Integrating and Adopting AI in the Radiology Workflow: A Primer for Standards and Integrating the Healthcare Enterprise (IHE) Profiles.

The deployment of artificial intelligence (AI) solutions in radiology practice creates new demands on existing imaging workflow. Accommodating custom integrations creates a substantial operational and maintenance burden. These custom integrations also increase the likelihood of unanticipated problems. Standards-based interoperability facilitates AI integration with systems from different vendors into a single environment by enabling seamless exchange between information systems in the radiology workflow. Integrating the Healthcare Enterprise (IHE) is an initiative to improve how computer systems share information across health care domains, including radiology. IHE integrates existing standards-such as Digital Imaging and Communications in Medicine, Health Level Seven, and health care lexicons and ontologies (ie, LOINC, RadLex, SNOMED Clinical Terms)-by mapping data elements from one standard to another. IHE Radiology manages profiles (standards-based implementation guides) for departmental workflow and information sharing across care sites, including profiles for scaling AI processing traffic and integrating AI results. This review focuses on the need for standards-based interoperability to scale AI integration in radiology, including a brief review of recent IHE profiles that provide a framework for AI integration. This review also discusses challenges and additional considerations for AI integration, including technical, clinical, and policy perspectives.

AAPM task group report 305: Guidance for standardization of vendor-neutral reject analysis in radiography.

Reject rate analysis is considered an integral part of a diagnostic radiography quality control (QC) program. A rejected image is a patient radiograph that was not presented to a radiologist for diagnosis and that contributes unnecessary radiation dose to the patient. Reject rates that are either too high or too low may suggest systemic department shortcomings in QC mechanisms. Due to the lack of standardization, reject data often cannot be easily compared between radiography systems from different vendors. The purpose of this report is to provide guidance to help standardize data elements that are required for comprehensive reject analysis and to propose data reporting and workflows to enable an effective and comprehensive reject rate monitoring program. Essential data elements, a proposed schema for classifying reject reasons, and workflow implementation options are recommended in this task group report.

Generation of structured light using pyramidal prisms.

We present a numerical study of the structured light produced by a laser beam transmitted by a symmetric pyramidal prism. From the Fresnel diffraction formulation, we obtain expressions for the amplitudes valid for an arbitrary number of prism faces, and for both acute and flat-topped prisms. The expressions are readily evaluated numerically and are a significant advancement over the restrictive plane wave models used in prior work. We consider applications in optical trapping and give examples in which the intensity distributions contain a number of bright spots having similar power, as is suitable for the simultaneous trapping of several particles. We also consider applications in lithography and, under other conditions, obtain results in which uniform periodic intensity patterns are produced. Advantages of employing pyramidal prisms in such applications are their excellent stability and their efficiency in the production of structured light.

Detachment of Dunaliella tertiolecta Microalgae from a Glass Surface by a Near-Infrared Optical Trap.

We report on the observation of the detachment in situ and in vivo of Dunaliella tertiolecta microalgae cells from a glass surface using a 1064 nm wavelength trapping laser beam. The principal bends of both flagella of Dunaliella were seen self-adhered to either the top or bottom coverslip surfaces of a 50 µm thick chamber. When a selected attached Dunaliella was placed in the trapping site, it photoresponded to the laser beam by moving its body and flagellar tips, which eventually resulted in its detachment. The dependence of the time required for detachment on the trapping power was measured. No significant difference was found in the detachment time for cells detached from the top or bottom coverslip, indicating that the induced detachment was not due solely to the optical forces applied to the cells. After detachment, the cells remained within the optical trap. Dunaliella detached from the bottom were seen rotating about their long axis in a counterclockwise direction, while those detached from the top did not rotate. The rotation frequency and the minimal force required to escape from the trap were also measured. The average rotation frequency was found to be independent of the trapping power, and the swimming force of a cell escaping the laser trap ranged from 4 to 10 picoNewtons. Our observations provide insight into the photostimulus produced when a near-infrared trapping beam encounters a Dunaliella. The microalgae frequently absorb more light than they can actually use in photosynthesis, which could cause genetic and molecular changes. Our findings may open new research directions into the study of photomovement in species of Dunaliella and other swimming microorganisms that could eventually help to solve technological problems currently confronting biomass production. In future work, studies of the response to excess light may uncover unrecognized mechanisms of photoprotection and photoacclimation.

