Thursday, March 29, 2012

1.4. Some terminology (important!)

1.4. Some terminology (important!) Local Authentication: this is the authentication performed by the Vasco Middleware, checking your PIN code and Digipass dynamic code. Back-End Authentication: this is the authentication performed by Windows Active Directory, checking your username and password. OTP: One-time password. This is the numeric code that the Digipass device displayswhen you push the button. The code changes every 36 seconds and each code can be used only once. PIN: a numeric code that the user needs to remember when working with his Digipass. When you deploy the solution you can choose if you want to work with or without PIN code (see later in this document). Static password: the Active Directory password of the user Serial number: the serial number on the back of each Digipass

vpn in china

VPN Error 783 solution

 

Error 783 - Can't enable ICS

Symptom: When you try to enable ICS, you may receive the following error message: "Error 783: Internet Connection Sharing cannot be enabled. The LAN connection selected as the private network is either not present, or is disconnected from the network. Please ensure that the LAN adapter is connected before enabling Internet Connection Sharing."

Resolution: When enabling ICS, your computer is assigned the 192.168.0.1 IP address, and if this address is already in use on the network, you will get this error message. To fix this problem, disconnect the computer using the 192.168.0.1 IP address from the network, or change its TCP/IP settings to use DHCP

 

Wednesday, March 28, 2012

Error 721:

Error 721:


Remote PPP peer or computer is not responding.

Solution: 
Switch from PPTP to L2TP.

 

 

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Tuesday, March 27, 2012

VPN Error 930 solution

VPN Error 930 solution
 
SYMPTOMS: after setup Routing and Remote Access service for VPN or dial-up on a server to use RADIUS, or upgrade the server to a new OS, 1) the client computers may receive the following error message: Error 930: The authentication server did not respond to authentication requests in a timely fashion. 2) On the RRAS server Event ID: 20073 The following error occurred in the Point-to-Point Protocol module port: Port, UserName: Username. The authentication server did not respond to authentication requests in a timely fashion. 3) On the IAS server, the following error message may be reported Event ID: 13 A request was received from the invalid client IP Address IP_Address.
Causes: 1) The default path to the Remote Access log file has been changed or is not valid.
2) The VPN server has not been set up as a RADIUS client in the IAS.
3) This behavior will occur if the VPN user has permissions to read only on the Active Directory directory service record.
4) Refer to error 619 resolution – add the vpn to the appropriate group.
Refer to 072704RLa

Sunday, March 25, 2012

Buy Portugal VPN Service - Fast, Reliable and Secure!

Buy Portugal VPN Service - Fast, Reliable and Secure!
 
Vpntraffic is a leading Portugal VPN services provider that enables our users from all around the world to enjoy Free Internet thought fast, secure and reliable servers. Yes! This means internet with no restrictions! Our customers have been using cheap VPN services for more than 3 Years now and they are delighted on the quality of service they get. It is because we strive to make sure our customers enjoy unmetered, uninterrupted, fast VPN services and if they get stuck, our Human Live Chat Support and Efficient Technical Support Ticket Department is always there to help them out!     We all understand the importance of a virtual private network. There are times when one wishes to remain completely anonymous and protected online. The peace and security that a vpn account can provide you with is priceless. An offshore vpn account is also helpful for those that wish to appear to be located in another country.
Vpntraffic is a leading Portugal VPN services provider that enables our users from all around the world to enjoy Free Internet thought fast, secure and reliable servers. Yes! This means internet with no restrictions! Our customers have been using cheap VPN services for more than 3 Years now and they are delighted on the quality of service they get. It is because we strive to make sure our customers enjoy unmetered, uninterrupted, fast VPN services and if they get stuck, our Human Live Chat Support and Efficient Technical Support Ticket Department is always there to help them out!     We all understand the importance of a virtual private network. There are times when one wishes to remain completely anonymous and protected online. The peace and security that a vpn account can provide you with is priceless. An offshore vpn account is also helpful for those that wish to appear to be located in another country.
Vpntraffic is a leading Portugal VPN services provider that enables our users from all around the world to enjoy Free Internet thought fast, secure and reliable servers. Yes! This means internet with no restrictions! Our customers have been using cheap VPN services for more than 3 Years now and they are delighted on the quality of service they get. It is because we strive to make sure our customers enjoy unmetered, uninterrupted, fast VPN services and if they get stuck, our Human Live Chat Support and Efficient Technical Support Ticket Department is always there to help them out!
 
