. Effective dose normalized by tube current-time product or DLP decreased exponentially with increasing chest diameter. Chest diameter was a stronger predictor of dose than weight and total scan length. Risk index normalized by tube current-time product or DLP decreased exponentially with both chest diameter and age. When normalized by DLP, effective dose and risk index were independent of collimation, pitch, and tube potential (<10% variation). The correlations of dose and risk with patient size and age can be used to estimate patient-specific dose and risk. They can further guide the design and optimization of pediatric chest CT protocols. http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11101900/-/DC1. RSNA, 2011

Percutaneous Breast Biopsy: Effect on Short-term Quality of Life

PubMed Central

Humphrey, Kathryn L.; Donelan, Karen; Kong, Chung Y.; Williams, Olubunmi; Itauma, Omosalewa; Halpern, Elkan F.; Gerade, Beverly J.; Rafferty, Elizabeth A.; Swan, J. Shannon

2014-01-01

Purpose To examine the effects of percutaneous breast biopsy on short-term quality of life. Materials and Methods The institutional review board approved this HIPAA-compliant prospective study. From December 1, 2007, through February 28, 2010, women undergoing percutaneous breast biopsy in an academic medical center were recruited to participate in a mixed-mode survey 2–4 days after biopsy. Patients described their biopsy experience by using the Testing Morbidities Index (TMI), a validated instrument for assessing short-term quality of life related to diagnostic testing. The scale ranged from 0 (worst possible experience) to 100 (no adverse effects). Seven attributes were assessed: pain or discomfort before and during testing, fear or anxiety before and during testing, embarrassment during testing, and physical and mental function after testing. Demographic and clinical information were also collected. Univariate and multivariate linear regression analyses were performed to identify significant predictors of TMI score. Results In 188 women (mean age, 51.4 years; range, 22–80 years), the mean TMI score (±standard deviation) was 82 ± 12. Univariate analysis revealed age and race as significant predictors of the TMI score (P < .05). In the multivariate model, only patient age remained a significant independent predictor (P = .001). TMI scores decreased by approximately three points for every decade decrease in patient age, which suggests that younger women were more adversely affected by the biopsy experience. Conclusion Younger patient age is a significant predictor of decreased short-term quality of life related to percutaneous breast biopsy procedures. Tailored prebiopsy counseling may better prepare women for percutaneous biopsy procedures and improve their experience. © RSNA, 2013 PMID:24471385

Articular Cartilage: Evaluation with Fluid-suppressed 7.0-T Sodium MR Imaging in Subjects with and Subjects without Osteoarthritis

PubMed Central

Babb, James; Xia, Ding; Chang, Gregory; Krasnokutsky, Svetlana; Abramson, Steven B.; Jerschow, Alexej; Regatte, Ravinder R.

2013-01-01

Purpose: To assess the potential use of sodium magnetic resonance (MR) imaging of cartilage, with and without fluid suppression by using an adiabatic pulse, for classifying subjects with versus subjects without osteoarthritis at 7.0 T. Materials and Methods: The study was approved by the institutional review board and was compliant with HIPAA. The knee cartilage of 19 asymptomatic (control subjects) and 28 symptomatic (osteoarthritis patients) subjects underwent 7.0-T sodium MR imaging with use of two different sequences: one without fluid suppression (radial three-dimensional sequence) and one with fluid suppression (inversion recovery [IR] wideband uniform rate and smooth truncation [WURST]). Fluid suppression was obtained by using IR with an adiabatic inversion pulse (WURST pulse). Mean sodium concentrations and their standard deviations were measured in the patellar, femorotibial medial, and lateral cartilage regions over four consecutive sections for each subject. The minimum, maximum, median, and average means and standard deviations were calculated over all measurements for each subject. The utility of these measures in the detection of osteoarthritis was evaluated by using logistic regression and the area under the receiver operating characteristic curve (AUC). Bonferroni correction was applied to the P values obtained with logistic regression. Results: Measurements from IR WURST were found to be significant predicators of all osteoarthritis (Kellgren-Lawrence score of 1–4) and early osteoarthritis (Kellgren-Lawrence score of 1 or 2). The minimum standard deviation provided the highest AUC (0.83) with the highest accuracy (>78%), sensitivity (>82%), and specificity (>74%) for both all osteoarthritis and early osteoarthritis groups. Conclusion: Quantitative sodium MR imaging at 7.0 T with fluid suppression by using adiabatic IR is a potential biomarker for osteoarthritis. © RSNA, 2013 PMID:23468572

Hippocampal Dysfunction in Gulf War Veterans: Investigation with ASL Perfusion MR Imaging and Physostigmine Challenge

PubMed Central

Li, Xiufeng; Spence, Jeffrey S.; Buhner, David M.; Hart, John; Cullum, C. Munro; Biggs, Melanie M.; Hester, Andrea L.; Odegard, Timothy N.; Carmack, Patrick S.; Haley, Robert W.

2011-01-01

Purpose: To determine, with arterial spin labeling (ASL) perfusion magnetic resonance (MR) imaging and physostigmine challenge, if abnormal hippocampal blood flow in ill Gulf War veterans persists 11 years after initial testing with single photon emission computed tomography and nearly 20 years after the 1991 Gulf War. Materials and Methods: The local institutional review board approved this HIPAA-compliant study. Veterans were screened for contraindications and gave written informed consent before the study. In a semiblinded retrospective protocol, veterans in three Gulf War illness groups—syndrome 1 (impaired cognition), syndrome 2 (confusion-ataxia), and syndrome 3 (central neuropathic pain)—and a control group received intravenous infusions of saline in an initial session and physostigmine in a second session, 48 hours later. Each infusion was followed by measurement of hippocampal regional cerebral blood flow (rCBF) with pulsed ASL. A mixed-effects linear model adjusted for age was used to test for differences in rCBF after the cholinergic challenge across the four groups. Results: Physostigmine significantly decreased hippocampal rCBF in control subjects (P < .0005) and veterans with syndrome 1 (P < .05) but significantly increased hippocampal rCBF in veterans with syndrome 2 (P < .005) and veterans with syndrome 3 (P < .002). The abnormal increase in rCBF was found to have progressed to the left hippocampus of the veterans with syndrome 2 and to both hippocampi of the veterans with syndrome 3. Conclusion: Chronic hippocampal perfusion dysfunction persists or worsens in veterans with certain Gulf War syndromes. ASL MR imaging examination of hippocampal rCBF in a cholinergic challenge experiment may be useful as a diagnostic test for this condition. © RSNA, 2011 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11101715/-/DC1 PMID:21914840

Femoral head avascular necrosis: a frequently missed incidental finding on multidetector CT.

PubMed

Barille, M F; Wu, Jim S; McMahon, Colm J

2014-03-01

To determine the incidence of missed femoral head avascular necrosis (AVN) on pelvic computed tomography (CT) performed for clinical indications other than assessment for AVN. The study was a Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective study. The picture archiving and communication system (PACS) database was queried for patients with diagnosis of femoral head AVN on magnetic resonance imaging (MRI), who also underwent pelvic multidetector CT after or <30 days before the MRI examination. The MRI and CT images of 144 hips of 72 patients (39 patients with reported AVN on MRI and 33 age-matched controls; mean age = 60 years, 28 male, 44 female), were reviewed in consensus by two readers in a randomized, blinded manner. Using MRI-proven CT-visible AVN as a reference standard, the incidence of missed AVN on initial CT interpretation was determined. Readers confirmed AVN in 33 patients on the MRI images. Nine hips with AVN underwent joint replacement of the affected joint(s) prior to subsequent CT and were excluded. Forty-three MRI-proven AVN cases in 28 patients (15 bilateral, 13 unilateral) were available for analysis. The study readers diagnosed 35/43 (81%) MRI-proven AVN cases in 22/28 (79%) patients. Four of the 35 (11%) cases of MRI-proven, CT-visible AVN were prospectively reported in 3/22 (14%) patients at initial clinical interpretation, with a miss rate of 89% per hip and 86% per patient. Multidetector CT has high accuracy for detection of AVN; however, this is frequently missed as an incidental finding (89% missed in the present study). Assessment for signs of femoral AVN should be part of routine search pattern in interpretation of pelvic CT. Copyright © 2013 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Carotid Artery Plaque Morphology and Composition in Relation to Incident Cardiovascular Events: The Multi-Ethnic Study of Atherosclerosis (MESA)

PubMed Central

Zavodni, Anna E. H.; Wasserman, Bruce A.; McClelland, Robyn L.; Gomes, Antoinette S.; Folsom, Aaron R.; Polak, Joseph F.; Lima, João A. C.

2014-01-01

Purpose To determine if carotid plaque morphology and composition with magnetic resonance (MR) imaging can be used to identify asymptomatic subjects at risk for cardiovascular events. Materials and Methods Institutional review boards at each site approved the study, and all sites were Health Insurance Portability and Accountability Act (HIPAA) compliant. A total of 946 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) were evaluated with MR imaging and ultrasonography (US). MR imaging was used to define carotid plaque composition and remodeling index (wall area divided by the sum of wall area and lumen area), while US was used to assess carotid wall thickness. Incident cardiovascular events, including myocardial infarction, resuscitated cardiac arrest, angina, stroke, and death, were ascertained for an average of 5.5 years. Multivariable Cox proportional hazards models, C statistics, and net reclassification improvement (NRI) for event prediction were determined. Results Cardiovascular events occurred in 59 (6%) of participants. Carotid IMT as well as MR imaging remodeling index, lipid core, and calcium in the internal carotid artery were significant predictors of events in univariate analysis (P < .001 for all). For traditional risk factors, the C statistic for event prediction was 0.696. For MR imaging remodeling index and lipid core, the C statistic was 0.734 and the NRI was 7.4% and 15.8% for participants with and those without cardiovascular events, respectively (P = .02). The NRI for US IMT in addition to traditional risk factors was not significant. Conclusion The identification of vulnerable plaque characteristics with MR imaging aids in cardiovascular disease prediction and improves the reclassification of baseline cardiovascular risk. © RSNA, 2014 PMID:24592924

PI3K pathway mutations are associated with longer time to local progression after radioembolization of colorectal liver metastases.

PubMed

Ziv, Etay; Bergen, Michael; Yarmohammadi, Hooman; Boas, F Ed; Petre, E Nadia; Sofocleous, Constantinos T; Yaeger, Rona; Solit, David B; Solomon, Stephen B; Erinjeri, Joseph P

2017-04-04

To establish the relationship between common mutations in the MAPK and PI3K signaling pathways and local progression after radioembolization. Retrospective review of a HIPAA-compliant institutional review-board approved database identified 40 patients with chemo-refractory colorectal liver metastases treated with radioembolization who underwent tumor genotyping for hotspot mutations in 6 key genes in the MAPK/PI3K pathways (KRAS, NRAS, BRAF, MEK1, PIK3CA, and AKT1). Mutation status as well as clinical, tumor, and treatment variables were recorded. These factors were evaluated in relation to time to local progression (TTLP), which was calculated from time of radioembolization to first radiographic evidence of local progression. Predictors of outcome were identified using a proportional hazards model for both univariate and multivariate analysis with death as a competing risk. Sixteen patients (40%) had no mutations in either pathway, eighteen patients (45%) had mutations in the MAPK pathway, ten patients (25%) had mutations in the PI3K pathway and four patients (10%) had mutations in both pathways. The cumulative incidence of progression at 6 and 12 months was 33% and 55% for the PI3K mutated group compared with 76% and 92% in the PI3K wild type group. Mutation in the PI3K pathway was a significant predictor of longer TTLP in both univariate (p=0.031, sHR 0.31, 95% CI: 0.11-0.90) and multivariate (p=0.015, sHR=0.27, 95% CI: 0.096-0.77) analysis. MAPK pathway alterations were not associated with TTLP. PI3K pathway mutation predicts longer time to local progression after radioembolization of colorectal liver metastases.

Can imaging criteria distinguish enchondroma from grade 1 chondrosarcoma?

PubMed

Crim, Julia; Schmidt, Robert; Layfield, Lester; Hanrahan, Christopher; Manaster, Betty Jean

2015-11-01

To minimize systematic bias and optimize agreement on imaging criteria in order to better define the accuracy of imaging criteria in the diagnosis of grade 1 chondrosarcoma. Study was IRB-approved and HIPAA compliant; informed consent was waived. Records were reviewed and disclosed 53 cases (38 women, 15 men ages 21-76) which were diagnosed as enchondroma or grade 1 chondrosarcoma and had available radiographs, contrast-enhanced MRI, and definitive diagnosis by histology or 5-year follow-up. 2 MSK radiologists read the studies independently after a session where they agreed on criteria for malignancy. Interobserver variability was determined as raw variability and with the kappa statistic. Accuracy was determined compared to final diagnosis. Reliability of imaging features of chondrosarcoma was determined using regression analysis. The correct diagnosis of enchondroma was made on radiographs in 43 (67.2%) of readings, and on MRI in 37/64 (57.8%). The correct diagnosis of chondrosarcoma was made on radiographs in 5/24 (20.8%) of readings, and on MRI in 14/24 (57.8%). A diagnosis of borderline lesion was made in 19/64 (29.7%) of enchondromas on radiographs and 18/64 (28.1%) on MRI. The false positive rate of radiographs for chondrosarcoma was 2/64 (3.1%) and the false positive rate of MRI was 9/64 (14.1%). There was substantial interobserver variability. Cortical thickening and bone expansion were rare but specific signs of chondrosarcoma. Both radiographs and MRI have limitations in the evaluation of low-grade cartilage lesions. MRI has an increased rate of both true-positive and false-positive diagnosis compared to radiographs. Differences in the findings of this study compared to previous literature may reflect the influence of systematic biases. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Feasibility of a novel mHealth management system to capture and improve medication adherence among adolescents with asthma.

PubMed

Cushing, Anna; Manice, Melissa P; Ting, Andrew; Parides, Michael K

2016-01-01

Currently, 7.1 million children in the United States have asthma. Nonadherence to daily controller asthma medication is common, leading to more severe symptoms, overuse of rescue medication, and increased hospitalizations. The purpose of this study was to develop and evaluate the feasibility and acceptability of a novel mHealth management system composed of a sensored device, which is connected to mobile phone app that is designed to monitor and improve asthma medication adherence. The asthma management system was designed using well-established behavioral theory. Seven adolescents aged 11-18 years were enrolled and given an adherence sensor, and four of those also received a mobile phone app with game features and reminders. Five patients completed the study, and one was lost to follow-up in each group. Mobile app users and their parents participated in focus groups to assess patient preferences. Feasibility was assessed by the ability of sensors to capture real-time medication data. Acceptability was assessed by patient questionnaire and focus group analysis. Successful upload of real-time data from six of seven inhaler sensors to the HIPAA-compliant server demonstrates the feasibility of at-home patient monitoring using the sensor device. All three mobile app users who completed the study reported interest in continued use of the management system and would recommend the app to friends. Unstructured interviews and focus groups revealed that patients felt that the intervention helped their sense of asthma control. This study demonstrates the feasibility of using the sensor device to remotely monitor real-time medication usage, and user feedback demonstrates the acceptability of the intervention for patient use. The findings provide guidance for the improvement of study design and technology development. Further research is needed to assess the efficacy of the intervention.

Probabilistic Air Segmentation and Sparse Regression Estimated Pseudo CT for PET/MR Attenuation Correction

PubMed Central

Chen, Yasheng; Juttukonda, Meher; Su, Yi; Benzinger, Tammie; Rubin, Brian G.; Lee, Yueh Z.; Lin, Weili; Shen, Dinggang; Lalush, David

2015-01-01

Purpose To develop a positron emission tomography (PET) attenuation correction method for brain PET/magnetic resonance (MR) imaging by estimating pseudo computed tomographic (CT) images from T1-weighted MR and atlas CT images. Materials and Methods In this institutional review board–approved and HIPAA-compliant study, PET/MR/CT images were acquired in 20 subjects after obtaining written consent. A probabilistic air segmentation and sparse regression (PASSR) method was developed for pseudo CT estimation. Air segmentation was performed with assistance from a probabilistic air map. For nonair regions, the pseudo CT numbers were estimated via sparse regression by using atlas MR patches. The mean absolute percentage error (MAPE) on PET images was computed as the normalized mean absolute difference in PET signal intensity between a method and the reference standard continuous CT attenuation correction method. Friedman analysis of variance and Wilcoxon matched-pairs tests were performed for statistical comparison of MAPE between the PASSR method and Dixon segmentation, CT segmentation, and population averaged CT atlas (mean atlas) methods. Results The PASSR method yielded a mean MAPE ± standard deviation of 2.42% ± 1.0, 3.28% ± 0.93, and 2.16% ± 1.75, respectively, in the whole brain, gray matter, and white matter, which were significantly lower than the Dixon, CT segmentation, and mean atlas values (P < .01). Moreover, 68.0% ± 16.5, 85.8% ± 12.9, and 96.0% ± 2.5 of whole-brain volume had within ±2%, ±5%, and ±10% percentage error by using PASSR, respectively, which was significantly higher than other methods (P < .01). Conclusion PASSR outperformed the Dixon, CT segmentation, and mean atlas methods by reducing PET error owing to attenuation correction. © RSNA, 2014 PMID:25521778

Accuracy of Multi-echo Magnitude-based MRI (M-MRI) for Estimation of Hepatic Proton Density Fat Fraction (PDFF) in Children

PubMed Central

Zand, Kevin A.; Shah, Amol; Heba, Elhamy; Wolfson, Tanya; Hamilton, Gavin; Lam, Jessica; Chen, Joshua; Hooker, Jonathan C.; Gamst, Anthony C.; Middleton, Michael S.; Schwimmer, Jeffrey B.; Sirlin, Claude B.

2015-01-01

Purpose To assess accuracy of magnitude-based magnetic resonance imaging (M-MRI) in children to estimate hepatic proton density fat fraction (PDFF) using two to six echoes, with magnetic resonance spectroscopy (MRS)-measured PDFF as a reference standard. Materials and Methods This was an IRB-approved, HIPAA-compliant, single-center, cross-sectional, retrospective analysis of data collected prospectively between 2008 and 2013 in children with known or suspected non-alcoholic fatty liver disease (NAFLD). Two hundred and eighty-six children (8 – 20 [mean 14.2 ± 2.5] yrs; 182 boys) underwent same-day MRS and M-MRI. Unenhanced two-dimensional axial spoiled gradient-recalled-echo images at six echo times were obtained at 3T after a single low-flip-angle (10°) excitation with ≥ 120-ms recovery time. Hepatic PDFF was estimated using the first two, three, four, five, and all six echoes. For each number of echoes, accuracy of M-MRI to estimate PDFF was assessed by linear regression with MRS-PDFF as reference standard. Accuracy metrics were regression intercept, slope, average bias, and R2. Results MRS-PDFF ranged from 0.2 – 40.4% (mean 13.1 ± 9.8%). Using three to six echoes, regression intercept, slope, and average bias were 0.46 – 0.96%, 0.99 – 1.01, and 0.57 – 0.89%, respectively. Using two echoes, these values were 2.98%, 0.97, and 2.72%, respectively. R2 ranged 0.98 – 0.99 for all methods. Conclusion Using three to six echoes, M-MRI has high accuracy for hepatic PDFF estimation in children. PMID:25847512

Bone marrow fat content is correlated with hepatic fat content in paediatric non-alcoholic fatty liver disease.

PubMed

Yu, N Y; Wolfson, T; Middleton, M S; Hamilton, G; Gamst, A; Angeles, J E; Schwimmer, J B; Sirlin, C B

2017-05-01

To investigate the relationship between bone marrow fat content and hepatic fat content in children with known or suspected non-alcoholic fatty liver disease (NAFLD). This was an institutional review board-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant, cross-sectional, prospective analysis of data collected between October 2010 to March 2013 in 125 children with known or suspected NAFLD. Written informed consent was obtained for same-day research magnetic resonance imaging (MRI) of the lumbar spine, liver, and abdominal adiposity. Lumbar spine bone marrow proton density fat fraction (PDFF) and hepatic PDFF were estimated using complex-based MRI (C-MRI) techniques and magnitude-based MRI (M-MRI), respectively. Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SCAT) were quantified using high-resolution MRI. All images were acquired by two MRI technologists. Hepatic M-MRI images were analysed by an image analyst; all other images were analysed by a single investigator. The relationship between lumbar spine bone marrow PDFF and hepatic PDFF was assessed with and without adjusting for the presence of covariates using correlation and regression analysis. Lumbar spine bone marrow PDFF was positively associated with hepatic PDFF in children with known or suspected NAFLD prior to adjusting for covariates (r=0.33, p=0.0002). Lumbar spine bone marrow PDFF was positively associated with hepatic PDFF in children with known or suspected NAFLD (r=0.24, p=0.0079) after adjusting for age, sex, body mass index z-score, VAT, and SCAT in a multivariable regression analysis. Bone marrow fat content is positively associated with hepatic fat content in children with known or suspected NAFLD. Further research is needed to confirm these results and understand their clinical and biological implications. Copyright © 2016 The Royal College of Radiologists. All rights reserved.

MR Imaging of the Prostate and Adjacent Anatomic Structures before, during, and after Ejaculation: Qualitative and Quantitative Evaluation1

PubMed Central

Medved, Milica; Sammet, Steffen; Yousuf, Ambereen; Oto, Aytekin

2015-01-01

Purpose To determine the possibility of obtaining high-quality magnetic resonance (MR) images before, during, and immediately after ejaculation and detecting measurable changes in quantitative MR imaging parameters after ejaculation. Materials and Methods In this prospective, institutional review board–approved, HIPAA-compliant study, eight young healthy volunteers (median age, 22.5 years), after providing informed consent, underwent MR imaging while masturbating to the point of ejaculation. A 1.5-T MR imaging unit was used, with an eight-channel surface coil and a dynamic single-shot fast spin-echo sequence. In addition, a quantitative MR imaging protocol that allowed calculation of T1, T2, and apparent diffusion coefficient (ADC) values was applied before and after ejaculation. Volumes of the prostate and seminal vesicles (SV) were calculated by using whole-volume segmentation on T2-weighted images, both before and after ejaculation. Pre- and postejaculation changes in quantitative MR parameters and measured volumes were evaluated by using the Wilcoxon signed rank test with Bonferroni adjustment. Results There was no significant change in prostate volumes on pre- and postejaculation images, while the SV contracted by 41% on average (median, 44.5%; P = .004). No changes before and after ejaculation were observed in T1 values or in T2 and ADC values in the central gland, while T2 and ADC values were significantly reduced in the peripheral zone by 12% and 14%, respectively (median, 13% and 14.5%, respectively; P = .004). Conclusion Successful dynamic MR imaging of ejaculation events and the ability to visualize internal sphincter closure, passage of ejaculate, and significant changes in SV volumes were demonstrated. Significant changes in peripheral zone T2 and ADC values were observed. PMID:24495265

Improving Spleen Volume Estimation via Computer Assisted Segmentation on Clinically Acquired CT Scans

PubMed Central

Xu, Zhoubing; Gertz, Adam L.; Burke, Ryan P.; Bansal, Neil; Kang, Hakmook; Landman, Bennett A.; Abramson, Richard G.

2016-01-01

OBJECTIVES Multi-atlas fusion is a promising approach for computer-assisted segmentation of anatomical structures. The purpose of this study was to evaluate the accuracy and time efficiency of multi-atlas segmentation for estimating spleen volumes on clinically-acquired CT scans. MATERIALS AND METHODS Under IRB approval, we obtained 294 deidentified (HIPAA-compliant) abdominal CT scans on 78 subjects from a recent clinical trial. We compared five pipelines for obtaining splenic volumes: Pipeline 1–manual segmentation of all scans, Pipeline 2–automated segmentation of all scans, Pipeline 3–automated segmentation of all scans with manual segmentation for outliers on a rudimentary visual quality check, Pipelines 4 and 5–volumes derived from a unidimensional measurement of craniocaudal spleen length and three-dimensional splenic index measurements, respectively. Using Pipeline 1 results as ground truth, the accuracy of Pipelines 2–5 (Dice similarity coefficient [DSC], Pearson correlation, R-squared, and percent and absolute deviation of volume from ground truth) were compared for point estimates of splenic volume and for change in splenic volume over time. Time cost was also compared for Pipelines 1–5. RESULTS Pipeline 3 was dominant in terms of both accuracy and time cost. With a Pearson correlation coefficient of 0.99, average absolute volume deviation 23.7 cm3, and 1 minute per scan, Pipeline 3 yielded the best results. The second-best approach was Pipeline 5, with a Pearson correlation coefficient 0.98, absolute deviation 46.92 cm3, and 1 minute 30 seconds per scan. Manual segmentation (Pipeline 1) required 11 minutes per scan. CONCLUSION A computer-automated segmentation approach with manual correction of outliers generated accurate splenic volumes with reasonable time efficiency. PMID:27519156

Does Local Recurrence of Prostate Cancer After Radiation Therapy Occur at the Site of Primary Tumor? Results of a Longitudinal MRI and MRSI Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arrayeh, Elnasif; Westphalen, Antonio C.; Kurhanewicz, John

2012-04-01

Purpose: To determine if local recurrence of prostate cancer after radiation therapy occurs at the same site as the primary tumor before treatment, using longitudinal magnetic resonance (MR) imaging and MR spectroscopic imaging to assess dominant tumor location. Methods and Materials: This retrospective study was HIPAA compliant and approved by our Committee on Human Research. We identified all patients in our institutional prostate cancer database (1996 onward) who underwent endorectal MR imaging and MR spectroscopic imaging before radiotherapy for biopsy-proven prostate cancer and again at least 2 years after radiotherapy (n = 124). Two radiologists recorded the presence, location, andmore » size of unequivocal dominant tumor on pre- and postradiotherapy scans. Recurrent tumor was considered to be at the same location as the baseline tumor if at least 50% of the tumor location overlapped. Clinical and biopsy data were collected from all patients. Results: Nine patients had unequivocal dominant tumor on both pre- and postradiotherapy imaging, with mean pre- and postradiotherapy dominant tumor diameters of 1.8 cm (range, 1-2.2) and 1.9 cm (range, 1.4-2.6), respectively. The median follow-up interval was 7.3 years (range, 2.7-10.8). Dominant recurrent tumor was at the same location as dominant baseline tumor in 8 of 9 patients (89%). Conclusions: Local recurrence of prostate cancer after radiation usually occurs at the same site as the dominant primary tumor at baseline, suggesting supplementary focal therapy aimed at enhancing local tumor control would be a rational addition to management.« less

MRI-guided Breast Biopsy: Outcomes and Impact on Patient Management

PubMed Central

Kamel, Ihab R; Macura, Katarzyna J

2014-01-01

Introduction The purpose of this study was to correlate the pathology results of magnetic resonance imaging (MRI)-guided breast biopsies at our institution to MRI findings and patient clinical history characteristics. The impact of MRI-guided breast biopsies on surgical management in patients with a new diagnosis of breast cancer was also assessed. Patients and Methods In this HIPAA-compliant study we retrospectively reviewed all MRI-guided breast biopsies performed 3/2006–5/2012. Clinical history, MRI features and pathology outcomes were reviewed. In patients undergoing breast MRI to evaluate extent of disease, any change in surgical management resulting from the MRI-guided biopsy was recorded. Statistical analysis included binary logistic regression and independent student’s t-test. Results Two-hundred fifteen lesions in 168 patients were included, of which 23 (10.7%) were malignant, 43 (20%) were high risk, and 149 (69.3%) were benign. No clinical characteristic was associated with malignancy in our cohort. MRI features associated with malignancy were: larger size (mean 2.6 cm versus 1.3 cm, p=0.046), washout kinetics (18% malignancy rate, p=0.02) and marked background parenchymal enhancement (40% malignancy rate, p-value <0.001 to 0.03). Nineteen (28%) of the 67 patients with a new diagnosis of breast cancer undergoing MRI-guided breast biopsy had a change in surgical management based on the biopsy result. Conclusions Malignancy rate was associated with lesion size, washout kinetics and marked background enhancement of the breast parenchyma but was not associated with any clinical history characteristics. Pre-operative MRI-guided breast biopsies changed surgical management in 28% of women with a new diagnosis of breast cancer. PMID:25499596

Comparing Mammography Abnormality Features and Genetic Variants in the Prediction of Breast Cancer in Women Recommended for Breast Biopsy

PubMed Central

Burnside, Elizabeth S.; Liu, Jie; Wu, Yirong; Onitilo, Adedayo A.; McCarty, Catherine; Page, C. David; Peissig, Peggy; Trentham-Dietz, Amy; Kitchner, Terrie; Fan, Jun; Yuan, Ming

2015-01-01

Rationale and Objectives The discovery of germline genetic variants associated with breast cancer has engendered interest in risk stratification for improved, targeted detection and diagnosis. However, there has yet to be a comparison of the predictive ability of these genetic variants with mammography abnormality descriptors. Materials and Methods Our IRB-approved, HIPAA-compliant study utilized a personalized medicine registry in which participants consented to provide a DNA sample and participate in longitudinal follow-up. In our retrospective, age-matched, case-controlled study of 373 cases and 395 controls who underwent breast biopsy, we collected risk factors selected a priori based on the literature including: demographic variables based on the Gail model, common germline genetic variants, and diagnostic mammography findings according to BI-RADS. We developed predictive models using logistic regression to determine the predictive ability of: 1) demographic variables, 2) 10 selected genetic variants, or 3) mammography BI-RADS features. We evaluated each model in turn by calculating a risk score for each patient using 10-fold cross validation; used this risk estimate to construct ROC curves; and compared the AUC of each using the DeLong method. Results The performance of the regression model using demographic risk factors was not statistically different from the model using genetic variants (p=0.9). The model using mammography features (AUC = 0.689) was superior to both the demographic model (AUC = .598; p<0.001) and the genetic model (AUC = .601; p<0.001). Conclusion BI-RADS features exceeded the ability of demographic and 10 selected germline genetic variants to predict breast cancer in women recommended for biopsy. PMID:26514439

Image storage in radiation oncology: What did we learn from diagnostic radiology?

NASA Astrophysics Data System (ADS)

Blodgett, Kurt; Luick, Marc; Colonias, Athanasios; Gayou, Olivier; Karlovits, Stephen; Werts, E. Day

2009-02-01

The Digital Imaging and Communications in Medicine (DICOM) standard was developed by the National Electrical Manufacturers Association (NEMA) and the American College of Radiology (ACR) for medical image archiving and retrieval. An extension to this implemented a standard named DICOM-RT for use in Radiation Oncology. There are currently seven radiotherapy-specific DICOM objects which include: RT Structure Set, RT Plan, RT Dose, RT Image, RT Beams Treatment Record, RT Brachy Treatment Record, and RT Treatment Summary Record. The type of data associated with DICOM-RT includes (1) Radiation treatment planning datasets (CT, MRI, PET) with radiation treatment plans showing beam arrangements, isodose distributions, and dose volume histograms of targets/normal tissues and (2) Image-guided radiation modalities such as Siemens MVision mega-voltage cone beam CT (MV-CBCT). With the advent of such advancing technologies, there has been an exponential increase in image data collected for each patient, and the need for reliable and accessible image storage has become critical. A potential solution is a Radiation Oncology specific picture archiving and communication systems (PACS) that would allow data storage from multiple vendor devices and support the storage and retrieval needs not only of a single site but of a large, multi-facility network of radiation oncology clinics. This PACS system must be reliable, expandable, and cost-effective to operate while protecting sensitive patient image information in a Health Insurance Portability and Accountability Act (HIPAA) compliant environment. This paper emphasizes the expanding DICOM-RT storage requirements across our network of 8 radiation oncology clinics and the initiatives we undertook to address the increased volume of data by using the ImageGrid (CANDELiS Inc, Irvine CA) server and the IGViewer license (CANDELiS Inc, Irvine CA) to create a DICOM-RT compatible PACS system.

Pediatric chest and abdominopelvic CT: organ dose estimation based on 42 patient models.

PubMed

Tian, Xiaoyu; Li, Xiang; Segars, W Paul; Paulson, Erik K; Frush, Donald P; Samei, Ehsan

2014-02-01

To estimate organ dose from pediatric chest and abdominopelvic computed tomography (CT) examinations and evaluate the dependency of organ dose coefficients on patient size and CT scanner models. The institutional review board approved this HIPAA-compliant study and did not require informed patient consent. A validated Monte Carlo program was used to perform simulations in 42 pediatric patient models (age range, 0-16 years; weight range, 2-80 kg; 24 boys, 18 girls). Multidetector CT scanners were modeled on those from two commercial manufacturers (LightSpeed VCT, GE Healthcare, Waukesha, Wis; SOMATOM Definition Flash, Siemens Healthcare, Forchheim, Germany). Organ doses were estimated for each patient model for routine chest and abdominopelvic examinations and were normalized by volume CT dose index (CTDI(vol)). The relationships between CTDI(vol)-normalized organ dose coefficients and average patient diameters were evaluated across scanner models. For organs within the image coverage, CTDI(vol)-normalized organ dose coefficients largely showed a strong exponential relationship with the average patient diameter (R(2) > 0.9). The average percentage differences between the two scanner models were generally within 10%. For distributed organs and organs on the periphery of or outside the image coverage, the differences were generally larger (average, 3%-32%) mainly because of the effect of overranging. It is feasible to estimate patient-specific organ dose for a given examination with the knowledge of patient size and the CTDI(vol). These CTDI(vol)-normalized organ dose coefficients enable one to readily estimate patient-specific organ dose for pediatric patients in clinical settings. This dose information, and, as appropriate, attendant risk estimations, can provide more substantive information for the individual patient for both clinical and research applications and can yield more expansive information on dose profiles across patient populations within a practice. © RSNA, 2013.

A smartphone application for psoriasis segmentation and classification (Conference Presentation)

NASA Astrophysics Data System (ADS)

Vasefi, Fartash; MacKinnon, Nicholas B.; Horita, Timothy; Shi, Kevin; Khan Munia, Tamanna Tabassum; Tavakolian, Kouhyar; Alhashim, Minhal; Fazel-Rezai, Reza

2017-02-01

Psoriasis is a chronic skin disease affecting approximately 125 million people worldwide. Currently, dermatologists monitor changes of psoriasis by clinical evaluation or by measuring psoriasis severity scores over time which lead to Subjective management of this condition. The goal of this paper is to develop a reliable assessment system to quantitatively assess the changes of erythema and intensity of scaling of psoriatic lesions. A smartphone deployable mobile application is presented that uses the smartphone camera and cloud-based image processing to analyze physiological characteristics of psoriasis lesions, identify the type and stage of the scaling and erythema. The application targets to automatically evaluate Psoriasis Area Severity Index (PASI) by measuring the severity and extent of psoriasis. The mobile application performs the following core functions: 1) it captures text information from user input to create a profile in a HIPAA compliant database. 2) It captures an image of the skin with psoriasis as well as image-related information entered by the user. 3) The application color correct the image based on environmental lighting condition using calibration process including calibration procedure by capturing Macbeth ColorChecker image. 4) The color-corrected image will be transmitted to a cloud-based engine for image processing. In cloud, first, the algorithm removes the non-skin background to ensure the psoriasis segmentation is only applied to the skin regions. Then, the psoriasis segmentation algorithm estimates the erythema and scaling boundary regions of lesion. We analyzed 10 images of psoriasis images captured by cellphone, determined PASI score for each subject during our pilot study, and correlated it with changes in severity scores given by dermatologists. The success of this work allows smartphone application for psoriasis severity assessment in a long-term treatment.

Ultrafast Brain MRI: Clinical Deployment and Comparison to Conventional Brain MRI at 3T.

PubMed

Prakkamakul, Supada; Witzel, Thomas; Huang, Susie; Boulter, Daniel; Borja, Maria J; Schaefer, Pamela; Rosen, Bruce; Heberlein, Keith; Ratai, Eva; Gonzalez, Gilberto; Rapalino, Otto

2016-09-01

To compare an ultrafast brain magnetic resonance imaging (MRI) protocol to the conventional protocol in motion-prone inpatient clinical settings. This retrospective study was HIPAA compliant and approved by the Institutional Review Board with waived inform consent. Fifty-nine inpatients (30 males, 29 females; mean age 55.1, range 23-93 years)who underwent 3-Tesla brain MRI using ultrafast and conventional protocols, both including five sequences, were included in the study. The total scan time for five ultrafast sequences was 4 minutes 59 seconds. The ideal conventional acquisition time was 10 minutes 32 seconds but the actual acquisition took 15-20 minutes. The average scan times for ultrafast localizers, T1-weighted, T2-weighted, fluid-attenuated inversion recovery (FLAIR), diffusion-weighted, T2*-weighted sequences were 14, 41, 62, 96, 80, 6 seconds, respectively. Two blinded neuroradiologists independently assessed three aspects: (1) image quality, (2) gray-white matter (GM-WM) differentiation, and (3) diagnostic concordance for the detection of six clinically relevant imaging findings. Wilcoxon signed-rank test was used to compare image quality and GM-WM scores. Interobserver reproducibility was calculated. The ultrafast T1-weighted sequence demonstrated significantly better image quality (P = .005) and GM-WM differentiation (P < .001) compared to the conventional sequence. There was high agreement (>85%) between both protocols for the detection of mass-like lesion, hemorrhage, diffusion restriction, WM FLAIR hyperintensities, subarachnoid FLAIR hyperintensities, and hydrocephalus. The ultrafast protocol achieved at least comparable image quality and high diagnostic concordance compared to the conventional protocol. This fast protocol can be a viable option to replace the conventional protocol in motion-prone inpatient clinical settings. Copyright © 2016 by the American Society of Neuroimaging.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Drukker, Karen, E-mail: kdrukker@uchicago.edu; Sennett, Charlene A.; Giger, Maryellen L.

Purpose: Develop a computer-aided detection method and investigate its feasibility for detection of breast cancer in automated 3D ultrasound images of women with dense breasts. Methods: The HIPAA compliant study involved a dataset of volumetric ultrasound image data, “views,” acquired with an automated U-Systems Somo•V{sup ®} ABUS system for 185 asymptomatic women with dense breasts (BI-RADS Composition/Density 3 or 4). For each patient, three whole-breast views (3D image volumes) per breast were acquired. A total of 52 patients had breast cancer (61 cancers), diagnosed through any follow-up at most 365 days after the original screening mammogram. Thirty-one of these patientsmore » (32 cancers) had a screening-mammogram with a clinically assigned BI-RADS Assessment Category 1 or 2, i.e., were mammographically negative. All software used for analysis was developed in-house and involved 3 steps: (1) detection of initial tumor candidates, (2) characterization of candidates, and (3) elimination of false-positive candidates. Performance was assessed by calculating the cancer detection sensitivity as a function of the number of “marks” (detections) per view. Results: At a single mark per view, i.e., six marks per patient, the median detection sensitivity by cancer was 50.0% (16/32) ± 6% for patients with a screening mammogram-assigned BI-RADS category 1 or 2—similar to radiologists’ performance sensitivity (49.9%) for this dataset from a prior reader study—and 45.9% (28/61) ± 4% for all patients. Conclusions: Promising detection sensitivity was obtained for the computer on a 3D ultrasound dataset of women with dense breasts at a rate of false-positive detections that may be acceptable for clinical implementation.« less

Effects of intravenous gadolinium administration and flip angle on the assessment of liver fat signal fraction with opposed-phase and in-phase imaging.

PubMed

Yokoo, Takeshi; Collins, Julie M; Hanna, Robert F; Bydder, Mark; Middleton, Michael S; Sirlin, Claude B

2008-07-01

To assess the effects of intravenous gadolinium (Gd) and flip angle (FA) on liver fat quantification by opposed-phase (OP) and in-phase (IP) imaging. Our Institutional Review Board (IRB) approved this Health Insurance Portability and Accountability Act (HIPAA)-compliant, retrospective, clinical study. We identified 79 patients in whom abdominal OP and IP gradient-echoes were obtained at 1.5T before and after Gd administration. All 79 patients were imaged at high FA (> or =70 degrees ); 57 were also imaged at low FA (< or =20 degrees ). Fat signal fraction (FSF) was calculated from pre- and post-Gd liver images for each subject and FA using the formula, FSF = (S(IP) - S(OP))/2S(IP), where S(IP) and S(OP) are the OP and IP signal intensities, respectively. The dataset pairs (pre-Gd vs. post-Gd; high-FA vs. low-FA) were compared using linear regression analysis. Before Gd, FSF was significantly greater at high FA than at low FA, with regression parameters (slope/intercept) of 1.27*/0.02*, where * indicates P value <0.01. After Gd, FSF was similar at high and low FA (0.99/-0.00). Gd administration caused an FA-dependent reduction in FSF, larger at high FA (0.68*/-0.03*) than at low FA (0.94, -0.01*). FSF by OP-IP imaging is highly dependent on FA before Gd, but this dependency is eliminated after administration of Gd. Gd appears to minimize the effect of T1-weighting and may improve the accuracy of liver fat quantification. (c) 2008 Wiley-Liss, Inc.

The U.S. Radiologist Workforce: An Analysis of Temporal and Geographic Variation by Using Large National Datasets.

PubMed

Rosenkrantz, Andrew B; Hughes, Danny R; Duszak, Richard

2016-04-01

To determine recent trends related to temporal as well as national and statewide geographic variation in the U.S. radiologist and radiology resident workforce. This retrospective HIPAA-compliant study was exempted from the internal review board. Federal Area Health Resources Files and Medicare 5% research identifiable files were used to compute parameters related to the radiologist workforce. Geographic variation and annual temporal trends were analyzed. Pearson and Spearman correlations were assessed. Nationally, the number of radiology trainees increased 84.2% from a nadir in 1997 (3080 trainees) to 2011 (5674 trainees) and showed high state-to-state variation (range, 0-678 trainees in 2011). However, total radiologists nationally increased 39.2% from 1995 (27 906 radiologists) to 2011 (38 875 radiologists), and radiologists per 100 000 population nationally increased by 7.5% from 1995 (10.62%) to 2011 (11.42%), while showing high state-to-state variation (highest-to-lowest state ratio of 4.3). Radiologists' share of the overall physician workforce declined nationally by 8.8% from 1995 (4.0%) to 2011 (3.7%), with moderate state-to-state variation (highest-to-lowest state ratio of 1.7). Radiology trainee numbers exhibited weak-to-moderate positive state-by-state correlation with radiologists per 100 000 population (r = 0.292-0.532), but moderate-to-strong inverse correlation with the percentage of radiologists in rural practice (r = -0.464 to -0.635). Although the number of radiology trainees dramatically increased, radiologists per 100 000 population increased only slightly, and radiologists' share of the overall physician workforce declined. State-to-state variations in radiologist and radiology resident workforces are high, which suggests a potential role for geographic redistribution rather than changes in the overall workforce size.

Making the invisible visible: improving conspicuity of noncalcified gallstones using dual-energy CT.

PubMed

Uyeda, Jennifer W; Richardson, Ian J; Sodickson, Aaron D

2017-12-01

To determine whether virtual monochromatic imaging (VMI) increases detectability of noncalcified gallstones on dual-energy CT (DECT) compared with conventional CT imaging. This retrospective IRB-approved, HIPAA-compliant study included consecutive patients who underwent DECT of the abdomen in the Emergency Department during a 30-month period (July 1, 2013-December 31, 2015), with a comparison US or MR within 1-year. 51 patients (36F, 15M; mean age 52 years) fulfilled the inclusion criteria. All DECT were acquired on a dual-source 128 × 2 slice scanner using either 80/Sn140 or 100/Sn140 kVp pairs. Source images at high and low kVp were used for DE post-processing with VMI. Within 3 mm reconstructed images, regions of interest of 0.5 cm 2 were placed on noncalcified gallstones and bile to record hounsfield units (HU) at VMI energy levels ranging between 40 and 190 keV. Noncalcified gallstones uniformly demonstrated lowest HU at 40 keV and increase at higher keV; the HU of bile varied at higher keV. Few of the noncalcified stones are visible at 70 keV (simulating a conventional 120 kVp scan), with measured contrast (bile-stone HU difference) <10 HU in 78%, 10-20 HU in 20%, and >20 HU in 2%. Contrast was maximal at 40 keV, where 100% demonstrated >20 HU difference from surrounding bile, 75% >44 HU difference, and 50% >60 HU difference. A paired t test demonstrated a significant difference (p < 0.0001) between this stone-bile contrast at 40 vs. 70 keV and 70 vs. 190 keV. Low keV virtual monochromatic imaging increased conspicuity of noncalcified gallstones, improving their detectability.

Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study.

PubMed

Semelka, Richard C; Hernandes, Mateus de A; Stallings, Clifton G; Castillo, Mauricio

2013-01-01

The purpose was to objectively evaluate a recently FDA-approved gadolinium-based contrast agent (GBCA) in comparison to our standard GBCA for acute adverse events and image quality by blinded evaluation. Evaluation was made of a recently FDA-approved GBCA, gadobutrol (Gadavist; Bayer), in comparison to our standard GBCA, gadobenate dimeglumine (MultiHance; Bracco), in an IRB- and HIPAA-compliant study. Both the imaging technologist and patient were not aware of the brand of the GBCA used. A total of 59 magnetic resonance studies were evaluated (59 patients, 31 men, 28 women, age range of 5-85 years, mean age of 52 years). Twenty-nine studies were performed with gadobutrol (22 abdominal and 7 brain studies), and 30 studies were performed with gadobenate dimeglumine (22 abdominal and 8 brain studies). Assessment was made of acute adverse events focusing on objective observations of vomiting, hives, and moderate and severe reactions. Adequacy of enhancement was rated as poor, fair and good by one of two experienced radiologists who were blinded to the type of agent evaluated. No patient experienced acute adverse events with either agent. The target minor adverse events of vomiting or hives, and moderate and severe reactions were not observed in any patient. Adequacy of enhancement was rated as good for both agents in all patients. Objective, blinded evaluation is feasible and readily performable for the evaluation of GBCAs. This proof-of-concept study showed that both GBCAs evaluated exhibited consistent good image quality and no noteworthy adverse events. Copyright © 2013 Elsevier Inc. All rights reserved.

Waiting for Radiology Test Results: Patient Expectations and Emotional Disutility.

PubMed

Woolen, Sean; Kazerooni, Ella A; Wall, Amber; Parent, Kelly; Cahalan, Shannon; Alameddine, Mitchell; Davenport, Matthew S

2018-02-01

To measure patient willingness to wait and emotional disutility of waiting for outpatient imaging test results. A prospective HIPAA-compliant multicenter outpatient quality improvement survey was administered by a trained interviewer to 218 outpatients from November 1, 2016, to February 1, 2017. The survey was vetted by patient- and family-centered care advocates with experience in survey design and underwent precognitive testing for readability. Six clinical scenarios were tested. Descriptive statistics were calculated. The response (93% [202 of 218]) and completion (93% [188 of 202]) rates were excellent. Anxiety (28% [57 of 202]), depression (26% [53 of 202]), and cancer (23% [46 of 202]) histories were common. Median stated expectations for imaging test results receipt were 3 days after a screening examination (interquartile range [IQR] 5 days); 2 days after chest x-ray for chest pain (IQR 3) or MRI or CT for back pain (IQR 2); and 1 day after chest x-ray for pneumonia (IQR 2), MRI or CT for brain tumor (IQR 2), or CT for cancer treatment (IQR 3). If imaging results are not received, the median time patients stated they would wait to call their provider was 1 to 5 days (varied by indication). Waiting for imaging results exerts an emotional change in 45% (91 of 202) of individuals, with the majority (85% [77 of 91]) experiencing anxiety (minimal 28%, mild 45%, moderate 22%, severe 4%, extreme 1%). Patients expect outpatient imaging results within 1 to 3 days and will call providers by 1 to 5 days. Waiting for test results commonly induces anxiety. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Active hemorrhage and vascular injuries in splenic trauma: utility of the arterial phase in multidetector CT.

