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1.  Automatic Monitoring of Localized Skin Dose with Fluoroscopic and Interventional Procedures 
Journal of Digital Imaging  2010;24(4):626-639.
This software tool locates and computes the intensity of radiation skin dose resulting from fluoroscopically guided interventional procedures. It is comprised of multiple modules. Using standardized body specific geometric values, a software module defines a set of male and female patients arbitarily positioned on a fluoroscopy table. Simulated X-ray angiographic (XA) equipment includes XRII and digital detectors with or without bi-plane configurations and left and right facing tables. Skin dose estimates are localized by computing the exposure to each 0.01 × 0.01 m2 on the surface of a patient irradiated by the X-ray beam. Digital Imaging and Communications in Medicine (DICOM) Structured Report Dose data sent to a modular dosimetry database automatically extracts the 11 XA tags necessary for peak skin dose computation. Skin dose calculation software uses these tags (gantry angles, air kerma at the patient entrance reference point, etc.) and applies appropriate corrections of exposure and beam location based on each irradiation event (fluoroscopy and acquistions). A physicist screen records the initial validation of the accuracy, patient and equipment geometry, DICOM compliance, exposure output calibration, backscatter factor, and table and pad attenuation once per system. A technologist screen specifies patient positioning, patient height and weight, and physician user. Peak skin dose is computed and localized; additionally, fluoroscopy duration and kerma area product values are electronically recorded and sent to the XA database. This approach fully addresses current limitations in meeting accreditation criteria, eliminates the need for paper logs at a XA console, and provides a method where automated ALARA montoring is possible including email and pager alerts.
PMCID: PMC3138926  PMID: 20706859
Peak skin dose; sentinal event; DICOM structured report dose; patient entrance reference point; fluoroscopy; interventional radiology; Joint Commission (JC); radiation dose; Digital Imaging and Communications in Medicine (DICOM)
2.  Tracking patient radiation exposure: challenges to integrating nuclear medicine with other modalities 
The cumulative radiation exposure to the patient from multiple radiological procedures can place some individuals at significantly increased risk for stochastic effects and tissue reactions. Approaches, such as those in the International Atomic Energy Agency’s Smart Card program, have been developed to track cumulative radiation exposures to individuals. These strategies often rely on the availability of structured dose reports, typically found in the DICOM header. Dosimetry information is currently readily available for many individual x-ray based procedures. Nuclear medicine, of which nuclear cardiology constitutes the majority of the radiation burden in the U.S., currently lags behind x-ray based procedures with respect to reporting of radiation dosimetric information. This paper discusses qualitative differences between nuclear medicine and x-ray based procedures, including differences in the radiation source and measurement of its strength, the impact of biokinetics on dosimetry, and the capability of current scanners to record dosimetry information. These differences create challenges in applying monitoring and reporting strategies used in x-ray based procedures to nuclear medicine, and integrating dosimetry information across modalities. A concerted effort by the medical imaging community, dosimetry specialists and manufacturers of imaging equipment is required to develop strategies to improve the reporting of radiation dosimetry data in nuclear medicine. Some ideas on how to address this issue are suggested.
PMCID: PMC3683971  PMID: 22695788
Radiation exposure tracking; Cumulative patient dose; Radiation dose nuclear imaging; Effective dose
3.  XML Schema Representation of DICOM Structured Reporting 
Objective: The Digital Imaging and Communications in Medicine (DICOM) Structured Reporting (SR) standard improves the expressiveness, precision, and comparability of documentation about diagnostic images and waveforms. It supports the interchange of clinical reports in which critical features shown by images and waveforms can be denoted unambiguously by the observer, indexed, and retrieved selectively by subsequent reviewers. It is essential to provide access to clinical reports across the health care enterprise by using technologies that facilitate information exchange and processing by computers as well as provide support for robust and semantically rich standards, such as DICOM. This is supported by the current trend in the healthcare industry towards the use of Extensible Markup Language (XML) technologies for storage and exchange of medical information. The objective of the work reported here is to develop XML Schema for representing DICOM SR as XML documents.
Design: We briefly describe the document type definition (DTD) for XML and its limitations, followed by XML Schema (the intended replacement for DTD) and its features. A framework for generating XML Schema for representing DICOM SR in XML is presented next.
Measurements: None applicable.
Results: A schema instance based on an SR example in the DICOM specification was created and validated against the schema. The schema is being used extensively in producing reports on Philips Medical Systems ultrasound equipment.
Conclusion: With the framework described it is feasible to generate XML Schema using the existing DICOM SR specification. It can also be applied to generate XML Schemas for other DICOM information objects.