 
We all understand the importance of a virtual private network. There are times when one wishes to remain completely anonymous and protected online. The peace and security that a vpn account can provide you with is priceless. An offshore vpn account is also helpful for those that wish to appear to be located in another country.
 

How to Watch Denmark's Streaming Online TV show from outside Denmark

How to Watch Denmark's Streaming Online TV show from outside Denmark

 

TV 2 is a publicly owned television station in Denmark based in Odense. The station began broadcasting on 1 October 1988, thereby ending the television monopoly previously exercised by the Danmarks Radio (DR).
TV 2 has five subsidiary stations known as TV 2 Zulu, targeted at the youth, TV 2 Charlie, oriented towards older audiences, TV 2 News, a 24-hour news channel (launched on 1 December 2006), TV 2 Film, a non-stop movie channel (launched on 1 November 2005), and TV 2 Sport, a dedicated sports channel, as well as the internet-based pay-per-view channel TV 2 Sputnik which started broadcasting in December 2004.
 
Maybe you're a citizen of the Denmark who's moved abroad and you miss keeping up with your favorite television shows-or maybe you're just an American who is curious what TV in another country is like. 
 
Whatever the reason, if you've ever tried to go to a streaming TV website such as iPlayer, iTV, Hulu or Netflix and you're in a different country, you're greeted with a message telling you that due to restrictions they can't let you watch anything. Bummer! 
 
How does it know that? What's happening is that the website looks at your public IP address and uses it to determine your location.  Watch TV on websites which restrict IP's,ou can now watch tv series outside of the Denmark.
 
The solution to this problem is to use what is called a VPN. Using our new Denmark VPN server we can help you traveling abroad to watch their favorite TV shows.
 

Saturday, March 24, 2012

How To Get A germany IP Address

How To Get A germany IP Address

 

WHY WOULD YOU WANT TO CHANGE TO AN IP ADDRESS IN GERMANY?   Well, perhaps:

  • You are a German citizen wishing to access German websites as if you're at home.
  • You are an Internet entrepreneur wanting to review your marketing campaigns in Germany.
  • You are learning German and desire to surf the Internet as if you are located in Germany.
  • You are a German traveler and your bank only allows online access from within Germany.
  • Etc, etc, etc.

 

How do I hide my IP address?

 
The most common method to hide your IP address is to use a vpn server in one form or another. A proxy server is a computer that offers a computer network service to allow clients to make indirect network connections to other network services. A client connects to the proxy server and then requests a connection, file, or other resource available on a different server. The proxy provides the resource either by connecting to the specified server or by serving it from a cache. In some cases, the proxy may alter the client's request or the server's response for various purposes.
 

You can get Free VPN accounts at vpntraffic!

 
If you are a recognized member of some online forum. Post Threads about us and get Free VPN accounts.
 
The content must remain on the forum permanent.
The forum should relate vpn,online game,voip and other topic about vpn use. The fourm PR>2

How To Get A Malaysia IP Address

How To Get A Malaysia IP Address

In addition to their safety features VPNs offer great reliability and speed to its users as well and can be configured easily on any computing platform. Keeping these advantages in mind it is safe to say that the use of a Malaysia VPN to get a Malaysian IP address is the best available option for anyone living outside their country.

 

How do I hide my IP address?

 
The most common method to hide your IP address is to use a vpn server in one form or another. A proxy server is a computer that offers a computer network service to allow clients to make indirect network connections to other network services. A client connects to the proxy server and then requests a connection, file, or other resource available on a different server. The proxy provides the resource either by connecting to the specified server or by serving it from a cache. In some cases, the proxy may alter the client's request or the server's response for various purposes.
 

You can get Free VPN accounts at vpntraffic!