PubMed

Uyeda, Jennifer W; LeBedis, Christina A; Penn, David R; Soto, Jorge A; Anderson, Stephan W

2014-01-01

To determine whether the addition of arterial phase computed tomography (CT) to the standard combination of portal venous and delayed phase imaging increases sensitivity in the diagnosis of active hemorrhage and/or contained vascular injuries in patients with splenic trauma. The institutional review board approved this HIPAA-compliant retrospective study; the requirement to obtain informed consent was waived. The study included all patients aged 15 years and older who sustained a splenic injury from blunt or penetrating trauma and who underwent CT in the arterial and portal venous phases of image acquisition during a 74-month period (September 2005 to November 2011). CT scans were reviewed by three radiologists, and a consensus interpretation was made to classify the splenic injuries according to the American Association for the Surgery of Trauma splenic injury scale. One radiologist independently recorded the presence of contained vascular injuries or active hemorrhage and the phase or phases at which these lesions were seen. Clinical outcome was assessed by reviewing medical records. The relationship between imaging findings and clinical management was assessed with the Fisher exact test. One hundred forty-seven patients met the inclusion criteria; 32 patients (22%) had active hemorrhage and 22 (15%) had several contained vascular injuries. In 13 of the 22 patients with contained injuries, the vascular lesion was visualized only at the arterial phase of image acquisition; the other nine contained vascular injuries were seen at all phases. Surgery or embolization was performed in 11 of the 22 patients with contained vascular injury. The arterial phase of image acquisition improves detection of traumatic contained splenic vascular injuries and should be considered to optimize detection of splenic injuries in trauma with CT. ©RSNA, 2013.

Nonalcoholic fatty liver disease: MR imaging of liver proton density fat fraction to assess hepatic steatosis.

PubMed

Tang, An; Tan, Justin; Sun, Mark; Hamilton, Gavin; Bydder, Mark; Wolfson, Tanya; Gamst, Anthony C; Middleton, Michael; Brunt, Elizabeth M; Loomba, Rohit; Lavine, Joel E; Schwimmer, Jeffrey B; Sirlin, Claude B

2013-05-01

To evaluate the diagnostic performance of magnetic resonance (MR) imaging-estimated proton density fat fraction (PDFF) for assessing hepatic steatosis in nonalcoholic fatty liver disease (NAFLD) by using centrally scored histopathologic validation as the reference standard. This prospectively designed, cross-sectional, internal review board-approved, HIPAA-compliant study was conducted in 77 patients who had NAFLD and liver biopsy. MR imaging-PDFF was estimated from magnitude-based low flip angle multiecho gradient-recalled echo images after T2* correction and multifrequency fat modeling. Histopathologic scoring was obtained by consensus of the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network Pathology Committee. Spearman correlation, additivity and variance stabilization for regression for exploring the effect of a number of potential confounders, and receiver operating characteristic analyses were performed. Liver MR imaging-PDFF was systematically higher, with higher histologic steatosis grade (P < .001), and was significantly correlated with histologic steatosis grade (ρ = 0.69, P < .001). The correlation was not confounded by age, sex, lobular inflammation, hepatocellular ballooning, NASH diagnosis, fibrosis, or magnetic field strength (P = .65). Area under the receiver operating characteristic curves was 0.989 (95% confidence interval: 0.968, 1.000) for distinguishing patients with steatosis grade 0 (n = 5) from those with grade 1 or higher (n = 72), 0.825 (95% confidence interval: 0.734, 0.915) to distinguish those with grade 1 or lower (n = 31) from those with grade 2 or higher (n = 46), and 0.893 (95% confidence interval: 0.809, 0.977) to distinguish those with grade 2 or lower (n = 58) from those with grade 3 (n = 19). MR imaging-PDFF showed promise for assessment of hepatic steatosis grade in patients with NAFLD. For validation, further studies with larger sample sizes are needed. © RSNA, 2013.

iGAS: A framework for using electronic intraoperative medical records for genomic discovery.

PubMed

Levin, Matthew A; Joseph, Thomas T; Jeff, Janina M; Nadukuru, Rajiv; Ellis, Stephen B; Bottinger, Erwin P; Kenny, Eimear E

2017-03-01

Design and implement a HIPAA and Integrating the Healthcare Enterprise (IHE) profile compliant automated pipeline, the integrated Genomics Anesthesia System (iGAS), linking genomic data from the Mount Sinai Health System (MSHS) BioMe biobank to electronic anesthesia records, including physiological data collected during the perioperative period. The resulting repository of multi-dimensional data can be used for precision medicine analysis of physiological readouts, acute medical conditions, and adverse events that can occur during surgery. A structured pipeline was developed atop our existing anesthesia data warehouse using open-source tools. The pipeline is automated using scheduled tasks. The pipeline runs weekly, and finds and identifies all new and existing anesthetic records for BioMe participants. The pipeline went live in June 2015 with 49.2% (n=15,673) of BioMe participants linked to 40,947 anesthetics. The pipeline runs weekly in minimal time. After eighteen months, an additional 3671 participants were enrolled in BioMe and the number of matched anesthetic records grew 21% to 49,545. Overall percentage of BioMe patients with anesthetics remained similar at 51.1% (n=18,128). Seven patients opted out during this time. The median number of anesthetics per participant was 2 (range 1-144). Collectively, there were over 35 million physiologic data points and 480,000 medication administrations linked to genomic data. To date, two projects are using the pipeline at MSHS. Automated integration of biobank and anesthetic data sources is feasible and practical. This integration enables large-scale genomic analyses that might inform variable physiological response to anesthetic and surgical stress, and examine genetic factors underlying adverse outcomes during and after surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Accuracy of multiecho magnitude-based MRI (M-MRI) for estimation of hepatic proton density fat fraction (PDFF) in children.

PubMed

Zand, Kevin A; Shah, Amol; Heba, Elhamy; Wolfson, Tanya; Hamilton, Gavin; Lam, Jessica; Chen, Joshua; Hooker, Jonathan C; Gamst, Anthony C; Middleton, Michael S; Schwimmer, Jeffrey B; Sirlin, Claude B

2015-11-01

To assess accuracy of magnitude-based magnetic resonance imaging (M-MRI) in children to estimate hepatic proton density fat fraction (PDFF) using two to six echoes, with magnetic resonance spectroscopy (MRS) -measured PDFF as a reference standard. This was an IRB-approved, HIPAA-compliant, single-center, cross-sectional, retrospective analysis of data collected prospectively between 2008 and 2013 in children with known or suspected nonalcoholic fatty liver disease (NAFLD). Two hundred eighty-six children (8-20 [mean 14.2 ± 2.5] years; 182 boys) underwent same-day MRS and M-MRI. Unenhanced two-dimensional axial spoiled gradient-recalled-echo images at six echo times were obtained at 3T after a single low-flip-angle (10°) excitation with ≥ 120-ms recovery time. Hepatic PDFF was estimated using the first two, three, four, five, and all six echoes. For each number of echoes, accuracy of M-MRI to estimate PDFF was assessed by linear regression with MRS-PDFF as reference standard. Accuracy metrics were regression intercept, slope, average bias, and R(2) . MRS-PDFF ranged from 0.2-40.4% (mean 13.1 ± 9.8%). Using three to six echoes, regression intercept, slope, and average bias were 0.46-0.96%, 0.99-1.01, and 0.57-0.89%, respectively. Using two echoes, these values were 2.98%, 0.97, and 2.72%, respectively. R(2) ranged 0.98-0.99 for all methods. Using three to six echoes, M-MRI has high accuracy for hepatic PDFF estimation in children. © 2015 Wiley Periodicals, Inc.

Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy.

PubMed

Collado-Mesa, F; Net, J M; Arheart, K; Klevos, G A; Yepes, M M

2015-09-01

To assess whether the application of a topical vapocoolant spray immediately prior to initial intradermal anaesthetic injection during ultrasound-guided breast biopsy decreases pain at the site of the initial injection. In this institutional review board-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant study, 50 women aged 49.1 ± 1.6 years (mean ± standard error) were recruited and provided written informed consent. Participants served as their own controls and were blinded as to whether a topical vapocoolant spray or a placebo was used immediately prior to the initial local anaesthetic injection at two separate biopsy sites. With the exception of the application of vapocoolant or placebo, the entire ultrasound-guided procedure was performed according to a routine protocol. Participants recorded pain at initial injection site on a visual analogue scale. General linear mixed models for repeated measures analysis of variance and a 0.05 significance level were used. Application of topical vapocoolant spray was shown to significantly decrease pain at the site of initial intradermal anaesthetic injection as compared to placebo (p<0.001). Treatment effect was independent of age of the subject, race/ethnicity, operator, type of biopsy device, and histopathology result. No complications from vapocoolant spray use were reported. Application of a topical vapocoolant spray immediately prior to initial intradermal anaesthetic injection during ultrasound-guided breast biopsy significantly decreases pain at the site of the initial injection and could contribute to improve the patient's overall procedural experience. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Management of Fractured Inferior Vena Cava Filters: Outcomes by Fragment Location.

PubMed

Trerotola, Scott O; Stavropoulos, S William

2017-09-01

Purpose To inform the management of fractured inferior vena cava filters on the basis of results from a tertiary referral center specializing in complex filter retrieval. Materials and Methods This study had institutional review board approval and was HIPAA compliant. Retrospective analysis of all patients with fractured filters and/or filter fragments evaluated for removal in a complex filter removal program was performed. Removal was attempted when fragments were intravascular or immediately extravascular by using primarily endobronchial forceps for caval fragments and snares for cardiac and pulmonary fragments. Data collected included success rate and complications of filter and fragment removal, symptoms relating to the filter or fragment, techniques used for removal, and follow-up of retained fragments. Results Sixty-five patients (12 men, 53 women) of a total of 222 patients referred for complex retrieval had fractured filters. Of these patients, two had undergone filter removal elsewhere and had retained fragments. All 63 filters were removed successfully with forceps (n = 61), a cone (n = 1), or a snare (n = 1). There were 116 separate filter fragments; removal was attempted for 78 fragments. Removal was successful for 63 (81%) of 78 fragments and varied by location. All extravascular fragments except one were retained. In all, 63 (54%) of 116 fragments were removed percutaneously, rendering 34 (54%) of 63 patients fragment free. Five minor (7.7% [five of 65]) and four major (6.2% [four of 65]) complications occurred. Conclusion Intravascular filter fragments can be removed safely with success rates that vary according to location. Because extravascular fragments are not readily accessible for removal, many patients are not rendered fragment free. © RSNA, 2017 Online supplemental material is available for this article.

Multimodal Randomized Functional MR Imaging of the Effects of Methylene Blue in the Human Brain

PubMed Central

Rodriguez, Pavel; Zhou, Wei; Barrett, Douglas W.; Altmeyer, Wilson; Gutierrez, Juan E.; Li, Jinqi; Lancaster, Jack L.; Gonzalez-Lima, Francisco

2016-01-01

Purpose To investigate the sustained-attention and memory-enhancing neural correlates of the oral administration of methylene blue in the healthy human brain. Materials and Methods The institutional review board approved this prospective, HIPAA-compliant, randomized, double-blinded, placebo-controlled clinical trial, and all patients provided informed consent. Twenty-six subjects (age range, 22–62 years) were enrolled. Functional magnetic resonance (MR) imaging was performed with a psychomotor vigilance task (sustained attention) and delayed match-to-sample tasks (short-term memory) before and 1 hour after administration of low-dose methylene blue or a placebo. Cerebrovascular reactivity effects were also measured with the carbon dioxide challenge, in which a 2 × 2 repeated-measures analysis of variance was performed with a drug (methylene blue vs placebo) and time (before vs after administration of the drug) as factors to assess drug × time between group interactions. Multiple comparison correction was applied, with cluster-corrected P < .05 indicating a significant difference. Results Administration of methylene blue increased response in the bilateral insular cortex during a psychomotor vigilance task (Z = 2.9–3.4, P = .01–.008) and functional MR imaging response during a short-term memory task involving the prefrontal, parietal, and occipital cortex (Z = 2.9–4.2, P = .03–.0003). Methylene blue was also associated with a 7% increase in correct responses during memory retrieval (P = .01). Conclusion Low-dose methylene blue can increase functional MR imaging activity during sustained attention and short-term memory tasks and enhance memory retrieval. © RSNA, 2016 Online supplemental material is available for this article. PMID:27351678

Cerebral Microbleeds: Burden Assessment by Using Quantitative Susceptibility Mapping

PubMed Central

Liu, Tian; Surapaneni, Krishna; Lou, Min; Cheng, Liuquan; Spincemaille, Pascal

2012-01-01

Purpose: To assess quantitative susceptibility mapping (QSM) for reducing the inconsistency of standard magnetic resonance (MR) imaging sequences in measurements of cerebral microbleed burden. Materials and Methods: This retrospective study was HIPAA compliant and institutional review board approved. Ten patients (5.6%) were selected from among 178 consecutive patients suspected of having experienced a stroke who were imaged with a multiecho gradient-echo sequence at 3.0 T and who had cerebral microbleeds on T2*-weighted images. QSM was performed for various ranges of echo time by using both the magnitude and phase components in the morphology-enabled dipole inversion method. Cerebral microbleed size was measured by two neuroradiologists on QSM images, T2*-weighted images, susceptibility-weighted (SW) images, and R2* maps calculated by using different echo times. The sum of susceptibility over a region containing a cerebral microbleed was also estimated on QSM images as its total susceptibility. Measurement differences were assessed by using the Student t test and the F test; P < .05 was considered to indicate a statistically significant difference. Results: When echo time was increased from approximately 20 to 40 msec, the measured cerebral microbleed volume increased by mean factors of 1.49 ± 0.86 (standard deviation), 1.64 ± 0.84, 2.30 ± 1.20, and 2.30 ± 1.19 for QSM, R2*, T2*-weighted, and SW images, respectively (P < .01). However, the measured total susceptibility with QSM did not show significant change over echo time (P = .31), and the variation was significantly smaller than any of the volume increases (P < .01 for each). Conclusion: The total susceptibility of a cerebral microbleed measured by using QSM is a physical property that is independent of echo time. © RSNA, 2011 PMID:22056688

FLAIR*: A Combined MR Contrast Technique for Visualizing White Matter Lesions and Parenchymal Veins

PubMed Central

George, Ilena C.; Shea, Colin D.; Gaitán, María I.; Reich, Daniel S.

2012-01-01

Purpose: To evaluate a magnetic resonance (MR) imaging contrast technique, called FLAIR*, that combines the advantages of T2-weighted fluid-attenuated inversion recovery (FLAIR) contrast and T2*-weighted contrast on a single image for assessment of white matter (WM) diseases such as multiple sclerosis (MS). Materials and Methods: This prospective pilot study was HIPAA compliant and institutional review board approved. Ten patients with clinically definite MS (eight men, two women; mean age, 41 years) provided informed consent and underwent 3.0-T MR imaging. Images from a T2-weighted FLAIR sequence were combined with images from a T2*-weighted segmented echo-planar imaging sequence performed during contrast material injection, yielding high-isotropic-resolution (0.55 × 0.55 × 0.55 mm3) FLAIR* images. Qualitative assessment was performed for image quality, lesion conspicuity, and vein conspicuity. Contrast-to-noise ratio (CNR) was calculated to compare normal-appearing WM (NAWM) with cerebrospinal fluid, lesions, and veins. To evaluate the differences in CNR among imaging modalities, a bootstrap procedure clustered on subjects was used, together with paired t tests. Results: High-quality FLAIR* images of the brain were produced at 3.0 T, yielding conspicuous lesions and veins. Lesion-to-NAWM and NAWM-to-vein CNR values were significantly higher for FLAIR* images than for T2-weighted FLAIR images (P < .0001). Findings on FLAIR* images included intralesional veins for lesions located throughout the brain and a hypointense rim around some WM lesions. Conclusion: High-isotropic-resolution FLAIR* images obtained at 3.0 T yield high contrast for WM lesions and parenchymal veins, making it well suited to investigate the relationship between WM abnormalities and veins in a clinical setting. © RSNA, 2012 PMID:23074257

The utility of CT for predicting bile leaks in hepatic trauma.

PubMed

LeBedis, Christina A; Anderson, Stephan W; Mercier, Gustavo; Kussman, Steven; Coleman, Stephanie L; Golden, Louis; Penn, David R; Uyeda, Jennifer W; Soto, Jorge A

2015-04-01

The purpose of this study was to determine the efficacy of CT to predict the development of bile leaks in hepatic trauma. This HIPAA-compliant retrospective study was IRB approved and consent was waived. All patients who sustained hepatic trauma between January 1, 2006, and January 31, 2012, and who underwent CT and hepatobiliary scans during the same hospital admission were included. One hundred and thirty-two patients met the inclusion criteria. Comparison between the presence of biliary injury relative to American Association for the Surgery of Trauma (AAST) hepatic injury grade and mean distance of the hepatic laceration to the inferior vena cava (IVC) was made. The ability of free fluid to predict bile injury was analyzed. Forty-one (31 %) of the 132 patients had positive hepatobiliary scans. Of these 41 patients, seven (17 %) sustained low-grade and 34 (83 %) sustained high-grade hepatic injury compared with the 37 (41 %) low-grade and 54 (59 %) high-grade hepatic injuries in the negative hepatobiliary scan group. The mean distance to the IVC was 2.4 cm (SD 2.9 cm) and 3.6 cm (SD 3.3 cm) in patients with and without bile leaks, respectively. A statistically significant difference in the proportion of high-grade injuries and the mean distance from the IVC between the two groups was identified. The presence of free fluid on CT is sensitive, but not specific, for detecting a bile leak. CT findings, including AAST liver injury grade and location of the liver laceration, are able to predict which patients are at risk for developing bile leaks as seen on hepatobiliary scintigraphy, whereas the presence of free fluid is not.

Brain MR imaging at ultra-low radiofrequency power.

PubMed

Sarkar, Subhendra N; Alsop, David C; Madhuranthakam, Ananth J; Busse, Reed F; Robson, Philip M; Rofsky, Neil M; Hackney, David B

2011-05-01

To explore the lower limits for radiofrequency (RF) power-induced specific absorption rate (SAR) achievable at 1.5 T for brain magnetic resonance (MR) imaging without loss of tissue signal or contrast present in high-SAR clinical imaging in order to create a potentially viable MR method at ultra-low RF power to image tissues containing implanted devices. An institutional review board-approved HIPAA-compliant prospective MR study design was used, with written informed consent from all subjects prior to MR sessions. Seven healthy subjects were imaged prospectively at 1.5 T with ultra-low-SAR optimized three-dimensional (3D) fast spin-echo (FSE) and fluid-attenuated inversion-recovery (FLAIR) T2-weighted sequences and an ultra-low-SAR 3D spoiled gradient-recalled acquisition in the steady state T1-weighted sequence. Corresponding high-SAR two-dimensional (2D) clinical sequences were also performed. In addition to qualitative comparisons, absolute signal-to-noise ratios (SNRs) and contrast-to-noise ratios (CNRs) for multicoil, parallel imaging acquisitions were generated by using a Monte Carlo method for quantitative comparison between ultra-low-SAR and high-SAR results. There were minor to moderate differences in the absolute tissue SNR and CNR values and in qualitative appearance of brain images obtained by using ultra-low-SAR and high-SAR techniques. High-SAR 2D T2-weighted imaging produced slightly higher SNR, while ultra-low-SAR 3D technique not only produced higher SNR for T1-weighted and FLAIR images but also higher CNRs for all three sequences for most of the brain tissues. The 3D techniques adopted here led to a decrease in the absorbed RF power by two orders of magnitude at 1.5 T, and still the image quality was preserved within clinically acceptable imaging times. RSNA, 2011

Comparison of Background Parenchymal Enhancement at Contrast-enhanced Spectral Mammography and Breast MR Imaging.

PubMed

Sogani, Julie; Morris, Elizabeth A; Kaplan, Jennifer B; D'Alessio, Donna; Goldman, Debra; Moskowitz, Chaya S; Jochelson, Maxine S

2017-01-01

Purpose To assess the extent of background parenchymal enhancement (BPE) at contrast material-enhanced (CE) spectral mammography and breast magnetic resonance (MR) imaging, to evaluate interreader agreement in BPE assessment, and to examine the relationships between clinical factors and BPE. Materials and Methods This was a retrospective, institutional review board-approved, HIPAA-compliant study. Two hundred seventy-eight women from 25 to 76 years of age with increased breast cancer risk who underwent CE spectral mammography and MR imaging for screening or staging from 2010 through 2014 were included. Three readers independently rated BPE on CE spectral mammographic and MR images with the ordinal scale: minimal, mild, moderate, or marked. To assess pairwise agreement between BPE levels on CE spectral mammographic and MR images and among readers, weighted κ coefficients with quadratic weights were calculated. For overall agreement, mean κ values and bootstrapped 95% confidence intervals were calculated. The univariate and multivariate associations between BPE and clinical factors were examined by using generalized estimating equations separately for CE spectral mammography and MR imaging. Results Most women had minimal or mild BPE at both CE spectral mammography (68%-76%) and MR imaging (69%-76%). Between CE spectral mammography and MR imaging, the intrareader agreement ranged from moderate to substantial (κ = 0.55-0.67). Overall agreement on BPE levels between CE spectral mammography and MR imaging and among readers was substantial (κ = 0.66; 95% confidence interval: 0.61, 0.70). With both modalities, BPE demonstrated significant association with menopausal status, prior breast radiation therapy, hormonal treatment, breast density on CE spectral mammographic images, and amount of fibroglandular tissue on MR images (P < .001 for all). Conclusion There was substantial agreement between readers for BPE detected on CE spectral mammographic and MR images. © RSNA, 2016.

Arthroscopic hip preservation surgery practice patterns: an international survey

PubMed Central

Smith, Kevin M.; Gerrie, Brayden J.; McCulloch, Patrick C.; Lewis, Brian D.; Mather, R. Chad; Van Thiel, Geoffrey; Nho, Shane J.

2017-01-01

Abstract To design and conduct a survey analyzing pre-, intra- and post- hip arthroscopy practice patterns among hip arthroscopists worldwide. A 21-question, IRB-exempt, HIPAA-compliant, cross-sectional survey was conducted via email using SurveyMonkey to examine pre-operative evaluation, intra-operative techniques and post-operative management. The survey was administered internationally to 151 hip arthroscopists identified from publicly available sources. Seventy-five respondents completed the survey (151 ± 116 hip arthroscopy procedures per year; 8.6 ± 7.1 years hip arthroscopy experience). Standing AP pelvis, false profile and Dunn 45 were the most common radiographs utilized. CT scans were utilized by 54% of surgeons at least some of the time. Only 56% of participants recommended an arthrogram with MRI. Nearly all surgeons either never (40%) or infrequently (58%) performed arthroscopy in Tönnis grade-2 or grade-3 osteoarthritis. Surgeons rarely performed hip arthroscopy on patients with dysplasia (51% never; 44% infrequently). Only 25% of participants perform a routine ‘T’ capsulotomy and 41% close the capsule if the patient is at risk for post-operative instability. Post-operatively, 52% never use a brace, 39% never use a continuous passive motion, 11% never recommended heterotopic ossification prophylaxis and 30% never recommended formal thromboembolic disease prophylaxis. Among a large number of high-volume experienced hip arthroscopists worldwide, pre-, intra- and post- hip arthroscopy practice patterns have been established and reported. Within this cohort of respondents, several areas of patient evaluation and management remain discordant and controversial without universal agreement. Future research should move beyond expert opinion level V evidence towards high-quality appropriately designed and conducted investigations. PMID:28630717

Characteristics of PI-RADS 4 lesions within the prostatic peripheral zone: a retrospective diagnostic accuracy study evaluating 170 lesions.

PubMed

Shankar, Prasad R; Curci, Nicole E; Davenport, Matthew S

2017-12-02

To determine whether peripheral zone PI-RADS 4 observations can be further risk-stratified. This was an IRB-approved HIPAA-compliant retrospective diagnostic accuracy study. Peripheral zone PI-RADS 4 observations prospectively identified at the study institution from 8/1/2015 to 12/31/2016 (n = 170 in 149 mpMRIs) were reviewed independently by two blinded genitourinary radiologists on the basis of (a) PI-RADS v2 shape, (b) pattern of peripheral zone sparing, and (c) rationale for PI-RADS 4 designation. Reference standard was targeted MR-ultrasound fusion biopsy and detection of Gleason 7+ prostate cancer. Positive predictive values (PPVs) were calculated. Predictors were assessed with binary logistic regression. PI-RADS 4 lesions with a DWI score of 4 were more likely to represent Gleason 7+ prostate cancer (p = 0.008-0.01; Reader 1 PPV: 53%; Reader 2 PPV: 48%). Pattern of peripheral zone sparing and most lesion shapes were not predictive (p > 0.05); however, oval lesions were predictive for Reader 1 (PPV = 59%, p = 0.03) and lentiform lesions were predictive for Reader 2 (PPV = 74%, p = 0.01). Lesions scored as "not meeting PI-RADS 4 criteria" had significantly lower PPV (p = 0.016-0.003; Reader 1 PPV: 14%, Reader 2 PPV: 16%). Peripheral zone PI-RADS 4 lesions with a DWI score of 4 are more likely Gleason 7+ cancer than those with a DWI score of 3. Lesions overcalled as PI-RADS 4 have PPV similar to published PI-RADS 3 data. Lesion shape and peripheral zone sparing in general do not predict Gleason 7+ cancer within PI-RADS 4 observations.

Quantification of Human Cortical Bone Bound and Free Water in Vivo with Ultrashort Echo Time MR Imaging: A Model-based Approach.

PubMed

Abbasi-Rad, Shahrokh; Saligheh Rad, Hamidreza

2017-06-01

Purpose To quantify free and bound water components of cortical bone with a model-based numeric approach with use of ultrashort echo time (UTE) magnetic resonance (MR) imaging in vivo in order to introduce a new predictor for age-related deterioration of cortical bone structure. Materials and Methods Human studies were compliant with HIPAA and approved by the institutional review board. Dual-repetition time three-dimensional hybrid-radial UTE imaging was performed, followed by the application of postprocessing algorithms, to quantify free and bound water parameters (concentration [ρ] and longitudinal relaxation time [T1]) of human cortical bone in vivo. The postprocessing algorithms included the decomposition of bulk equations into free- and bound-associated equations and solving resulted inverse problem by using evolutionary strategy methods. To test the validity of the introduced biomarker, it was measured in 40 healthy women by using the proposed method, and associations among parameters were evaluated with the Pearson correlation coefficient. Results The mean free water concentration, bound water concentration, free water T1, and bound water T1 in the recruited population were 5.9%, 19.6%, 306.79 msec, and 162.47 msec, respectively. All reported values were in good agreement with those in the literature. Cortical bone free water T1 (R 2 = 0.72) and cortical bone free water concentration (R 2 = 0.62) showed strong positive correlations with age. Conclusion The cortical bone free water concentration and free water T1 derived with UTE imaging are good predictors of age-related deterioration of cortical bone structure and are potentially superior to previously introduced measures such as bone water concentration and suppression ratio. © RSNA, 2017.

Lung cancers diagnosed at annual CT screening: volume doubling times.

PubMed

Henschke, Claudia I; Yankelevitz, David F; Yip, Rowena; Reeves, Anthony P; Farooqi, Ali; Xu, Dongming; Smith, James P; Libby, Daniel M; Pasmantier, Mark W; Miettinen, Olli S

2012-05-01

To empirically address the distribution of the volume doubling time (VDT) of lung cancers diagnosed in repeat annual rounds of computed tomographic (CT) screening in the International Early Lung Cancer Action Program (I-ELCAP), first and foremost with respect to rates of tumor growth but also in terms of cell types. All CT screenings in I-ELCAP from 1993 to 2009 were performed according to HIPAA-compliant protocols approved by the institutional review boards of the collaborating institutions. All instances of first diagnosis of primary lung cancer after a negative screening result 7-18 months earlier were identified, with symptom-prompted diagnoses included. Lesion diameter was calculated by using the measured length and width of each cancer at the time when the nodule was first identified for further work-up and at the time of the most recent prior screening, 7-18 months earlier. The length and width were measured a second time for each cancer, and the geometric mean of the two calculated diameters was used to calculate the VDT. The χ(2) statistic was used to compare the VDT distributions. The median VDT for 111 cancers was 98 days (interquartile range, 108). For 56 (50%) cancers it was less than 100 days, and for three (3%) cancers it was more than 400 days. Adenocarcinoma was the most frequent cell type (50%), followed by squamous cell carcinoma (19%), small cell carcinoma (19%), and others (12%). Lung cancers manifesting as subsolid nodules had significantly longer VDTs than those manifesting as solid nodules (P < .0001). Lung cancers diagnosed in annual repeat rounds of CT screening, as manifest by the VDT and cell-type distributions, are similar to those diagnosed in the absence of screening.

Computerized detection of breast cancer on automated breast ultrasound imaging of women with dense breasts

DOE Office of Scientific and Technical Information (OSTI.GOV)

Drukker, Karen, E-mail: kdrukker@uchicago.edu; Sennett, Charlene A.; Giger, Maryellen L.

2014-01-15

Purpose: Develop a computer-aided detection method and investigate its feasibility for detection of breast cancer in automated 3D ultrasound images of women with dense breasts. Methods: The HIPAA compliant study involved a dataset of volumetric ultrasound image data, “views,” acquired with an automated U-Systems Somo•V{sup ®} ABUS system for 185 asymptomatic women with dense breasts (BI-RADS Composition/Density 3 or 4). For each patient, three whole-breast views (3D image volumes) per breast were acquired. A total of 52 patients had breast cancer (61 cancers), diagnosed through any follow-up at most 365 days after the original screening mammogram. Thirty-one of these patientsmore » (32 cancers) had a screening-mammogram with a clinically assigned BI-RADS Assessment Category 1 or 2, i.e., were mammographically negative. All software used for analysis was developed in-house and involved 3 steps: (1) detection of initial tumor candidates, (2) characterization of candidates, and (3) elimination of false-positive candidates. Performance was assessed by calculating the cancer detection sensitivity as a function of the number of “marks” (detections) per view. Results: At a single mark per view, i.e., six marks per patient, the median detection sensitivity by cancer was 50.0% (16/32) ± 6% for patients with a screening mammogram-assigned BI-RADS category 1 or 2—similar to radiologists’ performance sensitivity (49.9%) for this dataset from a prior reader study—and 45.9% (28/61) ± 4% for all patients. Conclusions: Promising detection sensitivity was obtained for the computer on a 3D ultrasound dataset of women with dense breasts at a rate of false-positive detections that may be acceptable for clinical implementation.« less

CT colonography after incomplete optical colonoscopy

PubMed Central

Theis, Jake; Kim, David H.; Lubner, Meghan G.; del Rio, Alejandro Muñoz; Pickhardt, Perry J.

2017-01-01

Purpose To objectively compare the volume, density, and distribution of luminal fluid for same-day oral-contrast-enhanced CTC following incomplete optical colonoscopy (OC) versus deferred CTC on a separate day utilizing a dedicated CTC bowel preparation. Methods HIPAA-compliant, IRB-approved retrospective study compared 103 same-day CTC studies after incomplete OC (utilizing 30 ml oral diatrizoate) against 151 CTC examinations performed on a separate day after failed OC using a dedicated CTC bowel preparation (oral magnesium citrate/dilute barium/diatrizoate the evening before). A subgroup of 15 patients who had both same-day CTC and separate-day routine CTC was also identified and underwent separate analysis. CTC exams were analyzed for opacified fluid distribution within the GI tract, as well as density and volume. Data was analyzed utilizing Kruskal-Wallis and Wilcoxon Signed Rank tests. Results Opacified luminal fluid extended to the rectum in 56% (58/103) of same-day CTC versus 100% (151/151) of deferred separate-day CTC (p<0.0001). For same-day CTC, contrast failed to reach the colon in 11% (11/103) and failed to reach the left colon in 26% (27/103). Volumetric colonic fluid segmentation for fluid analysis (successful in 80 same-day and 147 separate-day cases) showed significantly more fluid in the same-day cohort (mean, 227 ml vs. 166 ml; p<0.0001); the actual difference is underestimated due to excluded cases. Mean colonic fluid attenuation was significantly lower in the same-day cohort (545 HU vs. 735 HU; p<0.0001). Similar findings were identified in the smaller cohort with direct intra-patient CTC comparison. Conclusions Dedicated CTC bowel preparation on a separate day following incomplete OC results in a much higher quality examination compared with same-day CTC. PMID:26830606

Retrospective analysis of patients for development of nephrogenic systemic fibrosis following conventional angiography using gadolinium-based contrast agents.

PubMed

Hoppe, Hanno; Spagnuolo, Sara; Froehlich, Johannes M; Nievergelt, Helga; Dinkel, Hans-Peter; Gretener, Silvia; Thoeny, Harriet C

2010-03-01

The purpose was to retrospectively review the data of 27 patients with renal insufficiency who underwent conventional angiography with gadolinium-based contrast agents (GDBCA) as alternative contrast agents and assess the occurrence of nephrogenic systemic fibrosis (NSF) together with associated potential risk factors. This HIPAA-compliant study had institutional review board approval, and informed consent was waived. Statistical analysis was performed for all available laboratory and clinical data, including dermatology reports. Type and amount of the GDBCA used were recorded for angiography and additional MRI studies, if applicable. Serum creatinine levels (SCr) pre- and post-angiography were recorded, and estimated glomerular filtration rates (eGFR) were calculated. Ten female and 17 male patients who underwent angiography with GDBCA were included. The mean amount of GDBCA administered was 44 +/- 15.5 ml (range 15-60 ml) or 0.24 + 0.12 mmol/kg (range 0.1-0.53 mmol/kg). At the time of angiography all patients had renal insufficiency (eGFR <60 ml/min/1.73 m(2)). Mean eGFR pre-angiography was 26 ml/min/1.73 m(2) and 33 ml/min/1.73 m(2) post-angiography. The mean follow-up period covers 28 months, range 1-84 months. Additional MRI studies with GDBCA administration were performed in 15 patients. One patient with typical skin lesions had developed biopsy-confirmed NSF. Conventional arterial angiography with GDBCA may play a role in the development of NSF in patients with renal insufficiency. Alternative contrast agents, such as CO(2) angiography or rather the use of low doses of iodinated contrast agents, should be considered in these patients.

“Chasing a Ghost”: Factors that Influence Primary Care Physicians to Follow Up on Incidental Imaging Findings

PubMed Central

Bugos, Eva K.; Langlotz, Curtis P.; Frasso, Rosemary

2016-01-01

Purpose To explore provider and patient characteristics that influence how primary care providers (PCPs) communicate and manage incidental imaging findings. Materials and Methods This HIPAA-compliant study was approved by the institutional review board. Through semistructured interviews, researchers explored concerns and perspectives of 30 PCPs on receiving and acting on incidental imaging findings. Open-ended questions were designed to elicit a range of responses rather than quantifiable data. Thematic codes were developed and explicitly defined. Three research assistants independently coded all 30 deidentified transcripts and resolved discrepancies (κ = 0.85). Codes pertaining to PCP and patient characteristics were organized into an explanatory model. Results Some PCPs felt compelled but frustrated to pursue costly follow-up for incidental imaging findings of limited clinical importance. Other PCPs did not act on findings that were unfamiliar or occurred in an unusual clinical context when follow-up recommendations were not given; the challenges of researching the clinical importance of these findings or seeking specialist consultation led to inaction. Some PCPs reported using a uniform approach to communicate and manage incidental findings, while others adapted their approach to the patient and the finding. Sometimes PCP characteristics such as follow-up style superseded patient characteristics. At other times patient characteristics such as health literacy superseded PCP characteristics. Conclusion PCPs cited a variety of objective and subjective factors that influence how they communicate and manage incidental imaging findings. These results suggest that some patients may receive inappropriate follow-up of incidental imaging findings and present an opportunity for radiologists to help PCPs and patients to best use the information conveyed in imaging reports. © RSNA, 2016 Online supplemental material is available for this article. PMID:27192458

Rib fractures after percutaneous radiofrequency and microwave ablation of lung tumors: incidence and relevance.

PubMed

Alexander, Erica S; Hankins, Carol A; Machan, Jason T; Healey, Terrance T; Dupuy, Damian E

2013-03-01

To retrospectively identify the incidence and probable risk factors for rib fractures after percutaneous radiofrequency ablation (RFA) and microwave ablation (MWA) of neoplasms in the lung and to identify complications related to these fractures. Institutional review board approval was obtained for this HIPAA-compliant retrospective study. Study population was 163 patients treated with MWA and/or RFA for 195 lung neoplasms between February 2004 and April 2010. Follow-up computed tomographic images of at least 3 months were retrospectively reviewed by board-certified radiologists to determine the presence of rib fractures. Generalized estimating equations were performed to assess the effect that patient demographics, tumor characteristics, treatment parameters, and ablation zone characteristics had on development of rib fractures. Kaplan-Meier curve was used to estimate patients' probability of rib fracture after ablation as a function of time. Clinical parameters (ie, pain in ribs or chest, organ damage caused by fractured rib) were evaluated for patients with confirmed fracture. Rib fractures in proximity to the ablation zone were found in 13.5% (22 of 163) of patients. Estimated probability of fracture was 9% at 1 year and 22% at 3 years. Women were more likely than were men to develop fracture after ablation (P = .041). Patients with tumors closer to the chest wall were more likely to develop fracture (P = .0009), as were patients with ablation zones that involved visceral pleura (P = .039). No patients with rib fractures that were apparently induced by RFA and MWA had organ injury or damage related to fracture, and 9.1% (2 of 22) of patients reported mild pain. Rib fractures were present in 13.5% of patients after percutaneous RFA and MWA of lung neoplasms. Patients who had ablations performed close to the chest wall should be monitored for rib fractures.

CT colonography: influence of 3D viewing and polyp candidate features on interpretation with computer-aided detection.

PubMed

Shi, Rong; Schraedley-Desmond, Pamela; Napel, Sandy; Olcott, Eric W; Jeffrey, R Brooke; Yee, Judy; Zalis, Michael E; Margolis, Daniel; Paik, David S; Sherbondy, Anthony J; Sundaram, Padmavathi; Beaulieu, Christopher F

2006-06-01

To retrospectively determine if three-dimensional (3D) viewing improves radiologists' accuracy in classifying true-positive (TP) and false-positive (FP) polyp candidates identified with computer-aided detection (CAD) and to determine candidate polyp features that are associated with classification accuracy, with known polyps serving as the reference standard. Institutional review board approval and informed consent were obtained; this study was HIPAA compliant. Forty-seven computed tomographic (CT) colonography data sets were obtained in 26 men and 10 women (age range, 42-76 years). Four radiologists classified 705 polyp candidates (53 TP candidates, 652 FP candidates) identified with CAD; initially, only two-dimensional images were used, but these were later supplemented with 3D rendering. Another radiologist unblinded to colonoscopy findings characterized the features of each candidate, assessed colon distention and preparation, and defined the true nature of FP candidates. Receiver operating characteristic curves were used to compare readers' performance, and repeated-measures analysis of variance was used to test features that affect interpretation. Use of 3D viewing improved classification accuracy for three readers and increased the area under the receiver operating characteristic curve to 0.96-0.97 (P<.001). For TP candidates, maximum polyp width (P=.038), polyp height (P=.019), and preparation (P=.004) significantly affected accuracy. For FP candidates, colonic segment (P=.007), attenuation (P<.001), surface smoothness (P<.001), distention (P=.034), preparation (P<.001), and true nature of candidate lesions (P<.001) significantly affected accuracy. Use of 3D viewing increases reader accuracy in the classification of polyp candidates identified with CAD. Polyp size and examination quality are significantly associated with accuracy. Copyright (c) RSNA, 2006.

Development of a Searchable Database of Cryoablation Simulations for Use in Treatment Planning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boas, F. Edward, E-mail: boasf@mskcc.org; Srimathveeravalli, Govindarajan, E-mail: srimaths@mskcc.org; Durack, Jeremy C., E-mail: durackj@mskcc.org

PurposeTo create and validate a planning tool for multiple-probe cryoablation, using simulations of ice ball size and shape for various ablation probe configurations, ablation times, and types of tissue ablated.Materials and MethodsIce ball size and shape was simulated using the Pennes bioheat equation. Five thousand six hundred and seventy different cryoablation procedures were simulated, using 1–6 cryoablation probes and 1–2 cm spacing between probes. The resulting ice ball was measured along three perpendicular axes and recorded in a database. Simulated ice ball sizes were compared to gel experiments (26 measurements) and clinical cryoablation cases (42 measurements). The clinical cryoablation measurements weremore » obtained from a HIPAA-compliant retrospective review of kidney and liver cryoablation procedures between January 2015 and February 2016. Finally, we created a web-based cryoablation planning tool, which uses the cryoablation simulation database to look up the probe spacing and ablation time that produces the desired ice ball shape and dimensions.ResultsAverage absolute error between the simulated and experimentally measured ice balls was 1 mm in gel experiments and 4 mm in clinical cryoablation cases. The simulations accurately predicted the degree of synergy in multiple-probe ablations. The cryoablation simulation database covers a wide range of ice ball sizes and shapes up to 9.8 cm.ConclusionCryoablation simulations accurately predict the ice ball size in multiple-probe ablations. The cryoablation database can be used to plan ablation procedures: given the desired ice ball size and shape, it will find the number and type of probes, probe configuration and spacing, and ablation time required.« less

Hepatic sarcoidosis in patients presenting with liver dysfunction: imaging appearance, pathological correlation and disease evolution.

PubMed

Fetzer, David T; Rees, Mitchell A; Dasyam, Anil K; Tublin, Mitchell E

2016-09-01

We hypothesize that hepatic sarcoidosis is a dynamic process that can lead to cirrhosis and portal hypertension, independent of the course of thoracic disease. Therefore, we assess the imaging appearance and progression of hepatic sarcoidosis in subjects presenting with hepatic dysfunction. An IRB-approved, HIPAA-compliant, single-institution retrospective review identified 39 subjects with sarcoidosis-related liver dysfunction. Clinical information was collected. Two abdominal radiologists analyzed baseline and follow-up imaging studies, scoring features of cirrhosis. Chest CT was also analyzed. At presentation, 23 subjects (59.0 %) exhibited >3 cirrhotic features and 15 (38.5 %) >2 findings of portal hypertension. Of subjects with available follow-up, 57.9 % (19 subjects; mean interval 4.7 years) showed worsening of >3 cirrhotic features (Pearson rho = 0.58; p = 0.009). Parenchymal nodules were uncommon (25.6 %), and most regressed. Although 87.2 % of subjects were diagnosed with thoracic sarcoidosis, there was poor correlation between severity of hepatic and chest disease (Pearson rho = 0.30; p = 0.119). A mean of 7.2 years elapsed between diagnosis of pulmonary and liver involvement. Sarcoidosis may present as liver dysfunction, cirrhosis or portal hypertension. Sarcoid-related liver disease may progress and can manifest without, alongside or significantly after a diagnosis of pulmonary disease. • Patients often present with elevated liver function tests indicating cholestasis. • Patients may present with portal hypertension, and some progress to cirrhosis. • Though biopsy can be considered for focal liver lesions, most will regress. • Extent of intra-abdominal involvement may not correlate with severity of thoracic disease. • Liver disease may manifest alongside, prior to or significantly after initial diagnosis.

Idiopathic Pulmonary Fibrosis: Data-driven Textural Analysis of Extent of Fibrosis at Baseline and 15-Month Follow-up.

PubMed

Humphries, Stephen M; Yagihashi, Kunihiro; Huckleberry, Jason; Rho, Byung-Hak; Schroeder, Joyce D; Strand, Matthew; Schwarz, Marvin I; Flaherty, Kevin R; Kazerooni, Ella A; van Beek, Edwin J R; Lynch, David A

2017-10-01

Purpose To evaluate associations between pulmonary function and both quantitative analysis and visual assessment of thin-section computed tomography (CT) images at baseline and at 15-month follow-up in subjects with idiopathic pulmonary fibrosis (IPF). Materials and Methods This retrospective analysis of preexisting anonymized data, collected prospectively between 2007 and 2013 in a HIPAA-compliant study, was exempt from additional institutional review board approval. The extent of lung fibrosis at baseline inspiratory chest CT in 280 subjects enrolled in the IPF Network was evaluated. Visual analysis was performed by using a semiquantitative scoring system. Computer-based quantitative analysis included CT histogram-based measurements and a data-driven textural analysis (DTA). Follow-up CT images in 72 of these subjects were also analyzed. Univariate comparisons were performed by using Spearman rank correlation. Multivariate and longitudinal analyses were performed by using a linear mixed model approach, in which models were compared by using asymptotic χ 2 tests. Results At baseline, all CT-derived measures showed moderate significant correlation (P < .001) with pulmonary function. At follow-up CT, changes in DTA scores showed significant correlation with changes in both forced vital capacity percentage predicted (ρ = -0.41, P < .001) and diffusing capacity for carbon monoxide percentage predicted (ρ = -0.40, P < .001). Asymptotic χ 2 tests showed that inclusion of DTA score significantly improved fit of both baseline and longitudinal linear mixed models in the prediction of pulmonary function (P < .001 for both). Conclusion When compared with semiquantitative visual assessment and CT histogram-based measurements, DTA score provides additional information that can be used to predict diminished function. Automatic quantification of lung fibrosis at CT yields an index of severity that correlates with visual assessment and functional change in subjects with IPF. © RSNA, 2017.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.

PubMed

Gareen, Ilana F; Sicks, JoRean D; Jain, Amanda Adams; Moline, Denise; Coffman-Kadish, Nancy

2013-01-01

In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. Copyright © 2012 Elsevier Inc. All rights reserved.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: The model used by the American College of Radiology arm of the National Lung Screening Trial

PubMed Central

Gareen, Ilana F.; Sicks, JoRean; Adams, Amanda; Moline, Denise; Coffman-Kadish, Nancy

2012-01-01

Background In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. Methods The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Results Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. Conclusions We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. PMID:22982342

Multi-institutional analysis of CT and MRI reports evaluating indeterminate renal masses: comparison to a national survey investigating desired report elements.