PMCID: PMC150374  PMID: 12595410
4.  The department of veterans affairs integration of imaging into the healthcare enterprise using the VistA hospital information system and Digital Imaging and Communications in Medicine 
Journal of Digital Imaging  1998;11(2):53-64.
The United States Department of Veterans Affairs is integrating imaging into the healthcare enterprise by using the Digital Imaging and Communication in Medicine (DICOM) standard protocols. Image management is directly integrated into the VistA Hospital Information System (HIS) software and clinical database. Radiology images are acquired with DICOM and are stored directly in the HIS database. Images can be displayed on low-cost clinician’s workstations throughout the medical center. High-resolution diagnostic quality multimonitor VistA workstations with specialized viewing software can be used for reading radiology images. Two approaches are used to acquire and handle images within the radiology department. Some sites have a commercial Picture Archiving and Communications System (PACS) interfaced to the VistA HIS, whereas other sites use the direct image acquisition and integrated diagnostic display capabilities of VistA itself. A small set of DICOM services has been implemented by VistA to allow patient and study text data to be transmitted to image producing modalities and the commercial PACS, and to enable images and study data to be transferred back. DICOM has been the cornerstone in the ability to integrate imaging functionality into the healthcare enterprise. Because of its openness, it allows the integration of system components from commercial and noncommercial sources to work together to provide functional cost-effective solutions.
PMCID: PMC3452993  PMID: 9608928
5.  Upgrading legacy systems for the integrating the healthcare enterprise (IHE) initiatative 
Journal of Digital Imaging  2000;13(Suppl 1):180-182.
As technology vendors have adopted standardized communication protocols, including Digital Imaging and Communications in Medicine (DICOM) and Health Level 7 (HL7), interconnectivity between various devices has been simplified. The recent Integrating the Healthcare Enterprise (IHE) initiative will further promote the use of standards for interconnectivity. Until these standards are universally accepted, we must live in a transitional world where some components will communicate without any modification, while others require upgrades to allow them to meet the new standards. In designing and implementing the network at University of California Los Angeles (UCLA) Medical Center, some integration problems were found that are common to the industry. Creating departmental workflow with only a limited number of acquisition devices supporting the DICOM worklist was the initial problem addressed. Although many manufacturers provide this function for their new scanners, upgrading existing equipment is often cost-prohibitive. To ensure the quality of the demographic information in the image data and the workflow of the system, third-party worklist components were required to upgrade the legacy acquisition devices. These worklist components provided a standards-compliant facade on top of the legacy equipment, allowing seamless integration with the remainder of the network. To support the distribution of worklist information and the feedback of procedure status, a bidirectional HL7/ DICOM protocol bridge was required. Although many radiology information system (RIS) manufacturers will be providing native DICOM capabilities in future product releases, the majority of current RIS installations have no DICOM functionality. Similar to the legacy scanners, the HL7/DICOM bridge provided a DICOM-compliant facade to the non-DICOM RIS. The additional use of web-based technology for worklist display further extended flexibility of this facade. We have demonstrated standards-compliant facade technology allowing legacy components to operate seamlessly in an IHE environment at a fraction of the cost of upgrading to new equipment.
PMCID: PMC3453251  PMID: 10847393
6.  Toward Clinically Relevant Standardization of Image Quality 
Journal of Digital Imaging  2004;17(4):271-278.
In recent years, notable progress has been made on standardization of medical image presentations in the definition and implementation of the Digital Imaging and Communications in Medicine (DICOM) Grayscale Standard Display Function (GSDF). In parallel, the American Association of Physicists in Medicine (AAPM) Task Group 18 has provided much needed guidelines and tools for visual and quantitative assessment of medical display quality. In spite of these advances, however, there are still notable gaps in the effectiveness of DICOM GSDF to assure consistent and high-quality display of medical images. In additions the degree of correlation between display technical data and diagnostic usability and performance of displays remains unclear. This article proposes three specific steps that DICOM, AAPM, and ACR may collectively take to bridge the gap between technical performance and clinical use: (1) DICOM does not provide means and acceptance criteria to evaluate the conformance of a display device to GSDF or to address other image quality characteristics. DICOM can expand beyond luminance response, extending the measurable, quantifiable elements of TG18 such as reflection and resolution. (2) In a large picture archiving and communication system (PACS) installation, it is critical to continually track the appropriate use and performance of multiple display devices. DICOM may help with this task by adding a Device Service Class to the standard to provide for communication and control of image quality parameters between applications and devices, (3) The question of clinical significance of image quality metrics has rarely been addressed by prior efforts. In cooperation with AAPM, the American College of Radiology (ACR), and the Society for Computer Applications in Radiology (SCAR), DICOM may help to initiate research that will determine the clinical consequence of variations in image quality metrics (eg, GSDF conformance) and to define what constitutes image quality from a diagnostic perspective. Implementation of these three initiatives may further the reach and impact of DICOM toward quality medicine.