Rheology of Cellulose Ether Excipients Designed for Hot Melt Extrusion.

A new family of cellulosic ether polymeric excipients has been recently engineered for fabrication of amorphous solid dispersions of active pharmaceutical ingredients via hot-melt extrusion (HME). These hydroxypropyl methyl cellulose excipients enable plasticizer-free melt processing at much lower temperatures (135-160 °C) due to their substantially reduced glass transition temperatures ( Tg = 98-110 °C). The novel amorphous cellulose ethers were found to be rheologically solidlike well above their glass transition ( Tg + 70 °C). We demonstrate that in the pharmaceutically relevant HME processing temperature range these polymers behave similarly to yield-stress fluids and flow only when the applied stress exceeds a critical stress value. This critical stress value (0.50 ± 0.05 MPa, 150 °C) is surprisingly high but is easily achieved under typical HME conditions. The origin of their yield-stress fluidlike behavior is hypothesized to arise from hydrogen bonds of the HPMC materials that act as physical cross-links and do not relax within the measured temperature and time window unless the applied stress exceeds the critical stress value. Support for this hypothesis arises from infrared spectroscopic estimates of the free and bound hydrogen bond levels at end-use temperatures.

DICOMweb™: Background and Application of the Web Standard for Medical Imaging.

This paper describes why and how DICOM, the standard that has been the basis for medical imaging interoperability around the world for several decades, has been extended into a full web technology-based standard, DICOMweb. At the turn of the century, healthcare embraced information technology, which created new problems and new opportunities for the medical imaging industry; at the same time, web technologies matured and began serving other domains well. This paper describes DICOMweb, how it extended the DICOM standard, and how DICOMweb can be applied to problems facing healthcare applications to address workflow and the changing healthcare climate.

A New Extrudable Form of Hypromellose: AFFINISOL™ HPMC HME.

Hypromellose is a hydrophilic polymer widely used in immediate- and modified-release oral pharmaceutical dosage forms. However, currently available grades of hypromellose are difficult, if not impossible, to process by hot melt extrusion (HME) because of their high glass transition temperature, high melt viscosity, and low degradation temperature. To overcome these challenges, a modified grade of hypromellose, AFFINISOL™ HPMC HME, was recently introduced. It has a significantly lower glass transition temperature and melt viscosity as compared to other available grades of hypromellose. The objective of this paper is to assess the extrudability and performance of AFFINISOL™ HPMC HME (100LV and 4M) as compared to other widely used polymers in HME, including HPMC 2910 100cP (the currently available hypromellose), Soluplus®, Kollidon® VA 64, and EUDRAGIT® E PO. Formulations containing polymer and carbamazepine (CBZ) were extruded on a co-rotating 16-mm twin-screw extruder, and the effect of temperature, screw speed, and feed rate was investigated. The performance of the solid dispersions was evaluated based on Flory-Huggins modeling and characterized by differential scanning calorimetry (DSC), X-ray powder diffraction (XRD), Raman spectroscopy, Fourier-transform infrared (FTIR) spectroscopy, and dissolution. All formulations extruded well except for HPMC 2910 100cP, which resulted in over-torqueing the extruder (machine overloading because the motor cannot provide efficient energy to rotate the shaft). Among the HME extrudates, only the EUDRAGIT® E PO formulation was crystalline as confirmed by DSC, XRD, and Raman, which agreed with predictions from Flory-Huggins modeling. Dissolution testing was conducted under both sink and non-sink conditions. Sink dissolution testing in neutral media revealed that amorphous CBZ in the HME extrudates completely dissolved within 15 min, which was much more rapid than the time for complete dissolution of bulk CBZ (60 min) and EUDRAGIT® E PO solid dispersion (more than 6 h). Non-sink dissolution in acidic media testing revealed that only CBZ contained in the AFFINISOL™ HPMC HME, and EUDRAGIT® E PO solid dispersions rapidly supersaturated after 15 min, reaching a twofold drug concentration compared to the CBZ equilibrium solubility. In summary, AFFINISOL™ HPMC HME 100LV and AFFINISOL™ HPMC HME 4M are useful in the pharmaceutical HME process to increase wetting and dissolution properties of poorly water-soluble drugs like CBZ.

