The announcement is wrapped in an aura of déjà vu: Universal Music Group is marketing an uncompressed, high-end digital audio format for Blu-ray called High Fidelity Pure Audio (HFPA). Where standard CD audio is 44.1KHz at 16 bits, HFPA's A2D sampling rate clocks in at a sky-high 96KHz at 24 bits.
Analog elitists will maintain that even extremely refined sampling is inherently inferior to capturing unchopped waveforms, and while that argument is fun to test, it is academic in the context of wide consumer adoption. Can a new audiophile format gain traction in a technomusical world governed by convenience and mobility?
Sony Network Entertainment and Sony Computer Entertainment are teaming up with payments processor Boku to support carrier billing in the United Kingdom. The new feature, which is reportedly compatible with all UK-based carriers, will enable consumers to top up their account wallets by charging the addition directly to cellular accounts. You'll be able to add funds through Sony's account management website and the PlayStation Store on PS3 by choosing "mobile" as the payment option, typing in your phone number and authorizing the transaction by responding to an SMS. You'll be on your way to charging games, themes, Music Unlimited subscriptions, video content and add-ons in no time.
Celeb moms including Halle Berry, Michelle Williams and Julie Bowen are fans of this company's cool craft kits, including their new Summer Discovery Pack.
Abiraterone: Hint of considerable added benefitPublic release date: 2-Jul-2013 [ | E-mail | Share ]
Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Certain men with metastatic prostate cancer have advantages in comparison with watchful waiting
Abiraterone acetate (abiraterone for short, trade name: Zytiga) has been approved in Germany since December 2012 for men with metastatic prostate cancer that is not responsive to hormone blockade, who only have mild symptoms or so far none at all, and in whom chemotherapy is not yet indicated. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
According to this, the new drug can prolong overall survival and delay the occurrence of severe pain in comparison with watchful waiting. Due to the poor data however, it cannot be excluded with certainty that abiraterone also causes greater harm in the form of side effects. Overall, IQWiG derives a hint of a considerable added benefit.
G-BA specified appropriate comparator therapy
The Federal Joint Committee (G-BA) specified watchful waiting, i.e. observation of the disease and its course without additional medical interventions, as the appropriate comparator therapy. However, current conventional androgen deprivation therapy, i.e. hormone blockade with drugs, was to be maintained or continued as combined, maximal androgen blockade with a non-steroidal anti-androgen (flutamide or bicalutamide).
Assessment on the basis of an approval study
The assessment was based on a direct comparative randomized controlled trial (RCT), namely the approval study for this indication (COU-AA-302). Patients in this study received either abiraterone and prednisone or placebo and prednisone. Almost all patients (94%) in both study arms also received a drug for hormone blockade.
In both study arms, treatment was continued until progression occurred, i.e. the disease got worse. In the abiraterone group, this was the case after 13.8 months on average (median), and in the placebo group, after 8.3 months. This means that the duration of treatment differed greatly in the two study arms.
Advantages in "mortality" and "morbidity"
The results of the study showed that, on the one hand, abiraterone had advantages in the outcome "overall survival", as life expectancy was about five months higher on average (median) in this study arm. On the other hand, severe pain occurred later in the abiraterone group, where it took about three months longer until one quarter of the patients needed an opiate. IQWiG sees an indication of an added benefit for both outcomes: in the case of "mortality" (overall survival) with the extent "minor", and in the case of "morbidity" (occurrence of severe pain) with the extent "considerable".
Data on "health-related quality of life" not usable
Data on "health-related quality of life" were obtained in this study using a questionnaire. The way these data were analysed was unsuitable, however, and therefore the results could not be used for the assessment. Therefore it remained unclear whether the differences recorded between the two study arms were really noticeable for the patients.
Results on "side effects" are uncertain
Most data on "side effects" presented by the pharmaceutical company were also not analysed appropriately, and could therefore not be used. This was true for the overall rate of adverse events and for serious adverse events, as well as for the specific adverse events "fractures" and "fluid retention/oedema".
The main reason these data could not be used was that the difference in treatment duration in the two study arms (13.8 versus 8.3 months) was not considered appropriately by the manufacturer in the analyses.
An analysis of severe adverse events that occurred during the first three months of the treatment from the approval documents could be used, however. At this early time, when the majority of patients was probably still treated with abiraterone or placebo, there was no statistically significant difference between the two treatment arms.
Hence a greater or lesser harm from abiraterone is not proven, but cannot be excluded with certainty, either.