PMCID: PMC3047179  PMID: 15551103
Display quality; display performance; display calibration; DICOM; AAPM; luminance response; image quality
7.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
8.  The use of Digital Imaging and Communications in Medicine (DICOM) in the integration of imaging into the electronic patient record at the Department of Veterans Affairs 
Journal of Digital Imaging  2000;13(Suppl 1):133-137.
The US Department of Veterans Affairs (VA) is using the Digital Imaging and Communications in Medicine (DICOM) standard to integrate image data objects from multiple systems for use across the health care enterprise. DICOM uses a structured representation of image data and a communication mechanism that allows the VA to easily acquire images from multiple sources and store them directly into the online patient record. The VA can obtain both radiology and nonradiology images using DICOM, and can display them on low-cost clinican’s color workstations throughout the medical center. High-resolution gray-scale diagnostic-quality multimonitor workstations with specialized viewing software can be used for reading radiology images. The VA’s DICOM capabilities can interface six different commercial picture archiving and communication systems (PACS) and more than 20 different image acquisition modalities. The VA is advancing its use of DICOM beyond radiology. New color imaging applications for gastrointestinal endoscopy and ophthalmology using DICOM are under development. These are the first DICOM offerings for the vendors, who are planning to support the recently passed DICOM Visible Light and Structured Reporting service classes. Implementing these in VistA is a challenge because of the different workflow and software support for these disciplines within the VA hospital information system (HIS) environment.
PMCID: PMC3453236  PMID: 10847382
9.  Digital radiography and film scanners: Automating the transition to filmless radiology 
Journal of Digital Imaging  2001;14(Suppl 1):128-130.
To facilitate the integration of digital radiography (DR) and legacy film/screen technology, we have devised a methodology for film digitization that optimizes workflow and integrates well with the picture archiving and communication system (PACS). This work was performed at Mercy Medical Center (Cedar Rapids, IA) using a film digitizer with built-in Digital Imaging and Communications in Medicine (DICOM) communication. The radiology department at Mercy has one DR system and three separate film/screen systems. The DR system software suite features DICOM Modality Worklist capability to provide complete radiology information system (RIS) integration functionality. This provides for patient demographic information to be automatically downloaded from the RIS worklist to populate the DICOM image header. Likewise, we have taken advantage of the film scanner’s DICOM capability to develop software linking it with the hospital RIS. This capability provides a worklist downloading functionality equivalent to that of the DR. Patient demographics can then be rapidly downloaded as each film is digitized. The worklist capability of the scanner is essential in several respects. First, it guarantees that patient demographic information is completely accurate and, therefore, that the digitized x-ray image will be merged with the correct patient file in the PACS. Additionally, high film scanner throughput is achieved, guaranteeing that all inpatient-digitized films are as readily available on the PACS as their DR image counterparts. The digitized images have proven to be of diagnostic quality on the typical 1K by IK PACS workstation. Also, as patients are admitted to the hospital, prior films from the radiology archive are digitized to form a readily available patient history for in-house physicians. Over time, we are building archival patient histories of soft-copy images that will enable increased availability of patient x-rays to both in-hospital and outside referring physicians, especially as more internet-viewing software becomes available to the out-of-hospital medical community. Finally, the results of this study show that high-throughput RIS integraton of film scanning equipment is a key component to making a graceful transition to the filmless hospital as more DR systems are installed.
PMCID: PMC3452673  PMID: 11442072
10.  Understanding and Using DICOM, the Data Interchange Standard for Biomedical Imaging 
The Digital Imaging and Communications in Medicine (DICOM) Standard specifies a non-proprietary data interchange protocol, digital image format, and file structure for biomedical images and image-related information. The fundamental concepts of the DICOM message protocol, services, and information objects are reviewed as background for a detailed discussion of the functionality of DICOM; the innovations and limitations of the Standard; and the impact of various DICOM features on information system users. DICOM addresses five general application areas: (1) network image management, (2) network image interpretation management, (3) network print management, (4) imaging procedure management, (5) off-line storage media management. DICOM is a complete specification of the elements required to achieve a practical level of automatic interoperability between biomedical imaging computer systems—from application layer to bit-stream encoding. The Standard is being extended and expanded in modular fashion to support new applications and incorporate new technology. An interface to other Information Systems provides for shared management of patient, procedure, and results information related to images. A Conformance Statement template enables a knowledgeable user to determine if interoperability between two implementations is possible. Knowledge of DICOM's benefits and realistic understanding of its limitations enable one to use the Standard effectively as the basis for a long term implementation strategy for image management and communications systems.