 
If you are a recognized member of some online forum. Post Threads about us and get Free VPN accounts.
 
The content must remain on the forum permanent.
The forum should relate vpn,online game,voip and other topic about vpn use. The fourm PR>2
The review must have a direct link to our http://www.vpntraffic.com
 
example:
 
 
 
1 Thread= Free 3 days vpn account
10 Threads= Free 30 days vpn account
 
One person at most apply free monthly vpn account
 

How to watch xunlei movie outside china

How to watch xunlei movie outside china

 

It took me a while to get how my Chinese mates watch TV and movies online. Usually around noon time, you could see the mainland Chinese bringing in take-away lunch from the cafeteria and watch movies or TV (mostly Taiwanese or American, I should point out). Even movies that haven't yet made it to the Hong Kong cinemas are already online with streaming DVD high definition (HD) quality.
 
It's not even that hard to find. It's remarkable that the Hollywood IP infringement folks didn't wake up to do something about those, as some of those websites are located in China's Special Economic Zones which I've heard are under more strict IP enforcement. Looking at the commercials, it's quite obvious the local Chinese movie industry not only doesn't care but supports this activity. How odd.
 

why you need china ip address?

with free china ip address, you can watch free online movie such as tudou.com, youku.com see  Watching Free online movie at tudou, youku

 
 

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Friday, March 23, 2012

reducing the VPN handoff

The main purpose of this thesis is to propose and to implement a new and novel solution on simulators and real devices to solve the mobility problem in a VPN. The new solution adds mobility support to existing L2TP/IPsec (Layer 2 Tunneling Protocol/IP Security) tunnels. It tunnels Layer 2 packets between a VPN client and a  VPN server without using Mobile IP, Chapter 1:  Introduction  Page 3 © 2009 Chen Xu  Page 3 without incurring tunnel-re-establishment at handoff, without losing packets during handoff, achieves better security than current mobility solutions for VPN, and supports fast handoff in IPv4 networks.  The new solution has particular application when several persons inside a moving vehicle are connected to a network at layer 2 (for  example a PPP link [39]). An L2TP/IPsec concentrator inside the vehicle is used to encapsulate Layer 2 packets and then to tunnel to the company network. It is also possible to encapsulate IP packets inside the L2TP/IPsec tunnel. The real world topology of the solution is shown in Figure 1-1. The new solution explained in this thesis handles the situation perfectly and quickly when the vehicle is moving and the L2TP/IPsec concentrator inside the vehicle changes IP addresses from time to time. Figure 1-1 Real World Topology This thesis focuses on reducing the VPN handoff time as much as possible. The time for VPN handoff is mainly caused by the time to get an IP address and the time for VPN negotiation. The time to get a new IP address varies from situation to situation as the new IP address can be got from UTMS, WiMAX [77] or even a wireless access point. Therefore, the main goal of this thesis is to reduce the VPN negotiation time. In the simulation, the time to get a new IP address was minimized by using the "ifconfig" command and a very small VPN handoff time was

Thursday, March 22, 2012

software gives VPN

and software gives VPN  you the best security and performance possible from a single device.Increased SimplicityFortiOS 4.0 software lowers costs and reduces IT staff workloads. Centralized management and analysis ensure consistent policy creation and enforcement while minimizing deployment and configuration challenges. You gain the flexibility of having a unified security policy at the device level along with an appliance-based centralized management platform for large deployments.Unique Visibility and ControlAdvanced security features such as Flow-based Inspection and Wireless Controller capability allow you to monitor and protect your network from endpoints to core, and from remote offices to headquarters. FortiOS allows greater traffic visibility and more consistent, granular control over users, applications and sensitive data.