PubMed

Hu, Eric M; Zhang, Andrew; Silverman, Stuart G; Pedrosa, Ivan; Wang, Zhen J; Smith, Andrew D; Chandarana, Hersh; Doshi, Ankur; Shinagare, Atul B; Remer, Erick M; Kaffenberger, Samuel D; Miller, David C; Davenport, Matthew S

2018-04-17

To determine the need for a standardized renal mass reporting template by analyzing reports of indeterminate renal masses and comparing their contents to stated preferences of radiologists and urologists. The host IRB waived regulatory oversight for this multi-institutional HIPAA-compliant quality improvement effort. CT and MRI reports created to characterize an indeterminate renal mass were analyzed from 6 community (median: 17 reports/site) and 6 academic (median: 23 reports/site) United States practices. Report contents were compared to a published national survey of stated preferences by academic radiologists and urologists from 9 institutions. Descriptive statistics and Chi-square tests were calculated. Of 319 reports, 85% (271; 192 CT, 79 MRI) reported a possibly malignant mass (236 solid, 35 cystic). Some essential elements were commonly described: size (99% [269/271]), mass type (solid vs. cystic; 99% [268/271]), enhancement (presence vs. absence; 92% [248/271]). Other essential elements had incomplete penetrance: the presence or absence of fat in solid masses (14% [34/236]), size comparisons when available (79% [111/140]), Bosniak classification for cystic masses (54% [19/35]). Preferred but non-essential elements generally were described in less than half of reports. Nephrometry scores usually were not included for local therapy candidates (12% [30/257]). Academic practices were significantly more likely than community practices to include mass characterization details, probability of malignancy, and staging. Community practices were significantly more likely to include management recommendations. Renal mass reporting elements considered essential or preferred often are omitted in radiology reports. Variation exists across radiologists and practice settings. A standardized template may mitigate these inconsistencies.

Indeterminate orbital masses: restricted diffusion at MR imaging with echo-planar diffusion-weighted imaging predicts malignancy.

PubMed

Sepahdari, Ali R; Aakalu, Vinay K; Setabutr, Pete; Shiehmorteza, Masoud; Naheedy, John H; Mafee, Mahmood F

2010-08-01

To determine whether magnetic resonance (MR) imaging with diffusion-weighted (DW) imaging can help discriminate between radiologically indeterminate benign and malignant orbital masses and to identify optimal apparent diffusion coefficient (ADC) thresholds for such discrimination. Informed consent was waived for this HIPAA-compliant institutional review board-approved retrospective study. Forty-seven orbital masses imaged with echo-planar DW imaging were identified in 47 patients (25 female patients, 22 male patients; average age, 35 years). A fellowship-trained orbital surgeon determined reference-standard diagnoses on the basis of chart review, and a neuroradiology fellow and senior neuroradiologist who were blinded to the diagnoses selected a region of interest for each lesion by consensus. ADC was calculated from signal intensity on DW images obtained with b = 1000 and b = 0 sec/mm(2). Lesion ADC was also compared with that of normal-appearing white matter (ADC ratio). The Student t test was used to compare groups. Receiver operating characteristic analysis was performed. Intraobserver agreement was assessed with a repeat data collection. Malignant lesions had lower ADCs than benign lesions, irrespective of patient age (P < .02) and in adults specifically (P < .05). Lymphomas had lower ADCs than pseudotumors (P < .001). An ADC of less than 1.0 x 10(-3) mm(2)/sec and an ADC ratio of less than 1.2 were optimal for predicting malignancy (sensitivity, 63% for both; specificity, 84% and 90%, respectively; and accuracy, 77% and 81%, respectively). Lymphoma was differentiated from pseudotumor with 100% accuracy (in 16 of 16 cases) by using these values. Infiltrative lesions that were hypointense on T2-weighted images were better characterized with DW imaging than lesions that were hyperintense or well defined. Echo-planar DW MR imaging can help characterize indeterminate orbital masses.

Impact of an Information Technology-Enabled Initiative on the Quality of Prostate Multiparametric MRI Reports

PubMed Central

Silveira, Patricia C.; Dunne, Ruth; Sainani, Nisha I.; Lacson, Ronilda; Silverman, Stuart G.; Tempany, Clare M.; Khorasani, Ramin

2015-01-01

Rationale and Objectives Assess the impact of implementing a structured report template and a computer-aided diagnosis (CAD) tool on the quality of prostate multiparametric MRI (mp-MRI) reports. Materials and Methods Institutional Review Board approval was obtained for this HIPAA-compliant study performed at an academic medical center. The study cohort included all prostate mp-MRI reports (n=385) finalized 6 months before and after implementation of a structured report template and a CAD tool (collectively the IT tools) integrated into the PACS workstation. Primary outcome measure was quality of prostate mp-MRI reports. An expert panel of our institution’s subspecialty trained abdominal radiologists defined prostate mp-MRI report quality as optimal, satisfactory or unsatisfactory based on documentation of 9 variables. Reports were reviewed to extract the predefined quality variables and determine whether the IT tools were used to create each report. Chi-square and Student’s t-tests were used to compare report quality before and after implementation of IT tools. Results The overall proportion of optimal or satisfactory reports increased from 29.8% (47/158) to 53.3% (121/227) (p<0.001) after implementing the IT tools. While the proportion of optimal or satisfactory reports increased among reports generated using at least one of the IT tools (47/158=[29.8%] vs. 105/161=[65.2%]; p<0.001), there was no change in quality among reports generated without use of the IT tools (47/158=[29.8%] vs. 16/66=[24.2%]; p=0.404). Conclusion The use of a structured template and CAD tool improved the quality of prostate mp-MRI reports compared to free-text report format and subjective measurement of contrast enhancement kinetic curve. PMID:25863794

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

MRI assessment of the thigh musculature in dermatomyositis and healthy subjects using diffusion tensor imaging, intravoxel incoherent motion and dynamic DTI.

PubMed

Sigmund, E E; Baete, S H; Luo, T; Patel, K; Wang, D; Rossi, I; Duarte, A; Bruno, M; Mossa, D; Femia, A; Ramachandran, S; Stoffel, D; Babb, J S; Franks, A; Bencardino, J

2018-06-04

Dermatomyositis (DM) is an idiopathic inflammatory myopathy involving severe debilitation in need of diagnostics. We evaluated the proximal lower extremity musculature with diffusion tensor imaging (DTI), intravoxel incoherent motion (IVIM) and dynamic DTI in DM patients and controls and compared with standard clinical workup.  METHODS: In this IRB-approved, HIPAA-compliant study with written informed consent, anatomical, Dixon fat/water and diffusion imaging were collected in bilateral thigh MRI of 22 controls and 27 DM patients in a 3T scanner. Compartments were scored on T1/T2 scales. Single voxel dynamic DTI metrics in quadriceps before and after 3-min leg exercise were measured. Spearman rank correlation and mixed model analysis of variance/covariance (ANOVA/ANCOVA) were used to correlate with T1 and T2 scores and to compare patients with controls. DM patients showed significantly lower pseudo-diffusion and volume in quadriceps than controls. All subjects showed significant correlation between T1 score and signal-weighted fat fraction; tissue diffusion and pseudo-diffusion varied significantly with T1 and T2 score in patients. Radial and mean diffusion exercise response in patients was significantly higher than controls. Static and dynamic diffusion imaging metrics show correlation with conventional imaging scores, reveal spatial heterogeneity, and provide means to differentiate dermatomyositis patients from controls. • Diffusion imaging shows regional differences between thigh muscles of dermatomyositis patients and controls. • Signal-weighted fat fraction and diffusion metrics correlate with T1/T2 scores of disease severity. • Dermatomyositis patients show significantly higher radial diffusion exercise response than controls.

Deep learning in breast cancer risk assessment: evaluation of fine-tuned convolutional neural networks on a clinical dataset of FFDMs

NASA Astrophysics Data System (ADS)

Li, Hui; Mendel, Kayla R.; Lee, John H.; Lan, Li; Giger, Maryellen L.

2018-02-01

We evaluated the potential of deep learning in the assessment of breast cancer risk using convolutional neural networks (CNNs) fine-tuned on full-field digital mammographic (FFDM) images. This study included 456 clinical FFDM cases from two high-risk datasets: BRCA1/2 gene-mutation carriers (53 cases) and unilateral cancer patients (75 cases), and a low-risk dataset as the control group (328 cases). All FFDM images (12-bit quantization and 100 micron pixel) were acquired with a GE Senographe 2000D system and were retrospectively collected under an IRB-approved, HIPAA-compliant protocol. Regions of interest of 256x256 pixels were selected from the central breast region behind the nipple in the craniocaudal projection. VGG19 pre-trained on the ImageNet dataset was used to classify the images either as high-risk or as low-risk subjects. The last fully-connected layer of pre-trained VGG19 was fine-tuned on FFDM images for breast cancer risk assessment. Performance was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC) in the task of distinguishing between high-risk and low-risk subjects. AUC values of 0.84 (SE=0.05) and 0.72 (SE=0.06) were obtained in the task of distinguishing between the BRCA1/2 gene-mutation carriers and low-risk women and between unilateral cancer patients and low-risk women, respectively. Deep learning with CNNs appears to be able to extract parenchymal characteristics directly from FFDMs which are relevant to the task of distinguishing between cancer risk populations, and therefore has potential to aid clinicians in assessing mammographic parenchymal patterns for cancer risk assessment.

Holistic component of image perception in mammogram interpretation: gaze-tracking study.

PubMed

Kundel, Harold L; Nodine, Calvin F; Conant, Emily F; Weinstein, Susan P

2007-02-01

To test the hypothesis that rapid and accurate performance of the proficient observer in mammogram interpretation involves a shift in the mechanism of image perception from a relatively slow search-to-find mode to a relatively fast holistic mode. This HIPAA-compliant study had institutional review board approval, and participant informed consent was obtained; patient informed consent was not required. The eye positions of three full-time mammographers, one attending radiologist, two mammography fellows, and three radiology residents were recorded during the interpretation of 20 normal and 20 subtly abnormal mammograms. The search time required to first locate a cancer, as well as the initial eye scan path, was determined and compared with diagnostic performance as measured with receiver operating characteristic (ROC) analysis. The median time for all observers to fixate a cancer, regardless of the decision outcome, was 1.13 seconds, with a range of 0.68 second to 3.06 seconds. Even though most of the lesions were fixated, recognition of them as cancerous ranged from 85% (17 of 20) to 10% (two of 20), with corresponding areas under the ROC curve of 0.87-0.40. The ROC index of detectability, d(a), was linearly related to the time to first fixate a cancer with a correlation (r(2)) of 0.81. The rapid initial fixation of a true abnormality is evidence for a global perceptual process capable of analyzing the visual input of the entire retinal image and pinpointing the spatial location of an abnormality. It appears to be more highly developed in the most proficient observers, replacing the less efficient initial search-to-find strategies. (c) RSNA, 2007.

"Chasing a Ghost": Factors that Influence Primary Care Physicians to Follow Up on Incidental Imaging Findings.

PubMed

Zafar, Hanna M; Bugos, Eva K; Langlotz, Curtis P; Frasso, Rosemary

2016-11-01

Purpose To explore provider and patient characteristics that influence how primary care providers (PCPs) communicate and manage incidental imaging findings. Materials and Methods This HIPAA-compliant study was approved by the institutional review board. Through semistructured interviews, researchers explored concerns and perspectives of 30 PCPs on receiving and acting on incidental imaging findings. Open-ended questions were designed to elicit a range of responses rather than quantifiable data. Thematic codes were developed and explicitly defined. Three research assistants independently coded all 30 deidentified transcripts and resolved discrepancies (κ = 0.85). Codes pertaining to PCP and patient characteristics were organized into an explanatory model. Results Some PCPs felt compelled but frustrated to pursue costly follow-up for incidental imaging findings of limited clinical importance. Other PCPs did not act on findings that were unfamiliar or occurred in an unusual clinical context when follow-up recommendations were not given; the challenges of researching the clinical importance of these findings or seeking specialist consultation led to inaction. Some PCPs reported using a uniform approach to communicate and manage incidental findings, while others adapted their approach to the patient and the finding. Sometimes PCP characteristics such as follow-up style superseded patient characteristics. At other times patient characteristics such as health literacy superseded PCP characteristics. Conclusion PCPs cited a variety of objective and subjective factors that influence how they communicate and manage incidental imaging findings. These results suggest that some patients may receive inappropriate follow-up of incidental imaging findings and present an opportunity for radiologists to help PCPs and patients to best use the information conveyed in imaging reports. © RSNA, 2016 Online supplemental material is available for this article.

Patient characteristics associated with venous thromboembolic events: a cohort study using pooled electronic health record data

PubMed Central

Foster, Wendy; Gilder, Jason; Love, Thomas E; Jain, Anil K

2012-01-01

Objective To demonstrate the potential of de-identified clinical data from multiple healthcare systems using different electronic health records (EHR) to be efficiently used for very large retrospective cohort studies. Materials and methods Data of 959 030 patients, pooled from multiple different healthcare systems with distinct EHR, were obtained. Data were standardized and normalized using common ontologies, searchable through a HIPAA-compliant, patient de-identified web application (Explore; Explorys Inc). Patients were 26 years or older seen in multiple healthcare systems from 1999 to 2011 with data from EHR. Results Comparing obese, tall subjects with normal body mass index, short subjects, the venous thromboembolic events (VTE) OR was 1.83 (95% CI 1.76 to 1.91) for women and 1.21 (1.10 to 1.32) for men. Weight had more effect then height on VTE. Compared with Caucasian, Hispanic/Latino subjects had a much lower risk of VTE (female OR 0.47, 0.41 to 0.55; male OR 0.24, 0.20 to 0.28) and African-Americans a substantially higher risk (female OR 1.83, 1.76 to 1.91; male OR 1.58, 1.50 to 1.66). This 13-year retrospective study of almost one million patients was performed over approximately 125 h in 11 weeks, part time by the five authors. Discussion As research informatics tools develop and more clinical data become available in EHR, it is important to study and understand unique opportunities for clinical research informatics to transform the scale and resources needed to perform certain types of clinical research. Conclusions With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources. PMID:22759621

Microwave Ablation of Lung Tumors Near the Heart: A Retrospective Review of Short-Term Procedural Safety in Ten Patients.

PubMed

Maxwell, Aaron W P; Healey, Terrance T; Dupuy, Damian E

2017-09-01

To evaluate the rate of short-term complications associated with microwave ablation of lung tumors located near the heart. This HIPAA-compliant study was performed with a waiver for informed consent. Patients who underwent microwave ablation of lung tumors located 10 mm or less from the heart were identified by retrospective chart review. Both primary and metastatic tumors were included. Only tumors directly adjacent to one of the four cardiac chambers were included. All patients were treated in a single session using CT guidance with continuous electrocardiographic monitoring. Rates of new-onset arrhythmia and myocardial infarction (MI) within 90 days of the procedure were quantified, and evidence of cardiac or pericardiac injury was assessed for using post-ablation contrast-enhanced chest CT, electrocardiography (EKG), and-when available-echocardiography. Complications were graded using the Common Terminology Criteria for Adverse Events (CTCAE) system. Ten patients (four males, six females; mean age 73.1 ± 9.5 years) met all inclusion criteria. Mean tumor distance from the heart was 3 mm (range, 0-6 mm). New-onset arrhythmia was not observed during or following any of the microwave ablation treatments, and there were no documented 90-day MI events. CTCAE Grade 1 complications were observed by CT in eight patients, most commonly mild focal pericardial thickening. EKG and echocardiography were normal in all patients. No major complications (CTCAE Grade 3 or greater) were observed. Microwave ablation of lung tumors located 10 mm or less from the heart appears to have low associated short-term morbidity and may be appropriate in selected patients.

Treatment of gonorrhoea in Auckland, New Zealand: marked variation in prescriber adherence to treatment guidelines.

PubMed

Forster, Rose; Ng, Diana; Upton, Arlo; Franklin, Rick; Thomas, Mark

2017-06-01

The relentless emergence and spread of strains of Neisseria gonorrhoeae that are resistant to many antimicrobial agents has led to frequent changes in treatment guidelines, with a consequent risk that prescribers may not be aware of current guidelines. To determine the proportion of patients with gonorrhoea who were treated with a regimen consistent with the New Zealand Sexual Health Society (NZSHS) guidelines. We audited the treatment given to adult patients with laboratory-proven gonorrhoea in Auckland, New Zealand, during the first 6 months of 2015. Treatment compliant with the current NZSHS guidelines was administered in only 65% (458/706) episodes overall. Guideline-compliant treatment was much more likely to be prescribed for patients who presented to a sexual health clinic (89%) than for patients who presented to either a general practice or other community clinic (52%) or to a hospital (56%) (P < 0.0001). Overall, 52 of 706 (7%) episodes were not treated with any antimicrobial regimen by the service that diagnosed the patients' gonorrhoea, 13 of 62 (21%) episodes in patients who presented to a hospital, 34 of 403 (8%) episodes in patients who presented to a general practice or other community clinic and 5 of 241 (2%) episodes in patients who presented to a sexual health clinic (P < 0.0001). Low levels of compliance with treatment guidelines increase the risk that antibiotic-resistant strains of N. gonorrhoeae will spread within the Auckland region. Improved compliance with treatment guidelines, particularly in patients who present either to general practice or to hospitals, is necessary to maintain the efficacy of current treatment regimens. © 2017 Royal Australasian College of Physicians.

Facts about Hospital Worker Safety

MedlinePlus

... Transferred FTE full-time employee (or full-time equivalent) HIPAA Health Insurance Portability and Accountability Act MSD ... injury and illness rates per 100 full-time equivalent employees (FTEs)—also known as the Total Case ...

HIPAA compliance and patient privacy protection.

PubMed

Grandison, Tyrone; Bhatti, Rafae

2010-01-01

Recent prosecution of violations of the Health Insurance Portability and Accountability Act (HIPAA), and the amendments currently in process to strengthen the Act of 1996, has led many companies to take serious notice of the measures they must take to be a compliance. A company's privacy policy states the business' privacy practices and embodies the firm's commitments to its users and is normally mandatory step in reaching legislative compliance. in the face of this, the patient has to decipher if the company's privacy practices are congruent with their thoughts on the level of privacy protection they should be receiving. This is the core of our investigation. In this paper, we explore the question "Is a healthcare entity's compliance with regulation sufficient to provide the patient with adequate privacy protection?" in the context of the United States of America.

Prescription opioid forgery: reporting to law enforcement and protection of medical information.

PubMed

Singh, Naileshni; Fishman, Scott; Rich, Ben; Orlowski, Anna

2013-06-01

To review confidentiality requirements of prescribers who become aware of a forged prescription. A case is reviewed in which a prescriber believes that a prescription has been forged. The literature and law related to prescription forgery and confidentiality are reviewed. Although prescription forgery is a crime, the prescriber's responsibility for reporting to law enforcement is not clear under current state and federal law. Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), do not permit prescribers in all circumstances to disclose prescription fraud to law enforcement. Under common circumstances, HIPAA may prohibit prescribers from reporting prescription forgery to law enforcement. However, collaborating with a dispensing pharmacist may offer a lawful pathway to reporting prescription forgery. State legislature may consider laws that clarify the reporting responsibilities of prescribers in cases of prescription forgery. Wiley Periodicals, Inc.

Discharge planning for acute coronary syndrome patients in a tertiary hospital: a best practice implementation project.

PubMed

Lu, Minmin; Tang, Jun; Wu, Jianjin; Yang, Jie; Yu, Jiangyue

2015-08-14

Acute coronary syndromes threaten the lives of patients, and pose a high risk for morbidity and mortality despite advances in treatment. Evidence highlights that effective discharge planning is associated with long-term prognosis of patients. The aim of this project was to improve local practice in discharge planning for acute coronary syndrome patients in Huadong Hospital, Shanghai. Five criteria identified by the Joanna Briggs Institute were used to conduct an audit in the Cardiovascular Ward and Coronary Care Unit of Huadong Hospital, Shanghai. Forty-two nurses and 65 patients were involved. The Joanna Briggs Institute Practical Application of Clinical Evidence System and Getting Research into Practice audit tools for promoting change in health practice were used to ascertain compliance with the criteria before and after the implementation of best practice. The program included three phases and was conducted over five months. The project showed that the compliance rates of in-house education, advice on lifestyle changes, education on discharge medication and left ventricular assessment reached 100%. Psychological screening also attained 97% compliance. There were improvements in the compliance rates of four criteria from 38% to 100%, excluding in-house education which was already 100% compliant. The project achieved significant improvements in establishing evidence-based practice of discharge planning for acute coronary syndrome patients in the Cardiovascular Ward and Coronary Care Unit. Strategies for sustaining best practice will continue to be developed in the future. The Joanna Briggs Institute.

45 CFR 150.205 - Sources of information triggering an investigation of State enforcement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... complaint received by CMS. (b) Information learned during informal contact between CMS and State officials... the various States regarding the status of their enforcement of HIPAA requirements. (e) Information...

45 CFR 150.317 - Factors CMS uses to determine the amount of penalty.

Code of Federal Regulations, 2011 CFR

2011-10-01

... before determination of the current violation or violations, CMS or any State found the responsible entity liable for civil or administrative sanctions in connection with a violation of HIPAA requirements...

Protecting the Privacy and Security of Your Health Information

MedlinePlus

... Access to Medical Records Privacy, Security, and HIPAA Laws, Regulation, and Policy Scientific Initiatives Standards & Technology Usability ... care providers and professionals, and the government. Federal laws require many of the key persons and organizations ...

45 CFR 150.205 - Sources of information triggering an investigation of State enforcement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... complaint received by CMS. (b) Information learned during informal contact between CMS and State officials... the various States regarding the status of their enforcement of HIPAA requirements. (e) Information...

Mental Health Concerns: Veterans & Active Duty

MedlinePlus

... recent years to encourage better mental health. The Department of Defense acknowledges that untreated mental health conditions pose a ... your care provider will inform you that the Department of Defense follows the privacy guidelines set down by HIPAA ...

32 CFR 536.39 - Use of experts, consultants and appraisers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... information protected by HIPAA is involved, the source must sign an agreement designed to protect the patient's privacy rights. ... an independent consultant's opinion or an IME. (c) The use of outside consultants and appraisers...

32 CFR 536.39 - Use of experts, consultants and appraisers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... information protected by HIPAA is involved, the source must sign an agreement designed to protect the patient's privacy rights. ... an independent consultant's opinion or an IME. (c) The use of outside consultants and appraisers...

32 CFR 536.39 - Use of experts, consultants and appraisers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... information protected by HIPAA is involved, the source must sign an agreement designed to protect the patient's privacy rights. ... an independent consultant's opinion or an IME. (c) The use of outside consultants and appraisers...

32 CFR 536.39 - Use of experts, consultants and appraisers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... information protected by HIPAA is involved, the source must sign an agreement designed to protect the patient's privacy rights. ... an independent consultant's opinion or an IME. (c) The use of outside consultants and appraisers...

32 CFR 536.39 - Use of experts, consultants and appraisers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... information protected by HIPAA is involved, the source must sign an agreement designed to protect the patient's privacy rights. ... an independent consultant's opinion or an IME. (c) The use of outside consultants and appraisers...

32 CFR 536.28 - Claims acknowledgment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... submission jurisdictionally deficient based on the requirements discussed in DA Pam 27-162, paragraphs 2-5... (HIPAA), 42 U.S.C. 1320d-1320d-8. See the parallel discussion at DA Pam 27-162, paragraph 2-7. ...

Health Insurance Portability and Accountability Act (HIPAA) legislation and its implication on speech privacy design in health care facilities

NASA Astrophysics Data System (ADS)

Tocci, Gregory C.; Storch, Christopher A.

2005-09-01

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (104th Congress, H.R. 3103, January 3, 1986), among many things, individual patient records and information be protected from unnecessary issue. This responsibility is assigned to the U.S. Department of Health and Human Services (HHS) which has issued a Privacy Rule most recently dated August 2002 with a revision being proposed in 2005 to strengthen penalties for inappropriate breaches of patient privacy. Despite this, speech privacy, in many instances in health care facilities need not be guaranteed by the facility. Nevertheless, the regulation implies that due regard be given to speech privacy in both facility design and operation. This presentation will explore the practical aspects of implementing speech privacy in health care facilities and make recommendations for certain specific speech privacy situations.

HIPAA, dermatology images, and the law.

PubMed

Scheinfeld, Noah; Rothstein, Brooke

2013-12-01

From smart phones to iPads, the world has grown increasingly reliant on new technology. In this ever-expanding digital age, medicine is at the forefront of these new technologies. In the field of dermatology and general medicine, digital images have become an important tool used in patient management. Today, one can even find physicians who use their cellular phone cameras to take patient images and transmit them to other physicians. However, as digital imaging technology has become more prevalent so too have concerns about the impact of this technology on the electronic medical record, quality of patient care, and medicolegal issues. This article will discuss the advent of digital imaging technology in dermatology and the legal ramifications digital images have on medical care, abiding by HIPAA, the use of digital images as evidence, and the possible abuses digital images can pose in a health care setting.

Taiwan's perspective on electronic medical records' security and privacy protection: lessons learned from HIPAA.

PubMed

Yang, Che-Ming; Lin, Herng-Ching; Chang, Polun; Jian, Wen-Shan

2006-06-01

The protection of patients' health information is a very important concern in the information age. The purpose of this study is to ascertain what constitutes an effective legal framework in protecting both the security and privacy of health information, especially electronic medical records. All sorts of bills regarding electronic medical data protection have been proposed around the world including Health Insurance Portability and Accountability Act (HIPAA) of the U.S. The trend of a centralized bill that focuses on managing computerized health information is the part that needs our further attention. Under the sponsor of Taiwan's Department of Health (DOH), our expert panel drafted the "Medical Information Security and Privacy Protection Guidelines", which identifies nine principles and entails 12 articles, in the hope that medical organizations will have an effective reference in how to manage their medical information in a confidential and secured fashion especially in electronic transactions.

Design of 3D-Printed Titanium Compliant Mechanisms

NASA Technical Reports Server (NTRS)

Merriam, Ezekiel G.; Jones, Jonathan E.; Howell, Larry L.

2014-01-01

This paper describes 3D-printed titanium compliant mechanisms for aerospace applications. It is meant as a primer to help engineers design compliant, multi-axis, printed parts that exhibit high performance. Topics covered include brief introductions to both compliant mechanism design and 3D printing in titanium, material and geometry considerations for 3D printing, modeling techniques, and case studies of both successful and unsuccessful part geometries. Key findings include recommended flexure geometries, minimum thicknesses, and general design guidelines for compliant printed parts that may not be obvious to the first time designer.

RBAC-Matrix-based EMR right management system to improve HIPAA compliance.

PubMed

Lee, Hung-Chang; Chang, Shih-Hsin

2012-10-01

Security control of Electronic Medical Record (EMR) is a mechanism used to manage electronic medical records files and protect sensitive medical records document from information leakage. Researches proposed the Role-Based Access Control(RBAC). However, with the increasing scale of medical institutions, the access control behavior is difficult to have a detailed declaration among roles in RBAC. Furthermore, with the stringent specifications such as the U.S. HIPAA and Canada PIPEDA etc., patients are encouraged to have the right in regulating the access control of his EMR. In response to these problems, we propose an EMR digital rights management system, which is a RBAC-based extension to a matrix organization of medical institutions, known as RBAC-Matrix. With the aim of authorizing the EMR among roles in the organization, RBAC-Matrix also allow patients to be involved in defining access rights of his records. RBAC-Matrix authorizes access control declaration among matrix organizations of medical institutions by using XrML file in association with each EMR. It processes XrML rights declaration file-based authorization of behavior in the two-stage design, called master & servant stage, thus makes the associated EMR to be better protected. RBAC-Matrix will also make medical record file and its associated XrML declaration to two different EMRA(EMR Authorization)roles, namely, the medical records Document Creator (DC) and the medical records Document Right Setting (DRS). Access right setting, determined by the DRS, is cosigned by the patient, thus make the declaration of rights and the use of EMR to comply with HIPAA specifications.

Audit Report on "The Department's Management of the ENERGY STAR Program"

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2009-10-01

The American Recovery and Reinvestment Act (Recovery Act) authorized about $300 million in consumer rebate incentives for purchases of products rated under the 'ENERGY STAR' Program. ENERGY STAR, a voluntary labeling program established in 1992, provides consumers with energy efficiency data for a range of products so that they can make informed purchase judgments. The overall goal of the program is to encourage consumers to choose energy efficient products, advancing the nationwide goal of reducing energy consumption. The U.S. Environmental Protection Agency (EPA) managed the ENERGY STAR Program on a stand-alone basis until 1996 when it joined forces with themore » Department of Energy (Department). A Memorandum of Cooperation expanded the ENERGY STAR product categories, giving the Department responsibility for overseeing eight product categories such as windows, dishwashers, clothes washers, and refrigerators, while EPA retained responsibility for electronic product categories and heating, ventilating, and cooling equipment. Each agency is responsible for setting product efficiency specifications for those items under its control and for ensuring the proper use of the ENERGY STAR label in the marketplace. In August 2007, the EPA Office of Inspector General issued an audit report identifying significant control weaknesses in EPA's management of ENERGY STAR. The Department, concerned by the findings at EPA and eager to improve its own program, developed an approach to verify adherence to product specifications, ensure proper use of the ENERGY STAR label in the marketplace, and improve the establishment of product specifications. As evidenced by the commitment of $300 million in Recovery Act funds, the ENERGY STAR Program plays an important role in the U.S. efforts to reduce energy consumption. We initiated this audit to determine whether the Department had implemented the actions it announced in 2007 to strengthen the Program. The Department had not implemented planned improvements in the ENERGY STAR Program. Our audit revealed that officials had not: (1) Developed a formal quality assurance program to help ensure that product specifications were adhered to; (2) Effectively monitored the use of the ENERGY STAR label to ensure that only qualifying products were labeled as compliant; and (3) Formalized procedures for establishing and revising product specifications and for documenting decisions regarding those specifications. In our judgment, the delay in the Department's planned improvements in its management of the ENERGY STAR Program could reduce consumer confidence in the integrity of the ENERGY STAR label. Such loss of credibility could reduce energy savings, increase consumer risk, and diminish the value of the recent infusion of $300 million for ENERGY STAR rebates under the Recovery Act.« less

Using Changes in Binding Globulins to Assess Oral Contraceptive Compliance

PubMed Central

Westhoff, Carolyn; Petrie, K.A.; Cremers, S.

2012-01-01

Background Validity of oral contraceptive pill (OCP) clinical trial results depends on participant compliance. Ethinyl estradiol (EE2) induces increases in hepatic binding globulin (BG) levels. Measuring these BG increases may provide an effective and convenient approach to distinguishing non-compliant from compliant OCP users in research settings. This analysis evaluated the usefulness of measuring increases in corticosteroid, sex hormone and thyroxine binding globulins (CBG, SHBG, TBG) as measures of OCP compliance. Methods We used frozen serum from a trial that compared ovarian suppression between normal weight and obese women randomized to one of two OCPs containing EE2 and levonorgestrel (LNG). Based on serial LNG measurements during the trial, 17% of participants were non-compliant. We matched non-compliant participants with compliant participants by age, BMI, ethnicity and OCP formulation. We measured CBG, SHBG and TBG levels, and compared change from baseline to 3-month follow-up between the non-compliant and compliant participants. Construction of receiver operator characteristic (ROC) curves allowed comparison of various BG measures. Results Changes in CBG and TBG distinguished OCP non-compliant users from compliant users (area under the ROC curve (AUROC), 0.86 and 0.89, p < 0.01). Changes in SHBG were less discriminating (AUROC 0.69) Conclusions EE2 induced increases in CBG and TBG provide a sensitive integrated marker of compliance with an LNG-containing OCP. PMID:22795088

Digital Imagery Compression Best Practices Guide - A Motion Imagery Standards Profile (MISP) Compliant Architecture

DTIC Science & Technology

2012-06-01

MISP) COMPLIANT ARCHITECTURE WHITE SANDS MISSILE RANGE REAGAN TEST SITE YUMA PROVING GROUND DUGWAY PROVING GROUND ABERDEEN TEST CENTER...DIGITAL MOTION IMAGERY COMPRESSION BEST PRACTICES GUIDE – A MOTION IMAGERY STANDARDS PROFILE (MISP) COMPLIANT ARCHITECTURE ...delivery, and archival purposes. These practices are based on a Motion Imagery Standards Profile (MISP) compliant architecture , which has been defined

The effect of compliance to a Rigo System Cheneau brace and a specific exercise programme on idiopathic scoliosis curvature: a comparative study: SOSORT 2014 award winner

PubMed Central

2014-01-01

Background There is controversy as to whether conservative management that includes wearing a brace and exercises is effective in stabilising idiopathic scoliosis curves. A brace only prevents progression of the curve and has been shown to have favourable outcomes when patients are compliant. So the aim of this study was to: determine the effect of compliance to the Rigo System Cheneau (RSC) brace and a specific exercise programme on Idiopathic Scoliosis curvature; and to compare the Quality of Life (QoL) and psychological traits of compliant and non compliant subjects. Methods A pre/post test study design was used with a post study comparison between subjects who complied with the management and those who did not. Fifty one subjects, girls aged 12-16 years, Cobb angles 20-50 degrees participated in the study. Subjects were divided into two groups, according to their compliance, at the end of the study. The compliant group wore the brace 20 or more hours a day and exercised three or more times per week. The non-compliant group wore the brace less than 20 hours a day and exercised less than three times per week. Cobb angles, vertebral rotation, scoliometer readings, peak flow, quality of life and personality traits were compared between groups, using the student’s two sample t-test and an analysis of covariance. Results The compliant group, wore the brace 21.5 hours per day and exercised four times a week, and significantly improved in all measures compared to non compliant subjects, who wore the brace 12 hours per day, exercised 1.7 times a week and significantly deteriorated (p < 0.0001). The major Cobb angles in the compliant group improved 10.19°(±5.5) and deteriorated 5.52°(±4.3) in the non compliant group (p < 0.0001). Compliant subjects had a significantly better QoL than the non compliant subjects (p = 0.001). The compliant group were significantly more emotionally mature, stable and realistic than the non compliant group (p = 0.03). Conclusions Good compliance of the RSC brace and a specific exercise regime resulted in a significant improvement in curvatures, poor compliance resulted in progression/deterioration. A poorer QoL in the non compliant group possibly was caused by personality traits of the group, being more emotionally immature and unstable. PMID:24926318

Does the HIPAA Privacy Rule Allow Parents the Right to See Their Children's Medical Records?

MedlinePlus

... 2) Covered Entities (14) Decedents (8) Disclosures for Law Enforcement Purposes (7) Disclosures for Rule Enforcement (2) Disclosures in Emergency Situations (2) Disclosures Required by Law (6) Disclosures to Family and Friends (28) Disposal ...

Patient privacy and social media.

PubMed

Hader, Amy L; Brown, Evan D

2010-08-01

Healthcare providers using social media must remain mindful of professional boundaries and patients' privacy rights. Facebook and other online postings must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), applicable facility policy, state law, and AANA's Code of Ethics.

32 CFR 701.122 - Medical records.

Code of Federal Regulations, 2011 CFR

2011-07-01

... THE NAVY DOCUMENTS AFFECTING THE PUBLIC DON Privacy Program § 701.122 Medical records. (a) Health Information Portability and Accountability Act (HIPAA). (1) DOD Directive 6025.18 establishes policies and assigns responsibilities for implementation of the standards for privacy of individually identifiable...

32 CFR 701.122 - Medical records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... THE NAVY DOCUMENTS AFFECTING THE PUBLIC DON Privacy Program § 701.122 Medical records. (a) Health Information Portability and Accountability Act (HIPAA). (1) DOD Directive 6025.18 establishes policies and assigns responsibilities for implementation of the standards for privacy of individually identifiable...

Compliant walking appears metabolically advantageous at extreme step lengths.

PubMed

Kim, Jaehoon; Bertram, John E A

2018-05-19

Humans alter gait in response to unusual gait circumstances to accomplish the task of walking. For instance, subjects spontaneously increase leg compliance at a step length threshold as step length increases. Here we test the hypothesis that this transition occurs based on the level of energy expenditure, where compliant walking becomes less energetically demanding at long step lengths. To map and compare the metabolic cost of normal and compliant walking as step length increases. 10 healthy individuals walked on a treadmill using progressively increasing step lengths (100%, 120%, 140% and 160% of preferred step length), in both normal and compliant leg walking as energy expenditure was recorded via indirect calorimetry. Leg compliance was controlled by lowering the center-of-mass trajectory during stance, forcing the leg to flex and extend as the body moved over the foot contact. For normal step lengths, compliant leg walking was more costly than normal walking gait, but compliant leg walking energetic cost did not increase as rapidly for longer step lengths. This led to an intersection between normal and compliant walking cost curves at 114% relative step length (regression analysis; r 2  = 0.92 for normal walking; r 2  = 0.65 for compliant walking). Compliant leg walking is less energetically demanding at longer step lengths where a spontaneous shift to compliant walking has been observed, suggesting the human motor control system is sensitive to energetic requirements and will employ alternate movement patterns if advantageous strategies are available. The transition could be attributed to the interplay between (i) leg work controlling body travel during single stance and (ii) leg work to control energy loss in the step-to-step transition. Compliant leg walking requires more stance leg work at normal step lengths, but involves less energy loss at the step-to-step transition for very long steps. Copyright © 2018 Elsevier B.V. All rights reserved.

Hand hygiene and the use of personal protective equipment.

PubMed

Wyeth, Jenny

Infection prevention and control nurses (IPCNs) have an extremely wide remit in relation to the facilitation of appropriate infection prevention and control practice within healthcare environments. In order to be effective IPCNs need to be involved at all stages of healthcare service delivery and need to form close working relationships with staff at all levels and in all departments within their organisation. The provision of the necessary facilities within the clinical environment, along with the ongoing training and support of staff are essential prerequisites to changing the behaviour of staff in order to consistently deliver effective hand hygiene and other infection prevention and control practices. Auditing of practice and the investigation of incidents enable the identification of areas of practice requiring improvement, which subsequently informs the continual development of training programmes and initiatives with a view to improving patient and staff safety. IPCNs need to be able to react swiftly to the emergence of new infectious organisms and/or evidence to identify what is required in order to ensure that staff are compliant with anticipated practice to maintain the safety of the patients in their care, themselves and their colleagues.

Can compliant fault zones be used to measure absolute stresses in the upper crust?

NASA Astrophysics Data System (ADS)

Hearn, E. H.; Fialko, Y.

2009-04-01

Geodetic and seismic observations reveal long-lived zones with reduced elastic moduli along active crustal faults. These fault zones localize strain from nearby earthquakes, consistent with the response of a compliant, elastic layer. Fault zone trapped wave studies documented a small reduction in P and S wave velocities along the Johnson Valley Fault caused by the 1999 Hector Mine earthquake. This reduction presumably perturbed a permanent compliant structure associated with the fault. The inferred changes in the fault zone compliance may produce a measurable deformation in response to background (tectonic) stresses. This deformation should have the same sense as the background stress, rather than the coseismic stress change. Here we investigate how the observed deformation of compliant zones in the Mojave Desert can be used to constrain the fault zone structure and stresses in the upper crust. We find that gravitational contraction of the coseismically softened zones should cause centimeters of coseismic subsidence of both the compliant zones and the surrounding region, unless the compliant fault zones are shallow and narrow, or essentially incompressible. We prefer the latter interpretation because profiles of line of sight displacements across compliant zones cannot be fit by a narrow, shallow compliant zone. Strain of the Camp Rock and Pinto Mountain fault zones during the Hector Mine and Landers earthquakes suggests that background deviatoric stresses are broadly consistent with Mohr-Coulomb theory in the Mojave upper crust (with μ ≥ 0.7). Large uncertainties in Mojave compliant zone properties and geometry preclude more precise estimates of crustal stresses in this region. With improved imaging of the geometry and elastic properties of compliant zones, and with precise measurements of their strain in response to future earthquakes, the modeling approach we describe here may eventually provide robust estimates of absolute crustal stress.

Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial.

PubMed

Krisciunas, Gintas P; Castellano, Kerlly; McCulloch, Timothy M; Lazarus, Cathy L; Pauloski, Barbara R; Meyer, Tanya K; Graner, Darlene; Van Daele, Douglas J; Silbergleit, Alice K; Crujido, Lisa R; Rybin, Denis; Doros, Gheorghe; Kotz, Tamar; Langmore, Susan E

2017-04-01

A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12-week intervention period. "Compliant" was defined as performing 10-12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered "compliant." After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Evaluation of a medication order writing standards policy in a regional health authority.

PubMed

Raymond, Colette B; Sproll, Barbara; Coates, Jan; Woloschuk, Donna M M

2013-09-01

The Winnipeg Regional Health Authority (WRHA) implemented a medication order writing standards (MOWS) policy (including banned abbreviations) to improve patient safety. Widespread educational campaigns and direct prescriber feedback were implemented. We audited orders within the WRHA from 2005 to 2009 and surveyed all WRHA staff in 2011 about the policy and suggestions for improving education and compliance. Overall, orders containing banned abbreviations, acronyms or symbols numbered 2261/8565 (26.4%) preimplementation. After WRHA-wide didactic education, the proportion declined to 1358/5461 (24.9%) (p = 0.043) and then, with targeted prescriber feedback, to 1186/6198 (19.1%) (p < 0.0001). A survey of 723 employees showed frequent violations of the MOWS, despite widespread knowledge of the policy. Respondents supported ongoing efforts to enforce the policy within the WRHA. Nonprescribers were significantly more likely than prescribers to agree with statements regarding enhancing compliance by defining prescriber/transcriber responsibilities and placing sanctions on noncompliant prescribers. Education, raising general awareness and targeted feedback to prescribers alone are insufficient to ensure compliance with MOWS policies. WRHA staff supported ongoing communication, improved tools such as compliant preprinted orders and reporting and feedback about medication incidents. A surprising number of respondents supported placing sanctions on noncompliant prescribers. Serial audits and targeted interventions such as direct prescriber feedback improve prescription quality in inpatient hospital settings. Education plus direct prescriber feedback had a greater impact than education alone on improving compliance with a MOWS policy. Future efforts at the WRHA to improve compliance will require an expanded focus on incentives, resources and development of action plans that involve all affected staff, not just prescribers. Plans include continued advertising, MOWS summaries in all charts, all-staff education, reminders and exploration of sustainable interventions for targeted feedback for prescribers.

A Generalized-Compliant-Motion Primitive

NASA Technical Reports Server (NTRS)

Backes, Paul G.

1993-01-01

Computer program bridges gap between planning and execution of compliant robotic motions developed and installed in control system of telerobot. Called "generalized-compliant-motion primitive," one of several task-execution-primitive computer programs, which receives commands from higher-level task-planning programs and executes commands by generating required trajectories and applying appropriate control laws. Program comprises four parts corresponding to nominal motion, compliant motion, ending motion, and monitoring. Written in C language.

Drag reduction through self-texturing compliant bionic materials

PubMed Central

Liu, Eryong; Li, Longyang; Wang, Gang; Zeng, Zhixiang; Zhao, Wenjie; Xue, Qunji

2017-01-01

Compliant fish skin is effectively in reducing drag, thus the design and application of compliant bionic materials may be a good choice for drag reduction. Here we consider the drag reduction of compliant bionic materials. First, ZnO and PDMS mesh modified with n-octadecane were prepared, the drag reduction of self-texturing compliant n-octadecane were studied. The results show that the mesh modified by ZnO and PDMS possess excellent lipophilic and hydrophobic, thus n-octadecane at solid, semisolid and liquid state all have good adhesion with modified mesh. The states of n-octadecane changed with temperature, thus, the surface contact angle and adhesive force all varies obviously at different state. The contact angle decreases with temperature, the adhesive force shows a lower value at semisolid state. Furthermore, the drag testing results show that the compliant n-octadecane film is more effectively in drag reduction than superhydrophobic ZnO/PDMS film, indicating that the drag reduction mechanism of n-octadecane is significantly different with superhydrophobic film. Further research shows that the water flow leads to self-texturing of semisolid state n-octadecane, which is similar with compliant fish skin. Therefore, the compliant bionic materials of semisolid state n-octadecane with regular bulge plays a major role in the drag reduction. PMID:28053309

Drag reduction through self-texturing compliant bionic materials.

PubMed

Liu, Eryong; Li, Longyang; Wang, Gang; Zeng, Zhixiang; Zhao, Wenjie; Xue, Qunji

2017-01-05

Compliant fish skin is effectively in reducing drag, thus the design and application of compliant bionic materials may be a good choice for drag reduction. Here we consider the drag reduction of compliant bionic materials. First, ZnO and PDMS mesh modified with n-octadecane were prepared, the drag reduction of self-texturing compliant n-octadecane were studied. The results show that the mesh modified by ZnO and PDMS possess excellent lipophilic and hydrophobic, thus n-octadecane at solid, semisolid and liquid state all have good adhesion with modified mesh. The states of n-octadecane changed with temperature, thus, the surface contact angle and adhesive force all varies obviously at different state. The contact angle decreases with temperature, the adhesive force shows a lower value at semisolid state. Furthermore, the drag testing results show that the compliant n-octadecane film is more effectively in drag reduction than superhydrophobic ZnO/PDMS film, indicating that the drag reduction mechanism of n-octadecane is significantly different with superhydrophobic film. Further research shows that the water flow leads to self-texturing of semisolid state n-octadecane, which is similar with compliant fish skin. Therefore, the compliant bionic materials of semisolid state n-octadecane with regular bulge plays a major role in the drag reduction.

Drag reduction through self-texturing compliant bionic materials

NASA Astrophysics Data System (ADS)

Liu, Eryong; Li, Longyang; Wang, Gang; Zeng, Zhixiang; Zhao, Wenjie; Xue, Qunji

2017-01-01

Compliant fish skin is effectively in reducing drag, thus the design and application of compliant bionic materials may be a good choice for drag reduction. Here we consider the drag reduction of compliant bionic materials. First, ZnO and PDMS mesh modified with n-octadecane were prepared, the drag reduction of self-texturing compliant n-octadecane were studied. The results show that the mesh modified by ZnO and PDMS possess excellent lipophilic and hydrophobic, thus n-octadecane at solid, semisolid and liquid state all have good adhesion with modified mesh. The states of n-octadecane changed with temperature, thus, the surface contact angle and adhesive force all varies obviously at different state. The contact angle decreases with temperature, the adhesive force shows a lower value at semisolid state. Furthermore, the drag testing results show that the compliant n-octadecane film is more effectively in drag reduction than superhydrophobic ZnO/PDMS film, indicating that the drag reduction mechanism of n-octadecane is significantly different with superhydrophobic film. Further research shows that the water flow leads to self-texturing of semisolid state n-octadecane, which is similar with compliant fish skin. Therefore, the compliant bionic materials of semisolid state n-octadecane with regular bulge plays a major role in the drag reduction.

Evaluation of the treatment of pectus carinatum with compressive orthotic bracing using three dimensional body scans.

PubMed

Wong, Kaitlyn E; Gorton, George E; Tashjian, David B; Tirabassi, Michael V; Moriarty, Kevin P

2014-06-01

The purpose of this study is to measure the effectiveness of compressive orthotic brace therapy for the treatment of pectus carinatum using an adjusted Haller Index (HI) measurement calculated from 3D body scan (BS) images. Pediatric patients with pectus carinatum were treated with either compressive orthotic bracing or observation. An adjusted BS Haller index (HI) was calculated from serial 3D BS images obtained on all patients. Medical records were evaluated to determine treatment with bracing and brace compliance more than 12hours daily. Compliant patient measurements were compared to non-compliant and non-brace groups. Forty patients underwent compressive orthotic bracing, while ten were observed. Twenty-three patients were compliant with bracing, and seventeen patients were non-compliant. Compliant patients exhibited an 8.2% increase, non-compliant patients had a 1.5% increase, and non-brace patients exhibited a 2.5% increase in BS HI. The change in BS HI of compliant patients was significantly different compared to non-brace patients (p=0.004) and non-compliant patients (p<0.001). Three dimensional BS is an effective, radiation free, and objective means to evaluate patients treated with compressive orthotic bracing. Copyright © 2014 Elsevier Inc. All rights reserved.