PMCID: PMC61235  PMID: 9147339
11.  Radiology smartphone applications; current provision and cautions 
Insights into Imaging  2013;4(5):555-562.
Medical smartphone applications are increasingly popular amongst doctors. However, the quality of their content is variable. We assessed contemporary radiology-related smartphone applications, focussing on the level of advertised medical involvement in application development.
Six major application stores were searched between 18-30 June 2012 using the terms radiology, radiation, x-ray(s), computed tomography/CT, magnetic resonance imaging/MRI, ultrasound, nuclear medicine, fluoroscopy and mammography/mammogram. Application ratings, cost and medical input in development were recorded.
321 applications were identified. One hundred fifty-eight were "teaching" and 96 “reference”. Three of the 29 DICOM viewing applications had FDA approval for primary diagnosis, while 62 % stated they should not be used for primary diagnosis; 24 % of applications stated named medical professional involvement, 12 % had unnamed medical involvement and 4 % acknowledged guidelines or papers; 42 % did not disclose authorship.
A large variety of radiology-related smartphone applications are available with many potential benefits. Advertised medical involvement in application design is variable, making assessment of their accuracy difficult prior to purchase. Additional measures are required to ensure the accuracy of such applications. The limitations of image interpretation using smartphones are a major drawback of DICOM viewing applications. Further research into the accuracy of primary diagnosis using such applications is needed.
Main Messages
• A large variety of radiology smartphone applications are available with many potential benefits
• Variable medical involvement in application design limits assessment of accuracy before purchase
• Limitations of image interpretation using smartphones are a drawback of DICOM viewing applications
• Further work on the accuracy of primary diagnosis using these DICOM viewing applications is needed
PMCID: PMC3781246  PMID: 23912880
Smartphone; Applications; Safety; Technology; Teleradiology
12.  VirtualPACS—A Federating Gateway to Access Remote Image Data Resources over the Grid 
Collaborations in biomedical research and clinical studies require that data, software, and computational resources be shared between geographically distant institutions. In radiology, there is a related issue of sharing remote DICOM data over the Internet. This paper focuses on the problem of federating multiple image data resources such that clients can interact with them as if they are stored in a centralized PACS. We present a toolkit, called VirtualPACS, to support this functionality. Using the toolkit, users can perform standard DICOM operations (query, retrieve, and submit) across distributed image databases. The key features of the toolkit are: (1) VirtualPACS makes it easy to use existing DICOM client applications for data access; (2) it can easily be incorporated into an imaging workflow as a DICOM source; (3) using VirtualPACS, heterogeneous collections of DICOM sources are exposed to clients through a uniform interface and common data model; and (4) DICOM image databases without DICOM messaging can be accessed.
PMCID: PMC3043676  PMID: 17876669
Grid computing; teleradiology; PACS; computer networks; Digital Imaging and Communications in Medicine (DICOM); imaging informatics; PACS integration
13.  What digital imaging and communication in medicine (DICOM) could look like in common object request broker (CORBA) and extensible markup language (XML) 
Journal of Digital Imaging  2001;14(Suppl 1):89-91.
Common object request broker architecture (CORBA) is a method for invoking distributed objects across a network. There has been some activity in applying this software technology to Digital Imaging and Communications in Medicine (DICOM), but no documented demonstration of how this would actually work. We report a CORBA demonstration that is functionally equivalent and in some ways superior to the DICOM communication protocol. In addition, in and outside of medicine, there is great interest in the use of extensible markup language (XML) to provide interoperation between databases. An example implementation of the DICOM data structure in XML will also be demonstrated. Using Visibroker ORB from Inprise (Scotts Valley, CA), a test bed was developed to simulate the principle DICOM operations: store, query, and retrieve (SQR). SQR is the most common interaction between a modality device application entity (AE) such as a computed tomography (CT) scanner, and a storage component, as well as between a storage component and a workstation. The storage of a CT study by invoking one of several storage objects residing on a network was simulated and demonstrated. In addition, XML database descriptors were used to facilitate the transfer of DICOM header information between independent databases. CORBA is demonstrated to have great potential for the next version of DICOM. It can provide redundant protection against single points of failure. XML appears to be an excellent method of providing interaction between separate databases managing the DICOM information object model, and may therefore eliminate the common use of proprietary client-server databases in commercial implementations of picture archiving and communication systems (PACS).