Wednesday, March 21, 2012

minimal usa vpn competition

For  programmers, the distribution market is more national or regional; programmers can sell to more purchasers if different distributors operate, even in different towns. This national market is also highly concentrated. In 2006, four cable TV distributors, which included two satellite operators, served approximately 63 percent of all cable TV subscribers. The top 10 cable TV distributors served 87 percent of subscribers.12 The two largest were Comcast and Time Warner Cable.13 While the telephone companies have taken some share, the market remains highly concentrated.  This minimal usa vpn competition results in bad outcomes for consumers. Cable operators have the lowest consumer satisfaction ratings of any industry,14 even while they soak up large profit margins and raise prices.15 Some had predicted that the advent of competition from satellite and phone companies would decrease prices and increase quality.16  Programming. The programming market is also concentrated, with a few dominant programmers, both non-broadcasters and broadcasters.17 Large non-broadcast players, whose content is available only through a cable TV subscription, include Viacom (owner of MTV Networks, Comedy Central and others) and Time Warner, a content company that split off from Time Warner Cable, and owns TBS, TNT and CNN. Broadcasters, available both on cable TV and over-the-air, for free, include ABC, NBC, CBS, and Fox.18 Programmers have high profit margins based on adding two revenue sources — advertising and per-subscriber fees. While programmers are sometimes "cagey" about their financials, the head of NBC's cable channels stated her channels' operating profit margins "are well over 50 percent."19Programming is often vertically integrated, with distributors owning programmers. In the FCC's last report in 2007 (which was before Time Warner's split from Time Warner Cable), the FCC found that of the 565 national non-broadcast channels it identified, many of the most popular were affiliated with a cable operator (84 channels total).20 Dozens more channels were affiliated with a satellite operator.21 At the time, five of the top seven cable operators held ownership interests in national programming networks.22

Tuesday, March 20, 2012

Netflix Brazil VPN ipad

The goal was simple: Offer $1 million to the first group or individual who can improve Cinematchʼs ratings accuracy by 10%.  In order to give developers something to work with, the firm turned over a large ratings database (with customer-identifying information masked, of course).  The effort has attracted over 20,000 teams from 170 countries.  Not bad when you consider that $1 million would otherwise fund just four senior Silicon Valley engineers for about a year.  And the effort earned Netflix a huge amount of PR, as newspapers, magazines, and bloggers chat up the effort.  While Netflix gains access to Netflix Brazil VPN ipad any of the code submitted as part of the prize, it isnʼt exclusive access.  The Prize underscores the value of the data asset.  Even if others incorporate the same technology as Netflix, the firm still has user data (and attendant customer switching costs) that prevent rivals with equal technology from posing any real threat.  Results incorporating many innovations offered by contest participants were scheduled for Fall 2008 incorporation into Cinematch.Patron Saint of the Independent Film CrowdMany critically acclaimed films that failed to be box-office hits have gained a second life on Netflix, netting significant revenue for the studios, with no additional studio marketing.  Babel, The Queen, and The Last King of Scotland are among the films that failed to crack the top 20 in the box office, but ranked among the most requested titles on Netflix during the year after their release. Netflix actually delivered more revenue to Fox from the Last King of Scotland than it did from the final X-Men film11.In the true spirit of the long tail, Netflix has begun acquiring small market titles for exclusive distribution.  One of its first efforts involved the Oscar-nominated PBS documentary, Daughters from Danang.  PBS hadnʼt planned to distribute the disc after the Academy Awards, it was simply too costly to justify producing a run of DVDs that almost no retailer would carry.  But in a deal with PBS, Netflix assumed all production costs in exchange for exclusive distribution rights.  For months after, the film repeatedly ranked in the Top 15 most requested titles in the Documentary category.  Cost to PBS?  $012.Netflix has since begun trawling film festivals for gems to add to its long tail.   Eighty-five percent of films screened at Sundance don't get distribution deals, so Netflix may be the only chance for budding directors to get their work in front of a wider audience. Netflix even uses data mined from its Cinematch ratings and viewer request patterns to determine what to pay for distribution rights.  The offer price for Favela Rising, a documentary about Brazilian musicians, was determined after examining customer requests for documentaries and movies set in Brazil13.