A Compliant Casing for Transonic Axial Compressors

NASA Technical Reports Server (NTRS)

Bloch, Gregory S.; Hah, Chunill

2003-01-01

A viewgraph presentation on the concept of compliant casing for transonic axial compressors is shown. The topics include: 1) Concept for compliant casing; 2) Rig and facility details; 3) Experimental results; and 4) Numerical results.

Hand forces exerted by long-term care staff when pushing wheelchairs on compliant and non-compliant flooring.

PubMed

Lachance, Chantelle C; Korall, Alexandra M B; Russell, Colin M; Feldman, Fabio; Robinovitch, Stephen N; Mackey, Dawn C

2018-09-01

Purpose-designed compliant flooring and carpeting have been promoted as a means for reducing fall-related injuries in high-risk environments, such as long-term care. However, it is not known whether these surfaces influence the forces that long-term care staff exert when pushing residents in wheelchairs. We studied 14 direct-care staff who pushed a loaded wheelchair instrumented with a triaxial load cell to test the effects on hand force of flooring overlay (vinyl versus carpet) and flooring subfloor (concrete versus compliant rubber [brand: SmartCells]). During straight-line pushing, carpet overlay increased initial and sustained hand forces compared to vinyl overlay by 22-49% over a concrete subfloor and by 8-20% over a compliant subfloor. Compliant subflooring increased initial and sustained hand forces compared to concrete subflooring by 18-31% when under a vinyl overlay. In contrast, compliant flooring caused no change in initial or sustained hand forces compared to concrete subflooring when under a carpet overlay. Copyright © 2018 Elsevier Ltd. All rights reserved.

78 FR 18594 - Delegation of Authorities

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Delegation of Authorities Notice is hereby given that I... Health Insurance Portability and Accountability Act of 1996 (HIPAA) insofar as such provisions pertain to..., Affordable Health Care for All Americans Subtitle B--Immediate Actions to Preserve and Expand Coverage...

Turbine airfoil with dual wall formed from inner and outer layers separated by a compliant structure

DOEpatents

Campbell,; Christian X. , Morrison; Jay, A [Oviedo, FL

2011-12-20

A turbine airfoil usable in a turbine engine with a cooling system and a compliant dual wall configuration configured to enable thermal expansion between inner and outer layers while eliminating stress formation is disclosed. The compliant dual wall configuration may be formed a dual wall formed from inner and outer layers separated by a compliant structure. The compliant structure may be configured such that the outer layer may thermally expand without limitation by the inner layer. The compliant structure may be formed from a plurality of pedestals positioned generally parallel with each other. The pedestals may include a first foot attached to a first end of the pedestal and extending in a first direction aligned with the outer layer, and may include a second foot attached to a second end of the pedestal and extending in a second direction aligned with the inner layer.

Medical image security in a HIPAA mandated PACS environment.

PubMed

Cao, F; Huang, H K; Zhou, X Q

2003-01-01

Medical image security is an important issue when digital images and their pertinent patient information are transmitted across public networks. Mandates for ensuring health data security have been issued by the federal government such as Health Insurance Portability and Accountability Act (HIPAA), where healthcare institutions are obliged to take appropriate measures to ensure that patient information is only provided to people who have a professional need. Guidelines, such as digital imaging and communication in medicine (DICOM) standards that deal with security issues, continue to be published by organizing bodies in healthcare. However, there are many differences in implementation especially for an integrated system like picture archiving and communication system (PACS), and the infrastructure to deploy these security standards is often lacking. Over the past 6 years, members in the Image Processing and Informatics Laboratory, Childrens Hospital, Los Angeles/University of Southern California, have actively researched image security issues related to PACS and teleradiology. The paper summarizes our previous work and presents an approach to further research on the digital envelope (DE) concept that provides image integrity and security assurance in addition to conventional network security protection. The DE, including the digital signature (DS) of the image as well as encrypted patient information from the DICOM image header, can be embedded in the background area of the image as an invisible permanent watermark. The paper outlines the systematic development, evaluation and deployment of the DE method in a PACS environment. We have also proposed a dedicated PACS security server that will act as an image authority to check and certify the image origin and integrity upon request by a user, and meanwhile act also as a secure DICOM gateway to the outside connections and a PACS operation monitor for HIPAA supporting information. Copyright 2002 Elsevier Science Ltd.

Evaluating re-identification risks with respect to the HIPAA privacy rule

PubMed Central

Benitez, Kathleen

2010-01-01

Objective Many healthcare organizations follow data protection policies that specify which patient identifiers must be suppressed to share “de-identified” records. Such policies, however, are often applied without knowledge of the risk of “re-identification”. The goals of this work are: (1) to estimate re-identification risk for data sharing policies of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule; and (2) to evaluate the risk of a specific re-identification attack using voter registration lists. Measurements We define several risk metrics: (1) expected number of re-identifications; (2) estimated proportion of a population in a group of size g or less, and (3) monetary cost per re-identification. For each US state, we estimate the risk posed to hypothetical datasets, protected by the HIPAA Safe Harbor and Limited Dataset policies by an attacker with full knowledge of patient identifiers and with limited knowledge in the form of voter registries. Results The percentage of a state's population estimated to be vulnerable to unique re-identification (ie, g=1) when protected via Safe Harbor and Limited Datasets ranges from 0.01% to 0.25% and 10% to 60%, respectively. In the voter attack, this number drops for many states, and for some states is 0%, due to the variable availability of voter registries in the real world. We also find that re-identification cost ranges from $0 to $17 000, further confirming risk variability. Conclusions This work illustrates that blanket protection policies, such as Safe Harbor, leave different organizations vulnerable to re-identification at different rates. It provides justification for locally performed re-identification risk estimates prior to sharing data. PMID:20190059

EPA Administrative Order on Consent (AOC) with ERP Compliant Coke, LLC

EPA Pesticide Factsheets

This Administrative Order on Consent with ERP Compliant Coke was effective August 2016. The Walter Coke facility located in North Birmingham was purchased by ERP Compliant Coke, LLC in February 2016 out of bankruptcy proceedings.

Energy star compliant voice over internet protocol (VoIP) telecommunications network including energy star compliant VoIP devices

DOEpatents

Kouchri, Farrokh Mohammadzadeh

2012-11-06

A Voice over Internet Protocol (VoIP) communications system, a method of managing a communications network in such a system and a program product therefore. The system/network includes an ENERGY STAR (E-star) aware softswitch and E-star compliant communications devices at system endpoints. The E-star aware softswitch allows E-star compliant communications devices to enter and remain in power saving mode. The E-star aware softswitch spools messages and forwards only selected messages (e.g., calls) to the devices in power saving mode. When the E-star compliant communications devices exit power saving mode, the E-star aware softswitch forwards spooled messages.

45 CFR 150.215 - Extension for good cause.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce HIPAA Requirements § 150.215 Extension for good cause. CMS may...

Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study

PubMed Central

2009-01-01

Background Data protection is important for all information systems that deal with human-subjects data. Grid-based systems – such as the cancer Biomedical Informatics Grid (caBIG) – seek to develop new mechanisms to facilitate real-time federation of cancer-relevant data sources, including sources protected under a variety of regulatory laws, such as HIPAA and 21CFR11. These systems embody new models for data sharing, and hence pose new challenges to the regulatory community, and to those who would develop or adopt them. These challenges must be understood by both systems developers and system adopters. In this paper, we describe our work collecting policy statements, expectations, and requirements from regulatory decision makers at academic cancer centers in the United States. We use these statements to examine fundamental assumptions regarding data sharing using data federations and grid computing. Methods An interview-based study of key stakeholders from a sample of US cancer centers. Interviews were structured, and used an instrument that was developed for the purpose of this study. The instrument included a set of problem scenarios – difficult policy situations that were derived during a full-day discussion of potentially problematic issues by a set of project participants with diverse expertise. Each problem scenario included a set of open-ended questions that were designed to elucidate stakeholder opinions and concerns. Interviews were transcribed verbatim and used for both qualitative and quantitative analysis. For quantitative analysis, data was aggregated at the individual or institutional unit of analysis, depending on the specific interview question. Results Thirty-one (31) individuals at six cancer centers were contacted to participate. Twenty-four out of thirty-one (24/31) individuals responded to our request- yielding a total response rate of 77%. Respondents included IRB directors and policy-makers, privacy and security officers, directors of offices of research, information security officers and university legal counsel. Nineteen total interviews were conducted over a period of 16 weeks. Respondents provided answers for all four scenarios (a total of 87 questions). Results were grouped by broad themes, including among others: governance, legal and financial issues, partnership agreements, de-identification, institutional technical infrastructure for security and privacy protection, training, risk management, auditing, IRB issues, and patient/subject consent. Conclusion The findings suggest that with additional work, large scale federated sharing of data within a regulated environment is possible. A key challenge is developing suitable models for authentication and authorization practices within a federated environment. Authentication – the recognition and validation of a person's identity – is in fact a global property of such systems, while authorization – the permission to access data or resources – mimics data sharing agreements in being best served at a local level. Nine specific recommendations result from the work and are discussed in detail. These include: (1) the necessity to construct separate legal or corporate entities for governance of federated sharing initiatives on this scale; (2) consensus on the treatment of foreign and commercial partnerships; (3) the development of risk models and risk management processes; (4) development of technical infrastructure to support the credentialing process associated with research including human subjects; (5) exploring the feasibility of developing large-scale, federated honest broker approaches; (6) the development of suitable, federated identity provisioning processes to support federated authentication and authorization; (7) community development of requisite HIPAA and research ethics training modules by federation members; (8) the recognition of the need for central auditing requirements and authority, and; (9) use of two-protocol data exchange models where possible in the federation. PMID:19527521

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders

PubMed Central

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. PMID:24302285

Pharmacy student perceptions of adverse event reporting.

PubMed

Kalari, Sirisha; Dormarunno, Matthew; Zvenigorodsky, Oleg; Mohan, Aparna

2011-09-10

To assess US pharmacy students' knowledge and perceptions of adverse event reporting. To gauge pharmacy students' impressions of adverse event reporting, a 10-question survey instrument was administered that addressed student perceptions of the reporting procedures of the Food and Drug Administration (FDA) and pharmaceutical manufacturers, as well as student understanding of the Health Insurance Portability and Accountability Act (HIPAA) and its relationship to adverse event reporting. Two hundred twenty-eight pharmacy students responded to the survey. The majority of respondents believed that the FDA is more likely than a pharmaceutical company to take action regarding an adverse event. There were misconceptions relating to the way adverse event reports are handled and the influence of HIPAA regulations on reporting. Communication between the FDA and pharmaceutical manufacturers regarding adverse event reports is not well understood by pharmacy students. Education about adverse event reporting should evolve so that by the time pharmacy students become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.

Compliant flooring to prevent fall-related injuries in older adults: A scoping review of biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety.

PubMed

Lachance, Chantelle C; Jurkowski, Michal P; Dymarz, Ania C; Robinovitch, Stephen N; Feldman, Fabio; Laing, Andrew C; Mackey, Dawn C

2017-01-01

Compliant flooring, broadly defined as flooring systems or floor coverings with some level of shock absorbency, may reduce the incidence and severity of fall-related injuries in older adults; however, a lack of synthesized evidence may be limiting widespread uptake. Informed by the Arksey and O'Malley framework and guided by a Research Advisory Panel of knowledge users, we conducted a scoping review to answer: what is presented about the biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety associated with compliant flooring systems that aim to prevent fall-related injuries in healthcare settings? We searched academic and grey literature databases. Any record that discussed a compliant flooring system and at least one of biomechanical efficacy, clinical effectiveness, cost-effectiveness, or workplace safety was eligible for inclusion. Two independent reviewers screened and abstracted records, charted data, and summarized results. After screening 3611 titles and abstracts and 166 full-text articles, we included 84 records plus 56 companion (supplementary) reports. Biomechanical efficacy records (n = 50) demonstrate compliant flooring can reduce fall-related impact forces with minimal effects on standing and walking balance. Clinical effectiveness records (n = 20) suggest that compliant flooring may reduce injuries, but may increase risk for falls. Preliminary evidence suggests that compliant flooring may be a cost-effective strategy (n = 12), but may also result in increased physical demands for healthcare workers (n = 17). In summary, compliant flooring is a promising strategy for preventing fall-related injuries from a biomechanical perspective. Additional research is warranted to confirm whether compliant flooring (i) prevents fall-related injuries in real-world settings, (ii) is a cost-effective intervention strategy, and (iii) can be installed without negatively impacting workplace safety. Avenues for future research are provided, which will help to determine whether compliant flooring is recommended in healthcare environments.

Compliant flooring to prevent fall-related injuries in older adults: A scoping review of biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety

PubMed Central

Jurkowski, Michal P.; Dymarz, Ania C.; Robinovitch, Stephen N.; Feldman, Fabio; Laing, Andrew C.; Mackey, Dawn C.

2017-01-01

Background Compliant flooring, broadly defined as flooring systems or floor coverings with some level of shock absorbency, may reduce the incidence and severity of fall-related injuries in older adults; however, a lack of synthesized evidence may be limiting widespread uptake. Methods Informed by the Arksey and O’Malley framework and guided by a Research Advisory Panel of knowledge users, we conducted a scoping review to answer: what is presented about the biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety associated with compliant flooring systems that aim to prevent fall-related injuries in healthcare settings? We searched academic and grey literature databases. Any record that discussed a compliant flooring system and at least one of biomechanical efficacy, clinical effectiveness, cost-effectiveness, or workplace safety was eligible for inclusion. Two independent reviewers screened and abstracted records, charted data, and summarized results. Results After screening 3611 titles and abstracts and 166 full-text articles, we included 84 records plus 56 companion (supplementary) reports. Biomechanical efficacy records (n = 50) demonstrate compliant flooring can reduce fall-related impact forces with minimal effects on standing and walking balance. Clinical effectiveness records (n = 20) suggest that compliant flooring may reduce injuries, but may increase risk for falls. Preliminary evidence suggests that compliant flooring may be a cost-effective strategy (n = 12), but may also result in increased physical demands for healthcare workers (n = 17). Conclusions In summary, compliant flooring is a promising strategy for preventing fall-related injuries from a biomechanical perspective. Additional research is warranted to confirm whether compliant flooring (i) prevents fall-related injuries in real-world settings, (ii) is a cost-effective intervention strategy, and (iii) can be installed without negatively impacting workplace safety. Avenues for future research are provided, which will help to determine whether compliant flooring is recommended in healthcare environments. PMID:28166265

On the theory of compliant wall drag reduction in turbulent boundary layers

NASA Technical Reports Server (NTRS)

Ash, R. L.

1974-01-01

A theoretical model has been developed which can explain how the motion of a compliant wall reduces turbulent skin friction drag. Available experimental evidence at low speeds has been used to infer that a compliant surface selectively removes energy from the upper frequency range of the energy containing eddies and through resulting surface motions can produce locally negative Reynolds stresses at the wall. The theory establishes a preliminary amplitude and frequency criterion as the basis for designing effective drag reducing compliant surfaces.

Compliant Interfacial Layers in Thermoelectric Devices

NASA Technical Reports Server (NTRS)

Firdosy, Samad A. (Inventor); Li, Billy Chun-Yip (Inventor); Ravi, Vilupanur A. (Inventor); Fleurial, Jean-Pierre (Inventor); Caillat, Thierry (Inventor); Anjunyan, Harut (Inventor)

2017-01-01

A thermoelectric power generation device is disclosed using one or more mechanically compliant and thermally and electrically conductive layers at the thermoelectric material interfaces to accommodate high temperature differentials and stresses induced thereby. The compliant material may be metal foam or metal graphite composite (e.g. using nickel) and is particularly beneficial in high temperature thermoelectric generators employing Zintl thermoelectric materials. The compliant material may be disposed between the thermoelectric segments of the device or between a thermoelectric segment and the hot or cold side interconnect of the device.

Hepatic fat quantification magnetic resonance for monitoring treatment response in pediatric nonalcoholic steatohepatitis.

PubMed

Koh, Hong; Kim, Seung; Kim, Myung-Joon; Kim, Hyun Gi; Shin, Hyun Joo; Lee, Mi-Jung

2015-09-07

To evaluate the possibility of treatment effect monitoring using hepatic fat quantification magnetic resonance (MR) in pediatric nonalcoholic steatohepatitis (NASH). We retrospectively reviewed the medical records of patients who received educational recommendations and vitamin E for NASH and underwent hepatic fat quantification MR from 2011 to 2013. Hepatic fat fraction (%) was measured using dual- and triple-echo gradient-recalled-echo sequences at 3T. The compliant and non-compliant groups were compared clinically, biochemically, and radiologically. Twenty seven patients (M:F = 24:3; mean age: 12 ± 2.3 years) were included (compliant group = 22, non-compliant = 5). None of the baseline findings differed between the 2 groups, except for triglyceride level (compliant vs non-compliant, 167.7 mg/dL vs 74.2 mg/dL, P = 0.001). In the compliant group, high-density lipoprotein increased and all other parameters decreased after 1-year follow-up. However, there were various changes in the non-compliant group. Dual-echo fat fraction (-19.2% vs 4.6, P < 0.001), triple-echo fat fraction (-13.4% vs 3.5, P < 0.001), alanine aminotransferase (-110.7 IU/L vs -10.6 IU/L, P = 0.047), total cholesterol (-18.1 mg/dL vs 3.8 mg/dL, P = 0.016), and triglyceride levels (-61.3 mg/dL vs 11.2 mg/dL, P = 0.013) were significantly decreased only in the compliant group. The change in body mass index and dual-echo fat fraction showed a positive correlation (ρ = 0.418, P = 0.030). Hepatic fat quantification MR can be a non-invasive, quantitative and useful tool for monitoring treatment effects in pediatric NASH.

16 CFR 318.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... information means “individually identifiable health information,” as defined in section 1171(6) of the Social... services through the Web site of a vendor of personal health records; (2) Offers products or services through the Web sites of HIPAA-covered entities that offer individuals personal health records; or (3...

16 CFR 318.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... information means “individually identifiable health information,” as defined in section 1171(6) of the Social... services through the Web site of a vendor of personal health records; (2) Offers products or services through the Web sites of HIPAA-covered entities that offer individuals personal health records; or (3...

12 CFR 334.32 - Sharing medical information with affiliates.

Code of Federal Regulations, 2011 CFR

2011-01-01

... affiliate— (1) In connection with the business of insurance or annuities (including the activities described... Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA); (3...) of the Gramm-Leach-Bliley Act; (5) In connection with a determination of the consumer's eligibility...

When Health Care Providers May Communicate About You with Your Family, Friends, or Others Involved in Your Care

MedlinePlus

... TO THE HIPAA P RIVACY R ULE : When Health Care Providers May Communicate About You with Your Family, ... doctors, nurses, pharmacies, hospitals, nursing homes, and other health care providers to protect the privacy of your health ...

45 CFR 150.213 - Form and content of notice.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS Enforcement Processes for Determining... consequence of a State's failure to substantially enforce HIPAA requirements is that CMS enforces them. (d... information that the State wishes CMS to consider in making the preliminary determination described in § 150...

45 CFR 150.343 - Notice of proposed penalty.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS Enforcement With Respect to Issuers and Non-Federal Governmental Plans-Civil Money Penalties § 150.343 Notice of proposed penalty. If CMS... penalty. The notice includes the following: (a) A description of the HIPAA requirements that CMS has...

45 CFR 150.211 - Notice to the State.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce HIPAA Requirements § 150.211 Notice to the State. If CMS is...

45 CFR 150.203 - Circumstances requiring CMS enforcement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Circumstances requiring CMS enforcement. 150.203... CARE ACCESS CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS Enforcement Processes for... requiring CMS enforcement. CMS enforces HIPAA requirements to the extent warranted (as determined by CMS) in...

Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance

PubMed Central

Patkar, Vivek; Acosta, Dionisio; Davidson, Tim; Jones, Alison; Fox, John

2012-01-01

Objectives The cancer multidisciplinary team (MDT) meeting (MDM) is regarded as the best platform to reduce unwarranted variation in cancer care through evidence-compliant management. However, MDMs are often overburdened with many different agendas and hence struggle to achieve their full potential. The authors developed an interactive clinical decision support system called MATE (Multidisciplinary meeting Assistant and Treatment sElector) to facilitate explicit evidence-based decision making in the breast MDMs. Design Audit study and a questionnaire survey. Setting Breast multidisciplinary unit in a large secondary care teaching hospital. Participants All members of the breast MDT at the Royal Free Hospital, London, were consulted during the process of MATE development and implementation. The emphasis was on acknowledging the clinical needs and practical constraints of the MDT and fitting the system around the team's workflow rather than the other way around. Delegates, who attended MATE workshop at the England Cancer Networks' Development Programme conference in March 2010, participated in the questionnaire survey. Outcome measures The measures included evidence-compliant care, measured by adherence to clinical practice guidelines, and promoting research, measured by the patient identification rate for ongoing clinical trials. Results MATE identified 61% more patients who were potentially eligible for recruitment into clinical trials than the MDT, and MATE recommendations demonstrated better concordance with clinical practice guideline than MDT recommendations (97% of MATE vs 93.2% of MDT; N=984). MATE is in routine use in breast MDMs at the Royal Free Hospital, London, and wider evaluations are being considered. Conclusions Sophisticated decision support systems can enhance the conduct of MDMs in a way that is acceptable to and valued by the clinical team. Further rigorous evaluations are required to examine cost-effectiveness and measure the impact on patient outcomes. The decision support technology used in MATE is generic and if found useful can be applied across medicine. PMID:22734113

Badging, Real ID

Science.gov Websites

. REAL ID LANL Impacts and Solutions The federal government has determined New Mexico is non-compliant Identification Cards whom will also become Non-Compliant. Access through LANL Vehicle Access Portals unaffected alternate ID if they are coming from "non-compliant" REAL-ID states LANS and the Field Office have

48 CFR 1552.239-103 - Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors and...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Compliant Microcomputers, Including Personal Computers, Monitors and Printers. 1552.239-103 Section 1552.239... Star Compliant Microcomputers, Including Personal Computers, Monitors and Printers. As prescribed in... Personal Computers, Monitors, and Printers (APR 1996) (a) The Contractor shall provide computer products...

48 CFR 1552.239-103 - Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors and...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Compliant Microcomputers, Including Personal Computers, Monitors and Printers. 1552.239-103 Section 1552.239... Star Compliant Microcomputers, Including Personal Computers, Monitors and Printers. As prescribed in... Personal Computers, Monitors, and Printers (APR 1996) (a) The Contractor shall provide computer products...

48 CFR 1552.239-103 - Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors and...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Compliant Microcomputers, Including Personal Computers, Monitors and Printers. 1552.239-103 Section 1552.239... Star Compliant Microcomputers, Including Personal Computers, Monitors and Printers. As prescribed in... Personal Computers, Monitors, and Printers (APR 1996) (a) The Contractor shall provide computer products...

Performance of a non-tapered 3D morphing wing with integrated compliant ribs

NASA Astrophysics Data System (ADS)

Previtali, F.; Ermanni, P.

2012-05-01

Morphing wings have a high potential for improving the performance and reducing the fuel consumption of modern aircraft. Thanks to its simplicity, the compliant belt-rib concept is regarded by the authors as a promising solution. Using the compliant rib designed by Hasse and Campanile as a starting point, a compliant morphing wing made of composite materials is designed. Innovative methods for optimal placing of the actuation and for the quantification of the morphing are used. The performance of the compliant morphing wing in terms of three-dimensional (3D) structural behaviour and aerodynamic properties, both two- and three-dimensional, is presented and discussed. The fundamental importance of considering 3D coupling effects in the determination of the performance of morphing aerofoils is shown.

75 FR 10019 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-04

... 8471), HIPAA Mental Health Parity Act (Sec. 54.9812). DATES: Written comments should be received on or... INFORMATION: Title: HIPPAA Mental Health Parity Act. OMB Number: 1545-1577. Regulation Project Number: Reg-109704-97. Abstract: The regulations provide guidance for group health plans with mental health benefits...

A Practitioner's Response to the New Health Privacy Regulations

ERIC Educational Resources Information Center

Yang, Julia A.; Kombarakaran, Francis A.

2006-01-01

The established professional practice requiring informed consent for the disclosure of personal health information with its implied right to privacy suffered a serious setback with the first federal privacy initiative of the Bush administration. The new Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L. 104-191) privacy…

Federal Privacy Laws That Apply to Children and Education. Safeguarding Data

ERIC Educational Resources Information Center

Data Quality Campaign, 2014

2014-01-01

This table identifies and briefly describes the following federal policies that safeguard and protect the confidentiality of personal information: (1) Family Educational Rights and Privacy Act (FERPA); (2) Protection of Pupil Rights Amendment (PPRA); (3) Health Insurance Portability and Accountability Act (HIPAA); (4) Children's Online Privacy…

Clinical management and patient persistence with antibiotic course in suspected group A streptococcal pharyngitis for primary prevention of rheumatic fever: the perspective from a New Zealand emergency department.

PubMed

Mathan, Jeremy J; Ekart, Jozsef; Houlding, Anthony; Payinda, Gary; Mills, Clair

2017-06-16

Rates of acute rheumatic fever in the Northland region are historically among the highest in New Zealand, impacting disproportionately on Māori children and youth. The primary aim of this study was to determine patient persistence to antibiotic treatment for group A streptococcus (GAS) pharyngitis in patients presenting with sore throat to the Whangarei Hospital Emergency Department. Secondarily, this study sought to determine prescriber adherence to the national antibiotic guideline for sore throat management. A retrospective audit of patients presenting to ED with presumed GAS pharyngitis between 1 May 2016 and 31 August 2016 was carried out. Data on patient demographics, clinical examination findings, investigations and antibiotic prescription were extracted from electronic medical records. Patients were contacted and after obtaining consent, were asked about their antibiotic treatment using a standardised telephone interview script. The patient population audited reflects those at high risk for acute rheumatic fever. All patients were discharged on the recommended medication, but only 82.7% (62/75) received the correct length (10 days) of oral antibiotics. Of the total of 75 patients audited, 61 (81%) had a swab taken and 41% (25/61) of these were confirmed positive for GAS. Patients were either advised to commence medication without waiting for a swab result (96%, 72/75) or delay treatment and commence only if no improvement in symptoms (4%, 3/75). Of those advised to commence medication immediately, 94% (67/72) obtained their medication from a community pharmacy. Three patients were advised to stop treatment after confirmation of a negative result. Of those patients assessable for medication persistence (n=65), 73.8% (48/65) of patients were compliant in completing the full course of antibiotic therapy. This is the first study to assess patient persistence to an antibiotic course for GAS after presentation at an emergency department in Northland and possibly New Zealand. The results indicate a relatively high persistence rate with oral antibiotic treatment by patients treated for suspected GAS pharyngitis. An important finding is that community pharmacy dispensing does not appear to be a major barrier to patients acquiring medications. Additionally, the study shows low levels of follow up of patients with negative throat swab results, resulting in these patients completing the course of antibiotics unnecessarily.

Using Taxonomic Indexing Trees to Efficiently Retrieve SCORM-Compliant Documents in e-Learning Grids

ERIC Educational Resources Information Center

Shih, Wen-Chung; Tseng, Shian-Shyong; Yang, Chao-Tung

2008-01-01

With the flourishing development of e-Learning, more and more SCORM-compliant teaching materials are developed by institutes and individuals in different sites. In addition, the e-Learning grid is emerging as an infrastructure to enhance traditional e-Learning systems. Therefore, information retrieval schemes supporting SCORM-compliant documents…

Training Children with Autism Spectrum Disorders to Be Compliant with an Oral Assessment

ERIC Educational Resources Information Center

Cuvo, Anthony J.; Godard, Anna; Huckfeldt, Rachel; DeMattei, Ronda

2010-01-01

Little research has been conducted on teaching children with autism spectrum disorders to be compliant with dental procedures. This study evaluated a behavioral package to train children with autism spectrum disorders to be compliant with an 8 component oral assessment. After a dental hygienist performed an assessment pretest, noncompliance on…

Power bases and attribution in three cultures.

PubMed

Alanazi, Falah M; Rodrigues, Aroldo

2003-06-01

The authors used a Saudi context to verify the cross-cultural generality of findings (A. Rodrigues & K. L. Lloyd, 1998) reported for U.S. and Brazilian samples in which compliant behavior caused by reward, informational, and referent influences was perceived as more controllable and more internal than compliant behavior resulting from legitimate, expert, and coercive influences. This differential attribution led, in turn, to different affective and behavioral responses. In the present study, cognitive and affective reactions of Saudi students were measured with regard to compliant behavior (leading to a good outcome or a bad outcome) caused by each of the 6 bases of power described by B. H. Raven (1965). As expected, power bases had significant effects. However, when the outcome of the compliant behavior was bad, compliant behavior caused by a coercive influence led to the perception of more internality and controllability. Also--and not found in previous studies--the perception of less internality and controllability of compliant behavior was caused by an informational influence. Findings are discussed in the light of related research and Saudi cultural characteristics.

Herd protection effect of N95 respirators in healthcare workers.

PubMed

Chen, Xin; Chughtai, Abrar Ahmad; MacIntyre, Chandini Raina

2017-12-01

Objective To determine if there was herd protection conferred to unprotected healthcare workers (HCWs) by N95 respirators worn by colleagues. Methods Data were analysed from a prospective cluster randomized clinical trial conducted in Beijing, China between 1 December 2008 and 15 January 2009. A minimum compliance level (MCL) of N95 respirators for prevention of clinical respiratory illness (CRI) was set based on various compliance cut-offs. The CRI rates were compared between compliant (≥MCL) and non-compliant (

Low Yield of Chest Radiography in a Large Tuberculosis Screening Program1

PubMed Central

Pollock, Nira R.

2010-01-01

Purpose: To assess the frequency and spectrum of abnormalities on routine screening chest radiographs in the pre-employment evaluation of health care workers with positive tuberculin skin test (TST) results. Materials and Methods: The institutional review board approved this HIPAA-compliant retrospective study and waived the need for written informed patient consent. Chest radiographic reports of all 2586 asymptomatic individuals with positive TST results who underwent pre-employment evaluation between January 1, 2003, and December 31, 2007, were evaluated to determine the frequency of detection of evidence of active tuberculosis (TB) or latent TB infection (LTBI) and the spectrum of imaging findings. All chest radiographs interpreted as positive were reviewed by an experienced board-certified radiologist. If there was a discrepancy between the two readings, a second experienced radiologist served as an independent and final arbiter. Any follow-up chest radiographs or computed tomographic images that had been acquired by employee health services or by the employee’s private physician as a result of a suspected abnormality detected at initial screening were also evaluated. Results: Of the 159 (6.1%) chest radiographic examinations that yielded abnormal results, there were no findings that were consistent with active TB. There were 92 cases of calcified granulomas, calcified lymph nodes, or both; 25 cases of apical pleural thickening; 16 cases of fibrous scarring; and 31 cases of noncalcified nodules. All cases of fibrous scarring involved an area smaller than 2 cm2. All noncalcified nodules were 4 mm in diameter or smaller, with the exception of one primary lung malignancy and one necrotizing granuloma (negative for acid-fast bacilli) that grew Mycobacterium kansasii on culture. Conclusion: Universal chest radiography in a large pre-employment TB screening program was of low yield in the detection of active TB or increased LTBI reactivation risk, and it provided no assistance in deciding which individuals to prioritize for LTBI treatment. © RSNA, 2010 PMID:20720079

Small lung cancers: improved detection by use of bone suppression imaging--comparison with dual-energy subtraction chest radiography.

PubMed

Li, Feng; Engelmann, Roger; Pesce, Lorenzo L; Doi, Kunio; Metz, Charles E; Macmahon, Heber

2011-12-01

To determine whether use of bone suppression (BS) imaging, used together with a standard radiograph, could improve radiologists' performance for detection of small lung cancers compared with use of standard chest radiographs alone and whether BS imaging would provide accuracy equivalent to that of dual-energy subtraction (DES) radiography. Institutional review board approval was obtained. The requirement for informed consent was waived. The study was HIPAA compliant. Standard and DES chest radiographs of 50 patients with 55 confirmed primary nodular cancers (mean diameter, 20 mm) as well as 30 patients without cancers were included in the observer study. A new BS imaging processing system that can suppress the conspicuity of bones was applied to the standard radiographs to create corresponding BS images. Ten observers, including six experienced radiologists and four radiology residents, indicated their confidence levels regarding the presence or absence of a lung cancer for each lung, first by using a standard image, then a BS image, and finally DES soft-tissue and bone images. Receiver operating characteristic (ROC) analysis was used to evaluate observer performance. The average area under the ROC curve (AUC) for all observers was significantly improved from 0.807 to 0.867 with BS imaging and to 0.916 with DES (both P < .001). The average AUC for the six experienced radiologists was significantly improved from 0.846 with standard images to 0.894 with BS images (P < .001) and from 0.894 to 0.945 with DES images (P = .001). Use of BS imaging together with a standard radiograph can improve radiologists' accuracy for detection of small lung cancers on chest radiographs. Further improvements can be achieved by use of DES radiography but with the requirement for special equipment and a potential small increase in radiation dose. © RSNA, 2011.

Deep Learning at Chest Radiography: Automated Classification of Pulmonary Tuberculosis by Using Convolutional Neural Networks.

PubMed

Lakhani, Paras; Sundaram, Baskaran

2017-08-01

Purpose To evaluate the efficacy of deep convolutional neural networks (DCNNs) for detecting tuberculosis (TB) on chest radiographs. Materials and Methods Four deidentified HIPAA-compliant datasets were used in this study that were exempted from review by the institutional review board, which consisted of 1007 posteroanterior chest radiographs. The datasets were split into training (68.0%), validation (17.1%), and test (14.9%). Two different DCNNs, AlexNet and GoogLeNet, were used to classify the images as having manifestations of pulmonary TB or as healthy. Both untrained and pretrained networks on ImageNet were used, and augmentation with multiple preprocessing techniques. Ensembles were performed on the best-performing algorithms. For cases where the classifiers were in disagreement, an independent board-certified cardiothoracic radiologist blindly interpreted the images to evaluate a potential radiologist-augmented workflow. Receiver operating characteristic curves and areas under the curve (AUCs) were used to assess model performance by using the DeLong method for statistical comparison of receiver operating characteristic curves. Results The best-performing classifier had an AUC of 0.99, which was an ensemble of the AlexNet and GoogLeNet DCNNs. The AUCs of the pretrained models were greater than that of the untrained models (P < .001). Augmenting the dataset further increased accuracy (P values for AlexNet and GoogLeNet were .03 and .02, respectively). The DCNNs had disagreement in 13 of the 150 test cases, which were blindly reviewed by a cardiothoracic radiologist, who correctly interpreted all 13 cases (100%). This radiologist-augmented approach resulted in a sensitivity of 97.3% and specificity 100%. Conclusion Deep learning with DCNNs can accurately classify TB at chest radiography with an AUC of 0.99. A radiologist-augmented approach for cases where there was disagreement among the classifiers further improved accuracy. © RSNA, 2017.

Quality-of-Life Assessment of Fibroid Treatment Options and Outcomes

PubMed Central

Kong, Chung Yin; Tempany, Clare M.; Swan, J. Shannon

2011-01-01

Purpose: To obtain utilities (a unit of measure of a person’s relative preferences for different health states compared with death or worst possible outcome) for uterine fibroids before and after treatment and to measure short-term utilities for the following uterine fibroid treatments: abdominal hysterectomy, magnetic resonance (MR) imaging–guided focused ultrasound surgery, and uterine artery embolization (UAE). Materials and Methods: This retrospective study was approved by the institutional review board and was HIPAA compliant. The waiting trade-off (WTO) method, a variation on the time trade-off (TTO) method, is used to obtain utilities for diagnostic procedures on the basis of the fact that people wait longer to avoid noxious tests and/or procedures. The WTO method provides short-term quality of life tolls in terms of quality-adjusted life-weeks by scaling wait times with pre- and posttreatment utilities. Utilities for uterine fibroids before and after treatment were obtained with the TTO method and a visual analog scale (VAS) by using a questionnaire administered by means of a phone interview. WTO wait times were adjusted for quality of life with VAS and TTO utilities and a transformation of VAS. Wait times were compared by using nonparametric tests. The study participants included 62 patients who had undergone abdominal hysterectomy, 74 who had undergone UAE, and 61 who had undergone MR imaging–guided focused ultrasound surgery. Results: Quality of life increased with all treatments. The median WTO wait time was higher for hysterectomy (21.6 weeks) than for UAE or MR imaging–guided focused ultrasound surgery (14.1 weeks for both) (P < .05). Quality-adjusted life-week tolls were smaller when scaled according to TTO than when scaled according to VAS or transformation of VAS. Conclusion: Quality of life increased after all fibroid treatments. WTO is feasible for assessing the quality-adjusted morbidity of treatment procedures. © RSNA, 2011 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11100704/-/DC1 PMID:21364084

Impact of Sodium Bicarbonate-Buffered Lidocaine on Patient Pain During Image-Guided Breast Biopsy.

PubMed

Vasan, Alison; Baker, Jay A; Shelby, Rebecca A; Soo, Mary Scott C

2017-09-01

This randomized, double-blind controlled study evaluated the effectiveness of sodium bicarbonate-buffered lidocaine on reducing pain during imaging-guided breast biopsies. This prospective, HIPAA-compliant study randomly assigned 85 women undergoing ultrasound- or stereotactic-guided core-needle breast biopsies to receive intradermally and intraparenchymally either 1% lidocaine buffered with sodium bicarbonate (9:1 ratio) (bicarbonate study group) or 1% lidocaine alone (control group). Pain was evaluated using a 0-to-10 Likert pain scale during both intradermal and intraparenchymal anesthesia injections and during tissue sampling. Prebiopsy breast pain, anxiety, medical history, demographics, biopsy type, radiologist level of training, breast density, and lesion histology were recorded. Data were analyzed using analysis of variance and analysis of covariance. Unadjusted mean pain scores were 1.47 and 2.07 (study and control groups, respectively; P = .15) during intradermal injections, and 1.84 and 2.98 (study and control groups, respectively; P = .03) during intraparenchymal injections. Tissue sampling mean pain scores were .81 and 1.71 (study and control groups, respectively; P = .07). Moderator analyses found (1) among patients with preprocedural pain, those in the bicarbonate group experienced less intradermal injection pain (0.85 ± 1.23) than patients in the control group (2.50 ± 2.09); (2) among patients with fatty or scattered fibroglandular tissue, those in the bicarbonate group (1.35 ± 1.95) experienced less intraparenchymal injection pain than the control group (3.52 ± 3.13); and (3) during ultrasound-guided biopsies, patients in the bicarbonate group experienced less tissue-sampling pain (0.23 ± 0.63) than the control group (1.79 ± 3.05). Overall, buffering lidocaine with sodium bicarbonate significantly reduced pain during intraparenchymal injections, and additional pain reduction was found in certain patient subgroups during intradermal injections, intraparenchymal injections, and tissue sampling. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Utility of preoperative ferumoxtran-10 MRI to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN 6671/GOG 0233☆

PubMed Central

Atri, Mostafa; Zhang, Zheng; Marques, Helga; Gorelick, Jeremy; Harisinghani, Mukesh; Sohaib, Aslam; Koh, Dow-Mu; Raman, Steven; Gee, Michael; Choi, Haesun; Landrum, Lisa; Mannel, Robert; Chuang, Linus; Yu, Jian Qin (Michael); McCourt, Carolyn Kay; Gold, Michael

2014-01-01

Rationale and objectives To assess if ferumoxtran-10 (f-10) improves accuracy of MRI to detect lymph node (LN) metastasis in advanced cervical cancer. Materials and methods F-10 MRI component of an IRB approved HIPAA compliant ACRIN/GOG trial was analyzed. Patients underwent f-10 MRI followed by extra-peritoneal or laparoscopic pelvic and abdominal lymphadenectomy. F-10-sensitive sequences were T2* GRE sequences with TE of 12 and 21. Seven independent blinded readers reviewed f-10-insensitive sequences and all sequences in different sessions. Region correlations were performed between pathology and MRI for eight abdomen and pelvis regions. Sensitivity and specificity were calculated at participant level. Reference standard is based on pathology result of surgically removed LNs. Results Among 43 women enrolled in the trial between September 2007 and November 2009, 33 women (mean age 49 ± 11 years old) with advanced cervical cancer (12 IB2, 3 IIA, 15 IIB and 3 IIIB, 29 squamous cell carcinomas, 32 grade 2 or 3) were evaluable. Based on histopathology, LN metastasis was 39% in abdomen and 70% in pelvis. Sensitivity of all sequence review in pelvis, abdomen, and combined were 83%, 60%, and 86%, compared with 78%, 54%, and 80% for f-10 insensitive sequences (P: 0.24, 0.44 and 0.14, respectively). Mean diameter of the largest positive focus on histopathology was 13.7 mm in abdomen and 18.8 mm in pelvis (P = 0.018). Specificities of all sequence review in pelvis, abdomen, and combined were 48%, 75%, and 43%, compared with 75%, 83%, and 73% (P: 0.003, 0.14, 0.002 respectively) for f-10 insensitive sequences. Conclusion Addition of f-10 increased MRI sensitivity to detect LN metastasis in advanced cervical cancer. Increased sensitivity did not reach statistical significance and was at the expense of lower specificity. PMID:25774381

Utility of preoperative ferumoxtran-10 MRI to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN 6671/GOG 0233.

PubMed

Atri, Mostafa; Zhang, Zheng; Marques, Helga; Gorelick, Jeremy; Harisinghani, Mukesh; Sohaib, Aslam; Koh, Dow-Mu; Raman, Steven; Gee, Michael; Choi, Haesun; Landrum, Lisa; Mannel, Robert; Chuang, Linus; Yu, Jian Qin Michael; McCourt, Carolyn Kay; Gold, Michael

To assess if ferumoxtran-10 (f-10) improves accuracy of MRI to detect lymph node (LN) metastasis in advanced cervical cancer. F-10 MRI component of an IRB approved HIPAA compliant ACRIN/GOG trial was analyzed. Patients underwent f-10 MRI followed by extra-peritoneal or laparoscopic pelvic and abdominal lymphadenectomy. F-10-sensitive sequences were T2* GRE sequences with TE of 12 and 21. Seven independent blinded readers reviewed f-10-insensitive sequences and all sequences in different sessions. Region correlations were performed between pathology and MRI for eight abdomen and pelvis regions. Sensitivity and specificity were calculated at participant level. Reference standard is based on pathology result of surgically removed LNs. Among 43 women enrolled in the trial between September 2007 and November 2009, 33 women (mean age 49 ±11 years old) with advanced cervical cancer (12 IB2, 3 IIA, 15 IIB and 3 IIIB, 29 squamous cell carcinomas, 32 grade 2 or 3) were evaluable. Based on histopathology, LN metastasis was 39% in abdomen and 70% in pelvis. Sensitivity of all sequence review in pelvis, abdomen, and combined were 83%, 60%, and 86%, compared with 78%, 54%, and 80% for f-10 insensitive sequences ( P : 0.24, 0.44 and 0.14, respectively). Mean diameter of the largest positive focus on histopathology was 13.7 mm in abdomen and 18.8 mm in pelvis ( P = 0.018). Specificities of all sequence review in pelvis, abdomen, and combined were 48%, 75%, and 43%, compared with 75%, 83%, and 73% ( P : 0.003, 0.14, 0.002 respectively) for f-10 insensitive sequences. Addition of f-10 increased MRI sensitivity to detect LN metastasis in advanced cervical cancer. Increased sensitivity did not reach statistical significance and was at the expense of lower specificity.

Anorexia Nervosa: Analysis of Trabecular Texture with CT

PubMed Central

Tabari, Azadeh; Torriani, Martin; Miller, Karen K.; Klibanski, Anne; Kalra, Mannudeep K.

2017-01-01

Purpose To determine indexes of skeletal integrity by using computed tomographic (CT) trabecular texture analysis of the lumbar spine in patients with anorexia nervosa and normal-weight control subjects and to determine body composition predictors of trabecular texture. Materials and Methods This cross-sectional study was approved by the institutional review board and compliant with HIPAA. Written informed consent was obtained. The study included 30 women with anorexia nervosa (mean age ± standard deviation, 26 years ± 6) and 30 normal-weight age-matched women (control group). All participants underwent low-dose single-section quantitative CT of the L4 vertebral body with use of a calibration phantom. Trabecular texture analysis was performed by using software. Skewness (asymmetry of gray-level pixel distribution), kurtosis (pointiness of pixel distribution), entropy (inhomogeneity of pixel distribution), and mean value of positive pixels (MPP) were assessed. Bone mineral density and abdominal fat and paraspinal muscle areas were quantified with quantitative CT. Women with anorexia nervosa and normal-weight control subjects were compared by using the Student t test. Linear regression analyses were performed to determine associations between trabecular texture and body composition. Results Women with anorexia nervosa had higher skewness and kurtosis, lower MPP (P < .001), and a trend toward lower entropy (P = .07) compared with control subjects. Bone mineral density, abdominal fat area, and paraspinal muscle area were inversely associated with skewness and kurtosis and positively associated with MPP and entropy. Texture parameters, but not bone mineral density, were associated with lowest lifetime weight and duration of amenorrhea in anorexia nervosa. Conclusion Patients with anorexia nervosa had increased skewness and kurtosis and decreased entropy and MPP compared with normal-weight control subjects. These parameters were associated with lowest lifetime weight and duration of amenorrhea, but there were no such associations with bone mineral density. These findings suggest that trabecular texture analysis might contribute information about bone health in anorexia nervosa that is independent of that provided with bone mineral density. © RSNA, 2016 PMID:27797678

Diabetes mellitus: long-term prognostic value of whole-body MR imaging for the occurrence of cardiac and cerebrovascular events.

PubMed

Bamberg, Fabian; Parhofer, Klaus G; Lochner, Elena; Marcus, Roy P; Theisen, Daniel; Findeisen, Hannes M; Hoffmann, Udo; Schönberg, Stefan O; Schlett, Christopher L; Reiser, Maximilian F; Weckbach, Sabine

2013-12-01

To study the predictive value of whole-body magnetic resonance (MR) imaging for the occurrence of cardiac and cerebrovascular events in a cohort of patients with diabetes mellitus (DM). This HIPAA-compliant study was approved by the institutional review board. Informed consent was obtained from all patients before enrollment into the study. The authors followed up 65 patients with DM (types 1 and 2) who underwent a comprehensive, contrast material-enhanced whole-body MR imaging protocol, including brain, cardiac, and vascular sequences at baseline. Follow-up was performed by phone interview. The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE), which was defined as composite cardiac-cerebrovascular death, myocardial infarction, cerebrovascular event, or revascularization. MR images were assessed for the presence of systemic atherosclerotic vessel changes, white matter lesions, and myocardial changes. Kaplan-Meier survival and Cox regression analyses were performed to determine associations. Follow-up was completed in 61 patients (94%; median age, 67.5 years; 30 women [49%]; median follow-up, 70 months); 14 of the 61 patients (23%) experienced MACCE. Although normal whole-body MR imaging excluded MACCE during the follow-up period (0%; 95% confidence interval [CI]: 0%, 17%), any detectable ischemic and/or atherosclerotic changes at whole-body MR imaging (prevalence, 66%) conferred a cumulative event rate of 20% at 3 years and 35% at 6 years. Whole-body MR imaging summary estimate of disease was strongly predictive for MACCE (one increment of vessel score and each territory with atherosclerotic changes: hazard ratio, 13.2 [95% CI: 4.5, 40.1] and 3.9 [95% CI: 2.2, 7.5], respectively), also beyond clinical characteristics as well as individual cardiac or cerebrovascular MR findings. These initial data indicate that disease burden as assessed with whole-body MR imaging confers strong prognostic information in patients with DM. Online supplemental material is available for this article. © RSNA, 2013.