Hint instead of indication
Therefore only positive effects remained on the basis of the available data, namely indications of a minor added benefit regarding "mortality" (overall survival) and of a considerable added benefit regarding "morbidity" (time of occurrence of severe pain). Due to the uncertainty regarding harm, however, overall, IQWiG did not derive an indication, but a hint of a considerable added benefit of abiraterone in comparison with watchful waiting.
IQWiG already published a first dossier assessment of abiraterone in January 2012. This assessment dealt with a different indication, however, namely its use in men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel.
G-BA decides on the extent of added benefit
The approach for deriving an overall conclusion on the extent of added benefit is a proposal by IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on abiraterone.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of abiraterone.
###
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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Abiraterone: Hint of considerable added benefitPublic release date: 2-Jul-2013 [ | E-mail | Share ]
Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Certain men with metastatic prostate cancer have advantages in comparison with watchful waiting
Abiraterone acetate (abiraterone for short, trade name: Zytiga) has been approved in Germany since December 2012 for men with metastatic prostate cancer that is not responsive to hormone blockade, who only have mild symptoms or so far none at all, and in whom chemotherapy is not yet indicated. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
According to this, the new drug can prolong overall survival and delay the occurrence of severe pain in comparison with watchful waiting. Due to the poor data however, it cannot be excluded with certainty that abiraterone also causes greater harm in the form of side effects. Overall, IQWiG derives a hint of a considerable added benefit.
G-BA specified appropriate comparator therapy
The Federal Joint Committee (G-BA) specified watchful waiting, i.e. observation of the disease and its course without additional medical interventions, as the appropriate comparator therapy. However, current conventional androgen deprivation therapy, i.e. hormone blockade with drugs, was to be maintained or continued as combined, maximal androgen blockade with a non-steroidal anti-androgen (flutamide or bicalutamide).
Assessment on the basis of an approval study
The assessment was based on a direct comparative randomized controlled trial (RCT), namely the approval study for this indication (COU-AA-302). Patients in this study received either abiraterone and prednisone or placebo and prednisone. Almost all patients (94%) in both study arms also received a drug for hormone blockade.
In both study arms, treatment was continued until progression occurred, i.e. the disease got worse. In the abiraterone group, this was the case after 13.8 months on average (median), and in the placebo group, after 8.3 months. This means that the duration of treatment differed greatly in the two study arms.
Advantages in "mortality" and "morbidity"
The results of the study showed that, on the one hand, abiraterone had advantages in the outcome "overall survival", as life expectancy was about five months higher on average (median) in this study arm. On the other hand, severe pain occurred later in the abiraterone group, where it took about three months longer until one quarter of the patients needed an opiate. IQWiG sees an indication of an added benefit for both outcomes: in the case of "mortality" (overall survival) with the extent "minor", and in the case of "morbidity" (occurrence of severe pain) with the extent "considerable".
Data on "health-related quality of life" not usable
Data on "health-related quality of life" were obtained in this study using a questionnaire. The way these data were analysed was unsuitable, however, and therefore the results could not be used for the assessment. Therefore it remained unclear whether the differences recorded between the two study arms were really noticeable for the patients.
Results on "side effects" are uncertain
Most data on "side effects" presented by the pharmaceutical company were also not analysed appropriately, and could therefore not be used. This was true for the overall rate of adverse events and for serious adverse events, as well as for the specific adverse events "fractures" and "fluid retention/oedema".
The main reason these data could not be used was that the difference in treatment duration in the two study arms (13.8 versus 8.3 months) was not considered appropriately by the manufacturer in the analyses.
An analysis of severe adverse events that occurred during the first three months of the treatment from the approval documents could be used, however. At this early time, when the majority of patients was probably still treated with abiraterone or placebo, there was no statistically significant difference between the two treatment arms.
Hence a greater or lesser harm from abiraterone is not proven, but cannot be excluded with certainty, either.
Hint instead of indication
Therefore only positive effects remained on the basis of the available data, namely indications of a minor added benefit regarding "mortality" (overall survival) and of a considerable added benefit regarding "morbidity" (time of occurrence of severe pain). Due to the uncertainty regarding harm, however, overall, IQWiG did not derive an indication, but a hint of a considerable added benefit of abiraterone in comparison with watchful waiting.
IQWiG already published a first dossier assessment of abiraterone in January 2012. This assessment dealt with a different indication, however, namely its use in men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel.