PMCID: PMC3452692  PMID: 11442131
14.  Assessing Organ Doses from Paediatric CT Scans—A Novel Approach for an Epidemiology Study (the EPI-CT Study) † 
The increasing worldwide use of paediatric computed tomography (CT) has led to increasing concerns regarding the subsequent effects of exposure to radiation. In response to this concern, the international EPI-CT project was developed to study the risk of cancer in a large multi-country cohort. In radiation epidemiology, accurate estimates of organ-specific doses are essential. In EPI-CT, data collection is split into two time periods—before and after introduction of the Picture Archiving Communication System (PACS) introduced in the 1990s. Prior to PACS, only sparse information about scanner settings is available from radiology departments. Hence, a multi-level approach was developed to retrieve information from a questionnaire, surveys, scientific publications, and expert interviews. For the years after PACS was introduced, scanner settings will be extracted from Digital Imaging and Communications in Medicine (DICOM) headers, a protocol for storing medical imaging data. Radiation fields and X-ray interactions within the body will be simulated using phantoms of various ages and Monte-Carlo-based radiation transport calculations. Individual organ doses will be estimated for each child using an accepted calculation strategy, scanner settings, and the radiation transport calculations. Comprehensive analyses of missing and uncertain dosimetry data will be conducted to provide uncertainty distributions of doses.
PMCID: PMC3635173  PMID: 23429160
paediatric computed tomography; organ dose reconstruction; scanner settings; leukaemia; cancer risk
15.  The VA's use of DICOM to integrate image data seamlessly into the online patient record. 
The US Department of Veterans Affairs (VA) is using the Digital Imaging and Communications in Medicine (DICOM) standard to integrate image data objects from multiple systems for use across the healthcare enterprise. DICOM uses a structured representation of image data and a communication mechanism that allows the VA to easily acquire radiology images and store them directly into the online patient record. Images can then be displayed on low-cost clinician's workstations throughout the medical center. High-resolution diagnostic quality multi-monitor VistA workstations with specialized viewing software can be used for reading radiology images. Various image and study specific items from the DICOM data object are essential for the correct display of images. The VA's DICOM capabilities are now used to interface seven different commercial Picture Archiving and Communication Systems (PACS) and over twenty different radiology image acquisition modalities.
PMCID: PMC2232574  PMID: 10566327
16.  A Framework for Integration of Heterogeneous Medical Imaging Networks 
Medical imaging is increasing its importance in matters of medical diagnosis and in treatment support. Much is due to computers that have revolutionized medical imaging not only in acquisition process but also in the way it is visualized, stored, exchanged and managed. Picture Archiving and Communication Systems (PACS) is an example of how medical imaging takes advantage of computers. To solve problems of interoperability of PACS and medical imaging equipment, the Digital Imaging and Communications in Medicine (DICOM) standard was defined and widely implemented in current solutions. More recently, the need to exchange medical data between distinct institutions resulted in Integrating the Healthcare Enterprise (IHE) initiative that contains a content profile especially conceived for medical imaging exchange: Cross Enterprise Document Sharing for imaging (XDS-i). Moreover, due to application requirements, many solutions developed private networks to support their services. For instance, some applications support enhanced query and retrieve over DICOM objects metadata.
This paper proposes anintegration framework to medical imaging networks that provides protocols interoperability and data federation services. It is an extensible plugin system that supports standard approaches (DICOM and XDS-I), but is also capable of supporting private protocols. The framework is being used in the Dicoogle Open Source PACS.
PMCID: PMC4181172  PMID: 25279021
Cloud computing; data integration; DICOM; medical imaging; PACS and XDS-I.
17.  A generic Digital Imaging and Communications in Medicine solution for a bidirectional interface between the modality and the radiology information system 
Journal of Digital Imaging  1999;12(Suppl 1):93-95.