Registry-based Study of Trends in Breast Cancer Screening Mammography before and after the 2009 U.S. Preventive Services Task Force Recommendations

PubMed Central

Bolton, Kenyon C.; Mace, John L.; Herschorn, Sally D.; James, Ted A.; Vacek, Pamela M.; Weaver, Donald L.; Geller, Berta M.

2014-01-01

Purpose To determine whether the 2009 U.S. Preventive Services Task Force (USPSTF) guidelines for breast cancer mammography screening were followed by changes in screening utilization in the state of Vermont. Materials and Methods This retrospective study was HIPAA compliant and approved by the institutional review board, with waiver of informed consent. Trends in screening mammography utilization during 1997–2011 were examined among approximately 150 000 women aged 40 years and older in the state of Vermont using statewide mammography registry data. Results The percentage of Vermont women aged 40 years and older screened in the past year declined from 45.3% in 2009% to 41.6% in 2011 (an absolute decrease of −3.7 percentage points; 95% confidence interval [CI]: −3.3, −4.1). The largest decline in utilization was among women aged 40–49 years (−4.8 percentage points; 95% CI: −4.1, −5.4), although substantial declines were also observed among women aged 50–74 years (−3.0 percentage points; 95% CI: −2.6, −3.5) and women aged 75 years and older (−3.1 percentage points; 95% CI: −2.3, −4.0). The percentage of women aged 50–74 years screened within the past 2 years declined by −3.4 percentage points (95% CI: −3.0, −3.9) from 65.4% in 2009 to 61.9% in 2011. Conclusion After years of increasing screening mammography utilization in Vermont, there was a decline in screening, which coincided with the release of the 2009 USPSTF recommendations. The age-specific patterns in utilization were generally consistent with the USPSTF recommendations, although there was also evidence that the percentage of women aged 50–74 years screened in the past 2 years declined since 2009. © RSNA, 2013 PMID:24072778

Predonation Volume of Future Remnant Cortical Kidney Helps Predict Postdonation Renal Function in Live Kidney Donors.

PubMed

Fananapazir, Ghaneh; Benzl, Robert; Corwin, Michael T; Chen, Ling-Xin; Sageshima, Junichiro; Stewart, Susan L; Troppmann, Christoph

2018-07-01

Purpose To determine whether the predonation computed tomography (CT)-based volume of the future remnant kidney is predictive of postdonation renal function in living kidney donors. Materials and Methods This institutional review board-approved, retrospective, HIPAA-compliant study included 126 live kidney donors who had undergone predonation renal CT between January 2007 and December 2014 as well as 2-year postdonation measurement of estimated glomerular filtration rate (eGFR). The whole kidney volume and cortical volume of the future remnant kidney were measured and standardized for body surface area (BSA). Bivariate linear associations between the ratios of whole kidney volume to BSA and cortical volume to BSA were obtained. A linear regression model for 2-year postdonation eGFR that incorporated donor age, sex, and either whole kidney volume-to-BSA ratio or cortical volume-to-BSA ratio was created, and the coefficient of determination (R 2 ) for the model was calculated. Factors not statistically additive in assessing 2-year eGFR were removed by using backward elimination, and the coefficient of determination for this parsimonious model was calculated. Results Correlation was slightly better for cortical volume-to-BSA ratio than for whole kidney volume-to-BSA ratio (r = 0.48 vs r = 0.44, respectively). The linear regression model incorporating all donor factors had an R 2 of 0.66. The only factors that were significantly additive to the equation were cortical volume-to-BSA ratio and predonation eGFR (P = .01 and P < .01, respectively), and the final parsimonious linear regression model incorporating these two variables explained almost the same amount of variance (R 2 = 0.65) as did the full model. Conclusion The cortical volume of the future remnant kidney helped predict postdonation eGFR at 2 years. The cortical volume-to-BSA ratio should thus be considered for addition as an important variable to living kidney donor evaluation and selection guidelines. © RSNA, 2018.

Gender Differences in Academic Rank of Radiologists in U.S. Medical Schools.

PubMed

Kapoor, Neena; Blumenthal, Daniel M; Smith, Stacy E; Ip, Ivan K; Khorasani, Ramin

2017-04-01

Purpose To determine whether there were gender differences in full professorship after accounting for factors known to influence academic advancement. Materials and Methods Institutional review board approval was obtained for this HIPAA-compliant study, with waiver of informed consent. In this cross-sectional study, the authors used a comprehensive 2014 physician database (5089 academic radiologists, inclusive of all U.S. academic radiologists in 2014; 11.3% of all U.S. radiologists) containing information on physician age, years since residency, National Institutes of Health funding, scientific publications (first or last author and total), clinical trial investigation, and clinical volume measured according to 2013 Medicare reimbursement. Primary outcome of gender differences in full professorship was estimated by using a multilevel logistic regression model adjusting for these factors. Results Among 5089 academic radiologists, 3638 (71.5%) were men. The average age for male and female radiologists was 52 and 49 years, respectively. Overall, 239 women (16.5%) and 948 (26.1%) men were full professors (P < .001). Women had fewer total and first or last author publications than men (total, 12.2 vs 17.6; first or last, 6.8 vs 10.7; P < .001 for both comparisons). Women were less likely than men to have National Institutes of Health funding (2.0% vs 3.6%; P = .004) and generated less annual Medicare revenue ($63 346 vs $75 854; P = .001). After multivariate adjustment, rates of full professorship among female and male radiologists were not significantly different (absolute adjusted difference for female vs male radiologists, -1.5%; 95% confidence interval: -3.8%, 0.9%). Conclusion Among radiologists with U.S. medical school faculty appointments in 2014, men and women were similarly likely to be full professor after several factors known to influence promotion were taken into account. However, unadjusted differences in promotion and research productivity were present, which suggests that female radiologists may lack equal research opportunities. © RSNA, 2016.

TU-CD-207-09: Analysis of the 3-D Shape of Patients’ Breast for Breast Imaging and Surgery Planning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Agasthya, G; Sechopoulos, I

2015-06-15

Purpose: Develop a method to accurately capture the 3-D shape of patients’ external breast surface before and during breast compression for mammography/tomosynthesis. Methods: During this IRB-approved, HIPAA-compliant study, 50 women were recruited to undergo 3-D breast surface imaging during breast compression and imaging for the cranio-caudal (CC) view on a digital mammography/breast tomosynthesis system. Digital projectors and cameras mounted on tripods were used to acquire 3-D surface images of the breast, in three conditions: (a) positioned on the support paddle before compression, (b) during compression by the compression paddle and (c) the anterior-posterior view with the breast in its natural,more » unsupported position. The breast was compressed to standard full compression with the compression paddle and a tomosynthesis image was acquired simultaneously with the 3-D surface. The 3-D surface curvature and deformation with respect to the uncompressed surface was analyzed using contours. The 3-D surfaces were voxelized to capture breast shape in a format that can be manipulated for further analysis. Results: A protocol was developed to accurately capture the 3-D shape of patients’ breast before and during compression for mammography. Using a pair of 3-D scanners, the 50 patient breasts were scanned in three conditions, resulting in accurate representations of the breast surfaces. The surfaces were post processed, analyzed using contours and voxelized, with 1 mm{sup 3} voxels, converting the breast shape into a format that can be easily modified as required. Conclusion: Accurate characterization of the breast curvature and shape for the generation of 3-D models is possible. These models can be used for various applications such as improving breast dosimetry, accurate scatter estimation, conducting virtual clinical trials and validating compression algorithms. Ioannis Sechopoulos is consultant for Fuji Medical Systems USA.« less

Nonalcoholic Fatty Liver Disease: MR Imaging of Liver Proton Density Fat Fraction to Assess Hepatic Steatosis

PubMed Central

Tang, An; Tan, Justin; Sun, Mark; Hamilton, Gavin; Bydder, Mark; Wolfson, Tanya; Gamst, Anthony C.; Middleton, Michael; Brunt, Elizabeth M.; Loomba, Rohit; Lavine, Joel E.; Schwimmer, Jeffrey B.

2013-01-01

Purpose: To evaluate the diagnostic performance of magnetic resonance (MR) imaging–estimated proton density fat fraction (PDFF) for assessing hepatic steatosis in nonalcoholic fatty liver disease (NAFLD) by using centrally scored histopathologic validation as the reference standard. Materials and Methods: This prospectively designed, cross-sectional, internal review board–approved, HIPAA-compliant study was conducted in 77 patients who had NAFLD and liver biopsy. MR imaging–PDFF was estimated from magnitude-based low flip angle multiecho gradient-recalled echo images after T2* correction and multifrequency fat modeling. Histopathologic scoring was obtained by consensus of the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network Pathology Committee. Spearman correlation, additivity and variance stabilization for regression for exploring the effect of a number of potential confounders, and receiver operating characteristic analyses were performed. Results: Liver MR imaging–PDFF was systematically higher, with higher histologic steatosis grade (P < .001), and was significantly correlated with histologic steatosis grade (ρ = 0.69, P < .001). The correlation was not confounded by age, sex, lobular inflammation, hepatocellular ballooning, NASH diagnosis, fibrosis, or magnetic field strength (P = .65). Area under the receiver operating characteristic curves was 0.989 (95% confidence interval: 0.968, 1.000) for distinguishing patients with steatosis grade 0 (n = 5) from those with grade 1 or higher (n = 72), 0.825 (95% confidence interval: 0.734, 0.915) to distinguish those with grade 1 or lower (n = 31) from those with grade 2 or higher (n = 46), and 0.893 (95% confidence interval: 0.809, 0.977) to distinguish those with grade 2 or lower (n = 58) from those with grade 3 (n = 19). Conclusion: MR imaging–PDFF showed promise for assessment of hepatic steatosis grade in patients with NAFLD. For validation, further studies with larger sample sizes are needed. © RSNA, 2013 PMID:23382291

Accuracy of PDFF estimation by magnitude-based and complex-based MRI in children with MR spectroscopy as a reference.

PubMed

Haufe, William M; Wolfson, Tanya; Hooker, Catherine A; Hooker, Jonathan C; Covarrubias, Yesenia; Schlein, Alex N; Hamilton, Gavin; Middleton, Michael S; Angeles, Jorge E; Hernando, Diego; Reeder, Scott B; Schwimmer, Jeffrey B; Sirlin, Claude B

2017-12-01

To assess and compare the accuracy of magnitude-based magnetic resonance imaging (MRI-M) and complex-based MRI (MRI-C) for estimating hepatic proton density fat fraction (PDFF) in children, using MR spectroscopy (MRS) as the reference standard. A secondary aim was to assess the agreement between MRI-M and MRI-C. This was a HIPAA-compliant, retrospective analysis of data collected in children enrolled in prospective, Institutional Review Board (IRB)-approved studies between 2012 and 2014. Informed consent was obtained from 200 children (ages 8-19 years) who subsequently underwent 3T MR exams that included MRI-M, MRI-C, and T 1 -independent, T 2 -corrected, single-voxel stimulated echo acquisition mode (STEAM) MRS. Both MRI methods acquired six echoes at low flip angles. T2*-corrected PDFF parametric maps were generated. PDFF values were recorded from regions of interest (ROIs) drawn on the maps in each of the nine Couinaud segments and three ROIs colocalized to the MRS voxel location. Regression analyses assessing agreement with MRS were performed to evaluate the accuracy of each MRI method, and Bland-Altman and intraclass correlation coefficient (ICC) analyses were performed to assess agreement between the MRI methods. MRI-M and MRI-C PDFF were accurate relative to the colocalized MRS reference standard, with regression intercepts of 0.63% and -0.07%, slopes of 0.998 and 0.975, and proportion-of-explained-variance values (R 2 ) of 0.982 and 0.979, respectively. For individual Couinaud segments and for the whole liver averages, Bland-Altman biases between MRI-M and MRI-C were small (ranging from 0.04 to 1.11%) and ICCs were high (≥0.978). Both MRI-M and MRI-C accurately estimated hepatic PDFF in children, and high intermethod agreement was observed. 1 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2017;46:1641-1647. © 2017 International Society for Magnetic Resonance in Medicine.

Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial.

PubMed

Ajam, Amna A; Nguyen, Xuan V; Kelly, Ronda A; Ladapo, Joseph A; Lang, Elvira V

2017-07-01

The aim of this study was to assess the effects of team training on operational efficiency during outpatient MRI. In this institutional review board-approved, HIPAA-compliant study, six MRI outpatient sites of a midwestern hospital system were randomized to serve as controls or have their teams trained in advanced communication skills. The fourth quarter of fiscal year 2015 was the trial baseline. The trial ended in the third quarter (Q3) of fiscal year 2016 (FY16). Equipment utilization (completed scans/available slots), hourly scan rates (total orders completed per machine per hour of operation), and no-show rates stratified by time were analyzed using the Cochran-Mantel-Haenszel method, with individual comparisons performed with Bonferroni correction. The study encompassed 27,425 MRI examinations. Overall volume peaked at baseline and then declined over the following quarters. Compared with baseline, untrained sites experienced significant drops in equipment utilization (P < .01 for the first quarter of FY16 and P < .0001 for the second quarter of FY16 and Q3 FY16), decreasing from 77% to 65% over the study period, corresponding to a decrease from 1.15 to 0.97 in hourly scan rates. For trained sites, these metrics showed no significant change, with maintenance of hourly scan rates of 1.23 and 1.27 and equipment utilization rates of 83% and 85% between baseline and Q3 FY16. No-show rates remained stable at trained sites but increased at untrained sites in the last two quarters (P < .05). Nationally benchmarked patient satisfaction percentile ranking gradually increased at trained sites from 56th at baseline to 70th and successively decreased at untrained sites from 66th to 44th. MRI outpatient facilities trained in advanced communication techniques may have more favorable operational efficiency than untrained sites in a saturated market. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Incidentally detected gallbladder polyps: is follow-up necessary?--Long-term clinical and US analysis of 346 patients.

PubMed

Corwin, Michael T; Siewert, Bettina; Sheiman, Robert G; Kane, Robert A

2011-01-01

To determine the natural history of gallbladder (GB) polyps incidentally detected at ultrasonography (US) and to propose management guidelines for these lesions based on polyp size. The HIPAA-compliant study was approved by the institutional review board, and informed consent was waived. A database search for "polyp" in all US examinations of the GB between January 1, 1999, and December 31, 2001, at a single institution was performed. All subsequent US reports were reviewed to determine changes in GB polyp size. The electronic medical record was searched to obtain clinical and pathologic follow-up. Three hundred forty-six patients (mean age, 51.6 years; range, 20-93 years) with GB polyps were included. There were 156 men (45%) and 190 women (55%). US follow-up (mean, 5.4 years; range, 2-11.5 years) was performed in 149 patients (43%). Polyp size was stable in 90 (60%) polyps, decreased in eight (5%), increased in one (1%), and resolved in 50 (34%). Forty-two patients (12%) underwent cholecystectomy, revealing 13 (31%) GBs with polypoid lesions, 24 (57%) with stones and no polyps, and five (12%) with neither a stone nor a polypoid lesion. Clinical follow-up (mean, 8 years; range, 5-10.4 years) was performed in 155 patients (45%). No patient had clinical evidence of GB-related disease. Overall, no cases of GB malignancy were identified in 346 patients. Mean polyp size was 5.0 mm (range, 1-18 mm). No neoplastic polyps were found at 1-6 mm, one neoplastic polyp was seen at 7-9 mm, and two neoplastic polyps were found at 10 mm or larger. The risk of GB malignancy resulting from incidentally detected polyps is extremely low. Incidentally detected GB polyps measuring 6 mm or less may require no additional follow-up. Data are inconclusive regarding polyps 7 mm or greater, and further studies are warranted. © RSNA, 2010

Proton Density Fat Fraction Measurements at 1.5- and 3-T Hepatic MR Imaging: Same-Day Agreement among Readers and across Two Imager Manufacturers.

PubMed

Serai, Suraj D; Dillman, Jonathan R; Trout, Andrew T

2017-07-01

Purpose To determine the agreement of proton density fat fraction (PDFF) measurements obtained with hepatic magnetic resonance (MR) imaging among readers, imager manufacturers, and field strengths. Materials and Methods This HIPAA-compliant study was approved by the institutional review board. After providing informed consent, 24 adult volunteers underwent imaging with one 1.5-T MR unit (Ingenia; Philips Healthcare, Best, the Netherlands) and two different 3.0-T units (750 W [GE Healthcare, Waukesha, Wis] and Ingenia) on the same day to estimate hepatic PDFF. A single-breath-hold multipoint Dixon-based acquisition was performed with commercially available pulse sequences provided by the MR imager manufacturers (mDIXON Quant [Philips Healthcare], IDEAL IQ [GE Healthcare]). Five readers placed one large region of interest, inclusive of as much liver parenchyma as possible in the right lobe while avoiding large vessels, on imager-generated parametric maps to measure hepatic PDFF. Two-way single-measure intraclass correlation coefficients (ICCs) were used to assess interreader agreement and agreement across the three imaging platforms. Results Excellent interreader agreement for hepatic PDFF measurements was obtained with mDIXON Quant and the Philips 1.5-T unit (ICC, 0.995; 95% confidence interval [CI]: 0.991, 0.998), mDIXON Quant and the Philips 3.0-T unit (ICC, 0.992; 95% CI: 0.986, 0.996), and IDEAL IQ and the GE 3.0-T unit (ICC, 0.966; 95% CI: 0.939, 0.984). Individual reader ICCs for hepatic PDFF measurements across all three imager manufacturer-field strength combinations also showed excellent interimager agreement, ranging from 0.914 to 0.954. Conclusion Estimation of PDFF with hepatic MR imaging by using multipoint Dixon techniques is highly reproducible across readers, field strengths, and imaging platforms. © RSNA, 2017.

Real-time FDG PET Guidance during Biopsies and Radiofrequency Ablation Using Multimodality Fusion with Electromagnetic Navigation

PubMed Central

Kadoury, Samuel; Abi-Jaoudeh, Nadine; Levy, Elliot B.; Maass-Moreno, Roberto; Krücker, Jochen; Dalal, Sandeep; Xu, Sheng; Glossop, Neil; Wood, Bradford J.

2011-01-01

Purpose: To assess the feasibility of combined electromagnetic device tracking and computed tomography (CT)/ultrasonography (US)/fluorine 18 fluorodeoxyglucose (FDG) positron emission tomography (PET) fusion for real-time feedback during percutaneous and intraoperative biopsies and hepatic radiofrequency (RF) ablation. Materials and Methods: In this HIPAA-compliant, institutional review board–approved prospective study with written informed consent, 25 patients (17 men, eight women) underwent 33 percutaneous and three intraoperative biopsies of 36 FDG-avid targets between November 2007 and August 2010. One patient underwent biopsy and RF ablation of an FDG-avid hepatic focus. Targets demonstrated heterogeneous FDG uptake or were not well seen or were totally inapparent at conventional imaging. Preprocedural FDG PET scans were rigidly registered through a semiautomatic method to intraprocedural CT scans. Coaxial biopsy needle introducer tips and RF ablation electrode guider needle tips containing electromagnetic sensor coils were spatially tracked through an electromagnetic field generator. Real-time US scans were registered through a fiducial-based method, allowing US scans to be fused with intraprocedural CT and preacquired FDG PET scans. A visual display of US/CT image fusion with overlaid coregistered FDG PET targets was used for guidance; navigation software enabled real-time biopsy needle and needle electrode navigation and feedback. Results: Successful fusion of real-time US to coregistered CT and FDG PET scans was achieved in all patients. Thirty-one of 36 biopsies were diagnostic (malignancy in 18 cases, benign processes in 13 cases). RF ablation resulted in resolution of targeted FDG avidity, with no local treatment failure during short follow-up (56 days). Conclusion: Combined electromagnetic device tracking and image fusion with real-time feedback may facilitate biopsies and ablations of focal FDG PET abnormalities that would be challenging with conventional image guidance. © RSNA, 2011 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11101985/-/DC1 PMID:21734159

Exposing exposure: automated anatomy-specific CT radiation exposure extraction for quality assurance and radiation monitoring.

PubMed

Sodickson, Aaron; Warden, Graham I; Farkas, Cameron E; Ikuta, Ichiro; Prevedello, Luciano M; Andriole, Katherine P; Khorasani, Ramin

2012-08-01

To develop and validate an informatics toolkit that extracts anatomy-specific computed tomography (CT) radiation exposure metrics (volume CT dose index and dose-length product) from existing digital image archives through optical character recognition of CT dose report screen captures (dose screens) combined with Digital Imaging and Communications in Medicine attributes. This institutional review board-approved HIPAA-compliant study was performed in a large urban health care delivery network. Data were drawn from a random sample of CT encounters that occurred between 2000 and 2010; images from these encounters were contained within the enterprise image archive, which encompassed images obtained at an adult academic tertiary referral hospital and its affiliated sites, including a cancer center, a community hospital, and outpatient imaging centers, as well as images imported from other facilities. Software was validated by using 150 randomly selected encounters for each major CT scanner manufacturer, with outcome measures of dose screen retrieval rate (proportion of correctly located dose screens) and anatomic assignment precision (proportion of extracted exposure data with correctly assigned anatomic region, such as head, chest, or abdomen and pelvis). The 95% binomial confidence intervals (CIs) were calculated for discrete proportions, and CIs were derived from the standard error of the mean for continuous variables. After validation, the informatics toolkit was used to populate an exposure repository from a cohort of 54 549 CT encounters; of which 29 948 had available dose screens. Validation yielded a dose screen retrieval rate of 99% (597 of 605 CT encounters; 95% CI: 98%, 100%) and an anatomic assignment precision of 94% (summed DLP fraction correct 563 in 600 CT encounters; 95% CI: 92%, 96%). Patient safety applications of the resulting data repository include benchmarking between institutions, CT protocol quality control and optimization, and cumulative patient- and anatomy-specific radiation exposure monitoring. Large-scale anatomy-specific radiation exposure data repositories can be created with high fidelity from existing digital image archives by using open-source informatics tools.

Peripheral Vasculature: High-Temporal- and High-Spatial-Resolution Three-dimensional Contrast-enhanced MR Angiography1

PubMed Central

Haider, Clifton R.; Glockner, James F.; Stanson, Anthony W.; Riederer, Stephen J.

2009-01-01

Purpose: To prospectively evaluate the feasibility of performing high-spatial-resolution (1-mm isotropic) time-resolved three-dimensional (3D) contrast material–enhanced magnetic resonance (MR) angiography of the peripheral vasculature with Cartesian acquisition with projection-reconstruction–like sampling (CAPR) and eightfold accelerated two-dimensional (2D) sensitivity encoding (SENSE). Materials and Methods: All studies were approved by the institutional review board and were HIPAA compliant; written informed consent was obtained from all participants. There were 13 volunteers (mean age, 41.9; range, 27–53 years). The CAPR sequence was adapted to provide 1-mm isotropic spatial resolution and a 5-second frame time. Use of different receiver coil element sizes for those placed on the anterior-to-posterior versus left-to-right sides of the field of view reduced signal-to-noise ratio loss due to acceleration. Results from eight volunteers were rated independently by two radiologists according to prominence of artifact, arterial to venous separation, vessel sharpness, continuity of arterial signal intensity in major arteries (anterior and posterior tibial, peroneal), demarcation of origin of major arteries, and overall diagnostic image quality. MR angiographic results in two patients with peripheral vascular disease were compared with their results at computed tomographic angiography. Results: The sequence exhibited no image artifact adversely affecting diagnostic image quality. Temporal resolution was evaluated to be sufficient in all cases, even with known rapid arterial to venous transit. The vessels were graded to have excellent sharpness, continuity, and demarcation of the origins of the major arteries. Distal muscular branches and the communicating and perforating arteries were routinely seen. Excellent diagnostic quality rating was given for 15 (94%) of 16 evaluations. Conclusion: The feasibility of performing high-diagnostic-quality time-resolved 3D contrast-enhanced MR angiography of the peripheral vasculature by using CAPR and eightfold accelerated 2D SENSE has been demonstrated. © RSNA, 2009 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.2533081744/-/DC1 PMID:19789238

Automated Critical Test Findings Identification and Online Notification System Using Artificial Intelligence in Imaging.

PubMed

Prevedello, Luciano M; Erdal, Barbaros S; Ryu, John L; Little, Kevin J; Demirer, Mutlu; Qian, Songyue; White, Richard D

2017-12-01

Purpose To evaluate the performance of an artificial intelligence (AI) tool using a deep learning algorithm for detecting hemorrhage, mass effect, or hydrocephalus (HMH) at non-contrast material-enhanced head computed tomographic (CT) examinations and to determine algorithm performance for detection of suspected acute infarct (SAI). Materials and Methods This HIPAA-compliant retrospective study was completed after institutional review board approval. A training and validation dataset of noncontrast-enhanced head CT examinations that comprised 100 examinations of HMH, 22 of SAI, and 124 of noncritical findings was obtained resulting in 2583 representative images. Examinations were processed by using a convolutional neural network (deep learning) using two different window and level configurations (brain window and stroke window). AI algorithm performance was tested on a separate dataset containing 50 examinations with HMH findings, 15 with SAI findings, and 35 with noncritical findings. Results Final algorithm performance for HMH showed 90% (45 of 50) sensitivity (95% confidence interval [CI]: 78%, 97%) and 85% (68 of 80) specificity (95% CI: 76%, 92%), with area under the receiver operating characteristic curve (AUC) of 0.91 with the brain window. For SAI, the best performance was achieved with the stroke window showing 62% (13 of 21) sensitivity (95% CI: 38%, 82%) and 96% (27 of 28) specificity (95% CI: 82%, 100%), with AUC of 0.81. Conclusion AI using deep learning demonstrates promise for detecting critical findings at noncontrast-enhanced head CT. A dedicated algorithm was required to detect SAI. Detection of SAI showed lower sensitivity in comparison to detection of HMH, but showed reasonable performance. Findings support further investigation of the algorithm in a controlled and prospective clinical setting to determine whether it can independently screen noncontrast-enhanced head CT examinations and notify the interpreting radiologist of critical findings. © RSNA, 2017 Online supplemental material is available for this article.

Liver Metabolite Concentrations Measured with 1H MR Spectroscopy

PubMed Central

Pettigrew, Roderic I.; Gharib, Ahmed M.

2012-01-01

Purpose: To determine the feasibility of measuring choline and glycogen concentrations in normal human liver in vivo with proton (hydrogen 1 [1H]) magnetic resonance (MR) spectroscopy. Materials and Methods: Signed consent to participate in an institutional review board–approved and HIPAA-compliant study was obtained from 46 subjects (mean age, 46 years ± 17 [standard deviation]; 24 women) consecutively recruited during 285 days. Navigator-gated MR images were used to select 8-mL volumes for point-resolved spectroscopy (PRESS) with a 35-msec echo time. Line widths were minimized with fast breath-hold B0 field mapping and further manual shimming. Navigator-gated spectra were recorded with and without water suppression to determine metabolite concentrations with water signals as an internal reference. In three subjects, echo time was varied to determine the glycogen and choline T2. Linear regression analysis was used to examine relations between choline, hepatic lipid content, body mass index, glycogen content, and age. Results: Choline concentrations could be determined in 46 of 48 studies and was found to be 8.6 mmol per kilogram of wet weight ± 3.1 (range, 3.8–17.6; n = 44). Twenty-seven spectra in 25 individuals with narrow line widths and low lipid content were adequate for quantitation of glycogen. The glycogen (glucosyl unit) concentration was 38.1 mmol/kg wet weight ± 14.4. The T2 of combined glycogen peaks in the liver of three subjects was 36 msec ± 8. Choline levels showed a weak but significant correlation with glycogen (r2 = 0.15; P < .05) but not with lipid content. Conclusion: Navigator-gated and gradient-echo shimmed PRESS 1H MR spectroscopy may allow quantification of liver metabolites that are important for understanding and identifying disorders of glucose and lipid metabolism. © RSNA, 2012 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12112344/-/DC1 PMID:22891360

Feasibility of a novel mHealth management system to capture and improve medication adherence among adolescents with asthma

PubMed Central

Cushing, Anna; Manice, Melissa P; Ting, Andrew; Parides, Michael K

2016-01-01

Purpose Currently, 7.1 million children in the United States have asthma. Nonadherence to daily controller asthma medication is common, leading to more severe symptoms, overuse of rescue medication, and increased hospitalizations. The purpose of this study was to develop and evaluate the feasibility and acceptability of a novel mHealth management system composed of a sensored device, which is connected to mobile phone app that is designed to monitor and improve asthma medication adherence. Patients and methods The asthma management system was designed using well-established behavioral theory. Seven adolescents aged 11–18 years were enrolled and given an adherence sensor, and four of those also received a mobile phone app with game features and reminders. Five patients completed the study, and one was lost to follow-up in each group. Mobile app users and their parents participated in focus groups to assess patient preferences. Feasibility was assessed by the ability of sensors to capture real-time medication data. Acceptability was assessed by patient questionnaire and focus group analysis. Results Successful upload of real-time data from six of seven inhaler sensors to the HIPAA-compliant server demonstrates the feasibility of at-home patient monitoring using the sensor device. All three mobile app users who completed the study reported interest in continued use of the management system and would recommend the app to friends. Unstructured interviews and focus groups revealed that patients felt that the intervention helped their sense of asthma control. Conclusion This study demonstrates the feasibility of using the sensor device to remotely monitor real-time medication usage, and user feedback demonstrates the acceptability of the intervention for patient use. The findings provide guidance for the improvement of study design and technology development. Further research is needed to assess the efficacy of the intervention. PMID:27853357

Can Shear-Wave Elastography be Used to Discriminate Obstructive Hydronephrosis from Nonobstructive Hydronephrosis in Children?

PubMed

Dillman, Jonathan R; Smith, Ethan A; Davenport, Matthew S; DiPietro, Michael A; Sanchez, Ramon; Kraft, Kate H; Brown, Richard K J; Rubin, Jonathan M

2015-10-01

To determine if ultrasonographic (US) renal shear-wave speed (SWS) measurements obtained either before or after intravenous diuretic administration can be used to discriminate obstructive hydronephrosis from unobstructive hydronephrosis in children, with diuretic renal scintigraphy as the reference standard. Institutional review board approval and parental informed consent were obtained for this HIPAA-compliant prospective cross-sectional blind comparison with a reference standard. Between November 2012 and September 2014, 37 children (mean age, 4.1 years; age range, 1 month to 17 years) underwent shear-wave elastography of the kidneys immediately before and immediately after diuretic renal scintigraphy (reference standard for presence of urinary tract obstruction). Median SWS measurements (in meters per second), as well as change in median SWS (median SWS after diuretic administration minus median SWS before diuretic administration) were correlated with the amount of time required for kidney radiotracer activity to fall by 50% after intravenous administration of the diuretic (T1/2). Median SWS measurements were compared with degree of obstruction and degree of hydronephrosis with analysis of variance. Receiver operating characteristic (ROC) curves were created. Radiotracer T1/2 values after diuretic administration did not correlate with median SWS measurements obtained before (r = -0.08, P = .53) or after (r = -0.0004, P >.99) diuretic administration, nor did they correlate with intraindividual change in median SWS (r = 0.07, P = .56). There was no significant difference in pre- or postdiuretic median SWS measurements between kidneys with scintigraphic evidence of no, equivocal, or definite urinary tract obstruction (P > .5) or for median SWS measurements between kidneys with increasing degree of hydronephrosis (P > .5). ROC curves showed poor diagnostic performance of median SWS in discerning no, equivocal, or definite urinary tract obstruction (area under the ROC curve ranged from 0.50 to 0.62). US SWS measurements did not enable discrimination of obstructive hydronephrosis from unobstructive hydronephrosis in children. (©) RSNA, 2015 Online supplemental material is available for this article.

Fully Automated Quantitative Estimation of Volumetric Breast Density from Digital Breast Tomosynthesis Images: Preliminary Results and Comparison with Digital Mammography and MR Imaging

PubMed Central

Pertuz, Said; McDonald, Elizabeth S.; Weinstein, Susan P.; Conant, Emily F.

2016-01-01

Purpose To assess a fully automated method for volumetric breast density (VBD) estimation in digital breast tomosynthesis (DBT) and to compare the findings with those of full-field digital mammography (FFDM) and magnetic resonance (MR) imaging. Materials and Methods Bilateral DBT images, FFDM images, and sagittal breast MR images were retrospectively collected from 68 women who underwent breast cancer screening from October 2011 to September 2012 with institutional review board–approved, HIPAA-compliant protocols. A fully automated computer algorithm was developed for quantitative estimation of VBD from DBT images. FFDM images were processed with U.S. Food and Drug Administration–cleared software, and the MR images were processed with a previously validated automated algorithm to obtain corresponding VBD estimates. Pearson correlation and analysis of variance with Tukey-Kramer post hoc correction were used to compare the multimodality VBD estimates. Results Estimates of VBD from DBT were significantly correlated with FFDM-based and MR imaging–based estimates with r = 0.83 (95% confidence interval [CI]: 0.74, 0.90) and r = 0.88 (95% CI: 0.82, 0.93), respectively (P < .001). The corresponding correlation between FFDM and MR imaging was r = 0.84 (95% CI: 0.76, 0.90). However, statistically significant differences after post hoc correction (α = 0.05) were found among VBD estimates from FFDM (mean ± standard deviation, 11.1% ± 7.0) relative to MR imaging (16.6% ± 11.2) and DBT (19.8% ± 16.2). Differences between VDB estimates from DBT and MR imaging were not significant (P = .26). Conclusion Fully automated VBD estimates from DBT, FFDM, and MR imaging are strongly correlated but show statistically significant differences. Therefore, absolute differences in VBD between FFDM, DBT, and MR imaging should be considered in breast cancer risk assessment. © RSNA, 2015 Online supplemental material is available for this article. PMID:26491909

Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program

PubMed Central

Zuckerman, Samantha P.; Keller, Brad M.; Maidment, Andrew D. A.; Barufaldi, Bruno; Weinstein, Susan P.; Synnestvedt, Marie; McDonald, Elizabeth S.

2016-01-01

Purpose To evaluate the early implementation of synthesized two-dimensional (s2D) mammography in a population screened entirely with s2D and digital breast tomosynthesis (DBT) (referred to as s2D/DBT) and compare recall rates and cancer detection rates to historic outcomes of digital mammography combined with DBT (referred to as digital mammography/DBT) screening. Materials and Methods This was an institutional review board–approved and HIPAA-compliant retrospective interpretation of prospectively acquired data with waiver of informed consent. Compared were recall rates, biopsy rates, cancer detection rates, and radiation dose for 15 571 women screened with digital mammography/DBT from October 1, 2011, to February 28, 2013, and 5366 women screened with s2D/DBT from January 7, 2015, to June 30, 2015. Two-sample z tests of equal proportions were used to determine statistical significance. Results Recall rate for s2D/DBT versus digital mammography/DBT was 7.1% versus 8.8%, respectively (P < .001). Biopsy rate for s2D/DBT versus digital mammography/DBT decreased (1.3% vs 2.0%, respectively; P = .001). There was no significant difference in cancer detection rate for s2D/DBT versus digital mammography/DBT (5.03 of 1000 vs 5.45 of 1000, respectively; P = .72). The average glandular dose was 39% lower in s2D/DBT versus digital mammography/DBT (4.88 mGy vs 7.97 mGy, respectively; P < .001). Conclusion Screening with s2D/DBT in a large urban practice resulted in similar outcomes compared with digital mammography/DBT imaging. Screening with s2D/DBT allowed for the benefits of DBT with a decrease in radiation dose compared with digital mammography/DBT. © RSNA, 2016 An earlier incorrect version of this article appeared online. This article was corrected on August 11, 2016. PMID:27467468

Impact of Immediate Interpretation of Screening Tomosynthesis Mammography on Performance Metrics.

PubMed

Winkler, Nicole S; Freer, Phoebe; Anzai, Yoshimi; Hu, Nan; Stein, Matthew

2018-05-07

This study aimed to compare performance metrics for immediate and delayed batch interpretation of screening tomosynthesis mammograms. This HIPAA compliant study was approved by institutional review board with a waiver of consent. A retrospective analysis of screening performance metrics for tomosynthesis mammograms interpreted in 2015 when mammograms were read immediately was compared to historical controls from 2013 to 2014 when mammograms were batch interpreted after the patient had departed. A total of 5518 screening tomosynthesis mammograms (n = 1212 for batch interpretation and n = 4306 for immediate interpretation) were evaluated. The larger sample size for the latter group reflects a group practice shift to performing tomosynthesis for the majority of patients. Age, breast density, comparison examinations, and high-risk status were compared. An asymptotic proportion test and multivariable analysis were used to compare performance metrics. There was no statistically significant difference in recall or cancer detection rates for the batch interpretation group compared to immediate interpretation group with respective recall rate of 6.5% vs 5.3% = +1.2% (95% confidence interval -0.3 to 2.7%; P = .101) and cancer detection rate of 6.6 vs 7.2 per thousand = -0.6 (95% confidence interval -5.9 to 4.6; P = .825). There was no statistically significant difference in positive predictive values (PPVs) including PPV1 (screening recall), PPV2 (biopsy recommendation), or PPV 3 (biopsy performed) with batch interpretation (10.1%, 42.1%, and 40.0%, respectively) and immediate interpretation (13.6%, 39.2%, and 39.7%, respectively). After adjusting for age, breast density, high-risk status, and comparison mammogram, there was no difference in the odds of being recalled or cancer detection between the two groups. There is no statistically significant difference in interpretation performance metrics for screening tomosynthesis mammograms interpreted immediately compared to those interpreted in a delayed fashion. Copyright © 2018. Published by Elsevier Inc.

High-Grade Serous Ovarian Cancer: Use of Machine Learning to Predict Abdominopelvic Recurrence on CT on the Basis of Serial Cancer Antigen 125 Levels.

PubMed

Shinagare, Atul B; Balthazar, Patricia; Ip, Ivan K; Lacson, Ronilda; Liu, Joyce; Ramaiya, Nikhil; Khorasani, Ramin

2018-05-19

The aim of this study was to use machine learning to predict abdominal recurrence on CT on the basis of serial cancer antigen 125 (CA125) levels in patients with advanced high-grade serous ovarian cancer on surveillance. This institutional review board-approved, HIPAA-compliant, retrospective, hypothesis-generating study included all 57 patients (mean age, 61 ± 11.2 years) with advanced high-grade serous ovarian cancer who underwent cytoreductive surgery from January to December 2012, followed by surveillance abdominopelvic CT and corresponding CA125 levels. A blinded radiologist reviewed abdominopelvic CT studies until recurrence was noted. Four measures of CA125 were assessed: actual CA125 levels at the time of CT, absolute change since prior CT, relative change since prior CT, and rate of change since prior CT. Using machine learning, support vector machine models were optimized and evaluated using 10-fold cross-validation to determine the CA125 measure most predictive of abdominal recurrence. The association of the most accurate CA125 measure was further analyzed using Cox proportional-hazards model along with age, tumor size, stage, and degree of cytoreduction. Rate of change in CA125 was most predictive of abdominal recurrence in a linear kernel support vector machine model and was significantly higher preceding CT studies showing abdominal recurrence (median 13.2 versus 0.6 units/month; P = .007). On multivariate analysis, a higher rate of CA125 increase was significantly associated with recurrence (hazard ratio, 1.02 per 10 units change; 95% confidence interval, 1.0006-1.04; P = .04). A higher rate of CA125 increase is associated with abdominal recurrence. The rate of increase of CA125 may help in the selection of patients who are most likely to benefit from abdominopelvic CT in surveillance of ovarian cancer. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Renal Cell Carcinoma: Comparison of RENAL Nephrometry and PADUA Scores with Maximum Tumor Diameter for Prediction of Local Recurrence after Thermal Ablation.

PubMed

Maxwell, Aaron W P; Baird, Grayson L; Iannuccilli, Jason D; Mayo-Smith, William W; Dupuy, Damian E

2017-05-01

Purpose To evaluate the performance of the radius, exophytic or endophytic, nearness to collecting system or sinus, anterior or posterior, and location relative to polar lines (RENAL) nephrometry and preoperative aspects and dimensions used for anatomic classification (PADUA) scoring systems and other tumor biometrics for prediction of local tumor recurrence in patients with renal cell carcinoma after thermal ablation. Materials and Methods This HIPAA-compliant study was performed with a waiver of informed consent after institutional review board approval was obtained. A retrospective evaluation of 207 consecutive patients (131 men, 76 women; mean age, 71.9 years ± 10.9) with 217 biopsy-proven renal cell carcinoma tumors treated with thermal ablation was conducted. Serial postablation computed tomography (CT) or magnetic resonance (MR) imaging was used to evaluate for local tumor recurrence. For each tumor, RENAL nephrometry and PADUA scores were calculated by using imaging-derived tumor morphologic data. Several additional tumor biometrics and combinations thereof were also measured, including maximum tumor diameter. The Harrell C index and hazard regression techniques were used to quantify associations with local tumor recurrence. Results The RENAL (hazard ratio, 1.43; P = .003) and PADUA (hazard ratio, 1.80; P < .0001) scores were found to be significantly associated with recurrence when regression techniques were used but demonstrated only poor to fair discrimination according to Harrell C index results (C, 0.68 and 0.75, respectively). Maximum tumor diameter showed the highest discriminatory strength of any individual variable evaluated (C, 0.81) and was also significantly predictive when regression techniques were used (hazard ratio, 2.98; P < .0001). For every 1-cm increase in diameter, the estimated rate of recurrence risk increased by 198%. Conclusion Maximum tumor diameter demonstrates superior performance relative to existing tumor scoring systems and other evaluated biometrics for prediction of local tumor recurrence after renal cell carcinoma ablation. © RSNA, 2016.

Thirty-day emergency room visits and hospital admissions after outpatient non-vascular image-guided procedures.

PubMed

Nguyen, Quang; Mehta, Sahil V; Fang, Jieming; Sheiman, Robert; Kane, Robert; Ahmed, Muneeb; Sarwar, Ammar; Siewert, Bettina; Brook, Olga R

2017-10-01

To evaluate the rate of post-procedure emergency department (ED) visits and hospital admissions following outpatient non-vascular image-guided interventions performed under moderate sedation and to identify common and preventable causes of emergency department visits and hospital admissions. Institutional review board approval was acquired for this HIPAA-compliant retrospective study with waiver of informed consent. 1426 consecutive patients undergoing 1512 outpatient image-guided procedures under moderate sedation from November 2012 to August 2014 were included. The average patient age was 57.2 ± 15.2 years, and 602 (42%) patients were women. Major procedure categories included ultrasound-guided liver biopsies, ultrasound-guided kidney biopsies, and CT-guided lung biopsies/fiducial placement. Procedure details and medical follow-up within and after 30 days of the procedure were analyzed. A total of 168 (11.8%) patients were admitted to the hospital within 30 days of the procedure, with 29 of the admissions (17.3% of total admissions and 1.9% of total procedures) being procedure related. The most common procedure-related complication that required admission was hemorrhage (10/29, 34.5% of procedure-related admissions, 6.0% of total admissions, and 0.7% of total procedures), followed by pneumothorax (9/29, 31%, 5.4%, 0.6%), infection (4/29, 13.8%, 2.4%, 0.3%), and pain (3/29, 10.3%, 1.8%, 0.2%). Eighteen (62.1%) procedure-related admissions were immediately indicated. Thirty patients visited the ED and were subsequently discharged without admission with eight of the visits being procedure related (8/1512, 0.5%). All the procedure-related ED visits were due to pain. There were two deaths (2/1512, 0.1%) related to procedures, one from a thromboembolic event and another from post-biopsy hemorrhage. Outpatient non-vascular image-guided procedures result in a 30-day 1.9% hospital admission, 30-day 0.5% emergency room visit, and 30-day 0.1% mortality rate.

Colorectal liver metastases: contrast agent diffusion coefficient for quantification of contrast enhancement heterogeneity at MR imaging.

PubMed

Jia, Guang; O'Dell, Craig; Heverhagen, Johannes T; Yang, Xiangyu; Liang, Jiachao; Jacko, Richard V; Sammet, Steffen; Pellas, Theodore; Cole, Patricia; Knopp, Michael V

2008-09-01

To describe and determine the reproducibility of a simplified model to quantitatively measure heterogeneous intralesion contrast agent diffusion in colorectal liver metastases. This HIPAA-compliant retrospective study received institutional review board approval, and written informed consent was obtained from 14 patients (mean age, 61 years +/- 9 [standard deviation]; range, 41-78 years), including 10 men (mean age, 65 years +/- 8; range, 47-78 years) and four women (mean age, 54 years +/- 9; range, 41-59 years), with colorectal liver metastases. Magnetic resonance (MR) imaging was performed twice (first baseline MR image [B(1)] and second baseline MR image [B(2)]) in a single target lesion prior to therapy. Dynamic contrast material-enhanced MR imaging was performed by using a saturation-recovery fast gradient-echo sequence. A simplified contrast agent diffusion model was proposed, and a contrast agent diffusion coefficient (CDC) was calculated. The reproducibility of the CDC measurement was evaluated by using the Bland-Altman plot and a linear regression model. The mean CDC was 0.22 mm(2)/sec (range, 0.01-0.73 mm(2)/sec) on B(1) and 0.24 mm(2)/sec (range, 0.01-0.71 mm(2)/sec) on B(2), with an intraclass correlation coefficient of 0.91 (P < .0001). Bland-Altman plot showed good agreement, with a mean difference in measurement pairs of 0.017 mm(2)/sec +/- 0.096. The slope from the linear regression model was 0.89 (95% confidence interval: 0.63, 1.15) and the intercept was 0.01 (95% confidence interval: -0.08, 0.09). The CDC enables a quantitative description of contrast enhancement heterogeneity in lesions. Given the high reproducibility of the CDC metric, CDC appears promising for further qualification as an imaging biomarker of change measurement in response assessment. http://radiology.rsnajnls.org/cgi/content/full/248/3/901/DC1. RSNA, 2008

High-Spatial- and High-Temporal-Resolution Dynamic Contrast-enhanced MR Breast Imaging with Sweep Imaging with Fourier Transformation: A Pilot Study

PubMed Central

Benson, John C.; Idiyatullin, Djaudat; Snyder, Angela L.; Snyder, Carl J.; Hutter, Diane; Everson, Lenore I.; Eberly, Lynn E.; Nelson, Michael T.; Garwood, Michael

2015-01-01

Purpose To report the results of sweep imaging with Fourier transformation (SWIFT) magnetic resonance (MR) imaging for diagnostic breast imaging. Materials and Methods Informed consent was obtained from all participants under one of two institutional review board–approved, HIPAA-compliant protocols. Twelve female patients (age range, 19–54 years; mean age, 41.2 years) and eight normal control subjects (age range, 22–56 years; mean age, 43.2 years) enrolled and completed the study from January 28, 2011, to March 5, 2013. Patients had previous lesions that were Breast Imaging Reporting and Data System 4 and 5 based on mammography and/or ultrasonographic imaging. Contrast-enhanced SWIFT imaging was completed by using a 4-T research MR imaging system. Noncontrast studies were completed in the normal control subjects. One of two sized single-breast SWIFT-compatible transceiver coils was used for nine patients and five controls. Three patients and five control subjects used a SWIFT-compatible dual breast coil. Temporal resolution was 5.9–7.5 seconds. Spatial resolution was 1.00 mm isotropic, with later examinations at 0.67 mm isotropic, and dual breast at 1.00 mm or 0.75 mm isotropic resolution. Results Two nonblinded breast radiologists reported SWIFT image findings of normal breast tissue, benign fibroadenomas (six of six lesions), and malignant lesions (10 of 12 lesions) concordant with other imaging modalities and pathologic reports. Two lesions in two patients were not visualized because of coil field of view. The images yielded by SWIFT showed the presence and extent of known breast lesions. Conclusion The SWIFT technique could become an important addition to breast imaging modalities because it provides high spatial resolution at all points during the dynamic contrast-enhanced examination. © RSNA, 2014 PMID:25247405

Crowdsourcing Disease Biomarker Discovery Research: The IP4IC Study.