Monday, March 19, 2012

How do I enable my VPN to work

A negative aspect of the 802.11e in the service provider's ,perspective is that it requires a hardware upgrade. That is, the ,legacy 802.11 MAC controllers cannot support the 802.11e. Our ,approach is to implement multiple queues in the device driver of ,the 802.11 MAC controller so that a frame scheduling can be ,performed in the driver level. A similar approach was made in ,[12][17]. In case of AP, this software upgrade means the firmware ,upgrade of the AP, which can be done even remotely.  ,Figure 6 shows the device driver structure for both the original ,device driver and a modified device driver supporting our ,approach. We have used the HostAP driver [2] of Intersil's Prism ,2.5 chipsets for our implementation. In the original driver, there is ,basically no queue for the frame transmission. A frame from the ,higher layer or from the wireline port is processed for the header ,and so on, and is forwarded to the MAC controller for the ,transmission. The MAC controller basically has a single first-in ,first-out (FIFO) queue. We have implemented two queues in the ,device driver level as shown in Figure 6 (b). We classify each ,frame to transmit into real-time (RT) or non-real-time (NRT). The ,current IP datagrams do not carry any information about the ,corresponding applications, and hence our implementation uses ,the port number as well as UDP packet type to classify a RT ,frame. That is, the device driver is provided the specific port ,number information of the real-time application in consideration. ,For example, KT's VoIP application utilizes a pre-assigned range ,of port numbers along with RTP over UDP protocols. For ,transmission scheduling, we have implemented a simple priority ,queuing so that the NRT queue is never served as long as the RT ,queue is not empty. We are currently investigating a more ,intelligent scheduling as will be discussed below.,

Sunday, March 18, 2012

traffic across N2N VPN

traffic across N2N communities. Packet forwarding through N2N is disabled by default, as this can be a security flaw. N2N users can enable it if necessary but doing so requires explicit user awareness.The need to cross NAT and firewall devices motivated the use of P2P principles for interconnecting N2N nodes. During the design phase, the authors analysed several popular P2P protocols [14] ranging from proprietary (e.g. Skype SDK) to open (e.g. BitTorrent [15]) protocols. Unfortunately most protocols have been created for file sharing and are not suitable for N2N because PDUs (Protocol Data Units) have been designed to carry file information (e.g. name, length, type, attributes such as MP3 tags) and perform distributed file searches. Even though existing P2P protocols were not immediately usable for N2N without modification, some concepts already present in other P2P architectures [16] have been utilised as is explained in the following chapter. In addition to the properties listed so far, N2N presents further differences from other approaches [28] [29] [30]: Unlike most P2P overlay networks such as Chord [25] and Pastry [26] that are affected by the problem or locating objects/peers in a limited number of overlay hops, in N2N this is not a problem as, by design, peers are reachable either directly or in one hop when passing through the N2N community. This design choice has dramatically simplified peer lookup and membership information without requiring complex algorithms for information bookkeeping [27].

Saturday, March 17, 2012

VPN active RAT

The process of active RAT re-selection at the UEinvolves discovering available networks for each RAT,evaluation of the potential handover candidates (bytaking into account operator policies, user preferences,and signal conditions), and the inter-technology handover trigger if the conditions are right.Starting with Release 8, 3GPP defined the accessnetwork discovery and selection function [3] in thenetwork to provide UE with the available access network information and associated service provider policies. UE can obtain the IP address of the ANDSF aspart of host IP information on initial network entry.

Friday, March 16, 2012

How To Get A Russia IP Address

How To Get A Russia IP Address

The simplest way to change your IP address while browsing is by using a Russia VPN. A VPN acts as an intermmediate between you and the site you visit. So, the targeted site will get the IP address of the proxy instead of yours.

How do I hide my IP address?

The most common method to hide your IP address is to use a vpn server in one form or another. A proxy server is a computer that offers a computer network service to allow clients to make indirect network connections to other network services. A client connects to the proxy server and then requests a connection, file, or other resource available on a different server. The proxy provides the resource either by connecting to the specified server or by serving it from a cache. In some cases, the proxy may alter the client's request or the server's response for various purposes.

You can get Free VPN accounts at vpntraffic!