Absolute calibration of a spectrometer using terrestrial solar radiation.

We present a method to provide absolute intensity calibration of a common low-resolution, wideband optical spectrometer. Terrestrial solar radiation is employed as the source of illumination, and the spectrometer output is compared to a solar spectral standard to determine its calibration. Over 3  days of observation, the procedure is demonstrated to yield reproducible results. Other evidence of calibration accuracy is presented.

Quantitative Chemical Mapping of InGaN Quantum Wells from Calibrated High-Angle Annular Dark Field Micrographs.

We present a simple and robust method to acquire quantitative maps of compositional fluctuations in nanostructures from low magnification high-angle annular dark field (HAADF) micrographs calibrated by energy-dispersive X-ray (EDX) spectroscopy in scanning transmission electron microscopy (STEM) mode. We show that a nonuniform background in HAADF-STEM micrographs can be eliminated, to a first approximation, by use of a suitable analytic function. The uncertainty in probe position when collecting an EDX spectrum renders the calibration of HAADF-STEM micrographs indirect, and a statistical approach has been developed to determine the position with confidence. Our analysis procedure, presented in a flowchart to facilitate the successful implementation of the method by users, was applied to discontinuous InGaN/GaN quantum wells in order to obtain quantitative determinations of compositional fluctuations on the nanoscale.

Dielectric spectroscopy for the determination of the glass transition temperature of pharmaceutical solid dispersions.

The purpose of this study was to evaluate analytical techniques for the measurement of the glass transition temperature of HPMC and formulated solid dispersions thereof. Unmodified samples of various grades of HPMC and solid dispersions of HPMC and itraconazole produced by hot melt extrusion were analyzed by thermomechanical analysis, differential scanning calorimetry, thermally stimulated depolarization current and dielectric spectroscopy. It was found that dielectric spectroscopy offers the best accuracy and reproducibility for analysis of the base HPMC powders regardless of the substitution type or viscosity grade and that the obtained results were not frequency dependent. The results of dielectric measurements of solid dispersions prepared by hot melt extrusion were compared with predicted values of the Gordon-Taylor equation. It was found that time-temperature superposition effects and small molecule frequency dependence makes broadly applying determination of the glass transition temperature in drug dispersions by dielectric spectroscopy prohibitively difficult.

Preparation of amorphous solid dispersions by rotary evaporation and KinetiSol Dispersing: approaches to enhance solubility of a poorly water-soluble gum extract.

Acetyl-11-keto-ß-boswellic acid (AKBA), a gum resin extract, possesses poor water-solubility that limits bioavailability and a high melting point making it difficult to successfully process into solid dispersions by fusion methods. The purpose of this study was to investigate solvent and thermal processing techniques for the preparation of amorphous solid dispersions (ASDs) exhibiting enhanced solubility, dissolution rates and bioavailability. Solid dispersions were successfully produced by rotary evaporation (RE) and KinetiSol® Dispersing (KSD). Solid state and chemical characterization revealed that ASD with good potency and purity were produced by both RE and KSD. Results of the RE studies demonstrated that AQOAT®-LF, AQOAT®-MF, Eudragit® L100-55 and Soluplus with the incorporation of dioctyl sulfosuccinate sodium provided substantial solubility enhancement. Non-sink dissolution analysis showed enhanced dissolution properties for KSD-processed solid dispersions in comparison to RE-processed solid dispersions. Variances in release performance were identified when different particle size fractions of KSD samples were analyzed. Selected RE samples varying in particle surface morphologies were placed under storage and exhibited crystalline growth following solid-state stability analysis at 12 months in comparison to stored KSD samples confirming amorphous instability for RE products. In vivo analysis of KSD-processed solid dispersions revealed significantly enhanced AKBA absorption in comparison to the neat, active substance.

A Case Study in Application of the Risk Knowledge Infinity Cycle.

The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) Quality Risk Management To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying out-of-specification investigation. This case study provides a stepwise walk-through of the cycle to illustrate how key concepts within the ICH Q9(R1) revision can be achieved through better connecting quality risk management and knowledge management with a framework such as the RKI Cycle.