PubMed

Chancellor, Michael B; Bartolone, Sarah N; Veerecke, Andrew; Lamb, Laura E

2018-05-01

Biomarker discovery is limited by readily assessable, cost efficient human samples available in large numbers that represent the entire heterogeneity of the disease. We developed a novel, active participation crowdsourcing method to determine BP-RS (Bladder Permeability Defect Risk Score). It is based on noninvasive urinary cytokines to discriminate patients with interstitial cystitis/bladder pain syndrome who had Hunner lesions from controls and patients with interstitial cystitis/bladder pain syndrome but without Hunner lesions. We performed a national crowdsourcing study in cooperation with the Interstitial Cystitis Association. Patients answered demographic, symptom severity and urinary frequency questionnaires on a HIPAA (Health Insurance Portability and Accountability Act) compliant website. Urine samples were collected at home, stabilized with a preservative and sent to Beaumont Hospital for analysis. The expression of 3 urinary cytokines was used in a machine learning algorithm to develop BP-RS. The IP4IC study collected a total of 448 urine samples, representing 153 patients (147 females and 6 males) with interstitial cystitis/bladder pain syndrome, of whom 54 (50 females and 4 males) had Hunner lesions. A total of 159 female and 136 male controls also participated, who were age matched. A defined BP-RS was calculated to predict interstitial cystitis/bladder pain syndrome with Hunner lesions or a bladder permeability defect etiology with 89% validity. In this novel participation crowdsourcing study we obtained a large number of urine samples from 46 states, which were collected at home, shipped and stored at room temperature. Using a machine learning algorithm we developed BP-RS to quantify the risk of interstitial cystitis/bladder pain syndrome with Hunner lesions, which is indicative of a bladder permeability defect etiology. To our knowledge BP-RS is the first validated urine biomarker assay for interstitial cystitis/bladder pain syndrome and one of the first biomarker assays to be developed using crowdsourcing. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Distributed Human Intelligence for Colonic Polyp Classification in Computer-aided Detection for CT Colonography

PubMed Central

Nguyen, Tan B.; Wang, Shijun; Anugu, Vishal; Rose, Natalie; McKenna, Matthew; Petrick, Nicholas; Burns, Joseph E.

2012-01-01

Purpose: To assess the diagnostic performance of distributed human intelligence for the classification of polyp candidates identified with computer-aided detection (CAD) for computed tomographic (CT) colonography. Materials and Methods: This study was approved by the institutional Office of Human Subjects Research. The requirement for informed consent was waived for this HIPAA-compliant study. CT images from 24 patients, each with at least one polyp of 6 mm or larger, were analyzed by using CAD software to identify 268 polyp candidates. Twenty knowledge workers (KWs) from a crowdsourcing platform labeled each polyp candidate as a true or false polyp. Two trials involving 228 KWs were conducted to assess reproducibility. Performance was assessed by comparing the area under the receiver operating characteristic curve (AUC) of KWs with the AUC of CAD for polyp classification. Results: The detection-level AUC for KWs was 0.845 ± 0.045 (standard error) in trial 1 and 0.855 ± 0.044 in trial 2. These were not significantly different from the AUC for CAD, which was 0.859 ± 0.043. When polyp candidates were stratified by difficulty, KWs performed better than CAD on easy detections; AUCs were 0.951 ± 0.032 in trial 1, 0.966 ± 0.027 in trial 2, and 0.877 ± 0.048 for CAD (P = .039 for trial 2). KWs who participated in both trials showed a significant improvement in performance going from trial 1 to trial 2; AUCs were 0.759 ± 0.052 in trial 1 and 0.839 ± 0.046 in trial 2 (P = .041). Conclusion: The performance of distributed human intelligence is not significantly different from that of CAD for colonic polyp classification. © RSNA, 2012 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11110938/-/DC1 PMID:22274839

Application of Modified Spin-Echo–based Sequences for Hepatic MR Elastography: Evaluation, Comparison with the Conventional Gradient-Echo Sequence, and Preliminary Clinical Experience

PubMed Central

Mariappan, Yogesh K.; Dzyubak, Bogdan; Glaser, Kevin J.; Venkatesh, Sudhakar K.; Sirlin, Claude B.; Hooker, Jonathan; McGee, Kiaran P.

2017-01-01

Purpose To (a) evaluate modified spin-echo (SE) magnetic resonance (MR) elastographic sequences for acquiring MR images with improved signal-to-noise ratio (SNR) in patients in whom the standard gradient-echo (GRE) MR elastographic sequence yields low hepatic signal intensity and (b) compare the stiffness values obtained with these sequences with those obtained with the conventional GRE sequence. Materials and Methods This HIPAA-compliant retrospective study was approved by the institutional review board; the requirement to obtain informed consent was waived. Data obtained with modified SE and SE echo-planar imaging (EPI) MR elastographic pulse sequences with short echo times were compared with those obtained with the conventional GRE MR elastographic sequence in two patient cohorts, one that exhibited adequate liver signal intensity and one that exhibited low liver signal intensity. Shear stiffness values obtained with the three sequences in 130 patients with successful GRE-based examinations were retrospectively tested for statistical equivalence by using a 5% margin. In 47 patients in whom GRE examinations were considered to have failed because of low SNR, the SNR and confidence level with the SE-based sequences were compared with those with the GRE sequence. Results The results of this study helped confirm the equivalence of SE MR elastography and SE-EPI MR elastography to GRE MR elastography (P = .0212 and P = .0001, respectively). The SE and SE-EPI MR elastographic sequences provided substantially improved SNR and stiffness inversion confidence level in 47 patients in whom GRE MR elastography had failed. Conclusion Modified SE-based MR elastographic sequences provide higher SNR MR elastographic data and reliable stiffness measurements; thus, they enable quantification of stiffness in patients in whom the conventional GRE MR elastographic sequence failed owing to low signal intensity. The equivalence of the three sequences indicates that the current diagnostic thresholds are applicable to SE MR elastographic sequences for assessing liver fibrosis. © RSNA, 2016 PMID:27509543

Acute gastrointestinal vaso-occlusive ischemia in sickle cell disease: CT imaging features and clinical outcome.

PubMed

Gardner, Carly S; Jaffe, Tracy A

2016-03-01

The purpose of this study was to determine the incidence, specific imaging features, and outcome of gastrointestinal vaso-occlusive ischemia (GVOI) in sickle cell patients undergoing CT for acute abdominal pain. This HIPAA-compliant, IRB-approved retrospective study evaluated sickle cell patients with an abdominal pain crisis and acute gastrointestinal abnormalities on CT from 1/2006 to 1/2014. CT findings were divided into those compatible and incompatible with bowel ischemia or clinical diagnosis of GVOI. Two abdominal radiologists (1, 13 years' experience) reviewed the CTs for specific imaging features of ischemia. Clinical laboratory values (lactate, WBC) and outcome were recorded. Descriptive statistics and Wilcoxon-Mann-Whitney two-sample rank-sum test were performed. Of 217 CTs, 33 had acute gastrointestinal abnormalities: 75% (25/33) consistent with ischemia and clinical GVOI. Complications of ischemia occurred in 16% (4/25): ileus (50%), perforation (25%), and pneumatosis (25%). In uncomplicated cases, all had bowel wall thickening: segmental 52% (11/21) or diffuse 48% (10/21). The colon was commonly involved (76%, 16/21), particularly the ascending (57%, 12/21). Most abnormalities (52%, 11/21) were in the superior mesenteric artery distribution. Average lactate (4.3 ± 4.0 mmol/L, p = 0.02) and WBC count (20.1 ± 10.4, ×1000 cells/μL, p = 0.01) were significantly higher in GVOI. Overall mortality in patients with GVOI was 17% (3/18). GVOI is an important feature of the acute abdominal crisis in patients with sickle cell disease and can be seen in up to 75% of patients with abnormal bowel findings on CT. The diagnosis should be strongly considered in sickle cell patients with CT findings of diffuse or segmental bowel wall thickening, particularly involving the colon.

Differentiation of Ductal Carcinoma In-Situ from Benign Micro-Calcifications by Dedicated Breast Computed Tomography

PubMed Central

Shakeri, Shadi A.; Abbey, Craig K.; Gazi, Peymon; Prionas, Nicolas; Nosratieh, Anita; Li, Chin-Shang; Boone, John M.; Lindfors, Karen K.

2015-01-01

Purpose Compare conspicuity of ductal carcinoma in-situ (DCIS) to benign calcifications on unenhanced (bCT), contrast-enhanced dedicated breast CT (CEbCT) and mammography (DM). Methods and Materials The institutional review board approved this HIPAA-compliant study. 42 women with Breast Imaging Reporting and Data System 4 or 5 category micro-calcifications had breast CT before biopsy. Three subjects with invasive disease at surgery were excluded. Two breast radiologists independently compared lesion conspicuity scores (CS) for CEbCT, to bCT and DM. Enhancement was measured in Hounsfield units (HU). Mean CS ± standard deviations are shown. Receiver operating characteristic analysis (ROC) measured radiologists’ discrimination performance by comparing CS to enhancement alone. Statistical measurements were made using ANOVA F-test, Wilcoxon rank-sum test and robust linear regression analyses. Results 39 lesions (17 DCIS, 22 benign) were analyzed. DCIS (8.5±0.9, n=17) was more conspicuous than benign micro-calcifications (3.6±2.9, n=22; p<0.0001) on CEbCT. DCIS was equally conspicuous on CEbCT and DM (8.5±0.9, 8.7±0.8, n=17; p=0.85) and more conspicuous when compared to bCT (5.3±2.6, n=17; p<0.001). All DCIS enhanced; mean enhancement (90HU ±53HU, n=17) was higher compared to benign lesions (33 ±30HU, n=22)(p<0.0001). ROC analysis of the radiologists’ CS showed high discrimination performance (AUC=0.94) compared to enhancement alone (AUC=0.85) (p<0.026). Conclusion DCIS is more conspicuous than benign micro-calcifications on CEbCT. DCIS visualization on CEbCT is equal to mammography but improved compared to bCT. Radiologists’ discrimination performance using CEBCT is significantly higher than enhancement values alone. CEbCT may have an advantage over mammography by reducing false positive examinations when calcifications are analyzed. PMID:26520874

Newly Diagnosed Breast Cancer: Comparison of Contrast-enhanced Spectral Mammography and Breast MR Imaging in the Evaluation of Extent of Disease.

PubMed

Lee-Felker, Stephanie A; Tekchandani, Leena; Thomas, Mariam; Gupta, Esha; Andrews-Tang, Denise; Roth, Antoinette; Sayre, James; Rahbar, Guita

2017-11-01

Purpose To compare the diagnostic performances of contrast material-enhanced spectral mammography and breast magnetic resonance (MR) imaging in the detection of index and secondary cancers in women with newly diagnosed breast cancer by using histologic or imaging follow-up as the standard of reference. Materials and Methods This institutional review board-approved, HIPAA-compliant, retrospective study included 52 women who underwent breast MR imaging and contrast-enhanced spectral mammography for newly diagnosed unilateral breast cancer between March 2014 and October 2015. Of those 52 patients, 46 were referred for contrast-enhanced spectral mammography and targeted ultrasonography because they had additional suspicious lesions at MR imaging. In six of the 52 patients, breast cancer had been diagnosed at an outside institution. These patients were referred for contrast-enhanced spectral mammography and targeted US as part of diagnostic imaging. Images from contrast-enhanced spectral mammography were analyzed by two fellowship-trained breast imagers with 2.5 years of experience with contrast-enhanced spectral mammography. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value were calculated for both imaging modalities and compared by using the Bennett statistic. Results Fifty-two women with 120 breast lesions were included for analysis (mean age, 50 years; range, 29-73 years). Contrast-enhanced spectral mammography had similar sensitivity to MR imaging (94% [66 of 70 lesions] vs 99% [69 of 70 lesions]), a significantly higher PPV than MR imaging (93% [66 of 71 lesions] vs 60% [69 of 115 lesions]), and fewer false-positive findings than MR imaging (five vs 45) (P < .001 for all results). In addition, contrast-enhanced spectral mammography depicted 11 of the 11 secondary cancers (100%) and MR imaging depicted 10 (91%). Conclusion Contrast-enhanced spectral mammography is potentially as sensitive as MR imaging in the evaluation of extent of disease in newly diagnosed breast cancer, with a higher PPV. © RSNA, 2017.

Comparison of Background Parenchymal Enhancement at Contrast-enhanced Spectral Mammography and Breast MR Imaging

PubMed Central

Morris, Elizabeth A.; Kaplan, Jennifer B.; D’Alessio, Donna; Goldman, Debra; Moskowitz, Chaya S.

2017-01-01

Purpose To assess the extent of background parenchymal enhancement (BPE) at contrast material–enhanced (CE) spectral mammography and breast magnetic resonance (MR) imaging, to evaluate interreader agreement in BPE assessment, and to examine the relationships between clinical factors and BPE. Materials and Methods This was a retrospective, institutional review board–approved, HIPAA-compliant study. Two hundred seventy-eight women from 25 to 76 years of age with increased breast cancer risk who underwent CE spectral mammography and MR imaging for screening or staging from 2010 through 2014 were included. Three readers independently rated BPE on CE spectral mammographic and MR images with the ordinal scale: minimal, mild, moderate, or marked. To assess pairwise agreement between BPE levels on CE spectral mammographic and MR images and among readers, weighted κ coefficients with quadratic weights were calculated. For overall agreement, mean κ values and bootstrapped 95% confidence intervals were calculated. The univariate and multivariate associations between BPE and clinical factors were examined by using generalized estimating equations separately for CE spectral mammography and MR imaging. Results Most women had minimal or mild BPE at both CE spectral mammography (68%–76%) and MR imaging (69%–76%). Between CE spectral mammography and MR imaging, the intrareader agreement ranged from moderate to substantial (κ = 0.55–0.67). Overall agreement on BPE levels between CE spectral mammography and MR imaging and among readers was substantial (κ = 0.66; 95% confidence interval: 0.61, 0.70). With both modalities, BPE demonstrated significant association with menopausal status, prior breast radiation therapy, hormonal treatment, breast density on CE spectral mammographic images, and amount of fibroglandular tissue on MR images (P < .001 for all). Conclusion There was substantial agreement between readers for BPE detected on CE spectral mammographic and MR images. © RSNA, 2016 PMID:27379544

Detection of prostate cancer with multiparametric MRI (mpMRI): effect of dedicated reader education on accuracy and confidence of index and anterior cancer diagnosis

PubMed Central

Garcia-Reyes, Kirema; Passoni, Niccolò M.; Palmeri, Mark L.; Kauffman, Christopher R.; Choudhury, Kingshuk Roy; Polascik, Thomas J.; Gupta, Rajan T.

2015-01-01

Purpose To evaluate the impact of dedicated reader education on accuracy/confidence of peripheral zone index cancer and anterior prostate cancer (PCa) diagnosis with mpMRI; secondary aim was to assess the ability of readers to differentiate low-grade cancer (Gleason 6 or below) from high-grade cancer (Gleason 7+). Materials and methods Five blinded radiology fellows evaluated 31 total prostate mpMRIs in this IRB-approved, HIPAA-compliant, retrospective study for index lesion detection, confidence in lesion diagnosis (1–5 scale), and Gleason grade (Gleason 6 or lower vs. Gleason 7+). Following a dedicated education program, readers reinterpreted cases after a memory extinction period, blinded to initial reads. Reference standard was established combining whole mount histopathology with mpMRI findings by a board-certified radiologist with 5 years of prostate mpMRI experience. Results Index cancer detection: pre-education accuracy 74.2%; post-education accuracy 87.7% (p = 0.003). Confidence in index lesion diagnosis: pre-education 4.22 ± 1.04; post-education 3.75 ± 1.41 (p = 0.0004). Anterior PCa detection: pre-education accuracy 54.3%; post-education accuracy 94.3% (p = 0.001). Confidence in anterior PCa diagnosis: pre-education 3.22 ± 1.54; post-education 4.29 ± 0.83 (p = 0.0003). Gleason score accuracy: pre-education 54.8%; post-education 73.5% (p = 0.0005). Conclusions A dedicated reader education program on PCa detection with mpMRI was associated with a statistically significant increase in diagnostic accuracy of index cancer and anterior cancer detection as well as Gleason grade identification as compared to pre-education values. This was also associated with a significant increase in reader diagnostic confidence. This suggests that substantial interobserver variability in mpMRI interpretation can potentially be reduced with a focus on education and that this can occur over a fellowship training year. PMID:25034558

Effect of intravascular contrast agent on diffusion and perfusion fraction coefficients in the peripheral zone and prostate cancer.

PubMed

Mazaheri, Yousef; Hötker, Andreas M; Shukla-Dave, Amita; Akin, Oguz; Hricak, Hedvig

2018-09-01

To determine whether water diffusion and the perfusion fraction coefficients in prostate peripheral zone (PZ) and prostate cancer (PCa) are affected by intravenous contrast injection and explore the potential mechanism behind previously reported differences between pre- and post-contrast ADC values. Our institutional review board waived informed consent for this HIPAA-compliant, retrospective study, which included 32 patients (median age, 63 years; range, 47-77 years) with biopsy-proven, untreated PCa who underwent 3-Tesla MRI, including DW-MRI at b-values 0, 400, 700, 1000 s/mm 2 before and after gadolinium injection. For regions of interest (ROIs) in presumed benign PZ and PZ PCa, apparent diffusion coefficient (ADC), perfusion fraction f, and diffusion coefficient D were estimated voxel-wise, and signal-to-noise ratio (SNR) and contrast-to-noise (CNR) were estimated. Pre- and post-contrast measurements were compared by Wilcoxon signed-rank test; P < 0.05 was considered significant. In PZ, f (P = 0.002) was significantly higher on post-contrast imaging than on pre-contrast imaging, but ADC and D values did not change significantly (P = 0.562 and 0.295 respectively). In PCa, all parameters differed significantly between post-contrast and pre-contrast imaging (P < 0.0001 for ADC, P = 0.0084 for D, and P = 0.029 for f). On post-contrast imaging, SNR was not significantly different in PZ (P = 0.260) but was significantly lower in PCa (P < 0.0001); CNR did not change significantly (P = 0.059). After contrast injection, ADC and D declined significantly in PCa only, while f increased significantly in both PCa and PZ. Pre- and post-contrast diffusion parameters cannot be used interchangeably for diagnostic purposes that require quantitative diffusion estimates. Copyright © 2018. Published by Elsevier Inc.

Imaging yield from 133 consecutive patients with prostate cancer and low trigger PSA from a single institution.

PubMed

Shinagare, A B; Keraliya, A; Somarouthu, B; Tirumani, S H; Ramaiya, N H; Kantoff, P W

2016-03-01

To investigate the yield of imaging in patients with relapsed prostate cancer (PC) with a low trigger prostate-specific antigen (PSA). This institutional review board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective study included all 133 patients (mean age 68 years; range 45-88; median 69 months since original diagnosis; interquartile range [IQR]: 32-139) with hormone-sensitive PC (HSPC, n=28) or castration-resistant PC (CRPC, n=105) and trigger PSA <4 ng/ml, who underwent same-day bone scintigraphy and computed tomography (CT; total 224 time points) at Dana-Farber Cancer Institute from January to December 2013. Clinical and pathological data were obtained by manual review of the electronic medical records. All the included bone scintigraphs and CT images were reviewed by a fellowship-trained oncoradiologist to record the metastatic pattern and any clinically significant non-metastatic findings. Ninety-four of the 133 (71%) patients had metastatic disease (18/28 [64%] with HSPC, 76/105 [72%] with CRPC). Forty-one of the 133 (31%) patients developed new metastatic disease and 23/133 (17%) developed new clinically significant non-metastatic findings. The incidence of osseous, nodal, and visceral metastases, and clinically significant non-metastatic findings was similar across the HSPC and CRPC groups (p>0.05 for all). Fifty-seven of the 133 (43%) patients had findings seen only at CT, of which 37 had new extra-osseous findings. Only 2/133 (2%) had findings at bone scintigraphy not seen at CT, both in areas not covered on CT. Imaging frequently demonstrated new metastatic and non-metastatic findings in patients with a low trigger PSA. CT is valuable in these patients because extra-osseous findings not visible at bone scintigraphy are frequently seen. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

CT Screening for Lung Cancer: Nonsolid Nodules in Baseline and Annual Repeat Rounds.

PubMed

Yankelevitz, David F; Yip, Rowena; Smith, James P; Liang, Mingzhu; Liu, Ying; Xu, Dong Ming; Salvatore, Mary M; Wolf, Andrea S; Flores, Raja M; Henschke, Claudia I

2015-11-01

To address the frequency of identifying nonsolid nodules, diagnosing lung cancer manifesting as such nodules, and the long-term outcome after treatment in a prospective cohort, the International Early Lung Cancer Action Program. A total of 57,496 participants underwent baseline and subsequent annual repeat computed tomographic (CT) screenings according to an institutional review board, HIPAA-compliant protocol. Informed consent was obtained. The frequency of participants with nonsolid nodules, the course of the nodule at follow-up, and the resulting diagnoses of lung cancer, treatment, and outcome are given separately for baseline and annual repeat rounds of screening. The χ(2) statistic was used to compare percentages. A nonsolid nodule was identified in 2392 (4.2%) of 57,496 baseline screenings, and pathologic pursuit led to the diagnosis of 73 cases of adenocarcinoma. A new nonsolid nodule was identified in 485 (0.7%) of 64,677 annual repeat screenings, and 11 had a diagnosis of stage I adenocarcinoma; none were in nodules 15 mm or larger in diameter. Nonsolid nodules resolved or decreased more frequently in annual repeat than in baseline rounds (322 [66%] of 485 vs 628 [26%] of 2392, P < .0001). Treatment of the cases of lung cancer was with lobectomy in 55, bilobectomy in two, sublobar resection in 26, and radiation therapy in one. Median time to treatment was 19 months (interquartile range [IQR], 6-41 months). A solid component had developed in 22 cases prior to treatment (median transition time from nonsolid to part-solid, 25 months). The lung cancer-survival rate was 100% with median follow-up since diagnosis of 78 months (IQR, 45-122 months). Nonsolid nodules of any size can be safely followed with CT at 12-month intervals to assess transition to part-solid. Surgery was 100% curative in all cases, regardless of the time to treatment. © RSNA, 2015

TH-AB-207A-03: Skin Dose to Patients Receiving Multiple CTA and CT Exams of the Head

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nawfel, RD; Young, G

Purpose: To measure patient skin dose from CT angiography (CTA) and CT exams of the head, and determine if patients having multiple exams could receive cumulative doses that approach or exceed deterministic thresholds. Methods: This study was HIPAA compliant and conducted with IRB approval. Patient skin doses were measured over a 4 month period using nanoDot OSL dosimeters placed on the head of 52 patients for two CT scanners. On each scanner, 26 patients received CT exams (scanner 1: 10 females, 16 males, mean age 64.2 years; scanner 2: 18 females, 8 males, mean age 61.2 years). CT exam dosemore » metrics, CTDIvol and dose-length product (DLP) were recorded for each exam. Additionally, skin dose was measured on an acrylic skull phantom in each scanner and on a neuro-interventional imaging system using clinical protocols. Measured dose data was used to estimate peak skin dose (PSD) for 4 patients receiving multiple exams including CTA, head CT, and cerebral angiography. Results: For scanner 1, the mean PSD for CTA exams (98.9 ± 5.3 mGy) and for routine head CT exams (39.2 ± 3.7 mGy) agreed reasonably well with the PSD measured on the phantom, 105.4 mGy and 40.0 mGy, respectively. Similarly for scanner 2, the mean PSD for CTA exams (98.8 ± 7.4 mGy) and for routine head CT exams (42.9 ± 9.4 mGy) compared well with phantom measurements, 95.2 mGy and 37.6 mGy, respectively. In addition, the mean PSD was comparable between scanners for corresponding patient exams, CTA and routine head CT respectively. PSD estimates ranged from 1.9 – 4.5 Gy among 4 patients receiving multiple exams. Conclusion: Patients having several exams including both CTA and routine head CT may receive cumulative doses approaching or exceeding the threshold for single dose deterministic effects.« less

Computer-aided liver volumetry: performance of a fully-automated, prototype post-processing solution for whole-organ and lobar segmentation based on MDCT imaging.

PubMed

Fananapazir, Ghaneh; Bashir, Mustafa R; Marin, Daniele; Boll, Daniel T

2015-06-01

To evaluate the performance of a prototype, fully-automated post-processing solution for whole-liver and lobar segmentation based on MDCT datasets. A polymer liver phantom was used to assess accuracy of post-processing applications comparing phantom volumes determined via Archimedes' principle with MDCT segmented datasets. For the IRB-approved, HIPAA-compliant study, 25 patients were enrolled. Volumetry performance compared the manual approach with the automated prototype, assessing intraobserver variability, and interclass correlation for whole-organ and lobar segmentation using ANOVA comparison. Fidelity of segmentation was evaluated qualitatively. Phantom volume was 1581.0 ± 44.7 mL, manually segmented datasets estimated 1628.0 ± 47.8 mL, representing a mean overestimation of 3.0%, automatically segmented datasets estimated 1601.9 ± 0 mL, representing a mean overestimation of 1.3%. Whole-liver and segmental volumetry demonstrated no significant intraobserver variability for neither manual nor automated measurements. For whole-liver volumetry, automated measurement repetitions resulted in identical values; reproducible whole-organ volumetry was also achieved with manual segmentation, p(ANOVA) 0.98. For lobar volumetry, automated segmentation improved reproducibility over manual approach, without significant measurement differences for either methodology, p(ANOVA) 0.95-0.99. Whole-organ and lobar segmentation results from manual and automated segmentation showed no significant differences, p(ANOVA) 0.96-1.00. Assessment of segmentation fidelity found that segments I-IV/VI showed greater segmentation inaccuracies compared to the remaining right hepatic lobe segments. Automated whole-liver segmentation showed non-inferiority of fully-automated whole-liver segmentation compared to manual approaches with improved reproducibility and post-processing duration; automated dual-seed lobar segmentation showed slight tendencies for underestimating the right hepatic lobe volume and greater variability in edge detection for the left hepatic lobe compared to manual segmentation.

Oxygen-weighted Hyperpolarized 3He MR Imaging: A Short-term Reproducibility Study in Human Subjects

PubMed Central

Ishii, Masaru; Hamedani, Hooman; Clapp, Justin T.; Kadlecek, Stephen J.; Xin, Yi; Gefter, Warren B.; Rossman, Milton D.

2015-01-01

Purpose To determine whether hyperpolarized helium 3 magnetic resonance (MR) imaging to measure alveolar partial pressure of oxygen (Pao2) shows sufficient test-retest repeatability and between-cohort differences to be used as a reliable technique for detection of alterations in gas exchange in asymptomatic smokers. Materials and Methods The protocol was approved by the local institutional review board and was HIPAA compliant. Informed consent was obtained from all subjects. Two sets of MR images were obtained 10 minutes apart in 25 subjects: 10 nonsmokers (five men, five women; mean ± standard deviation age, 50 years ± 6) and 15 smokers (seven women, eight men; mean age, 50 years ± 8). A mixed-effects model was developed to identify the regional repeatability of Pao2 measurements as an intraclass correlation coefficient. Ten smokers were matched with the 10 nonsmokers on the basis of signal-to-noise ratio (SNR). Three separate models were generated: one for nonsmokers, one for the SNR-matched smokers, and one for the five remaining smokers, who were imaged with a significantly higher SNR. Results Short-term back-to-back regional reproducibility was assessed by using intraclass correlation coefficients, which were 0.67 and 0.65 for SNR case-matched nonsmokers and smokers, respectively. Repeatability was a strong function of SNR; a 50% increase in SNR in the remaining smokers improved the intraclass correlation coefficient to 0.82. Although repeatability was not significantly different between the SNR-matched cohorts (P = .44), the smoker group showed higher spatial and temporal variability in Pao2. Conclusion The short-term test-retest repeatability of hyperpolarized gas MR imaging of regional Pao2 was good. Asymptomatic smokers exhibited greater spatial and temporal variability in Pao2 than did the nonsmokers, which suggests that this parameter allows detection of small functional alterations associated with smoking. © RSNA, 2015 Online supplemental material is available for this article. PMID:26110668

Imaging Cerebral Microhemorrhages in Military Service Members with Chronic Traumatic Brain Injury

PubMed Central

Liu, Wei; Soderlund, Karl; Senseney, Justin S.; Joy, David; Yeh, Ping-Hong; Ollinger, John; Sham, Elyssa B.; Liu, Tian; Wang, Yi; Oakes, Terrence R.; Riedy, Gerard

2017-01-01

Purpose To detect cerebral microhemorrhages in military service members with chronic traumatic brain injury by using susceptibility-weighted magnetic resonance (MR) imaging. The longitudinal evolution of microhemorrhages was monitored in a subset of patients by using quantitative susceptibility mapping. Materials and Methods The study was approved by the Walter Reed National Military Medical Center institutional review board and is compliant with HIPAA guidelines. All participants underwent two-dimensional conventional gradient-recalled-echo MR imaging and three-dimensional flow-compensated multi-echo gradient-recalled-echo MR imaging (processed to generate susceptibility-weighted images and quantitative susceptibility maps), and a subset of patients underwent follow-up imaging. Microhemorrhages were identified by two radiologists independently. Comparisons of microhemorrhage number, size, and magnetic susceptibility derived from quantitative susceptibility maps between baseline and follow-up imaging examinations were performed by using the paired t test. Results Among the 603 patients, cerebral microhemorrhages were identified in 43 patients, with six excluded for further analysis owing to artifacts. Seventy-seven percent (451 of 585) of the microhemorrhages on susceptibility-weighted images had a more conspicuous appearance than on gradient-recalled-echo images. Thirteen of the 37 patients underwent follow-up imaging examinations. In these patients, a smaller number of microhemorrhages were identified at follow-up imaging compared with baseline on quantitative susceptibility maps (mean ± standard deviation, 9.8 microhemorrhages ± 12.8 vs 13.7 microhemorrhages ± 16.6; P = .019). Quantitative susceptibility mapping–derived quantitative measures of microhemorrhages also decreased over time: −0.85 mm3 per day ± 1.59 for total volume (P = .039) and −0.10 parts per billion per day ± 0.14 for mean magnetic susceptibility (P = .016). Conclusion The number of microhemorrhages and quantitative susceptibility mapping–derived quantitative measures of microhemorrhages all decreased over time, suggesting that hemosiderin products undergo continued, subtle evolution in the chronic stage. PMID:26371749

Imaging Cerebral Microhemorrhages in Military Service Members with Chronic Traumatic Brain Injury.

PubMed

Liu, Wei; Soderlund, Karl; Senseney, Justin S; Joy, David; Yeh, Ping-Hong; Ollinger, John; Sham, Elyssa B; Liu, Tian; Wang, Yi; Oakes, Terrence R; Riedy, Gerard

2016-02-01

To detect cerebral microhemorrhages in military service members with chronic traumatic brain injury by using susceptibility-weighted magnetic resonance (MR) imaging. The longitudinal evolution of microhemorrhages was monitored in a subset of patients by using quantitative susceptibility mapping. The study was approved by the Walter Reed National Military Medical Center institutional review board and is compliant with HIPAA guidelines. All participants underwent two-dimensional conventional gradient-recalled-echo MR imaging and three-dimensional flow-compensated multiecho gradient-recalled-echo MR imaging (processed to generate susceptibility-weighted images and quantitative susceptibility maps), and a subset of patients underwent follow-up imaging. Microhemorrhages were identified by two radiologists independently. Comparisons of microhemorrhage number, size, and magnetic susceptibility derived from quantitative susceptibility maps between baseline and follow-up imaging examinations were performed by using the paired t test. Among the 603 patients, cerebral microhemorrhages were identified in 43 patients, with six excluded for further analysis owing to artifacts. Seventy-seven percent (451 of 585) of the microhemorrhages on susceptibility-weighted images had a more conspicuous appearance than on gradient-recalled-echo images. Thirteen of the 37 patients underwent follow-up imaging examinations. In these patients, a smaller number of microhemorrhages were identified at follow-up imaging compared with baseline on quantitative susceptibility maps (mean ± standard deviation, 9.8 microhemorrhages ± 12.8 vs 13.7 microhemorrhages ± 16.6; P = .019). Quantitative susceptibility mapping-derived quantitative measures of microhemorrhages also decreased over time: -0.85 mm(3) per day ± 1.59 for total volume (P = .039) and -0.10 parts per billion per day ± 0.14 for mean magnetic susceptibility (P = .016). The number of microhemorrhages and quantitative susceptibility mapping-derived quantitative measures of microhemorrhages all decreased over time, suggesting that hemosiderin products undergo continued, subtle evolution in the chronic stage. © RSNA, 2015.

Prospective Trial with Optical Molecular Imaging for Percutaneous Interventions in Focal Hepatic Lesions

PubMed Central

Sheth, Rahul A.; Arellano, Ronald S.; Uppot, Raul N.; Samir, Anthony E.; Goyal, Lipika; Zhu, Andrew X.; Gervais, Debra A.

2015-01-01

Purpose To demonstrate the clinical translation of optical molecular imaging (OMI) for the localization of focal hepatic lesions during percutaneous hepatic interventions. Materials and Methods Institutional review board approval was obtained for this prospective, single-center, HIPAA-compliant trial. Patients who were suspected of having hepatocellular carcinoma or liver metastases from colorectal cancer and were scheduled for percutaneous liver biopsy or thermal ablation were eligible for this study. Patients (n = 5) received 0.5 mg per kilogram of body weight of indocyanine green (ICG) intravenously 24 hours prior to their scheduled procedure in this study. Intraprocedurally, a handheld device composed of an endoscope that fits coaxially through a standard 17-gauge introducer needle was advanced into the liver, and real-time measurements of ICG fluorescence were obtained. A point-of-care fluorescence imaging system was used to image ICG fluorescence in biopsy samples. Target-to-background ratios (TBRs) were calculated by dividing the mean fluorescence intensity in the lesion by the mean fluorescence intensity in the adjacent liver parenchyma. The reference standard for determination of proper needle positioning in patients undergoing biopsy was final pathologic analysis of biopsy specimens or follow-up imaging. Results Intraprocedural OMI was successfully performed in six lesions (two lesions in patient 3) in five patients. The median size of the targeted lesions was 16 mm (range, 10–21 mm). Four of five biopsies (80%) yielded an accurate pathologic diagnosis, and one biopsy specimen showed benign liver parenchyma; both ablated lesions showed no residual disease 1 month after the procedure. The median overall added procedure time to perform OMI was 2 minutes. ICG was found to localize with TBRs greater than 2.0 (median, 7.9; range, 2.4–13.4) in all target lesions. No trial-related adverse events were reported. Conclusion The clinical translation of OMI to percutaneous hepatic interventions was demonstrated. © RSNA, 2014 Online supplemental material is available for this article. PMID:25302707

Computer-aided detection of colorectal polyps: can it improve sensitivity of less-experienced readers? Preliminary findings.

PubMed

Baker, Mark E; Bogoni, Luca; Obuchowski, Nancy A; Dass, Chandra; Kendzierski, Renee M; Remer, Erick M; Einstein, David M; Cathier, Pascal; Jerebko, Anna; Lakare, Sarang; Blum, Andrew; Caroline, Dina F; Macari, Michael

2007-10-01

To determine whether computer-aided detection (CAD) applied to computed tomographic (CT) colonography can help improve sensitivity of polyp detection by less-experienced radiologist readers, with colonoscopy or consensus used as the reference standard. The release of the CT colonographic studies was approved by the individual institutional review boards of each institution. Institutions from the United States were HIPAA compliant. Written informed consent was waived at all institutions. The CT colonographic studies in 30 patients from six institutions were collected; 24 images depicted at least one confirmed polyp 6 mm or larger (39 total polyps) and six depicted no polyps. By using an investigational software package, seven less-experienced readers from two institutions evaluated the CT colonographic images and marked or scored polyps by using a five-point scale before and after CAD. The time needed to interpret the CT colonographic findings without CAD and then to re-evaluate them with CAD was recorded. For each reader, the McNemar test, adjusted for clustered data, was used to compare sensitivities for readers without and with CAD; a Wilcoxon signed-rank test was used to analyze the number of false-positive results per patient. The average sensitivity of the seven readers for polyp detection was significantly improved with CAD-from 0.810 to 0.908 (P=.0152). The number of false-positive results per patient without and with CAD increased from 0.70 to 0.96 (95% confidence interval for the increase: -0.39, 0.91). The mean total time for the readings was 17 minutes 54 seconds; for interpretation of CT colonographic findings alone, the mean time was 14 minutes 16 seconds; and for review of CAD findings, the mean time was 3 minutes 38 seconds. Results of this feasibility study suggest that CAD for CT colonography significantly improves per-polyp detection for less-experienced readers. Copyright (c) RSNA, 2007.

Ultrafast 3D balanced steady-state free precession MRI of the lung: Assessment of anatomic details in comparison to low-dose CT.

PubMed

Heye, Tobias; Sommer, Gregor; Miedinger, David; Bremerich, Jens; Bieri, Oliver

2015-09-01

To evaluate the anatomical details offered by a new single breath-hold ultrafast 3D balanced steady-state free precession (uf-bSSFP) sequence in comparison to low-dose chest computed tomography (CT). This was an Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant prospective study. A total of 20 consecutive patients enrolled in a lung cancer screening trial underwent same-day low-dose chest CT and 1.5T MRI. The presence of pulmonary nodules and anatomical details on 1.9 mm isotropic uf-bSSFP images was compared to 2 mm lung window reconstructions by two readers. The number of branching points on six predefined pulmonary arteries and the distance between the most peripheral visible vessel segment to the pleural surface on thin slices and 50 mm maximum intensity projections (MIP) were assessed. Image quality and sharpness of the pulmonary vasculature were rated on a 5-point scale. The uf-bSSFP detection rate of pulmonary nodules (32 nodules visible on CT and MRI, median diameter 3.9 mm) was 45.5% with 21 false-positive findings (pooled data of both readers). Uf-bSSFP detected 71.2% of branching points visible on CT data. The mean distance between peripheral vasculature and pleural surface was 13.0 ± 4.2 mm (MRI) versus 8.5 ± 3.3 mm (CT) on thin slices and 8.6 ± 3.9 mm (MRI) versus 4.6 ± 2.5 mm (CT) on MIPs. Median image quality and sharpness were rated 4 each. Although CT is superior to MRI, uf-bSSFP imaging provides good anatomical details with sufficient image quality and sharpness obtainable in a single breath-hold covering the entire chest. © 2014 Wiley Periodicals, Inc.

Spectral CT with metal artifacts reduction software for improvement of tumor visibility in the vicinity of gold fiducial markers.

PubMed

Brook, Olga R; Gourtsoyianni, Sofia; Brook, Alexander; Mahadevan, Anand; Wilcox, Carol; Raptopoulos, Vassilios

2012-06-01

To evaluate spectral computed tomography (CT) with metal artifacts reduction software (MARS) for reduction of metal artifacts associated with gold fiducial seeds. Thirteen consecutive patients with 37 fiducial seeds implanted for radiation therapy of abdominal lesions were included in this HIPAA-compliant, institutional review board-approved prospective study. Six patients were women (46%) and seven were men (54%). The mean age was 61.1 years (median, 58 years; range, 29-78 years). Spectral imaging was used for arterial phase CT. Images were reconstructed with and without MARS in axial, coronal, and sagittal planes. Two radiologists independently reviewed reconstructions and selected the best image, graded the visibility of the tumor, and assessed the amount of artifacts in all planes. A linear-weighted κ statistic and Wilcoxon signed-rank test were used to assess interobserver variability. Histogram analysis with the Kolmogorov-Smirnov test was used for objective evaluation of artifacts reduction. Fiducial seeds were placed in pancreas (n = 5), liver (n = 7), periportal lymph nodes (n = 1), and gallbladder bed (n = 1). MARS-reconstructed images received a better grade than those with standard reconstruction in 60% and 65% of patients by the first and second radiologist, respectively. Tumor visibility was graded higher with standard versus MARS reconstruction (grade, 3.7 ± 1.0 vs 2.8 ± 1.1; P = .001). Reduction of blooming was noted on MARS-reconstructed images (P = .01). Amount of artifacts, for both any and near field, was significantly smaller on sagittal and coronal MARS-reconstructed images than on standard reconstructions (P < .001 for all comparisons). Far-field artifacts were more prominent on axial MARS-reconstructed images than on standard reconstructions (P < .01). Linear-weighted κ statistic showed moderate to perfect agreement between radiologists. CT number distribution was narrower with MARS than with standard reconstruction in 35 of 37 patients (P < .001). Spectral CT with use of MARS improved tumor visibility in the vicinity of gold fiducial seeds.

Effect of Direct Marketing for Uterine Artery Embolization on Rates of Leiomyomas, Incidental Findings, and Management After Pelvic MRI.

PubMed

Gurwara, Sheena; Allen, Brian C; Kouri, Brian; Clingan, M Jennings; Picard, Melissa; Leyendecker, John R

2016-07-01

The aim of this study was to determine whether a self-referred population screened by an interventional radiology (IR) clinic and a non-IR, physician-referred population differed with regard to suitability for uterine artery embolization (UAE) for symptomatic leiomyomas on the basis of preprocedure MRI. This was an institutional review board-approved, HIPAA-compliant retrospective study of 301 women evaluated in an IR clinic for possible UAE from January 2009 to September 2012. Subjects were retrospectively divided into two groups: self-referred via direct marketing (group A, n = 203; mean age, 41.8 years; range, 22-58 years) and physician referred (group B, n = 98; mean age, 42.9 years; range, 30-65 years). There was no significant difference between groups in presenting symptoms (multiple symptoms, bleeding, bulk-related symptoms, pain). After initial screening, 73.4% of group A (149 of 203) and 79.6% of group B (78 of 98) underwent MRI (P = .242). On the basis of MRI findings, 91.3% of group A (136 of 149) and 94.9% of group B (74 of 78) had uterine leiomyomas (P = .328). Adenomyosis without leiomyoma was present in 4.0% of group A (6 of 149) and 3.8% of group B (3 of 78) (P = .947). Incidental findings requiring further clinical or imaging evaluation were found in 20.8% of group A (31 of 149) and 24.4% of group B (19 of 78) (P = .539). After MRI, 41.6% of group A (62 of 149) and 48.7% of group B (38 of 78) proceeded to UAE (P = .306). After initial screening, similar proportions of self-referred and physician-referred patients were candidates for UAE. The rates of confirmed leiomyomas and incidental findings on MRI were similar between groups. Copyright © 2016 American College of Radiology. All rights reserved.

Determining contrast medium dose and rate on basis of lean body weight: does this strategy improve patient-to-patient uniformity of hepatic enhancement during multi-detector row CT?

PubMed

Ho, Lisa M; Nelson, Rendon C; Delong, David M

2007-05-01

To prospectively evaluate the use of lean body weight (LBW) as the main determinant of the volume and rate of contrast material administration during multi-detector row computed tomography of the liver. This HIPAA-compliant study had institutional review board approval. All patients gave written informed consent. Four protocols were compared. Standard protocol involved 125 mL of iopamidol injected at 4 mL/sec. Total body weight (TBW) protocol involved 0.7 g iodine per kilogram of TBW. Calculated LBW and measured LBW protocols involved 0.86 g of iodine per kilogram and 0.92 g of iodine per kilogram calculated or measured LBW for men and women, respectively. Injection rate used for the three experimental protocols was determined proportionally on the basis of the calculated volume of contrast material. Postcontrast attenuation measurements during portal venous phase were obtained in liver, portal vein, and aorta for each group and were summed for each patient. Patient-to-patient enhancement variability in same group was measured with Levene test. Two-tailed t test was used to compare the three experimental protocols with the standard protocol. Data analysis was performed in 101 patients (25 or 26 patients per group), including 56 men and 45 women (mean age, 53 years). Average summed attenuation values for standard, TBW, calculated LBW, and measured LBW protocols were 419 HU +/- 50 (standard deviation), 443 HU +/- 51, 433 HU +/- 50, and 426 HU +/- 33, respectively (P = not significant for all). Levene test results for summed attenuation data for standard, TBW, calculated LBW, and measured LBW protocols were 40 +/- 29, 38 +/- 33 (P = .83), 35 +/- 35 (P = .56), and 26 +/- 19 (P = .05), respectively. By excluding highly variable but poorly perfused adipose tissue from calculation of contrast medium dose, the measured LBW protocol may lessen patient-to-patient enhancement variability while maintaining satisfactory hepatic and vascular enhancement.

Contrast-enhanced MR angiography of the chest and abdomen with use of controlled apnea in children.

PubMed

Saleh, Roya S; Patel, Swati; Lee, Margaret H; Boechat, M Ines; Ratib, Osman; Saraiva, Carla R; Finn, J Paul

2007-06-01

To retrospectively determine if controlled apnea improves the image quality of contrast material--enhanced magnetic resonance (MR) angiography of the chest and abdomen in children. Institutional review board approval and waiver of informed consent were obtained for this HIPAA-compliant study. The authors evaluated contrast-enhanced MR angiographic procedures performed in the chest, abdomen, or both, in 23 children (14 boys, nine girls; age range, 1 month to 8 years) who were under general anesthesia. All patients underwent mechanical ventilation with preoxygenation (100% oxygen) prior to controlled apnea during image acquisition. In control subjects, the authors assessed contrast-enhanced MR angiographic procedures performed in the chest, abdomen, or both, in 23 children (matched for age and type of study with children in the controlled apnea group; 11 boys, 12 girls; age range, 1 month to 8 years) who were under general anesthesia (n=15) or deep sedation (n=8) and were breathing spontaneously during image acquisition. MR angiograms of the chest, abdomen, or both, were assessed for image quality, motion artifacts, and vessel definition by two radiologists working in consensus with a subjective grading scale. Wilcoxon signed rank test was used to assess differences in measurements. Image quality was rated excellent in 97% (30 of 31) of studies with controlled apnea and in 30% (nine of 31) of control studies (P<.001). Motion artifacts were absent in 97% (30 of 31) of studies with controlled apnea and 13% (four of 31) of control studies (P<.001). Vessel sharpness was rated as being significantly better on images obtained with controlled apnea (P<.05). There were no complications caused by anesthesia or sedation in either group. Controlled apnea is highly effective in children for eliminating respiratory motion artifacts with contrast-enhanced MR angiographic studies, resulting in greatly improved image quality and spatial resolution. (c) RSNA, 2007.