If you are a recognized member of some online forum. Post Threads about us and get Free VPN accounts.
The content must remain on the forum permanent.
The forum should relate vpn,online game,voip and other topic about vpn use. The fourm PR>2

Thursday, March 15, 2012

supported by a huge VPN network

A very large number of associations can be easily supported by a huge VPN network, and lots of millions can be easily supported by the Internet. So it requires a huge number of VCs which generally makes the process so weak. When every service-linktoward-partner relation is evaluated onto a VC, then the networks having C links of service will generate C(C-1)/2 VCs. Conventional IP-based Virtual Private Networks (VPNs) have been broadly employed all over the world for remote connectivity; however they are usually vulnerable by multifarious client software and complexities in handling the health position of remote clients. A lot of worms and viruses broadcast through these abandoned VPN endpoints causing destruction of the internal security of the networks. Thus with the Internet, one of the most important issue is the VPN's security, particularly for those which depend upon the publicly designed Internet used for transportation. The IP-based network (unlike ATM/frame relay or private-line services) doesn't allocate the constant logical/physical pipes to the special sites, applications or protocols. To address the Internet security, IPSec (Davis, 2001) is the latest IETF (Internet Engineering Taskforce) solution that was initially proposed for the IPv6 (Deering et al., 1998) protocol; however, it has been used in the current's IPv4 networks. Since, it describes a framework for giving a powerful security in support of network transport over the IP-based environments.

Wednesday, March 14, 2012

This is a very basic description of what VPNs are all about

Virtual Private Network is a computer network in which some of the links between nodes are carried by open connections or virtual circuits in some larger networks, such as the internet, as opposed to running across a single private network.  The link layer protocols of thevirtual network are said to be tunneled through the transport network. [2]  In mid 1990s, the rise of the Internet and the increase of speed for cheap Internet connections paved the way for new technologies. Many developers, administrators, and, last but not the least, managers had discovered that there might be better solutions than spending several hundreds of dollars, if not thousands of dollars, on dedicated and dial-up access lines.  The idea was to use the Internet for communication between branches and at the same time ensure safety and secrecy of the data transferred. In other words: providing secure connections between enterprise branches via low-cost lines using the Internet. This is a very basic description of what VPNs are all about.  Taking into account literally the acronym VPN (Virtual Private Network) Virtual means there is no direct network connection between the two communication partners, but only a virtual connection provided by VPN. Software, realized normally over public internet connection. And considered to be private because only the members of the company connection by the VPN software are allowed to read data transform.[3] With a VPN The network entities are described as a set of logical connections secured by special software that establishes privacy of safeguard the connection endpoint. As depicted in the Today the Internet is a work medium used, and privacy is achieved by modern cryptographic methods.  

what is vpn?

"Virtual" is a concept that is slightly more complicated.  The New Hacker's Dictionary (formerly known as the Jargon File) [2] defines
virtual as –
virtual /adj./ [via the technical term "virtual memory", prob.  from the term "virtual image" in optics] 1.  Common alternative to
{logical}; often used to refer to the artificial objects (like addressable virtual memory larger than physical memory) simulated by
a computer system as a convenient way to manage access to shared resources.   2.  Simulated; performing the functions of
something that isn't really there.  An imaginative child's doll may be a virtual playmate.  Oppose {real}.
Insofar as VPN's are concerned, the definition in  2.  above is perhaps the most appropriate comparison for virtual networks.  The
"virtualization" aspect is one that is similar to what we briefly described above as "private," however, the scenario is slightly modified – the
private communication is now conducted across a network infrastructure that is shared by more than a single organization.  Thus, the
private resource is actually constructed by using the foundation of a logical partitioning of some underlying common shared resource,
rather than by using a foundation of discrete and dedicated physical circuits and communications services.  Accordingly, the "private"
network has no corresponding "private" physical communications system.  Instead, the "private" network is a virtual creation which has
no physical counterpart.  The virtual communications between two (or more) devices is due to the fact that the devices which are not
participating in the virtual communications are not privy to the content of the data, and that they are also altogether unaware of the
private relationship between the virtual peers.  The shared network infrastructure could, for example, be the global Internet and the
number of organizations or other users not participating in the virtual network may literally number into the thousands, hundreds of
thousands, or millions.