Standardizing imaging findings representation: harnessing Common Data Elements semantics and Fast Healthcare Interoperability Resources structures.

OBJECTIVES: Designing a framework representing radiology results in a standards-based data structure using joint Radiological Society of North America/American College of Radiology Common Data Elements (CDEs) as the semantic labels on standard structures. This allows radiologist-created report data to integrate with artificial intelligence-generated results for use throughout downstream systems. MATERIALS AND METHODS: We developed a framework modeling radiology findings as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) observations using CDE set/element identifiers as standardized semantic labels. This framework deploys CDE identifiers to specify radiology findings and attributes, providing consistent labels for radiology report concepts-diagnoses, recommendations, tabular/quantitative data-with built-in integration with RadLex, SNOMED CT, LOINC, and other ontologies. Observation structures fit within larger HL7 FHIR DiagnosticReport resources, providing output including both nuanced text and structured data. RESULTS: Labeling radiology findings as discrete data for interchange between systems requires two components: structure and semantics. CDE definitions provide semantic identifiers for findings and their component values. The FHIR observation resource specifies a structure for associating identifiers with radiology findings in the context of reports, with CDE-encoded observations referring to definitions for CDE identifiers in a central repository. The discussion includes an example of encoding pulmonary nodules on a chest CT as CDE-labeled observations, demonstrating the application of this framework to exchange findings throughout the imaging workflow, making imaging data available to downstream clinical systems. DISCUSSION: CDE-labeled observations establish a lingua franca for encoding, exchanging, and consuming radiology data at the level of individual findings, facilitating use throughout healthcare systems. IMPORTANCE: CDE-labeled FHIR observation objects can increase the value of radiology results by facilitating their use throughout patient care.

Ocular Imaging Challenges, Current State, and a Path to Interoperability: A HIMSS-SIIM Enterprise Imaging Community Whitepaper.

Office-based testing, enhanced by advances in imaging technology, is routinely used in eye care to non-invasively assess ocular structure and function. This type of imaging coupled with autonomous artificial intelligence holds immense opportunity to diagnose eye diseases quickly. Despite the wide availability and use of ocular imaging, there are several factors that hinder optimization of clinical practice and patient care. While some large institutions have developed end-to-end digital workflows that utilize electronic health records, enterprise imaging archives, and dedicated diagnostic viewers, this experience has not yet made its way to smaller and independent eye clinics. Fractured interoperability practices impact patient care in all healthcare domains, including eye care where there is a scarcity of care centers, making collaboration essential among providers, specialists, and primary care who might be treating systemic conditions with profound impact on vision. The purpose of this white paper is to describe the current state of ocular imaging by focusing on the challenges related to interoperability, reporting, and clinical workflow.

Pulmonary dispersion formulations: the impact of dispersed powder properties on pressurized metered dose inhaler stability.

Suspension-type metered dose inhaler formulations characteristically have a high degree of dispersion instability. This may occur as the result of any of a large number of formulation issues including phase separation, particle growth, agglomeration/flocculation, moisture ingress, and particle interactions with both the canister material and other particles. Many of these undesirable instabilities may arise as a result of the physical and chemical properties of the dispersed powder in the liquid propellant system. As such, this review provides a detailed understanding of the characteristics of the dispersed phase in the liquid propellant system necessary to ensure stability of the final formulation.

Gallbladder damage control: compromised procedure for compromised patients.