Contrast enhancement of central nervous system lesions: multicenter intraindividual crossover comparative study of two MR contrast agents.

PubMed

Maravilla, Kenneth R; Maldjian, Joseph A; Schmalfuss, Ilona M; Kuhn, Matthew J; Bowen, Brian C; Wippold, Franz J; Runge, Val M; Knopp, Michael V; Kremer, Stephane; Wolansky, Leo J; Anzalone, Nicoletta; Essig, Marco; Gustafsson, Lars

2006-08-01

To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions. This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years +/- 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test. Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions. Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging. RSNA, 2006

ALK molecular phenotype in non-small cell lung cancer: CT radiogenomic characterization.

PubMed

Yamamoto, Shota; Korn, Ronald L; Oklu, Rahmi; Migdal, Christopher; Gotway, Michael B; Weiss, Glen J; Iafrate, A John; Kim, Dong-Wan; Kuo, Michael D

2014-08-01

To present a radiogenomic computed tomographic (CT) characterization of anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) (ALK+). In this HIPAA-compliant institutional review board-approved retrospective study, CT studies, ALK status, and clinical-pathologic data in 172 patients with NSCLC from three institutions were analyzed. A screen of 24 CT image traits was performed in a training set of 59 patients, followed by random forest variable selection incorporating 24 CT traits plus six clinical-pathologic covariates to identify a radiogenomic predictor of ALK+ status. This predictor was then validated in an independent cohort (n = 113). Test-for-accuracy and subset analyses were performed. A similar analysis was performed to identify a biomarker associated with shorter progression-free survival (PFS) after therapy with the ALK inhibitor crizotinib. ALK+ status was associated with central tumor location, absence of pleural tail, and large pleural effusion. An ALK+ radiogenomic CT status biomarker consisting of these three imaging traits with patient age of younger than 60 years showed strong discriminatory power for ALK+ status, with a sensitivity of 83.3% (15 of 18), a specificity of 77.9% (74 of 95), and an accuracy of 78.8% (89 of 113) in independent testing. The discriminatory power was particularly strong in patients with operable disease (stage IIIA or lower), with a sensitivity of 100.0% (five of five), a specificity of 88.1% (37 of 42), and an accuracy of 89.4% (42 of 47). Tumors with a disorganized vessel pattern had a shorter PFS with crizotinib therapy than tumors without this trait (11.4 vs 20.2 months, P = .041). ALK+ NSCLC has distinct characteristics at CT imaging that, when combined with clinical covariates, discriminate ALK+ from non-ALK tumors and can potentially identify patients with a shorter durable response to crizotinib.

Anorexia Nervosa: Analysis of Trabecular Texture with CT.

PubMed

Tabari, Azadeh; Torriani, Martin; Miller, Karen K; Klibanski, Anne; Kalra, Mannudeep K; Bredella, Miriam A

2017-04-01

Purpose To determine indexes of skeletal integrity by using computed tomographic (CT) trabecular texture analysis of the lumbar spine in patients with anorexia nervosa and normal-weight control subjects and to determine body composition predictors of trabecular texture. Materials and Methods This cross-sectional study was approved by the institutional review board and compliant with HIPAA. Written informed consent was obtained. The study included 30 women with anorexia nervosa (mean age ± standard deviation, 26 years ± 6) and 30 normal-weight age-matched women (control group). All participants underwent low-dose single-section quantitative CT of the L4 vertebral body with use of a calibration phantom. Trabecular texture analysis was performed by using software. Skewness (asymmetry of gray-level pixel distribution), kurtosis (pointiness of pixel distribution), entropy (inhomogeneity of pixel distribution), and mean value of positive pixels (MPP) were assessed. Bone mineral density and abdominal fat and paraspinal muscle areas were quantified with quantitative CT. Women with anorexia nervosa and normal-weight control subjects were compared by using the Student t test. Linear regression analyses were performed to determine associations between trabecular texture and body composition. Results Women with anorexia nervosa had higher skewness and kurtosis, lower MPP (P < .001), and a trend toward lower entropy (P = .07) compared with control subjects. Bone mineral density, abdominal fat area, and paraspinal muscle area were inversely associated with skewness and kurtosis and positively associated with MPP and entropy. Texture parameters, but not bone mineral density, were associated with lowest lifetime weight and duration of amenorrhea in anorexia nervosa. Conclusion Patients with anorexia nervosa had increased skewness and kurtosis and decreased entropy and MPP compared with normal-weight control subjects. These parameters were associated with lowest lifetime weight and duration of amenorrhea, but there were no such associations with bone mineral density. These findings suggest that trabecular texture analysis might contribute information about bone health in anorexia nervosa that is independent of that provided with bone mineral density. © RSNA, 2016.

Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular-patterned Lesions of the Thyroid: Diagnostic Accuracy and Optimal Measurement Plane.

PubMed

Samir, Anthony E; Dhyani, Manish; Anvari, Arash; Prescott, Jason; Halpern, Elkan F; Faquin, William C; Stephen, Antonia

2015-11-01

To evaluate the diagnostic accuracy of shear-wave elastography (SWE) for the diagnosis of malignancy in follicular lesions and to identify the optimal SWE measurement plane. The institutional review board approved this HIPAA-compliant, single-institution, prospective pilot study. Subjects scheduled for surgery after a previous fine-needle aspiration report of "atypia of undetermined significance" or "follicular lesion of undetermined significance," "suspicion for follicular neoplasm," or "suspicion for Hurthle cell neoplasm," were enrolled after obtaining informed consent. Subjects underwent conventional ultrasonography (US), Doppler evaluation, and SWE preoperatively, and their predictive value for thyroid malignancy was evaluated relative to the reference standard of surgical pathologic findings. Thirty-five patients (12 men, 23 women) with a mean age of 55 years (range, 23-85 years) and a fine-needle aspiration diagnosis of atypia of undetermined significance or follicular lesion of undetermined significance (n = 16), suspicion for follicular neoplasm (n = 14), and suspicion for Hurthle cell neoplasm (n = 5) were enrolled in the study. Male sex was a statistically significant (P = .02) predictor of malignancy, but age was not. No sonographic morphologic parameter, including nodule size, microcalcification, macrocalcification, halo sign, taller than wide dimension, or hypoechogenicity, was associated with malignancy. Similarly, no Doppler feature, including intranodular vascularity, pulsatility index, resistive index, or peak-systolic velocity, was associated with malignancy. Higher median SWE tissue Young modulus estimates from the transverse insonation plane were associated with malignancy, yielding an area under the receiver operating characteristic curve of 0.81 (95% confidence interval: 0.62, 1.00) for differentiation of malignant from benign nodules. At a cutoff value of 22.3 kPa, sensitivity, specificity, positive predictive value, and negative predictive value of 82%, 88%, 75%, and 91%, respectively, were observed. This prospective pilot study indicates that SWE may be a valuable tool in preoperative malignancy risk assessment of follicular-patterned thyroid nodules. © RSNA, 2015

Diagnostic features of quantitative comb-push shear elastography for breast lesion differentiation

PubMed Central

Denis, Max; Gregory, Adriana; Mehrmohammadi, Mohammad; Kumar, Viksit; Meixner, Duane; Fazzio, Robert T.; Fatemi, Mostafa

2017-01-01

Background Lesion stiffness measured by shear wave elastography has shown to effectively separate benign from malignant breast masses. The aim of this study was to evaluate different aspects of Comb-push Ultrasound Shear Elastography (CUSE) performance in differentiating breast masses. Methods With written signed informed consent, this HIPAA- compliant, IRB approved prospective study included patients from April 2014 through August 2016 with breast masses identified on conventional imaging. Data from 223 patients (19–85 years, mean 59.93±14.96 years) with 227 suspicious breast masses identifiable by ultrasound (mean size 1.83±2.45cm) were analyzed. CUSE was performed on all patients. Three regions of interest (ROI), 3 mm in diameter each, were selected inside the lesion on the B-mode ultrasound which also appeared in the corresponding shear wave map. Lesion elasticity values were measured in terms of the Young’s modulus. In correlation to pathology results, statistical analyses were performed. Results Pathology revealed 108 lesions as malignant and 115 lesions as benign. Additionally, 4 lesions (BI-RADS 2 and 3) were considered benign and were not biopsied. Average lesion stiffness measured by CUSE resulted in 84.26% sensitivity (91 of 108), 89.92% specificity (107 of 119), 85.6% positive predictive value, 89% negative predictive value and 0.91 area under the curve (P<0.0001). Stiffness maps showed spatial continuity such that maximum and average elasticity did not have significantly different results (P > 0.21). Conclusion CUSE was able to distinguish between benign and malignant breast masses with high sensitivity and specificity. Continuity of stiffness maps allowed for choosing multiple quantification ROIs which covered large areas of lesions and resulted in similar diagnostic performance based on average and maximum elasticity. The overall results of this study, highlights the clinical value of CUSE in differentiation of breast masses based on their stiffness. PMID:28257467

Diagnostic features of quantitative comb-push shear elastography for breast lesion differentiation.

PubMed

Bayat, Mahdi; Denis, Max; Gregory, Adriana; Mehrmohammadi, Mohammad; Kumar, Viksit; Meixner, Duane; Fazzio, Robert T; Fatemi, Mostafa; Alizad, Azra

2017-01-01

Lesion stiffness measured by shear wave elastography has shown to effectively separate benign from malignant breast masses. The aim of this study was to evaluate different aspects of Comb-push Ultrasound Shear Elastography (CUSE) performance in differentiating breast masses. With written signed informed consent, this HIPAA- compliant, IRB approved prospective study included patients from April 2014 through August 2016 with breast masses identified on conventional imaging. Data from 223 patients (19-85 years, mean 59.93±14.96 years) with 227 suspicious breast masses identifiable by ultrasound (mean size 1.83±2.45cm) were analyzed. CUSE was performed on all patients. Three regions of interest (ROI), 3 mm in diameter each, were selected inside the lesion on the B-mode ultrasound which also appeared in the corresponding shear wave map. Lesion elasticity values were measured in terms of the Young's modulus. In correlation to pathology results, statistical analyses were performed. Pathology revealed 108 lesions as malignant and 115 lesions as benign. Additionally, 4 lesions (BI-RADS 2 and 3) were considered benign and were not biopsied. Average lesion stiffness measured by CUSE resulted in 84.26% sensitivity (91 of 108), 89.92% specificity (107 of 119), 85.6% positive predictive value, 89% negative predictive value and 0.91 area under the curve (P<0.0001). Stiffness maps showed spatial continuity such that maximum and average elasticity did not have significantly different results (P > 0.21). CUSE was able to distinguish between benign and malignant breast masses with high sensitivity and specificity. Continuity of stiffness maps allowed for choosing multiple quantification ROIs which covered large areas of lesions and resulted in similar diagnostic performance based on average and maximum elasticity. The overall results of this study, highlights the clinical value of CUSE in differentiation of breast masses based on their stiffness.

Cancer Cases from ACRIN Digital Mammographic Imaging Screening Trial: Radiologist Analysis with Use of a Logistic Regression Model1

PubMed Central

Pisano, Etta D.; Acharyya, Suddhasatta; Cole, Elodia B.; Marques, Helga S.; Yaffe, Martin J.; Blevins, Meredith; Conant, Emily F.; Hendrick, R. Edward; Baum, Janet K.; Fajardo, Laurie L.; Jong, Roberta A.; Koomen, Marcia A.; Kuzmiak, Cherie M.; Lee, Yeonhee; Pavic, Dag; Yoon, Sora C.; Padungchaichote, Wittaya; Gatsonis, Constantine

2009-01-01

Purpose: To determine which factors contributed to the Digital Mammographic Imaging Screening Trial (DMIST) cancer detection results. Materials and Methods: This project was HIPAA compliant and institutional review board approved. Seven radiologist readers reviewed the film hard-copy (screen-film) and digital mammograms in DMIST cancer cases and assessed the factors that contributed to lesion visibility on both types of images. Two multinomial logistic regression models were used to analyze the combined and condensed visibility ratings assigned by the readers to the paired digital and screen-film images. Results: Readers most frequently attributed differences in DMIST cancer visibility to variations in image contrast—not differences in positioning or compression—between digital and screen-film mammography. The odds of a cancer being more visible on a digital mammogram—rather than being equally visible on digital and screen-film mammograms—were significantly greater for women with dense breasts than for women with nondense breasts, even with the data adjusted for patient age, lesion type, and mammography system (odds ratio, 2.28; P < .0001). The odds of a cancer being more visible at digital mammography—rather than being equally visible at digital and screen-film mammography—were significantly greater for lesions imaged with the General Electric digital mammography system than for lesions imaged with the Fischer (P = .0070) and Fuji (P = .0070) devices. Conclusion: The significantly better diagnostic accuracy of digital mammography, as compared with screen-film mammography, in women with dense breasts demonstrated in the DMIST was most likely attributable to differences in image contrast, which were most likely due to the inherent system performance improvements that are available with digital mammography. The authors conclude that the DMIST results were attributable primarily to differences in the display and acquisition characteristics of the mammography devices rather than to reader variability. PMID:19703878

Normal Central Zone of the Prostate and Central Zone Involvement by Prostate Cancer: Clinical and MR Imaging Implications

PubMed Central

Akin, Oguz; Franiel, Tobias; Goldman, Debra A.; Udo, Kazuma; Touijer, Karim A.; Reuter, Victor E.; Hricak, Hedvig

2012-01-01

Purpose: To describe the anatomic features of the central zone of the prostate on T2-weighted and diffusion-weighted (DW) magnetic resonance (MR) images and evaluate the diagnostic performance of MR imaging in detection of central zone involvement by prostate cancer. Materials and Methods: The institutional review board waived informed consent and approved this retrospective, HIPAA-compliant study of 211 patients who underwent T2-weighted and DW MR imaging of the prostate before radical prostatectomy. Whole-mount step-section pathologic findings were the reference standard. Two radiologists independently recorded the visibility, MR signal intensity, size, and symmetry of the central zone and scored the likelihood of central zone involvement by cancer on T2-weighted MR images and on T2-weighted MR images plus apparent diffusion coefficient (ADC) maps generated from the DW MR images. Descriptive summary statistics were calculated for central zone imaging features. Sensitivity, specificity, and area under the curve were used to evaluate reader performance in detecting central zone involvement. Results: For readers 1 and 2, the central zone was visible, at least partially, in 177 (84%) and 170 (81%) of 211 patients, respectively. The most common imaging appearance of the central zone was symmetric, homogeneous low signal intensity. Cancers involving the central zone had higher prostate-specific antigen values, Gleason scores, and rates of extracapsular extension and seminal vesicle invasion compared with cancers not involving the central zone (P < .05). Area under the curve, sensitivity, and specificity in detecting central zone involvement were 0.70, 0.30, and 0.96 for reader 1 and 0.65, 0.35, and 0.93 for reader 2, and these values did not differ significantly between T2-weighted imaging and T2-weighted imaging plus ADC maps. Conclusion: The central zone was visualized in most patients. Cancers involving the central zone were associated with more aggressive disease than those without central zone involvement. © RSNA, 2012 PMID:22357889

Common pediatric cerebellar tumors: correlation between cell densities and apparent diffusion coefficient metrics.

PubMed

Koral, Korgün; Mathis, Derek; Gimi, Barjor; Gargan, Lynn; Weprin, Bradley; Bowers, Daniel C; Margraf, Linda

2013-08-01

To test whether there is correlation between cell densities and apparent diffusion coefficient (ADC) metrics of common pediatric cerebellar tumors. This study was reviewed for issues of patient safety and confidentiality and was approved by the Institutional Review Board of the University of Texas Southwestern Medical Center and was compliant with HIPAA. The need for informed consent was waived. Ninety-five patients who had preoperative magnetic resonance imaging and surgical pathologic findings available between January 2003 and June 2011 were included. There were 37 pilocytic astrocytomas, 34 medulloblastomas (23 classic, eight desmoplastic-nodular, two large cell, one anaplastic), 17 ependymomas (13 World Health Organization [WHO] grade II, four WHO grade III), and seven atypical teratoid rhabdoid tumors. ADCs of solid tumor components and normal cerebellum were measured. Tumor-to-normal brain ADC ratios (hereafter, ADC ratio) were calculated. The medulloblastomas and ependymomas were subcategorized according to the latest WHO classification, and tumor cellularity was calculated. Correlation was sought between cell densities and mean tumor ADCs, minimum tumor ADCs, and ADC ratio. When all tumors were considered together, negative correlation was found between cellularity and mean tumor ADCs (ρ = -0.737, P < .05) and minimum tumor ADCs (ρ = -0.736, P < .05) of common pediatric cerebellar tumors. There was no correlation between cellularity and ADC ratio. Negative correlation was found between cellularity and minimum tumor ADC in atypical teratoid rhabdoid tumors (ρ = -0.786, P < .05). In atypical teratoid rhabdoid tumors, no correlation was found between cellularity and mean tumor ADC and ADC ratio. There was no correlation between the ADC metrics and cellularity of the pilocytic astrocytomas, medulloblastomas, and ependymomas. Negative correlation was found between cellularity and ADC metrics of common pediatric cerebellar tumors. Although ADC metrics are useful in the preoperative diagnosis of common pediatric cerebellar tumors and this utility is generally attributed to differences in cellularity of tumors, tumor cellularity may not be the sole determinant of the differences in diffusivity.

Cost and Morbidity Analysis of Chest Port Insertion: Interventional Radiology Suite Versus Operating Room.

PubMed

LaRoy, Jennifer R; White, Sarah B; Jayakrishnan, Thejus; Dybul, Stephanie; Ungerer, Dirk; Turaga, Kiran; Patel, Parag J

2015-06-01

To compare complications and cost, from a hospital perspective, of chest port insertions performed in an interventional radiology (IR) suite versus in surgery in an operating room (OR). This study was approved by an institutional review board and is HIPAA compliant. Medical records were retrospectively searched on consecutive chest port placement procedures, in the IR suite and the OR, between October 22, 2010 and February 26, 2013, to determine patients' demographic information and chest port-related complications and/or infections. A total of 478 charts were reviewed (age range: 21-85 years; 309 women, 169 men). Univariate and bivariate analyses were performed to identify risk factors associated with an increased complication rate. Cost data on 149 consecutive Medicare outpatients (100 treated in the IR suite; 49 treated in the OR) who had isolated chest port insertions between March 2012 and February 2013 were obtained for both the operative services and pharmacy. Nonparametric tests for heterogeneity were performed using the Kruskal-Wallis method. Early complications occurred in 9.2% (22 of 239) of the IR patients versus 13.4% (32 of 239) of the OR patients. Of the 478 implanted chest ports, 9 placed in IR and 18 placed in surgery required early removal. Infections from the ports placed in IR versus the OR were 0.25 versus 0.18 infections per 1000 catheters, respectively. Overall mean costs for chest port insertion were significantly higher in the OR, for both room and pharmacy costs (P < .0001). Overall average cost to place chest ports in an OR setting was almost twice that of placement in the IR suite. Hospital costs to place a chest port were significantly lower in the IR suite than in the OR, whereas radiology and surgery patients did not show a significantly different rate of complications and/or infections. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Radiation dose reduction in soft tissue neck CT using adaptive statistical iterative reconstruction (ASIR).

PubMed

Vachha, Behroze; Brodoefel, Harald; Wilcox, Carol; Hackney, David B; Moonis, Gul

2013-12-01

To compare objective and subjective image quality in neck CT images acquired at different tube current-time products (275 mAs and 340 mAs) and reconstructed with filtered-back-projection (FBP) and adaptive statistical iterative reconstruction (ASIR). HIPAA-compliant study with IRB approval and waiver of informed consent. 66 consecutive patients were randomly assigned to undergo contrast-enhanced neck CT at a standard tube-current-time-product (340 mAs; n = 33) or reduced tube-current-time-product (275 mAs, n = 33). Data sets were reconstructed with FBP and 2 levels (30%, 40%) of ASIR-FBP blending at 340 mAs and 275 mAs. Two neuroradiologists assessed subjective image quality in a blinded and randomized manner. Volume CT dose index (CTDIvol), dose-length-product (DLP), effective dose, and objective image noise were recorded. Signal-to-noise ratio (SNR) was computed as mean attenuation in a region of interest in the sternocleidomastoid muscle divided by image noise. Compared with FBP, ASIR resulted in a reduction of image noise at both 340 mAs and 275 mAs. Reduction of tube current from 340 mAs to 275 mAs resulted in an increase in mean objective image noise (p=0.02) and a decrease in SNR (p = 0.03) when images were reconstructed with FBP. However, when the 275 mAs images were reconstructed using ASIR, the mean objective image noise and SNR were similar to those of the standard 340 mAs CT images reconstructed with FBP (p>0.05). Subjective image noise was ranked by both raters as either average or less-than-average irrespective of the tube current and iterative reconstruction technique. Adapting ASIR into neck CT protocols reduced effective dose by 17% without compromising image quality. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Human- Versus System-Level Factors and Their Effect on Electronic Work List Variation: Challenging Radiology's Fundamental Attribution Error.

PubMed

Davenport, Matthew S; Khalatbari, Shokoufeh; Platt, Joel F

2015-09-01

The aim of this study was to analyze sources of variation influencing the unread volume on an electronic abdominopelvic CT work list and to compare those results with blinded radiologist perception. The requirement for institutional review board approval was waived for this HIPAA-compliant quality improvement effort. Data pertaining to an electronic abdominopelvic CT work list were analyzed retrospectively from July 1, 2013, to June 30, 2014, and modeled with respect to the unread case total at 6 pm (Monday through Friday, excluding holidays). Eighteen system-level factors outside individual control (eg, number of workers, workload) and 7 human-level factors within individual control (eg, individual productivity) were studied. Attending radiologist perception was assessed with a blinded anonymous survey (n = 12 of 15 surveys completed). The mean daily unread total was 24 (range, 3-72). The upper control limit (48 CT studies [3 SDs above the mean]) was exceeded 10 times. Multivariate analysis revealed that the rate of unread CT studies was affected principally by system-level factors, including the number of experienced trainees on service (postgraduate year 5 residents [odds ratio, 0.83; 95% confidence interval, 0.74-0.92; P = .0008] and fellows [odds ratio, 0.84; 95% confidence interval, 0.74-0.95; P = .005]) and the daily workload (P = .02 to P < .0001). Individual faculty productivity had a weak effect (Spearman ρ = 0.13, P = .03; adequacy: 3% of variance explained). The majority (67%) of radiologists (8 of 12) completing the survey believed that variation in faculty effort was the most important influence on the daily unread total. System-level factors best predict the variation in unread CT examinations, but blinded faculty radiologists believe that it relates most strongly to variable individual effort. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

(Lack of) Measurable Clinical or Knowledge Gains From Resident Participation in Noon Conference.

PubMed

Meyer, Nathaniel B; Gaetke-Udager, Kara; Shampain, Kimberly L; Spencer, Amy; Cohan, Richard H; Davenport, Matthew S

2018-06-01

The objective of this study was to determine whether noon conference attendance by diagnostic radiology residents is predictive of measurable performance. This single-center retrospective Health Insurance and Portability and Accountability Act (HIPAA)-compliant cross-sectional study was considered "not regulated" by the institutional review board. All diagnostic radiology residents who began residency training from 2008 to 2012 were included (N = 54). Metrics of clinical performance and knowledge were collected, including junior and senior precall test results, American Board of Radiology scores (z-score transformed), American College of Radiology in-training scores (years 1-3), on-call "great call" and minor and major discrepancy rates, on-call and daytime case volumes, and training rotation scores. Multivariate regression models were constructed to determine if conference attendance, match rank order, or starting year could predict these outcomes. Pearson bivariate correlations were calculated. Senior precall test results were moderately correlated with American Board of Radiology (r = 0.41) and American College of Radiology (r = 0.38-0.48) test results and mean rotation scores (r = 0.41), indicating moderate internal validity. However, conference attendance, match rank order, and year of training did not correlate with (r = -0.16-0.16) or predict (P > .05) measurable resident knowledge. On multivariate analysis, neither match rank order (P = .14-.96) nor conference attendance (P = .10-.88) predicted measurable clinical efficiency or accuracy. Year started training predicted greater cross-sectional case volume (P < .0001, β = 0.361-0.516) and less faculty-to-resident feedback (P < 0.0001, β = [-0.628]-[-0.733]). Residents with lower conference attendance are indistinguishable from those who attend more frequently in a wide range of clinical and knowledge-based performance assessments, suggesting that required attendance may not be necessary to gain certain measurable core competencies. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Patients with Testicular Cancer Undergoing CT Surveillance Demonstrate a Pitfall of Radiation-induced Cancer Risk Estimates: The Timing Paradox

PubMed Central

Eisenberg, Jonathan D.; Lee, Richard J.; Gilmore, Michael E.; Turan, Ekin A.; Singh, Sarabjeet; Kalra, Mannudeep K.; Liu, Bob; Kong, Chung Yin; Gazelle, G. Scott

2013-01-01

Purpose: To demonstrate a limitation of lifetime radiation-induced cancer risk metrics in the setting of testicular cancer surveillance—in particular, their failure to capture the delayed timing of radiation-induced cancers over the course of a patient’s lifetime. Materials and Methods: Institutional review board approval was obtained for the use of computed tomographic (CT) dosimetry data in this study. Informed consent was waived. This study was HIPAA compliant. A Markov model was developed to project outcomes in patients with testicular cancer who were undergoing CT surveillance in the decade after orchiectomy. To quantify effects of early versus delayed risks, life expectancy losses and lifetime mortality risks due to testicular cancer were compared with life expectancy losses and lifetime mortality risks due to radiation-induced cancers from CT. Projections of life expectancy loss, unlike lifetime risk estimates, account for the timing of risks over the course of a lifetime, which enabled evaluation of the described limitation of lifetime risk estimates. Markov chain Monte Carlo methods were used to estimate the uncertainty of the results. Results: As an example of evidence yielded, 33-year-old men with stage I seminoma who were undergoing CT surveillance were projected to incur a slightly higher lifetime mortality risk from testicular cancer (598 per 100 000; 95% uncertainty interval [UI]: 302, 894) than from radiation-induced cancers (505 per 100 000; 95% UI: 280, 730). However, life expectancy loss attributable to testicular cancer (83 days; 95% UI: 42, 124) was more than three times greater than life expectancy loss attributable to radiation-induced cancers (24 days; 95% UI: 13, 35). Trends were consistent across modeled scenarios. Conclusion: Lifetime radiation risk estimates, when used for decision making, may overemphasize radiation-induced cancer risks relative to short-term health risks. © RSNA, 2012 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12121015/-/DC1 PMID:23249573

Estimating Patient Dose from X-ray Tube Output Metrics: Automated Measurement of Patient Size from CT Images Enables Large-scale Size-specific Dose Estimates

PubMed Central

Ikuta, Ichiro; Warden, Graham I.; Andriole, Katherine P.; Khorasani, Ramin

2014-01-01

Purpose To test the hypothesis that patient size can be accurately calculated from axial computed tomographic (CT) images, including correction for the effects of anatomy truncation that occur in routine clinical CT image reconstruction. Materials and Methods Institutional review board approval was obtained for this HIPAA-compliant study, with waiver of informed consent. Water-equivalent diameter (DW) was computed from the attenuation-area product of each image within 50 adult CT scans of the thorax and of the abdomen and pelvis and was also measured for maximal field of view (FOV) reconstructions. Linear regression models were created to compare DW with the effective diameter (Deff) used to select size-specific volume CT dose index (CTDIvol) conversion factors as defined in report 204 of the American Association of Physicists in Medicine. Linear regression models relating reductions in measured DW to a metric of anatomy truncation were used to compensate for the effects of clinical image truncation. Results In the thorax, DW versus Deff had an R2 of 0.51 (n = 200, 50 patients at four anatomic locations); in the abdomen and pelvis, R2 was 0.90 (n = 150, 50 patients at three anatomic locations). By correcting for image truncation, the proportion of clinically reconstructed images with an extracted DW within ±5% of the maximal FOV DW increased from 54% to 90% in the thorax (n = 3602 images) and from 95% to 100% in the abdomen and pelvis (6181 images). Conclusion The DW extracted from axial CT images is a reliable measure of patient size, and varying degrees of clinical image truncation can be readily corrected. Automated measurement of patient size combined with CT radiation exposure metrics may enable patient-specific dose estimation on a large scale. © RSNA, 2013 PMID:24086075

Systems and Methods for Implementing Bulk Metallic Glass-Based Macroscale Compliant Mechanisms

NASA Technical Reports Server (NTRS)

Hofmann, Douglas C. (Inventor); Agnes, Gregory (Inventor)

2017-01-01

Systems and methods in accordance with embodiments of the invention implement bulk metallic glass-based macroscale compliant mechanisms. In one embodiment, a bulk metallic glass-based macroscale compliant mechanism includes: a flexible member that is strained during the normal operation of the compliant mechanism; where the flexible member has a thickness of 0.5 mm; where the flexible member comprises a bulk metallic glass-based material; and where the bulk metallic glass-based material can survive a fatigue test that includes 1000 cycles under a bending loading mode at an applied stress to ultimate strength ratio of 0.25.

Environmentally Compliant Coating Remover Evaluation

DTIC Science & Technology

2012-08-30

22 9 Total of 491 products evaluated 7 Background • Many DoD depainting operations currently use environmentally compliant peroxide -assisted... benzyl alcohol strippers • These strippers have acceptable coating removal rates with minimal physical damage to metallic substrates • However, several...Coatings • Environmentally compliant benzyl alcohol product • Passed corrosion testing conducted by SMI in 2011 11 Laboratory Testing Scope

Variation in practice: an analysis of Scottish Surgical Profiles ENT data.

PubMed

Yeo, J C L; Ah-See, K W; Mackenzie, K

2013-02-01

Variation in otolaryngology intervention rates is reported in the Scottish Surgical Profiles Project. Tonsillectomy is one of the selected key indicator procedures. The variation in practice was discussed nationally at the Scottish Otolaryngology Society summer meetings in 2009 and 2010. NHS Grampian had a significantly higher tonsillectomy rate compared with other Scottish NHS boards. To determine the accuracy of NHS Grampian data reported by the Information Service Division (ISD) and to record the appropriateness of listing of patients for tonsillectomy with reference to the Scottish Intercollegiate Guidelines Network (SIGN). Retrospective review of case notes and surgical records of patients who had undergone tonsillectomy between March 2007 and March 2008 in NHS Grampian. Between March 2007 and March 2008, 509 tonsillectomy cases were performed in NHS Grampian. This corresponded to the data received from ISD. 87% of tonsillectomies performed were compliant with SIGN guidelines. The Scottish otolaryngology clinicians have found the reporting of the intervention rates stimulating and challenging. Discussion of the surgical profile project regularly at national specialty meetings resulted in a preliminary detailed targeted audit of those who were persistent outliers for tonsillectomy. This refuted the presumed reasons for this variation, namely inaccurate figures from ISD and inappropriate listings by clinicians.

External Hand Forces Exerted by Long-Term Care Staff to Push Floor-Based Lifts: Effects of Flooring System and Resident Weight.

PubMed

Lachance, Chantelle C; Korall, Alexandra M B; Russell, Colin M; Feldman, Fabio; Robinovitch, Stephen N; Mackey, Dawn C

2016-09-01

The aim of this study was to investigate the effects of flooring type and resident weight on external hand forces required to push floor-based lifts in long-term care (LTC). Novel compliant flooring is designed to reduce fall-related injuries among LTC residents but may increase forces required for staff to perform pushing tasks. A motorized lift may offset the effect of flooring on push forces. Fourteen female LTC staff performed straight-line pushes with two floor-based lifts (conventional, motor driven) loaded with passengers of average and 90th-percentile resident weights over four flooring systems (concrete+vinyl, compliant+vinyl, concrete+carpet, compliant+carpet). Initial and sustained push forces were measured by a handlebar-mounted triaxial load cell and compared to participant-specific tolerance limits. Participants rated pushing difficulty. Novel compliant flooring increased initial and sustained push forces and subjective ratings compared to concrete flooring. Compared to the conventional lift, the motor-driven lift substantially reduced initial and sustained push forces and perceived difficulty of pushing for all four floors and both resident weights. Participants exerted forces above published tolerance limits only when using the conventional lift on the carpet conditions (concrete+carpet, compliant+carpet). With the motor-driven lift only, resident weight did not affect push forces. Novel compliant flooring increased linear push forces generated by LTC staff using floor-based lifts, but forces did not exceed tolerance limits when pushing over compliant+vinyl. The motor-driven lift substantially reduced push forces compared to the conventional lift. Results may help to address risk of work-related musculoskeletal injury, especially in locations with novel compliant flooring. © 2016, Human Factors and Ergonomics Society.

Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients – Results from a Multi-center Clinical Trial

PubMed Central

Krisciunas, Gintas P.; McCulloch, Timothy M.; Lazarus, Cathy L.; Pauloski, Barbara R.; Meyer, Tanya K.; Graner, Darlene; Van Daele, Douglas J.; Silbergleit, Alice K.; Crujido, Lisa R.; Rybin, Denis; Doros, Gheorghe; Kotz, Tamar; Langmore, Susan E.

2016-01-01

Purpose A 5yr, 16 site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. Methods A home program, performed 2×/day, 6d/wk, for 12wks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12wk intervention period. “Compliant” was defined as performing 10-12 sessions/wk. Outcomes were change in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12wks of therapy. Results Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/wk (median=10.25). Fifty four percent of patients (n=83) were considered “compliant”. After 12wks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p=0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. Conclusions The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population. PMID:27848021

Compliance with gastric cancer guidelines is associated with improved outcomes.

PubMed

Worhunsky, David J; Ma, Yifei; Zak, Yulia; Poultsides, George A; Norton, Jeffrey A; Rhoads, Kim F; Visser, Brendan C

2015-03-01

Limited data are available on the implementation and effectiveness of NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer. We sought to assess rates of compliance with NCCN Guidelines, specifically stage-specific therapy during the initial episode of care, and to determine its impact on outcomes. The California Cancer Registry was used to identify cases of gastric cancer from 2001 to 2006. Logistic regression and Cox proportional hazard models were used to predict guideline compliance and the adjusted hazard ratio for mortality. Patients with TNM staging or summary stage (SS) were also analyzed separately. Compliance with NCCN Guidelines occurred in just 45.5% of patients overall. Patients older than 55 years were less likely to receive guideline-compliant care, and compliance was associated with a median survival of 20 versus 7 months for noncompliant care (P<.001). Compliant care was also associated with a 55% decreased hazard of mortality (P<.001). Further analysis revealed that 50% of patients had complete TNM staging versus an SS, and TNM-staged patients were more likely to receive compliant care (odds ratio, 1.59; P<.001). TNM-staged patients receiving compliant care had a median survival of 25.3 months compared with 15.1 months for compliant SS patients. Compliance with NCCN Guidelines and stage-specific therapy at presentation for the treatment of patients with gastric cancer was poor, which was a significant finding given that compliant care was associated with a 55% reduction in the hazard of death. Additionally, patients with TNM-staged cancer were more likely to receive compliant care, perhaps a result of having received more intensive therapy. Combined with the improved survival among compliant TNM-staged patients, these differences have meaningful implications for health services research. Copyright © 2015 by the National Comprehensive Cancer Network.

Generalized constitutive equations for piezo-actuated compliant mechanism

NASA Astrophysics Data System (ADS)

Cao, Junyi; Ling, Mingxiang; Inman, Daniel J.; Lin, Jin

2016-09-01

This paper formulates analytical models to describe the static displacement and force interactions between generic serial-parallel compliant mechanisms and their loads by employing the matrix method. In keeping with the familiar piezoelectric constitutive equations, the generalized constitutive equations of compliant mechanism represent the input-output displacement and force relations in the form of a generalized Hooke’s law and as analytical functions of physical parameters. Also significantly, a new model of output displacement for compliant mechanism interacting with piezo-stacks and elastic loads is deduced based on the generalized constitutive equations. Some original findings differing from the well-known constitutive performance of piezo-stacks are also given. The feasibility of the proposed models is confirmed by finite element analysis and by experiments under various elastic loads. The analytical models can be an insightful tool for predicting and optimizing the performance of a wide class of compliant mechanisms that simultaneously consider the influence of loads and piezo-stacks.

Assessing Factors Affecting Physician's Intention to Adopt Biometric Authentication Technology in Electronic Medical Records

ERIC Educational Resources Information Center

Corazao, Cesar E.

2014-01-01

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulated the privacy and security of patient information. Since HIPPA became a law, hospital operators have struggled to comply fully with its security and privacy provisions. The proximity-based biometric authentication (PBBA) technology evolved in last decade to help…

78 FR 23872 - HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

... any unintended adverse consequences for individuals seeking needed mental health services that may be... Check System (NICS) to help enforce these prohibitions.\\4\\ The NICS Index, a database administered by... to the NICS. Such an amendment might produce clarity regarding the Privacy Rule and help make it as...

45 CFR 150.209 - Verification of exhaustion of remedies and contact with State officials.

Code of Federal Regulations, 2010 CFR

2010-10-01

... REQUIREMENTS RELATING TO HEALTH CARE ACCESS CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS... § 150.209 Verification of exhaustion of remedies and contact with State officials. If CMS receives a complaint or other information indicating that a State is failing to enforce HIPAA requirements, CMS...

Fingerprints in Place of Passwords: A Study of Technology Adoption in the Nursing Profession

ERIC Educational Resources Information Center

Francisco, James R.

2010-01-01

Health care is one of the most highly regulated industries in the United States. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandates the implementation of information systems security to protect the personal information of patients. Properly planned implementations ease the process of introducing new technologies like…

76 FR 56712 - CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-14

...; Patients' Access to Test Reports AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers for...) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test... provide for release of test reports to authorized persons and, if applicable, the individuals (or their...

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders.

PubMed

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Biobanking Research and Privacy Laws in the United States.

PubMed

Harrell, Heather L; Rothstein, Mark A

2016-03-01

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU-US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. © 2016 American Society of Law, Medicine & Ethics.

Personal computer security: part 1. Firewalls, antivirus software, and Internet security suites.

PubMed

Caruso, Ronald D

2003-01-01

Personal computer (PC) security in the era of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) involves two interrelated elements: safeguarding the basic computer system itself and protecting the information it contains and transmits, including personal files. HIPAA regulations have toughened the requirements for securing patient information, requiring every radiologist with such data to take further precautions. Security starts with physically securing the computer. Account passwords and a password-protected screen saver should also be set up. A modern antivirus program can easily be installed and configured. File scanning and updating of virus definitions are simple processes that can largely be automated and should be performed at least weekly. A software firewall is also essential for protection from outside intrusion, and an inexpensive hardware firewall can provide yet another layer of protection. An Internet security suite yields additional safety. Regular updating of the security features of installed programs is important. Obtaining a moderate degree of PC safety and security is somewhat inconvenient but is necessary and well worth the effort. Copyright RSNA, 2003

Connections for solid oxide fuel cells

DOEpatents

Collie, Jeffrey C.

1999-01-01

A connection for fuel cell assemblies is disclosed. The connection includes compliant members connected to individual fuel cells and a rigid member connected to the compliant members. Adjacent bundles or modules of fuel cells are connected together by mechanically joining their rigid members. The compliant/rigid connection permits construction of generator fuel cell stacks from basic modular groups of cells of any desired size. The connections can be made prior to installation of the fuel cells in a generator, thereby eliminating the need for in-situ completion of the connections. In addition to allowing pre-fabrication, the compliant/rigid connections also simplify removal and replacement of sections of a generator fuel cell stack.

Verification of drag-reduction capabilities of stiff compliant coatings in air flow at moderate speeds

NASA Astrophysics Data System (ADS)

Boiko, Andrey V.; Kulik, Victor M.; Chun, Ho-Hwan; Lee, Inwon

2011-12-01

Skin frictional drag reduction efficiency of "stiff" compliant coating was investigated in a wind tunnel experiment. Flat plate compliant coating inserts were installed in a wind tunnel and the measurements of skin frictional drag and velocity field were carried out. The compliant coatings with varying viscoelastic properties had been prepared using different composition. In order to optimize the coating thickness, the most important design parameter, the dynamic viscoelastic properties had been determined experimentally. The aging of the materials (variation of their properties) during half a year was documented as well. A design procedure proposed by Kulik et al. (2008) was applied to get an optimal value for the coating thickness. Along with the drag measurement using the strain balance, velocity and pressure were measured for different coatings. The compliant coatings with the thickness h = 7mm achieved 4~5% drag reduction within a velocity range 30~40 m/s. The drag reduction mechanism of the attenuation of turbulence velocity fluctuations due to the compliant coating was demonstrated. It is envisioned that larger drag reduction effect is obtainable at higher flow velocities for high speed trains and subsonic aircrafts.

Stiffness modeling of compliant parallel mechanisms and applications in the performance analysis of a decoupled parallel compliant stage

NASA Astrophysics Data System (ADS)

Jiang, Yao; Li, Tie-Min; Wang, Li-Ping

2015-09-01

This paper investigates the stiffness modeling of compliant parallel mechanism (CPM) based on the matrix method. First, the general compliance matrix of a serial flexure chain is derived. The stiffness modeling of CPMs is next discussed in detail, considering the relative positions of the applied load and the selected displacement output point. The derived stiffness models have simple and explicit forms, and the input, output, and coupling stiffness matrices of the CPM can easily be obtained. The proposed analytical model is applied to the stiffness modeling and performance analysis of an XY parallel compliant stage with input and output decoupling characteristics. Then, the key geometrical parameters of the stage are optimized to obtain the minimum input decoupling degree. Finally, a prototype of the compliant stage is developed and its input axial stiffness, coupling characteristics, positioning resolution, and circular contouring performance are tested. The results demonstrate the excellent performance of the compliant stage and verify the effectiveness of the proposed theoretical model. The general stiffness models provided in this paper will be helpful for performance analysis, especially in determining coupling characteristics, and the structure optimization of the CPM.

A new hybrid piezo-actuated compliant mechanism with self-tuned flexure arm

NASA Astrophysics Data System (ADS)

Ling, Mingxiang; Cao, Junyi

2017-04-01

Recent interests and demands for developing video-rate atomic force microscopes, high-throughput probe-based nanofabrication and high-frequency vibration generator for assisted-machining are increasingly posing new challenges for designing high-bandwidth and large-range piezo-actuated compliant mechanisms. The previous studies mainly focused on making the trade-off between natural frequency and motion range by designing a proper topology. Differing from the previous works, this paper attempts to break the deadlock by employing both piezo-stacks and piezoelectric patches to actuate compliant mechanisms. In this method, piezo-stacks provide an actuating force similar to the traditional way, while piezoelectric patches are bonded on the surface of the flexure arms in compliant mechanisms. These `active' laminaes are used to further actuate the hosting flexural beam by inducing strains on the interface and then give additional bending moments to the flexural arms, which enlarge the output displacement of the compliant mechanism while without the sacrifice of natural frequency. An analytical formulation is established to illustrate the new driving principle and the compound static behaviour of a specific hybrid piezo-actuated multistage compliant mechanism. Initial prototype is also manufactured and experimentally testing is conducted to verify the feasibility of the method.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS). Final rule.

PubMed

2016-01-06

The Department of Health and Human Services (HHS or "the Department'') is issuing this final rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal "mental health prohibitor'' that disqualifies them from shipping, transporting, possessing, or receiving a firearm. The NICS is a national system maintained by the Federal Bureau of Investigation (FBI) to conduct background checks on persons who may be disqualified from receiving firearms based on Federally prohibited categories or State law. Among the persons subject to the Federal mental health prohibitor established under the Gun Control Act of 1968 and implementing regulations issued by the Department of Justice (DOJ) are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence or mental illness, incompetency, condition, or disease. Under this final rule, only covered entities with lawful authority to make the adjudications or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes, are permitted to disclose the information needed for these purposes. The disclosure is restricted to limited demographic and certain other information needed for NICS purposes. The rule specifically prohibits the disclosure of diagnostic or clinical information, from medical records or other sources, and any mental health information beyond the indication that the individual is subject to the Federal mental health prohibitor.

Complying with the Health Insurance Portability and Accountability Act. Privacy standards.

PubMed

Shuren, A W; Livsey, K

2001-11-01

The Privacy Rule: Limits the use and disclosure of PHI to purposes of treatment, payment, or routine health care operations. Requires covered entities to provide advance notice to the public of its policy governing disclosure of PHI. Requires entities covered by the Standard to secure general client consent to use and to disclose PHI for treatment, payment, or routine health care operations and to obtain specific client authorization to use or to disclose PHI for all other purposes unless the disclosure is specifically permitted without consent or authorization (e.g., a covered entity may disclose PHI to a health care oversight agency such as the Office of the Inspector General without first obtaining client authorization). In certain situations, a covered entity need only obtain client agreement to disclose PHI which may be oral or inferred from the circumstances surrounding the disclosure. For example, a covered entity could disclose PHI to a relative caring for the individual who is the subject of the health information. Expects covered entities to take measures to protect PHI from both inadvertent and deliberate misuse and disclosure. Requires, except in certain circumstances, the amount of PHI disclosed on any occasion to be limited to the minimum necessary to achieve the purpose of the disclosure. Gives individuals more control of their health information by permitting them to review and amend health information pertaining to themselves and to demand an accounting of persons to whom their health information has been disclosed. Establishes terms under which a covered entity may disclose PHI to a business associate. Permits states to maintain state laws that are more stringent than the Privacy Rule. The statute provides for significant civil and criminal penalties for failure to comply with the Standards. Violations are punishable by fines as much as $250,000 and 10 years imprisonment. The HHS, Office of Civil Rights is charged with enforcing the Standards. The HHS is expected to issue a single Enforcement Rule applicable to all three of the HIPAA Administrative Simplification Standards. Many worksite records will not be protected under the HIPAA Privacy Rule because employers are not covered entities and few occupational health professionals meet the criteria of being considered a covered entity. Nevertheless, occupational health professionals need to be knowledgeable about the application of HIPAA in the occupational health care setting. Furthermore, given that the Rule does not preempt state privacy laws that are more stringent than the Standards, occupational health professionals should monitor legislative activity related to privacy in the states in which they practice. To date, Oregon, Texas, and New Jersey have broadened HIPAA's definitions to create more covered entities and services.

Grandfathered, Grandmothered, And ACA-Compliant Health Plans Have Equivalent Premiums.

PubMed

Whitmore, Heidi; Gabel, Jon R; Satorius, Jennifer L; Green, Matthew

2017-02-01

Many small employers offer employees health plans that are not fully compliant with Affordable Care Act (ACA) provisions such as covering preventive services without cost sharing. These "grandfathered" and "grandmothered" plans accounted for about 65 percent of enrollment in the small-group market in 2014. Premium costs for these and ACA-compliant plans were equivalent. Project HOPE—The People-to-People Health Foundation, Inc.

Factors Influencing the Adoption of Electronic Medical Records: Phenomenological Study of Physicians in Private Practice

ERIC Educational Resources Information Center

Backherms, Dennis A.

2017-01-01

Information technology has become increasingly necessary for competition in the 21st century. The medical industry has taken on a more comprehensive approach by creating and adopting different types of electronic medical records (EMR). Laws and regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) or the Meaningful…

HIPAA's Role in E-Mail Communications between Doctors and Patients: Privacy, Security, and Implications of the Bill

ERIC Educational Resources Information Center

Stephens, James H.; Parrillo, Anthony V.