Tuesday, March 13, 2012

Connection Technologies

Connection Technologies
The VPN Client lets you use any of the following technologies to connect to the Internet:
• POTS (Plain Old Telephone Service)—Uses a dial-up modem to connect.
• ISDN (Integrated Services Digital Network)—May use a dial-up modem to connect.
• Cable—Uses a cable modem; always connected.
• DSL (Digital Subscriber Line)—Uses a DSL modem; always connected.
You can also use the VPN Client on a PC with a direct LAN connection.

Monday, March 12, 2012

how to IPSec tunnel endpointsare the VPN client

In an end-to-end VPN, the IPSec tunnel endpointsare the VPN client and the enterprise VPN gateway.This means, as shown in Figure 2, that the innerIP header, the transmission control protocol (TCP)header, and the application payload are not visible atthe IPSS. The IPSS is simply a router that routes packets based on the destination IP address on the outer IPheader. Thus, the IPSS cannot provide any valueadded services to client sessions.In a network-based VPN, there are two IPSec tunnels, one from the VPN client to the IPSS and anotherfrom the IPSS to the enterprise VPN gateway. When apacket is received at the IPSS, the IPSS decrypts theinner IP header, the TCP header, and the applicationpayload. These data are now available in the clear atthe IPSS, as shown in Figure 3. The packet is thenencrypted and put in an IPSec tunnel to the VPN gateway. The aggregation of traffic on IPSec tunnels frommultiple clients onto one IPSec tunnel to the VPNgateway is itself a value-added service provided bythe IPSS. In addition, by using information containedin the headers and the payload, the IPSS can provideother value-added services to the client session; theseare described in the next section. The overhead incurred in providing these services is the cost of thedecryption and encryption of packets at the IPSS

VPN over WDM

In the context of future optical networks, providing qualityof service is one of the critical research issues. Traditionaloptical networks such as synchronous optical networks/synchronous digital hierarchy (SONET/SDH) have beenperceived as high transmission rate networks withoutproviding any QoS to different traffic flows. Recently,some attention has been given to coarse-grain QoS usingdifferentiated optical services [5], and hierarchical scheduling for two classes of traffic in [6]. Some designs for offlineVPN have been proposed in [3, 4]. However, little researchwork has considered providing online VPN on opticalnetworks. By applying the virtual private network conceptto WDM, we explore in this paper how fine-grained QoSfor dynamic VPN traffic may be provided.

Sunday, March 11, 2012

Outsourcing Issues and Challenges Facing CEOs and CIOs: JITCAR JITCA

Outsourcing means getting a service performed outside of the focal firm utilizing the global ICT infrastructure for back and forth communication and delivery of service. The two primary types of outsourcing are: IT Outsourcing or ITO and Business Process outsourcing or BPO. Outsourcing results in exporting of white collar jobs. When blue collar work went to countries like China and Japan and South Korea in the 1980sit was called exporting of blue collar jobs and not outsourcing. Outsourcing in its myriad forms and shapes is here to stay. Companies, large, medium size and small, cannot survive without some outsourcing. ITO includes outsourcing of systems development (designing, coding, testing etc.) and systems maintenance. BPO includes diverse business as well as non-business functions like accounting, call centers, film cartoons and animation, financial analysis, human resources management, legal work, radiology analysis, taxes filing, tutoring etc. In terms of location of outsourcing, it can be on shore, near shore, off shore, or far shore.

Special issues of leading journals are being devoted to the phenomenon of outsourcing: JITCA/JITCAR has had 4 issued on this topic, and an upcoming issue of MISQ will be devoted to offshoring. Several conferences and shows focus on bringing together diverse stakeholders of outsourcing under one roof for knowledge sharing and networking: annual international outsourcing conferences organized by the center for global outsourcing, world outsourcing summits organized annually by Corbett Associates, HRO shows organized annually, periodic conferences organized by Outsourceworld in USA and Europe and others based in Europe, Russia, India etc. To summarize, in the words of Dr. Joseph O. Okpaku, "outsourcing, which epitomizes the quintessence of true globalization, with services being provided where they can most efficiently and economically be produced and delivered where they are most needed and valued, is a reality that is fast becoming the permanent feature of the global economic context."