The Relay is a generic Digital Imaging and Communications in Medicine (DICOM)-compliant software package. It is a bidirectional interface between the modality and the radiology information system (RIS) that uses DICOM modality worklist and modality-performed procedure step services. This device can eliminate discrepancies between patient demographic information contained in the RIS and that entered at the imaging modality. The Relay receives the worklist for a modality from the RIS. It verifies the accession number (ACC#) and medical record number (MRN) received from the RIS for a study against the ACC# and MRN entered at the modality after that study is pushed to the Relay by the modality. If the values for the ACC# and MRN contained in the image header coincide with the values stored on the RIS, the patient demographics and study protocol contained in the RIS is downloaded into the image header. The study is then automatically routed to the specified destination without technologist intervention. Images whose header does not coincide with data on the RIS are flagged for subsequent reconciliation by the technologist. When the study is completed, the Relay updates the status of the study in the RIS, if the RIS provides DICOM performed procedure step service. When required, the Relay is able to split a single study into two or more series and assign each an ACC#. Other Relay functionality includes sending studies to multiple DICOM devices, adding comments to the image header, and DICOM print service. Should the archive be unavailable to receive images for whatever reason, the Relay can store studies so image acquisition can continue without interruption or it can divert studies directly to a diagnostic workstation. This Relay provides redundancy and fault-tolerance capabilities for picture archiving and communications systems. It is vendor-independent and will function with any DICOM modality, RIS, or archive.
PMCID: PMC3452913  PMID: 10342178
18.  DicomBrowser: Software for Viewing and Modifying DICOM Metadata 
Journal of Digital Imaging  2012;25(5):635-645.
Digital Imaging and Communications in Medicine (DICOM) is the dominant standard for medical imaging data. DICOM-compliant devices and the data they produce are generally designed for clinical use and often do not match the needs of users in research or clinical trial settings. DicomBrowser is software designed to ease the transition between clinically oriented DICOM tools and the specialized workflows of research imaging. It supports interactive loading and viewing of DICOM images and metadata across multiple studies and provides a rich and flexible system for modifying DICOM metadata. Users can make ad hoc changes in a graphical user interface, write metadata modification scripts for batch operations, use partly automated methods that guide users to modify specific attributes, or combine any of these approaches. DicomBrowser can save modified objects as local files or send them to a DICOM storage service using the C-STORE network protocol. DicomBrowser is open-source software, available for download at
PMCID: PMC3447088  PMID: 22349992
Digital imaging and communications in medicine (DICOM); Workflow; Image viewer; Imaging informatics
19.  Development, Implementation, and Multicenter Clinical Validation of the TeleDICOM—Advanced, Interactive Teleconsultation System 
Journal of Digital Imaging  2010;24(3):541-551.
There is a need to make medical diagnosis available to critically ill patients on-site, without the necessity of time-consuming and risky transportation to larger reference hospitals. The teleconsultation of medical images is possible with the use of Internet-based TeleDICOM software developed in Krakow, Poland. Interactive consultation between two or more centers offers real-time voice communication, visualization of synchronized Digital Imaging and Communications in Medicine images, and use of interactive pointers and specific calculation tools. If direct interaction between physicians is not needed, the system can also be used in “offline” mode. In 2006, TeleDICOM was successfully deployed in the John Paul II Hospital in Krakow as well as a dozen other cooperating medical centers throughout southeast Poland. It is used for routine referral for cardiosurgical procedures. Aims of the study were to evaluate the image quality, software stability, constant availability, data transmission speed, and quality of real-time synchronized viewing of the images during the TeleDICOM teleconsultation; to evaluate the clinical utility of the TeleDICOM system; and to analyze the compatibility of TeleDICOM with the storage data formats of various imaging machine manufacturers. The analysis of angiographic offline teleconsultations was based on 918 patients referred remotely for coronary artery bypass grafting (CABG). The echocardiographic teleconsultations were performed during 63 live interactive consultations, several of them were presented to live during medical conferences. Measurement tools of the TeleDICOM software were tested against original measurement tools of echocardiographic machines from four different manufacturers. As a result of TeleDICOM consultation, a CABG decision was made in 806 of 918 patients consulted (87.8%). In remaining 12 patients, medical therapy or percutaneous angioplasty was recommended. CABG was performed in 98.6% of the admitted patients. Treatment decisions were changed after admission in 1.4% of patients—however, in all cases, it was not related to analysis of angiography data but rather to the change of clinical condition of the patients. All medical personnel involved in both offline and interactive teleconsultations judged the system positively in all assessed aspects. Lesser scores were observed only in the centers connected by slower networks. Measurements performed in the ECHO-TeleDICOM module were accurate as compared with those performed on a standard echo-machine (correlation r > 0.980, p < 0.001), independently of the echocardiograph model. Conclusion: This study demonstrates that telemedicine can improve patients' management using a clinically effective teleconsultation system. The TeleDICOM system is suited for professional use in the field of cardiovascular disease. It is also prepared for remote live demonstrations of clinical cases during large medical meetings.
PMCID: PMC3092051  PMID: 20495992
Telemedicine; angiography; cardiac imaging; clinical application; computers in medicine; digital image management; image analysis; ultrasonography
20.  DicomWorks: Software for Reviewing DICOM Studies and Promoting Low-cost Teleradiology 
Journal of Digital Imaging  2007;20(2):122-130.