2011-01-01

The confidentiality of a patient's information has been sacred since the days of Hippocrates, the Father of Medicine. Today, however, merely taking an oath to respect a patient's privacy has been overshadowed by regulations governing how certain healthcare establishments handle an individual's health information on the web. Consequently, if a…

45 CFR 150.303 - Basis for initiating an investigation of a potential violation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... REQUIREMENTS RELATING TO HEALTH CARE ACCESS CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS CMS... may be failing to meet an applicable HIPAA requirement, may warrant an investigation. CMS may consider... acting on that individual's behalf, may file a complaint with CMS if he or she believes that a right to...

Compliant mechanism road bicycle brake: a rigid-body replacement case study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Olsen, Brian M; Howell, Larry L; Magleby, Spencer P

2011-01-19

The design of high-performance bicycle brakes is complicated by the competing design objectives of increased performance and low weight. But this challenge also provides a good case study to demonstrate the design of compliant mechanisms to replace current rigid-link mechanisms. This paper briefly reviews current road brake designs, demonstrates the use of rigid-body replacement synthesis to design a compliant mechanism, and illustrates the combination of compliant mechanism design tools. The resulting concept was generated from the modified dual-pivot brake design and is a partially compliant mechanism where one pin has the dual role of a joint and a mounting pin.more » The pseudo-rigid-body model, finite element analysis, and optimization algorithms are used to generate design dimensions, and designs are considered for both titanium and E-glass flexures. The resulting design has the potential of reducing the part count and overall weight while maintaining a performance similar to the benchmark.« less

Compliant displacement-multiplying apparatus for microelectromechanical systems

DOEpatents

Kota, Sridhar; Rodgers, M. Steven; Hetrick, Joel A.

2001-01-01

A pivotless compliant structure is disclosed that can be used to increase the geometric advantage or mechanical advantage of a microelectromechanical (MEM) actuator such as an electrostatic comb actuator, a capacitive-plate electrostatic actuator, or a thermal actuator. The compliant structure, based on a combination of interconnected flexible beams and cross-beams formed of one or more layers of polysilicon or silicon nitride, can provide a geometric advantage of from about 5:1 to about 60:1 to multiply a 0.25-3 .mu.m displacement provided by a short-stroke actuator so that such an actuator can be used to generate a displacement stroke of about 10-34 .mu.m to operate a ratchet-driven MEM device or a microengine. The compliant structure has less play than conventional displacement-multiplying devices based on lever arms and pivoting joints, and is expected to be more reliable than such devices. The compliant structure and an associated electrostatic or thermal actuator can be formed on a common substrate (e.g. silicon) using surface micromachining.

Specialist perioperative allergy clinic services in the UK 2016: Results from the Royal College of Anaesthetists Sixth National Audit Project.

PubMed

Egner, W; Cook, T; Harper, N; Garcez, T; Marinho, S; Kong, K L; Nasser, S; Thomas, M; Warner, A; Hitchman, J; Floss, K

2017-10-01

Guidelines for investigation of perioperative drug allergy exist, but the quality of services is unknown. Specialist perioperative anaphylaxis services were surveyed through the Royal College of Anaesthetists 6 th National Audit Project. We compare self-declared UK practice in specialist perioperative allergy services with national recommendations. A SurveyMonkey™ questionnaire was distributed to providers of allergy services in the UK. Responses were assessed for adherence to the best practice recommendations of the British Society for Allergy and Clinical Immunology (BSACI), the Association of Anaesthetists of Great Britain and Ireland and the National Institute for Health and Care Excellence (NICE) Guidance on Drug Allergy-CG183. Over 1200 patients were evaluated in 44 centres annually. Variation in workload, waiting times, access, staffing and diagnostic approach was noted. Paediatric centres had the longest routine waiting times (most wait >13 weeks) in contrast to adult centres (most wait <12 weeks). Service leads are allergists/immunologists (91%) or anaesthetists (7%). Potentially important differences were seen in: testing repertoire [10/44 (23%) lacked BSACI compliant neuromuscular blocking agent (NMBA) panels and 17/44 (39%) lacked a NAP6-defined extended panel; many failed to screen all cases for chlorhexidine 19/44 (43%) or latex 21/44 (48%)], staffing [only 26/44 (59%) had specialist nurses and 18/44 (41%) an anaesthetist] and provision of information [18/44 (41%) gave immediate information in clinic and 5/44 (11%) sign-posted support groups]. Most centres were able to provide diagnostic challenges to antibiotics [40/44 (91%]) and local anaesthetics [41/44 (93%)]. Diagnostic testing is not harmonized, with marked variability in the NMBA panels used to identify safe alternatives. Chlorhexidine and latex are not part of routine testing in many centres. Poor access to services and patient information provision require attention. Harmonization of diagnostic approach is desirable, particularly with regard to a minimum NMBA panel for identification of safe alternatives. © 2017 John Wiley & Sons Ltd.

Study of non-compliance among chronic hemodialysis patients and its impact on patients' outcomes.

PubMed

Ibrahim, Salwa; Hossam, Mohammed; Belal, Dawlat

2015-03-01

Non-adherence to prescription is common among hemodialysis (HD) patients and has been associated with significant morbidity. At least 50% of HD patients are believed to be non-adherent to some part of their treatment. We aimed to assess the prevalence of non-adherence to dialysis prescription among 100 chronic HD patients. We explored the relationship between non-adherence on one hand and socioeconomic profile, depression scores and cognitive function on the other hand. The impact of patients' non-adherence on nutritional status, quality of life and dialysis adequacy was also assessed. The mean age of the study group was 50.51 ± 12.0 years. There were 62 females and 38 males in the study. Thirty-six patients (36%) were non-compliant to their dialysis prescription. No significant differences were detected between compliant and non-compliant patients in their education level and employment status. Inter-dialytic weight gain, serum phosphorus and depression scores were significantly higher in non-compliant patients compared with compliant patients, whereas body weight, serum albumin, serum calcium, quality of life scores and nutrition scores were significantly higher in compliant patients (P <0.05). In conclusion, non-adherence is highly prevalent among chronic HD patients and is associated with poor quality of life, depression and malnutrition.

Elastic/plastic analyses of advanced composites investigating the use of the compliant layer concept in reducing residual stresses resulting from processing

NASA Technical Reports Server (NTRS)

Arnold, Steven M.; Arya, Vinod K.; Melis, Matthew E.

1990-01-01

High residual stresses within intermetallic and metal matrix composite systems can develop upon cooling from the processing temperature to room temperature due to the coefficient of thermal expansion (CTE) mismatch between the fiber and matrix. As a result, within certain composite systems, radial, circumferential, and/or longitudinal cracks have been observed to form at the fiber-matrix interface. The compliant layer concept (insertion of a compensating interface material between the fiber and matrix) was proposed to reduce or eliminate the residual stress buildup during cooling and thus minimize cracking. The viability of the proposed compliant layer concept is investigated both elastically and elastoplastically. A detailed parametric study was conducted using a unit cell model consisting of three concentric cylinders to determine the required character (i.e., thickness and material properties) of the compliant layer as well as its applicability. The unknown compliant layer mechanical properties were expressed as ratios of the corresponding temperature dependent Ti-24Al-11Nb (a/o) matrix properties. The fiber properties taken were those corresponding to SCS-6 (SiC). Results indicate that the compliant layer can be used to reduce, if not eliminate, radial and circumferential residual stresses within the fiber and matrix and therefore also reduce or eliminate the radial cracking. However, with this decrease in in-plane stresses, one obtains an increase in longitudinal stress, thus potentially initiating longitudinal cracking. Guidelines are given for the selection of a specific compliant material, given a perfectly bonded system.

Deformation of conjugate compliant fault zones induced by the 2013 Mw7.7 Baluchistan (Pakistan) earthquake

NASA Astrophysics Data System (ADS)

Dutta, Rishabh; Wang, Teng; Feng, Guangcai; Harrington, Jonathan; Vasyura-Bathke, Hannes; Jónsson, Sigurjón

2017-04-01

Strain localizations in compliant fault zones (with elastic moduli lower than the surrounding rocks) induced by nearby earthquakes have been detected using geodetic observations in a few cases in the past. Here we observe small-scale changes in interferometric Synthetic Aperture Radar (InSAR) measurements along multiple conjugate faults near the rupture of the 2013 Mw7.7 Baluchistan (Pakistan) earthquake. After removing the main coseismic deformation signal in the interferograms and correcting them for topography-related phase, we observe 2-3 cm signal along several conjugate faults that are 15-30 km from the mainshock fault rupture. These conjugate compliant faults have strikes of N30°E and N45°W. The sense of motion indicates left-lateral deformation across the N30°E faults and right-lateral deformation across the N45°W faults, which suggests the conjugate faults were subjected to extensional coseismic stresses along the WSW-ENE direction. The spacing between the different sets of faults is around 5 to 8 km. We explain the observed strain localizations as an elastic response of the compliant conjugate faults induced by the Baluchistan earthquake. Using 3D Finite Element models (FEM), we impose coseismic static displacements due to the earthquake along the boundaries of the FEM domain to reproduce the coseismic stress changes acting across the compliant faults. The InSAR measurements are used to constrain the geometry and rigidity variations of the compliant faults with respect to the surrounding rocks. The best fitting models show the compliant fault zones to have a width of 0.5 km to 2 km and a reduction of the shear modulus by a factor of 3 to 4. Our study yields similar values as were found for compliant fault zones near the 1992 Landers and the 1999 Hector Mine earthquakes in California, although here the strain localization is occurring on more complex conjugate sets of faults.

AUDIT OF THE AUDITS.

PubMed

Alam, Malik Mahmood

2015-01-01

Audits play an important role in improving the services to patient care. Our department was involved in carrying out Audits by the trainees on regular basis as suggested by the Royal college and each House officer or the Registrar rotating through was doing an Audit in his/her tenure. Ninteen Audits were done in 3 years in the Pediatric department. We used the criteria suggested for evaluating the quality of Audits and put into the category of full Audits, Partial Audits, Potential Audits and planning Audits. Six of our Audits were full Audits, eleven were partial Audits, two were Potential Audits and none were Planning Audits. We think that as a general trend we had similar shortcomings in quality of our Audits which need to be improved by involving seniors specially in implementing the changes suggested in the Audits otherwise it will not fulfill the Aims and objectives.

Autovibration and chaotic motion of an unbalanced rotor in massive non-linear compliant supports

NASA Astrophysics Data System (ADS)

Pasynkova, I. A.; Stepanova, P. P.

2018-05-01

Stability loss scenarios of an unbalanced rotor with a flexible massless shaft mounted in massive non-linear compliant supports are studied on the example of cylindrical precession. Dyffing type of non-linearity in compliant supports is considered. The system "rotor - supports" has eight degrees of freedom. Internal and external friction are taken into account. Autovibrations and chaotic vibrations are obtained. The results are confirmed by numerical check.

Turbine airfoil with a compliant outer wall

DOEpatents

Campbell, Christian X [Oviedo, FL; Morrison, Jay A [Oviedo, FL

2012-04-03

A turbine airfoil usable in a turbine engine with a cooling system and a compliant dual wall configuration configured to enable thermal expansion between inner and outer layers while eliminating stress formation in the outer layer is disclosed. The compliant dual wall configuration may be formed a dual wall formed from inner and outer layers separated by a support structure. The outer layer may be a compliant layer configured such that the outer layer may thermally expand and thereby reduce the stress within the outer layer. The outer layer may be formed from a nonplanar surface configured to thermally expand. In another embodiment, the outer layer may be planar and include a plurality of slots enabling unrestricted thermal expansion in a direction aligned with the outer layer.

Adherence to oral bisphosphonates and the risk of subtrochanteric and femoral shaft fractures among female medicare beneficiaries

PubMed Central

Wang, Z.; Ward, M. M.; Chan, L.

2014-01-01

Summary Previous studies have shown an association between duration of bisphosphonate use and atypical femur fractures. This cohort study showed an increasingly higher risk of subtrochanteric and femoral shaft fractures among those who were more adherent to oral bisphosphonates. Introduction Long-term use of oral bisphosphonates has been implicated in an increased risk of atypical femur fractures located in subtrochanteric and femoral shaft regions. Another measure of drug exposure, medication adherence, however, has not been investigated. Methods Among all Medicare fee-for-service female beneficiaries from 2006–2010, we followed 522,287 new bisphosphonate users from their index prescription until being censored or having a primary diagnosis of closed subtrochanteric/ femoral shaft or intertrochanteric/femoral neck fractures. Data about radiographs of fracture site and features were not available. Adherence was classified according to the medication possession ratio (MPR) as the following: MPR<1/3 as less compliant, MPR≥1/3–<2/3 as compliant, and MPR≥2/3 as highly compliant. Alternative cutoff points at 50 and 80 % were also used. Survival analysis was used to determine the cumulative incidence and hazard of subtrochanteric/femoral shaft or intertrochanteric/femoral neck fractures. Results There was a graded increase in incidence of subtrochanteric/femoral shaft fractures as the level of adherence increased (Gray’s test, P<0.001). The adjusted hazard ratio (HR) for the highly compliant vs. the less compliant was 1.23 (95 % Confidence Interval [CI] 1.06–1.43) overall, became significant after 2 years of follow-up (HR=1.51, 95 % CI 1.06–2.15) and reached the highest risk in the fifth year (HR=4.06, 95 % CI 1.47–11.19). However, age-adjusted incidence rates of intertrochanteric/femoral neck fractures were significantly lower among highly compliant beneficiaries, compared to less compliant users (HR=0.69, 95 % CI 0.66–0.73). Similar results were obtained when the cutoff points for being compliant and highly compliant were set at 50 and 80 %, respectively. Conclusions Subtrochanteric/femoral shaft fractures, unlike intertrochanteric/femoral neck fractures, are positively associated with higher adherence to long-term (≥3 years) oral bisphosphonates in the elderly female Medicare population. PMID:24846316

The effect of compliant walls on three-dimensional primary and secondary instabilities in boundary layer transition

NASA Astrophysics Data System (ADS)

Joslin, R. D.

1991-04-01

The use of passive devices to obtain drag and noise reduction or transition delays in boundary layers is highly desirable. One such device that shows promise for hydrodynamic applications is the compliant coating. The present study extends the mechanical model to allow for three-dimensional waves. This study also looks at the effect of compliant walls on three-dimensional secondary instabilities. For the primary and secondary instability analysis, spectral and shooting approximations are used to obtain solutions of the governing equations and boundary conditions. The spectral approximation consists of local and global methods of solution while the shooting approach is local. The global method is used to determine the discrete spectrum of eigenvalue without any initial guess. The local method requires a sufficiently accurate initial guess to converge to the eigenvalue. Eigenvectors may be obtained with either local approach. For the initial stage of this analysis, two and three dimensional primary instabilities propagate over compliant coatings. Results over the compliant walls are compared with the rigid wall case. Three-dimensional instabilities are found to dominate transition over the compliant walls considered. However, transition delays are still obtained and compared with transition delay predictions for rigid walls. The angles of wave propagation are plotted with Reynolds number and frequency. Low frequency waves are found to be highly three-dimensional.

Preliminary Assessment of a Compliant Gait Exoskeleton.

PubMed

Cestari, Manuel; Sanz-Merodio, Daniel; Garcia, Elena

2017-06-01

Current commercial wearable gait exoskeletons contain joints with stiff actuators that cannot adapt to unpredictable environments. These actuators consume a significant amount of energy, and their stiffness may not be appropriate for safe human-machine interactions. Adjustable compliant actuators are being designed and implemented because of their ability to minimize large forces due to shocks, to safely interact with the user, and to store and release energy in passive elastic elements. Introduction of such compliant actuation in gait exoskeletons, however, has been limited by the larger power-to-weight and volume ratio requirement. This article presents a preliminary assessment of the first compliant exoskeleton for children. Compliant actuation systems developed by our research group were integrated into the ATLAS exoskeleton prototype. The resulting device is a compliant exoskeleton, the ATLAS-C prototype. The exoskeleton is coupled with a special standing frame to provide balance while allowing a semi-natural gait. Experiments show that when comparing the behavior of the joints under different stiffness conditions, the inherent compliance of the implemented actuators showed natural adaptability during the gait cycle and in regions of shock absorption. Torque tracking of the joint is achieved, identifying the areas of loading response. The implementation of a state machine in the control of knee motion allowed reutilization of the stored energy during deflection at the end of the support phase to partially propel the leg and achieve a more natural and free swing.

75 FR 40867 - Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-14

.... The Act also provides for the development of guidance, reports, and studies in a number of areas... Privacy and Security enforcement (section 13424(a)); a study and report on the application of privacy and... (section 13424(c)); and a study on the Privacy Rule's definition of ``psychotherapy notes'' at 45 CFR 164...

Reviewing and reforming policy in health enterprise information security

NASA Astrophysics Data System (ADS)

Sostrom, Kristen; Collmann, Jeff R.

2001-08-01

Health information management policies usually address the use of paper records with little or no mention of electronic health records. Information Technology (IT) policies often ignore the health care business needs and operational use of the information stored in its systems. Representatives from the Telemedicine & Advanced Technology Research Center, TRICARE and Offices of the Surgeon General of each Military Service, collectively referred to as the Policies, Procedures and Practices Work Group (P3WG), examined military policies and regulations relating to computer-based information systems and medical records management. Using a system of templates and matrices created for the purpose, P3WG identified gaps and discrepancies in DoD and service compliance with the proposed Health Insurance Portability and Accountability Act (HIPAA) Security Standard. P3WG represents an unprecedented attempt to coordinate policy review and revision across all military health services and the Office of Health Affairs. This method of policy reform can identify where changes need to be made to integrate health management policy and IT policy in to an organizational policy that will enable compliance with HIPAA standards. The process models how large enterprises may coordinate policy revision and reform across broad organizational and work domains.

CALINX (California Information Exchange): a multi-stakeholder statewide initiative to improve healthcare information flows.

PubMed

Hopkins, D S; Oswald, N; McCaffrey, K; Bressler, S; Davidson, N; Vela, L

2000-01-01

Given the diffusion of responsibilities for gathering and reporting healthcare information in a managed care environment, California stakeholders are taking concrete steps to break the deadlock on data and information flows that has characterized the industry for some time. The California Information Exchange (CALINX) was established to facilitate the implementation of the Health Insurance Portability and Accountability Act (HIPAA) standards in California and to create trust for data exchange between trading partners, without which data exchange still will not occur. Strategic directions are set by the chief executives of key associations and organizations representing purchasers, plans, providers, and consumers. Multi-stakeholder workgroups have produced detailed data guidelines for the HIPAA standards along with rules for exchange of key data sets between trading partners. These rules address frequency, timeliness, and accuracy of data submission. Both the data guidelines and the rules have been tested in live demonstration projects, and the results of these projects have been reported to substantiate the business case for implementation. Further incentives are being built into contracts between purchasers and plans, and between plans and providers. CALINX is currently promoting widespread adoption of the data guidelines and rules for exchange with all members of the industry.

Potential impact of HITECH security regulations on medical imaging.

PubMed

Prior, Fred; Ingeholm, Mary Lou; Levine, Betty A; Tarbox, Lawrence

2009-01-01

Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act (ARRA) of 2009 [1] include a provision commonly referred to as the "Health Information Technology for Economic and Clinical Health Act" or "HITECH Act" that is intended to promote the electronic exchange of health information to improve the quality of health care. Subtitle D of the HITECH Act includes key amendments to strengthen the privacy and security regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). The HITECH act also states that "the National Coordinator" must consult with the National Institute of Standards and Technology (NIST) in determining what standards are to be applied and enforced for compliance with HIPAA. This has led to speculation that NIST will recommend that the government impose the Federal Information Security Management Act (FISMA) [2], which was created by NIST for application within the federal government, as requirements to the public Electronic Health Records (EHR) community in the USA. In this paper we will describe potential impacts of FISMA on medical image sharing strategies such as teleradiology and outline how a strict application of FISMA or FISMA-based regulations could have significant negative impacts on information sharing between care providers.

Development of a multistage compliant mechanism with new boundary constraint

NASA Astrophysics Data System (ADS)

Ling, Mingxiang; Cao, Junyi; Jiang, Zhou; Li, Qisheng

2018-01-01

This paper presents a piezo-actuated compliant mechanism with a new boundary constraint to provide concurrent large workspace and high dynamic frequency for precision positioning or other flexible manipulation applications. A two-stage rhombus-type displacement amplifier with the "sliding-sliding" boundary constraint is presented to maximize the dynamic frequency while retaining a large output displacement. The vibration mode is also improved by the designed boundary constraint. A theoretical kinematic model of the compliant mechanism is established to optimize the geometric parameters, and a prototype is fabricated with a compact dimension of 60 mm × 60 mm × 12 mm. The experimental testing shows that the maximum stroke is approximately 0.6 mm and the output stiffness is 1.1 N/μm with the fundamental frequency of larger than 2.2 kHz. Lastly, the excellent performance of the presented compliant mechanism is compared with several mechanisms in the previous literature. As a conclusion, the presented boundary constraint strategy provides a new way to balance the trade-off between the frequency response and the stroke range widely existed in compliant mechanisms.

DNA origami compliant nanostructures with tunable mechanical properties.

PubMed

Zhou, Lifeng; Marras, Alexander E; Su, Hai-Jun; Castro, Carlos E

2014-01-28

DNA origami enables fabrication of precise nanostructures by programming the self-assembly of DNA. While this approach has been used to make a variety of complex 2D and 3D objects, the mechanical functionality of these structures is limited due to their rigid nature. We explore the fabrication of deformable, or compliant, objects to establish a framework for mechanically functional nanostructures. This compliant design approach is used in macroscopic engineering to make devices including sensors, actuators, and robots. We build compliant nanostructures by utilizing the entropic elasticity of single-stranded DNA (ssDNA) to locally bend bundles of double-stranded DNA into bent geometries whose curvature and mechanical properties can be tuned by controlling the length of ssDNA strands. We demonstrate an ability to achieve a wide range of geometries by adjusting a few strands in the nanostructure design. We further developed a mechanical model to predict both geometry and mechanical properties of our compliant nanostructures that agrees well with experiments. Our results provide a basis for the design of mechanically functional DNA origami devices and materials.

Clinical Presentation and Outcomes of Stage III or Stage IV Retinoblastoma in 80 Asian Indian Patients.

PubMed

Kaliki, Swathi; Patel, Anamika; Iram, Sadiya; Palkonda, Vijay Anand Reddy

2017-05-01

To describe the clinical features and outcomes of patients with stage III or IV retinoblastoma. This was a retrospective study of 80 patients. Based on the International Retinoblastoma Staging System (IRSS), the tumors (n = 81) belonged to stage IIIa (n = 38, 47%), IIIb (n = 1, 1%), IVa2 (n = 10, 12%), IVb1 (n = 14, 17%), and IVb3 (n = 18, 22%). Of 80 patients, 42 (53%) were compliant to treatment and 38 (47%) were non-compliant. All 38 patients who were non-compliant to treatment died of the disease at a mean duration of 13 months from diagnosis. Of the 42 patients compliant to treatment, 22 (52%) died before completion of treatment. Twenty patients with stage III disease (25%) could complete the multimodal treatment and 17 (71%) were alive and well at a median follow-up duration of 77 months. Compliant multimodality treatment is beneficial in patients with IRSS stage III disease. IRSS stage IV retinoblastoma has poor prognosis despite treatment. [J Pediatr Ophthalmol Strabismus. 2017;54(3):177-184.]. Copyright 2017, SLACK Incorporated.

Coefficient of restitution in fractional viscoelastic compliant impacts using fractional Chebyshev collocation

NASA Astrophysics Data System (ADS)

Dabiri, Arman; Butcher, Eric A.; Nazari, Morad

2017-02-01

Compliant impacts can be modeled using linear viscoelastic constitutive models. While such impact models for realistic viscoelastic materials using integer order derivatives of force and displacement usually require a large number of parameters, compliant impact models obtained using fractional calculus, however, can be advantageous since such models use fewer parameters and successfully capture the hereditary property. In this paper, we introduce the fractional Chebyshev collocation (FCC) method as an approximation tool for numerical simulation of several linear fractional viscoelastic compliant impact models in which the overall coefficient of restitution for the impact is studied as a function of the fractional model parameters for the first time. Other relevant impact characteristics such as hysteresis curves, impact force gradient, penetration and separation depths are also studied.

Utilization of kinematical redundancy of a rehabilitation robot to produce compliant motions under limitation on actuator performance.

PubMed

Goto, Takaaki; Dobashi, Hiroki; Yoshikawa, Tsuneo; Loureiro, Rui C V; Harwin, William S; Miyamura, Yuga; Nagai, Kiyoshi

2017-07-01

This paper addresses the mechanical structure and control method of a redundant drive robot (RDR) to produce compliant motions, and show how the design parameters of the RDR can effect the produced motions and the mechanical and performance limitations of the actuators of the RDR. The structure and control method of the RDR can have been proper to produce compliant motions, but the effect of the design parameters of the RDR to the mechanical and performance limitations have not been clear. Therefore, the feasibility of producing compliant motions in the case of the prototype of the RDR is confirmed by conducting simulations and experiments, and then the design parameters of the RDR to the mechanical and performance limitations are verified by conducting simulations.

41 CFR 102-118.405 - Are my agency's prepayment audited transportation bills subject to periodic postpayment audit...

Code of Federal Regulations, 2010 CFR

2010-07-01

... prepayment audited transportation bills subject to periodic postpayment audit oversight from the GSA Audit... Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION TRANSPORTATION 118-TRANSPORTATION PAYMENT AND AUDIT Prepayment Audits of Transportation Services Waivers from Mandatory Prepayment Audit...

A Novel Network Attack Audit System based on Multi-Agent Technology

NASA Astrophysics Data System (ADS)

Jianping, Wang; Min, Chen; Xianwen, Wu

A network attack audit system which includes network attack audit Agent, host audit Agent and management control center audit Agent is proposed. And the improved multi-agent technology is carried out in the network attack audit Agent which has achieved satisfactory audit results. The audit system in terms of network attack is just in-depth, and with the function improvement of network attack audit Agent, different attack will be better analyzed and audit. In addition, the management control center Agent should manage and analyze audit results from AA (or HA) and audit data on time. And the history files of network packets and host log data should also be audit to find deeper violations that cannot be found in real time.

Software Assists in Extensive Environmental Auditing

NASA Technical Reports Server (NTRS)

Callac, Christopher; Matherne, Charlie

2002-01-01

The Base Enivronmental Management System (BEMS) is a Web-based application program for managing and tracking audits by the Environmental Office of Stennis Space Center in conformity with standard 14001 of the International Organization for Standardization (ISO 14001). (This standard specifies requirements for an environmental-management system.) BEMS saves time by partly automating what were previously manual processes for creating audit checklists; recording and tracking audit results; issuing, tracking, and implementing corrective-action requests (CARs); tracking continuous improvements (CIs); and tracking audit results and statistics. BEMS consists on an administration module and an auditor module. As its name suggests, the administration module is used to administer the audit. It helps administrators to edit the list of audit questions; edit the list of audit locations; assign manditory questions to locations; track, approve, and edit CARs; and edit completed audits. The auditor module is used by auditors to perform audits and record audit results: It helps the auditors to create audit checklists, complete audits, view completed audits, create CARs, record and acknowledge CIs, and generate reports from audit results.

Software Assists in Extensive Environmental Auditing

NASA Technical Reports Server (NTRS)

Callac, Christopher; Matherne, Charlie

2003-01-01

The Base Environmental Management System (BEMS) is a Web-based application program for managing and tracking audits by the Environmental Office of Stennis Space Center in conformity with standard 14001 of the International Organization for Standardization (ISO 14001). (This standard specifies requirements for an environmental-management system.) BEMS saves time by partly automating what were previously manual processes for creating audit checklists; recording and tracking audit results; issuing, tracking, and implementing corrective-action requests (CARs); tracking continuous improvements (CIs); and tracking audit results and statistics. BEMS consists of an administration module and an auditor module. As its name suggests, the administration module is used to administer the audit. It helps administrators to edit the list of audit questions; edit the list of audit locations; assign mandatory questions to locations; track, approve, and edit CARs; and edit completed audits. The auditor module is used by auditors to perform audits and record audit results: it helps the auditors to create audit checklists, complete audits, view completed audits, create CARs, record and acknowledge CIs, and generate reports from audit results.

Software Assists in Extensive Environmental Auditing

NASA Technical Reports Server (NTRS)

Callac, Christopher; Matherne, Charlie; Selinsky, T.

2002-01-01

The Base Environmental Management System (BEMS) is a Web-based application program for managing and tracking audits by the Environmental Office of Stennis Space Center in conformity with standard 14001 of the International Organization for Standardization (ISO 14001). (This standard specifies requirements for an environmental-management system.) BEMS saves time by partly automating what were previously manual processes for creating audit checklists; recording and tracking audit results; issuing, tracking, and implementing corrective-action requests (CARs); tracking continuous improvements (CIs); and tracking audit results and statistics. BEMS consists of an administration module and an auditor module. As its name suggests, the administration module is used to administer the audit. It helps administrators to edit the list of audit questions; edit the list of audit locations; assign mandatory questions to locations; track, approve, and edit CARs; and edit completed audits. The auditor module is used by auditors to perform audits and record audit results: it helps the auditors to create audit checklists, complete audits, view completed audits, create CARs, record and acknowledge CIs, and generate reports from audit results.

Measurement and Analysis of Failures in Computer Systems

NASA Technical Reports Server (NTRS)

Thakur, Anshuman

1997-01-01

This thesis presents a study of software failures spanning several different releases of Tandem's NonStop-UX operating system running on Tandem Integrity S2(TMR) systems. NonStop-UX is based on UNIX System V and is fully compliant with industry standards, such as the X/Open Portability Guide, the IEEE POSIX standards, and the System V Interface Definition (SVID) extensions. In addition to providing a general UNIX interface to the hardware, the operating system has built-in recovery mechanisms and audit routines that check the consistency of the kernel data structures. The analysis is based on data on software failures and repairs collected from Tandem's product report (TPR) logs for a period exceeding three years. A TPR log is created when a customer or an internal developer observes a failure in a Tandem Integrity system. This study concentrates primarily on those TPRs that report a UNIX panic that subsequently crashes the system. Approximately 200 of the TPRs fall into this category. Approximately 50% of the failures reported are from field systems, and the rest are from the testing and development sites. It has been observed by Tandem developers that fewer cases are encountered from the field than from the test centers. Thus, the data selection mechanism has introduced a slight skew.

Advance care planning for nursing home residents with dementia: Influence of 'we DECide' on policy and practice.

PubMed

Ampe, Sophie; Sevenants, Aline; Smets, Tinne; Declercq, Anja; Van Audenhove, Chantal

2017-01-01

(1) To pilot 'we DECide' in terms of influence on advance care planning policy and practice in nursing home dementia care units. (2) To investigate barriers and facilitators for implementing 'we DECide'. This was a pre-test-post-test study in 18 nursing homes. Measurements included: compliance with best practice of advance care planning policy (ACP-audit); advance care planning practice (ACP criteria: degree to which advance care planning was discussed, and OPTION scale: degree of involvement of residents and families in conversations). Advance care planning policy was significantly more compliant with best practice after 'we DECide'; policy in the control group was not. Advance care planning was not discussed more frequently, nor were residents and families involved to a higher degree in conversations after 'we DECide'. Barriers to realizing advance care planning included staff's limited responsibilities; facilitators included support by management staff, and involvement of the whole organization. 'We DECide' had a positive influence on advance care planning policy. Daily practice, however, did not change. Future studies should pay more attention to long-term implementation strategies. Long-term implementation of advance care planning requires involvement of the whole organization and a continuing support system for health care professionals. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Designing Academic Audit: Lessons Learned in Europe and Asia.

ERIC Educational Resources Information Center

Dill, David D.

2000-01-01

Reviews lessons learned from early experiments with academic audits in the United Kingdom, Sweden, New Zealand, and Hong Kong in areas such as: focus of audits, selection and training of audit teams, nature of audit self-studies, conduct of audit visits, audit reports, and audit follow-up and enhancement activities. Suggests guidelines for design…

38 CFR 41.215 - Relation to other audit requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Relation to other audit... (CONTINUED) AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Audits § 41.215 Relation to other audit requirements. (a) Audit under this part in lieu of other audits. An audit made in accordance...

Basic Exploratory Research versus Guideline-Compliant Studies Used for Hazard Evaluation and Risk Assessment: Bisphenol A as a Case Study

PubMed Central

Tyl, Rochelle W.

2009-01-01

Background Myers et al. [Environ Health Perspect 117:309–315 (2009)] argued that Good Laboratory Practices (GLPs) cannot be used as a criterion for selecting data for risk assessment, using bisphenol A (BPA) as a case study. They did not discuss the role(s) of guideline-compliant studies versus basic/exploratory research studies, and they criticized both GLPs and guideline-compliant studies and their roles in formal hazard evaluation and risk assessment. They also specifically criticized our published guideline-compliant dietary studies on BPA in rats and mice and 17β-estradiol (E2) in mice. Objectives As the study director/first author of the criticized E2 and BPA studies, I discuss the uses of basic research versus guideline-compliant studies, how testing guidelines are developed and revised, how new end points are validated, and the role of GLPs. I also provide an overview of the BPA guideline-compliant and exploratory research animal studies and describe BPA pharmacokinetics in rats and humans. I present responses to specific criticisms by Myers et al. Discussion and conclusions Weight-of-evidence evaluations have consistently concluded that low-level BPA oral exposures do not adversely affect human developmental or reproductive health, and I encourage increased validation efforts for “new” end points for inclusion in guideline studies, as well as performance of robust long-term studies to follow early effects (observed in small exploratory studies) to any adverse consequences. PMID:20049112

Parametric studies to determine the effect of compliant layers on metal matrix composite systems

NASA Technical Reports Server (NTRS)

Caruso, J. J.; Chamis, C. C.; Brown, H. C.

1990-01-01

Computational simulation studies are conducted to identify compliant layers to reduce matrix stresses which result from the coefficient of thermal expansion mismatch and the large temperature range over which the current metal matrix composites will be used. The present study includes variations of compliant layers and their properties to determine their influence on unidirectional composite and constituent response. Two simulation methods are used for these studies. The first approach is based on a three-dimensional linear finite element analysis of a 9 fiber unidirectional composite system. The second approach is a micromechanics based nonlinear computer code developed to determine the behavior of metal matrix composite system for thermal and mechanical loads. The results show that an effective compliant layer for the SCS 6 (SiC)/Ti-24Al-11Nb (Ti3Al + Nb) and SCS 6 (SiC)/Ti-15V-3Cr-3Sn-3Al (Ti-15-3) composite systems should have modulus 15 percent that of the matrix and a coefficient of thermal expansion of the compliant layer roughly equal to that of the composite system without the CL. The matrix stress in the longitudinal and the transverse tangent (loop) direction are tensile for the Ti3Al + Nb and Ti-15-3 composite systems upon cool down from fabrication. The fiber longitudinal stress is compressive from fabrication cool down. Addition of a recommended compliant layer will result in a reduction in the composite modulus.

The Privacy Officer: A Critical Success Factor in the Implementation and Maintenance of HIPAA Legislation in DoD Medical Treatment Facilities

DTIC Science & Technology

2002-05-21

don’t mind having such records available for public viewing in the dank basement of a city hall building, observers have noted, because it takes time...Officer: The battle for trust among customers in the emerging digital economy is just getting started. The commitment of executive attention to the matter

Informed Consent and Clinical Research Involving Children and Adolescents: Implications of the Revised APA Ethics Code and HIPAA

ERIC Educational Resources Information Center

Fisher, Celia B.

2004-01-01

In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part…

Effect of Compliant Walls on Secondary Instabilities in Boundary-Layer Transition

NASA Technical Reports Server (NTRS)

Joslin, Ronald D.; Morris, Philip J.

1991-01-01

For aerodynamic and hydrodynamic vehicles, it is highly desirable to reduce drag and noise levels. A reduction in drag leads to fuel savings. In particular for submersible vehicles, a decrease in noise levels inhibits detection. A suggested means to obtain these reduction goals is by delaying the transition from laminar to turbulent flow in external boundary layers. For hydrodynamic applications, a passive device which shows promise for transition delays is the compliant coating. In previous studies with a simple mechanical model representing the compliant wall, coatings were found that provided transition delays as predicted from the semi-empirical e(sup n) method. Those studies were concerned with the linear stage of transition where the instability of concern is referred to as the primary instability. For the flat-plate boundary layer, the Tollmien-Schlichting (TS) wave is the primary instability. In one of those studies, it was shown that three-dimensional (3-D) primary instabilities, or oblique waves, could dominate transition over the coatings considered. From the primary instability, the stretching and tilting of vorticity in the shear flow leads to a secondary instability mechanism. This has been theoretical described by Herbert based on Floquet theory. In the present study, Herbert's theory is used to predict the development of secondary instabilities over isotropic and non-isotropic compliant walls. Since oblique waves may be dominant over compliant walls, a secondary theory extention is made to allow for these 3-D primary instabilities. The effect of variations in primary amplitude, spanwise wavenumber, and Reynolds number on the secondary instabilities are examined. As in the rigid wall case, over compliant walls the subharmonic mode of secondary instability dominates for low-amplitude primary disturbances. Both isotropic and non-isotropic compliant walls lead to reduced secondary growth rates compared to the rigid wall results. For high frequencies, the non-isotropic wall suppresses the amplification of the secondary instabilities, while instabilities over the isotropic wall may grow with an explosive rate similar to the rigid wall results. For the more important lower frequencies, both isotropic and non-isotropic compliant walls suppress the amplification of secondary instabilities compared to the rigid wall results. The twofold major discovery and demonstration of the present investigation are: (1) the use of passive devices, such as compliant walls, can lead to significant reductions in the secondary instability growth rates and amplification; (2) suppressing the primary growth rates and subsequent amplification enable delays in the growth of the explosive secondary instability mechanism.

Quality Control Review of the Defense Contract Management Agency Internal Review Audit Function

DTIC Science & Technology

2013-04-18

DMI-2011-001, “Audit of DCMA Telework Program,” November 29, 2011, we identified issues with independence. For the Audit of DCMA Telework Program...and Audit of DCMA Telework Program, we identified issues with audit planning. Specifically, we found that both audits did not include documentation...of fraud risks had been performed during audit planning. For the audit of the DCMA Telework Program, steps were added to the audit program to

Report on Review of the Department of Military and Veterans Affairs Single Audit for the Audit Period October 1, 2005 through September 30, 2007

DTIC Science & Technology

2009-05-22

State of Michigan, single audit and supporting workpapers for the audit period October I, 2005 through September 30, 2007 (biennial audit period), to...determine whether the audit was conducted in accordance with government auditing standards and the auditing and reporting requirements of Office of

12 CFR 550.440 - When do I have to audit my fiduciary activities?

Code of Federal Regulations, 2010 CFR

2010-01-01

... have to audit my fiduciary activities? (a) Annual Audit. If you do not use a continuous audit system... audit, you may adopt a continuous audit system. Under a continuous audit system, you must arrange for a... 12 Banks and Banking 5 2010-01-01 2010-01-01 false When do I have to audit my fiduciary activities...

29 CFR 96.43 - Relation of organization-wide audits to other audit requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Relation of organization-wide audits to other audit requirements. 96.43 Section 96.43 Labor Office of the Secretary of Labor AUDIT REQUIREMENTS FOR GRANTS, CONTRACTS, AND OTHER AGREEMENTS Access to Records, Audit Standards and Relation of Organization-wide Audits to Other Audit Requirements § 96.43 Relation...

29 CFR 99.215 - Relation to other audit requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Relation to other audit requirements. 99.215 Section 99.215... Audits § 99.215 Relation to other audit requirements. (a) Audit under this part in lieu of other audits... audited as a major program using the risk-based audit approach described in § 99.520 and, if not, the...

[Blood transfusion audit methodology: the auditors, reference systems and audit guidelines].

PubMed

Chevrolle, F; Hadzlik, E; Arnold, J; Hergon, E

2000-12-01

The audit has become an essential aspect of the blood transfusion sector, and is a management tool that should be used judiciously. The main types of audit that can be envisaged in blood transfusion are the following: operational audit concerning a predetermined activity; systems quality audit; competence audit, combining the operational audit on a specific activity with quality management, e.g., laboratory accreditation; audit of the environmental management system; and social audit involving the organization of an activity and the management of human resources. However, the main type of audit considered in this article is the conformity audit, which in this context does not refer to internal control but to conformity with an internal guideline issued by the French National Blood Service. All audits are carried out on the basis of a predescribed method (contained in ISO 10 011). The audit is a system of investigation, evaluation and measurement, and also a means of continuous assessment and therefore improvement. The audit is based on set guidelines, but in fact consists of determining the difference between the directions given and what has actually been done. Auditing requires operational rigor and integrity, and has now become a profession in its own right.

Environmental auditing and the role of the accountancy profession: a literature review.

PubMed

de Moor, Philippe; de Beelde, Ignace

2005-08-01

This review of the literature on environmental auditing and the potential role of accountants distinguishes between compliance audits and audits of the environmental management system. After an extensive introduction to the concept, this review focuses on the similarities and differences between an environmental audit and a financial statement audit. The general approach to both types of audits is similar, except that environmental audits are largely unregulated. Both audits place an emphasis on the evaluation of control systems, which is an argument in favor of external auditors playing a role in environmental audits. Another argument for including external accountants is their code of ethics. However, these professionals seem to be reluctant to enter the field of environmental auditing. It is argued that this reluctance is because of a lack of generally accepted principles for conducting environmental audits. If external accountants are engaged in environmental auditing, they should be part of multidisciplinary teams that also include scientists and engineers to avoid a too strong focus on procedures. Rather than treating these audits as totally different, it is proposed that there be a move towards integrated, or even universal, audits.

Dry compliant seal for phosphoric acid fuel cell

DOEpatents

Granata, Jr., Samuel J.; Woodle, Boyd M.

1990-01-01

A dry compliant overlapping seal for a phosphoric acid fuel cell preformed f non-compliant Teflon to make an anode seal frame that encircles an anode assembly, a cathode seal frame that encircles a cathode assembly and a compliant seal frame made of expanded Teflon, generally encircling a matrix assembly. Each frame has a thickness selected to accommodate various tolerances of the fuel cell elements and are either bonded to one of the other frames or to a bipolar or end plate. One of the non-compliant frames is wider than the other frames forming an overlap of the matrix over the wider seal frame, which cooperates with electrolyte permeating the matrix to form a wet seal within the fuel cell that prevents process gases from intermixing at the periphery of the fuel cell and a dry seal surrounding the cell to keep electrolyte from the periphery thereof. The frames may be made in one piece, in L-shaped portions or in strips and have an outer perimeter which registers with the outer perimeter of bipolar or end plates to form surfaces upon which flanges of pan shaped, gas manifolds can be sealed.

Klebanoff (K-) modes in boundary layers (BLs) over compliant surfaces

NASA Astrophysics Data System (ADS)

Ali, Reza; Carpenter, Peter

2002-11-01

We investigate the effect of wall compliance on K-modes. These are associated with streaks observed in the transitional BL, generated by spanwise modulation of the streamwise velocity, and are thought to be the mechanism for bypass transition. They have been widely studied over flat-plate, rigid surfaces but not compliant surfaces. A novel velocity-vorticity formulation is adopted for the numerical simulations, and a freestream spanwise body force is used to generate the streaks. We find compliant walls are less receptive than rigid walls, i.e. freestream turbulence generates weaker disturbances over compliant walls. This effect intensifies with increasing compliance. Where a compliant panel is embedded into a rigid surface, the leading and trailing edges of the panel can introduce a stabilising or destabilising disturbance on the streaks depending on the Reynolds number. It is therefore possible to optimise the wall to suppress streaks and hence bypass. K-modes can also act as a theoretical model for the near-wall structures that generate the high skin-friction drag in turbulent BLs. In this scenario, increasing compliance increases the spanwise spacing and weakens the streak. This explains experimental observations that wall compliance reduces skin-friction drag and turbulence levels in turbulent BLs.

Electrophysiological assessment in patients with long term hypoxia.

PubMed

Ilik, Faik; Pazarli, Ahmet C; Kayhan, Fatih; Karamanli, Harun; Ozlece, Hatice K

2016-01-01

To evaluate visual evoked potentials (VEP) patterns in chronic obstructive pulmonary disease (COPD) patients who were compliant with supplemental oxygen treatment relative to non-compliant COPD patients. This prospective study protocol was reviewed and approved by the local ethical committee of Selcuk University and the research was performed in the Department of Neurology, Elbistan State Hospital, Kahramanmaras, Turkey from May to October 2014. Blood gas measurements and pulmonary function tests were carried out in patients with advanced stage COPD. The VEP was assessed in both eyes in both compliant and non-compliant patients. The study included 43 patients; 24 (55.8%) of the patients were not in compliance with their supplemental oxygen treatment, while 19 patients (44.2%) received adequate oxygen treatment. There was no statistically significant difference between patients with regards to pulmonary function test results and blood gas measurements. The VEP latency was significantly greater in both eyes of the non-compliant patients. Previous studies have reported prolonged VEP latencies in inflammatory diseases of the central nervous system. Similar electrophysiological findings were observed in our study and we propose that this may be due to oxidative stress, and inflammation that occurs secondary to chronic ischemia.

Design of a piezoelectric inchworm actuator and compliant end effector for minimally invasive surgery

NASA Astrophysics Data System (ADS)

Canfield, Shawn; Edinger, Ben; Frecker, Mary I.; Koopmann, Gary H.

1999-06-01

Recent advances in robotics, tele-robotics, smart material actuators, and mechatronics raise new possibilities for innovative developments in millimeter-scale robotics capable of manipulating objects only fractions of a millimeter in size. These advances can have a wide range of applications in the biomedical community. A potential application of this technology is in minimally invasive surgery (MIS). The focus of this paper is the development of a single degree of freedom prototype to demonstrate the viability of smart materials, force feedback and compliant mechanisms for minimally invasive surgery. The prototype is a compliant gripper that is 7-mm by 17-mm, made from a single piece of titanium that is designed to function as a needle driver for small scale suturing. A custom designed piezoelectric `inchworm' actuator drives the gripper. The integrated system is computer controlled providing a user interface device capable of force feedback. The design methodology described draws from recent advances in three emerging fields in engineering: design of innovative tools for MIS, design of compliant mechanisms, and design of smart materials and actuators. The focus of this paper is on the design of a millimeter-scale inchworm actuator for use with a compliant end effector in MIS.

18 CFR 286.103 - Notice to audited person.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AUTHORITIES ACCOUNTS, RECORDS, MEMORANDA AND DISPOSITION OF CONTESTED AUDIT FINDINGS AND PROPOSED REMEDIES Disposition of Contested Audit Findings and Proposed Remedies § 286.103 Notice to audited person. An audit... deficiency or audit report or similar document containing a finding or findings that the audited person has...

18 CFR 158.1 - Notice to audited person.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., records, accounts, books, communications or papers relevant to the audit of the audited person; matters... DISPOSITION OF CONTESTED AUDIT FINDINGS AND PROPOSED REMEDIES Disposition of Contested Audit Findings and Proposed Remedies § 158.1 Notice to audited person. An audit conducted by the Commission's staff under...