BACKGROUND: The objective of this study was to analyze a population-based database for (1) recent 9-year trends in utilization of partial cholecystectomy (PC), laparoscopic PC, and trocar cholecystostomy (TC), (2) demographics, associated diagnoses, and hospital characteristics, and (3) relevant inpatient outcomes. METHODS: Retrospective cohort analysis of the Nationwide Inpatient Sample (NIS) files from 2000 to 2008 was performed. For the purposes of the study, gallbladder damage control was defined as PC, laparoscopic PC, and TC. RESULTS: A national estimate of 10,872 gallbladder damage control cases was obtained. Procedures performed included PC (47.8 %), laparoscopic PC (27.2 %), TC (25.3 %), and intraoperative cholangiogram (IOC) (19.7 %). A total of 1,479 (13.6 %) postoperative complications were identified, including pulmonary complications (4.3 %), hemorrhage/hematoma/seroma (3.4 %), and accidental puncture or laceration during procedure (3.3 %). Common bile duct injury occurred in 3.3 % overall. Hospital types included nonteaching (82.1 %) and urban (67.8 %), with regional variations of 42.1 % from the South and 45.2 % from the West. Inpatient outcomes included mean length of stay of 11.4 (0.16 SEM) days, mean total hospital charge of $71,296.69 ($1,106.03 SEM), 7.4 % mortality, and 16.8 % discharge to skilled nursing facility. Multivariate logistic regression analysis identified independent risk variables for common bile duct injury: teaching hospitals (OR = 1.517, CI = 1.155-1.991, P = 0.003). IOC (OR = 2.030, CI = 1.590-2.591, P < 0.001) was a commonly associated procedure in the setting of common bile duct injury. CONCLUSION: Various circumstances may require gallbladder damage control with PC and TC. Postoperative complications and common bile duct injury remain significantly high despite limited resection, and the teaching status of the hospital is associated with CBD injury. High morbidity and mortality of gallbladder damage control may reflect both the compromised nature of the procedures and multiple comorbidities.

Observations of dispersion cancellation of entangled photon pairs.

An experimental study of the dispersion cancellation occurring in frequency-entangled photon pairs is presented. The approach uses time-resolved up-conversion of the pairs, which has temporal resolution at the femtosecond level, and group-delay dispersion sensitivity of ≈ 20 fs2 under experimental conditions. The cancellation is demonstrated with dispersion stronger than ± 10(3) fs2 in the signal (-) and idler (+) modes.

Radiation exposure monitoring: a new IHE profile.

A method is described for gathering and distributing radiation exposure data from X-ray-based imaging procedures such as CT, angiography, fluoroscopy, mammography and digital X-ray systems with integrated generators. The data are recorded in a standard format as a DICOM dose object and are managed in a similar fashion to the DICOM images produced by the procedure. The Integrating the Healthcare Enterprise (IHE) process for standardizing such methods is presented and applications of such data for activities, such as dose QA and national dose repositories, are also discussed.

Supercritical-CO2 Foam Extrusion of Hydroxypropyl Methyl Cellulose Acetate Succinate/Itraconazole Amorphous Solid Dispersions: Processing-Structure-Property Relations.

This study investigates the effects of supercritical CO2 as a foaming agent on structure and physical properties of hot melt extruded hydroxypropyl methylcellulose acetate succinate (HPMCAS)-itraconazole (ITZ) amorphous solid dispersions (ASDs) with the aim of improving the milling efficiency and tabletability of these ASDs. Two different grades of AFFINISOLTM HPMCAS, the standard grade (Std) and the High Productivity grade (HP) were used. The HP-grade has a lower molecular weight, melt viscosity and wider processing temperature range. Extrudates with different ITZ concentrations (0%, 20% and 40%) and CO2 injection pressure of 100 and 200 bar were prepared. The cellular microstructure of the foams showed that HP-grade HPMCAS had better affinity with the CO2 resulting in better distribution of CO2. The results of DSC and X-ray diffraction analysis revealed that the supercritical CO2 did not affect the amorphous state of the API in the extrudates. Milling efficiency of the ASDs was significantly improved up to around 90% increase in the mass recovery. The tabletability of the milled extrudates showed a considerable increase in tablet tensile strength. In addition, foaming considerably improved the supersaturation of HP-grade ASD while showing minimal improvement in dissolution behavior of the Std-grade material.

The role of patient advocacy organizations in shaping medical research: the Pompe model.

The Pompe model is the term used by the Pompe community to describe the relationship that exists between the patient community, the medical/scientific community, and industry. The development of the Pompe model represented a new paradigm for the involvement of patients in new treatments-and also for scientists and pharmaceutical companies. It saw patients developing a sense of agency, of involvement in the process of treatment development rather than powerless recipients or (if lucky) occasional spectators. At the same time, as described below, it benefited the other partners in the process with the result that the different components of the model added up to more than the sum of their parts. However, in order for this to happen, each part had to undergo a transformation in mindset. The development of enzyme replacement therapy (ERT) for Pompe disease represented a unique set of circumstances and individuals that helped to bring about this change and, in doing so, created a model that has had far wider applications.