DicomWorks is freeware software for reading and working on medical images [digital imaging and communication in medicine (DICOM)]. It was jointly developed by two research laboratories, with the feedback of more than 35,000 registered users throughout the world who provided information to guide its development. We detail their occupations (50% radiologists, 20% engineers, 9% medical physicists, 7% cardiologists, 6% neurologists, and 8% others), geographic origins, and main interests in the software. The viewer’s interface is similar to that of a picture archiving and communication system viewing station. It provides basic but efficient tools for opening DICOM images and reviewing and exporting them to teaching files or digital presentations. E-mail, FTP, or DICOM protocols are supported for transmitting images through a local network or the Internet. Thanks to its wide compatibility, a localized (15 languages) and user-friendly interface, and its opened architecture, DicomWorks helps quick development of non proprietary, low-cost image review or teleradiology solutions in developed and emerging countries.
PMCID: PMC3043902  PMID: 17333414
Computers; digital imaging and communication in medicine (DICOM); DICOM viewer; teleradiology
21.  Integration of digital gross pathology images for enterprise-wide access 
Sharing digital pathology images for enterprise- wide use into a picture archiving and communication system (PACS) is not yet widely adopted. We share our solution and 3-year experience of transmitting such images to an enterprise image server (EIS).
Gross pathology images acquired by prosectors were integrated with clinical cases into the laboratory information system's image management module, and stored in JPEG2000 format on a networked image server. Automated daily searches for cases with gross images were used to compile an ASCII text file that was forwarded to a separate institutional Enterprise Digital Imaging and Communications in Medicine (DICOM) Wrapper (EDW) server. Concurrently, an HL7-based image order for these cases was generated, containing the locations of images and patient data, and forwarded to the EDW, which combined data in these locations to generate images with patient data, as required by DICOM standards. The image and data were then “wrapped” according to DICOM standards, transferred to the PACS servers, and made accessible on an institution-wide basis.
In total, 26,966 gross images from 9,733 cases were transmitted over the 3-year period from the laboratory information system to the EIS. The average process time for cases with successful automatic uploads (n=9,688) to the EIS was 98 seconds. Only 45 cases (0.5%) failed requiring manual intervention. Uploaded images were immediately available to institution- wide PACS users. Since inception, user feedback has been positive.
Enterprise- wide PACS- based sharing of pathology images is feasible, provides useful services to clinical staff, and utilizes existing information system and telecommunications infrastructure. PACS-shared pathology images, however, require a “DICOM wrapper” for multisystem compatibility.
PMCID: PMC3327039  PMID: 22530178
DICOM; digital image; LIS; PACS; pathology; wrapper
22.  The Clinical Application of a PACS-Dependent 12-Lead ECG and Image Information System in E-Medicine and Telemedicine 
Journal of Digital Imaging  2009;23(4):501-513.
This study presents a software technology to transform paper-based 12-lead electrocardiography (ECG) examination into (1) 12-lead ECG electronic diagnoses (e-diagnoses) and (2) mobile diagnoses (m-diagnoses) in emergency telemedicine. While Digital Imaging and Communications in Medicine (DICOM)-based images are commonly used in hospitals, the development of computerized 12-lead ECG is impeded by heterogeneous data formats of clinically used 12-lead ECG instrumentations, such as Standard Communications Protocol (SCP) ECG and Extensible Markup Language (XML) ECG. Additionally, there is no data link between clinically used 12-lead ECG instrumentations and mobile devices. To realize computerized 12-lead ECG examination procedures and ECG telemedicine, this study develops a DICOM-based 12-lead ECG information system capable of providing clinicians with medical images and waveform-based ECG diagnoses via Picture Archiving and Communication System (PACS). First, a waveform-based DICOM-ECG converter transforming clinically used SCP-ECG and XML-ECG to DICOM is applied to PACS for image- and waveform-based DICOM file manipulation. Second, a mobile Structured Query Language database communicating with PACS is installed in physicians’ mobile phones so that they can retrieve images and waveform-based ECG ubiquitously. Clinical evaluations of this system indicated the following. First, this developed PACS-dependent 12-lead ECG information system improves 12-lead ECG management and interoperability. Second, this system enables the remote physicians to perform ubiquitous 12-lead ECG and image diagnoses, which enhances the efficiency of emergency telemedicine. These findings prove the effectiveness and usefulness of the PACS-dependent 12-lead ECG information system, which can be easily adopted in telemedicine.