G-BA decides on the extent of added benefit
The approach for deriving an overall conclusion on the extent of added benefit is a proposal by IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on abiraterone.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of abiraterone.
###
[ | E-mail | Share ]
?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Military technology doesn't simply spring forth fully formed from a DARPA engineer's head like some GI Athena. It requires extensive development cycles and field testing before it's put on the front lines. At this year's semi-annual Network Integration Evaluations (NIE) at the White Sands Missile Range, in New Mexico, Army researchers put a trio of technologies through their paces. Technologies that could radically alter how future wars are waged by delivering a more complete battlefield view to troops in the line of fire.
Aside from testing the devices themselves, the NIE gives commanders a chance to integrate the new technology into their existing tactics, techniques and procedures (TTPs). ?Over the last few NIEs, the network has become much more stable than it was," said Col. Beth Bierden, chief of the Network Integration Division at Brigade Modernization Command. "We are able to get at the TTPs and figure out mission command and do all that kind of stuff much more now than we have in the past, when we were really just trying to figure out the architecture.? Here are three systems expected to make the biggest impact on tomorrow's battlefield.
Nett Warrior
Originally known as the Ground Soldier System, the Nett Warrior is an integrated situational awareness system for dismounted combat leaders (those not sitting in a HumVee or remote command center). It's a mini-map that notes every squad member's positions (to avoid friendly fire and set more effective crossfires) as well as a host of other pertinent tactical and navigation information that's shared amongst the squad over secured radio waves using Rifleman Radios.
It effectively becomes a tiny, mobile ad hoc network?known as the On-The-Move self-forming network?whose voice, data, and GPS information can be displayed either on a mobile handset or on the soldier's HUD. What's more, commanders can use the system to access Secret or Sensitive-but-Unclassified ISR information during on-the-fly mission planning. And even if the commander is incapacitated or killed in action, the next-most senior member of the group will be able to pick up where the previous commander left off.
Warfighter Information Network ? Tactical Increment 2 (WIN-T)
Domestic carrier coverage is spotty even in the boondocks of Iowa; what makes you think you'll get any bars in the wilds of Afghanistan? So instead of relying on the Big Three, future soldiers will carry their network along with them. Known as the Warfighter Information Network - Tactical Increment 2, this network will form the basis of the entire Army's secured troop communication services.
WIN-T will enable commanders to track (via voice, video, and data) and coordinate a mobile and dispersed strike force from anywhere on the battlefield while remaining tapped into the Army's intel network. The system consists of infrastructure and network components that securely relay satellite and terrestrial tactical communications (known as Command, Control, Communications, Computers, Intelligence, Surveillance, and Reconnaissance?C4ISR) between individual soldiers and command.
So rather than shouting into a walkie-talkie during the pitch of battle to get status updates from the squad's radio operator, the WIN-T network will allow commanders monitor and redeploy forces in real time as well as transmit tactical information?everything from Ku-band RADAR and Super High Frequency datalinks to GPS and the Secure, Mobile, Anti-Jam, Reliable, Tactical - Terminal (SMART-T). Think of it as a secured, miniature Internet that exists only within a theater of operations but spans from the front lines to the rear guard.
Distributed Common Ground System
There are a lot of moving pieces on a battlefield. So to make sure that elements from the Army, Air Force, Navy, and Marines are all on the same page, there's the Distributed Common Ground System (DCGS).
The DCGS is the primary means of analyzing and disseminating ISR data?from the weather forecast to threat assessments?collected by the Air Force's U-2, RQ-4 Global Hawk, MQ-9 Reaper and MQ-1 Predator drones. It comprises 45 geographically distinct, networked sites manned by a mixture of active-duty, national guard, and reservists service members. And while previous human-based systems required weeks of analysis to deliver actionable results, the cloud-based DCGS churns through millions of data points in near real time.
?It was not that long ago that intelligence analysis was a very labor-intensive business,? explained Col. Charles Wells, the project manager for the Army's wing of the DCGS. ?With the cloud and with lightweight applications that run analytics, we can now look through all that data?all 20 million records?and literally in a matter of seconds to minutes get a diagram that has been provided and start the analysis from there. We're not having to filter the data. We're not having to look at a subset of the data. We're looking at every one of those records in real time, and getting an answer.?
This allows commanders worldwide to deliver accurate, actionable intelligence faster than ever before and will help save American lives.
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Public release date: 2-Jul-2013
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