PMCID: PMC3046657  PMID: 19711129
ECG; DICOM; PACS; telemedicine
23.  A method for calculating the dose length product from CT DICOM images 
The British Journal of Radiology  2011;84(999):236-243.
The dosimetric calculations in CT examinations are currently based on two quantities: the volume weighted CT dose index (CTDIvol) and the dose–length product (DLP). The first quantity is dependent on the exposure factors, scan field of view, collimation and pitch factor selections, whereas the second is additionally dependent on the scan length.
In this study a method for the calculation of these quantities from digital imaging and communication in medicine (DICOM) CT images is presented that allows an objective audit of patient doses. This method was based on software that has been developed to enable the automatic extraction of the DICOM header information of each image (relating to the parameters that affect the aforementioned quantities) into a spreadsheet with embedded functions for calculating the contribution of each image to the CTDIvol and DLP values. The applicability and accuracy of this method was investigated using data from actual examinations carried out in three different multislice CT scanners. These examinations have been performed with the automatic exposure control systems activated, and therefore the tube current and tube loading values varied during the scans.
The calculated DLP values were in good agreement (±5%) with the displayed values. The calculated average CDTIvol values were in similar agreement with the displayed CTDIvol values but only for two of the three scanners. In the other scanner the displayed CTDIvol values were found to be overestimated by about 25%. As an additional application of this method the differences among the tube modulation techniques used by the three CT scanners were investigated.
This method is a useful tool for radiation dose surveys.
PMCID: PMC3473864  PMID: 21081566
24.  Image Retake Analysis in Digital Radiography Using DICOM Header Information 
A methodology to automatically detect potential retakes in digital imaging, using the Digital Imaging and Communications in Medicine (DICOM) header information, is presented. In our hospital, neither the computed radiography workstations nor the picture archiving and communication system itself are designed to support reject analysis. A system called QCOnline, initially developed to help in the management of images and patient doses in a digital radiology department, has been used to identify those images with the same patient identification number, same modality, description, projection, date, cassette orientation, and image comments. The pilot experience lead to 6.6% and 1.9% repetition rates for abdomen and chest images. A thorough analysis has shown that the real repetitions were 3.3% and 0.9% for abdomen and chest images being the main cause of the discrepancy being the wrong image identification. The presented methodology to automatically detect potential retakes in digital imaging using DICOM header information is feasible and allows to detect deficiencies in the department performance like wrong identifications, positioning errors, wrong radiographic technique, bad image processing, equipment malfunctions, artefacts, etc. In addition, retake images automatically collected can be used for continuous training of the staff.
PMCID: PMC3043704  PMID: 18592314
Diagnostic image quality; Digital Imaging and Communications in Medicine (DICOM); image analysis
25.  Linking Whole-Slide Microscope Images with DICOM by Using JPEG2000 Interactive Protocol 
Journal of Digital Imaging  2009;23(4):454-462.
The use of digitized histopathologic specimens (also known as whole-slide images (WSIs)) in clinical medicine requires compatibility with the Digital Imaging and Communications in Medicine (DICOM) standard. Unfortunately, WSIs usually exceed DICOM image object size limit, making it impossible to store and exchange them in a straightforward way. Moreover, transmitting the entire DICOM image for viewing is ineffective for WSIs. With the JPEG2000 Interactive Protocol (JPIP), WSIs can be linked with DICOM by transmitting image data over an auxiliary connection, apart from patient data. In this study, we explored the feasibility of using JPIP to link JPEG2000 WSIs with a DICOM-based Picture Archiving and Communications System (PACS). We first modified an open-source DICOM library by adding support for JPIP as described in the existing DICOM Supplement 106. Second, the modified library was used as a basis for a software package (JVSdicom), which provides a proof-of-concept for a DICOM client–server system that can transmit patient data, conventional DICOM imagery (e.g., radiological), and JPIP-linked JPEG2000 WSIs. The software package consists of a compression application (JVSdicom Compressor) for producing DICOM-compatible JPEG2000 WSIs, a DICOM PACS server application (JVSdicom Server), and a DICOM PACS client application (JVSdicom Workstation). JVSdicom is available for free from our Web site (, which also features a public JVSdicom Server, containing example X-ray images and histopathology WSIs of breast cancer cases. The software developed indicates that JPEG2000 and JPIP provide a well-working solution for linking WSIs with DICOM, requiring only minor modifications to current DICOM standard specification.
PMCID: PMC2896636  PMID: 19415383
Digital pathology; telepathology; DICOM; JPEG2000; JPIP; virtual slide; whole-slide imaging; WSI

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