PREDICTIONS ABOUT GLOBAL OUTSOURCING

The following predictions speak volumes about the size and scope of global outsourcing:

1. IDC estimates the global BPO market will grow to $1.2 trillion in 2006, up from $300 billion in 2004, with both U.S. and European companies planning to outsource businesses, accounting for nearly 23% of their revenues versus 5% today.

2. According to Gartner Inc. and IDC, the market for offshore IT services will more than double from about 3% of overall IT services spending in 2005 to between 6% and 7% of overall spending within the next three years. Gartner expects offshore IT services spending to reach $50 billion by 2007. IDC analysis anticipates that the worldwide IT outsourcing market will grow to $18 billion by 2008, at an annual compound growth rate of 20%.

3. By 2008, nearly one-quarter of U.S. spending on application development, integration and management services will go to offshore providers, according to IDC.

4. In its Global Economics report, Goldman Sachs has created a scenario where over the next 50 years, Brazil, Russia, India and China could become much larger forces in the world economy. In fact, in less than 40 years, some emerging economies could become larger than the G6 in U.S. dollar terms. The report goes on to state that by 2025, they could be more than half the size of the G6. Of the current G6, only the U.S. and Japan may be among the six largest economies in U.S. dollar terms in 2050.

5. By 2008, the Global Insight report concludes, IT offshoring will account for roughly $125 billion in additional U.S. gross domestic product annually, a $9 billion jump in real U.S. exports, and, most important, net 317,000 new jobs in the United States. By 2015, the amount will be increased to $250 billion.

6. More than 80% of the major global multinational corporations will have an offshore presence by the end of 2005.

7. The Foresight Exchange published the claim in Future of IT Jobs that if futures markets trade above $0.50, then there will be more IT jobs in America in 2012 than there were in 2000.

8. After surveying IT services vendors, IDC reported that the offshore component in delivery of U.S. IT services might rise as much as 23% by 2007, up dramatically from 5% in 2003.

View Image - Table 1: Nine Generic Issues Facing CEOs and CIOs

CRITICAL OUTSOURCING ISSUES FACING CEOs AND CIOs

Given the predictions for phenomenal increases in outsourcing and offshoring on the world landscape, it is imperative that the MNCs as well as SMEs start paying attention to the critical outsourcing issues facing CEOs and CIOs.

A structured Delphi iteration approach was used during July-August, 2005 to generate a list of rank ordered outsourcing issues facing CEOs and CIOs of client companies. Companies represented in this study are: BAE Systems, GSA Federal Technology, Herbalife International, MacDonald Corporation, MFXchange, Montgomery Chamber, Prudential Financial, Sate of Maryland, World Bank, and The Hawthorne Press Inc. Nine generic issues generated in the first iteration are described in Table 1 on the previous page.

These nine issues have been summarized in Table 2.

View Image - Table 2: Nine Summarized Issues Facing CEOs and CIOs

In the second iteration, each research participant was asked to rank order the above nine issues in order of importance to them for present and the near future. Based on mean rank received by each issue from the research participants, rank ordered issues are depicted in Table 3.

View Image - Table 3: Six Rank Ordered Issues Facing CEOs and CIOs

Rank One - Evaluating Cost Effectiveness of outsourcing onshore and offshore

Cost savings and labor arbitrage opportunity are largely driven by country decision rather than vendor decision (Vashishtha & Vashishtha, 2005; Palvia S., 2004). For a US based outsourcing organization (outsourcer), the cost savings due to wages can be as high as 70% when outsourced to India/China or as high as 40% when outsourced to Ireland/Canada. However, other costs pertaining to setup, physical infrastructure differences, travel, extra training to help in communication due to language and culture differences, must be factored in. Carmel and Tija (2005) also talk about costs related to technology transfer, overhead, governance, and risk mitigation. Robinson and Kalakota (2005) estimate these additional offshoring costs to be about 40% for India/China thus bringing the net cost advantage to only 30%. Sometimes outsourcing within the country may be better, considering all tangible and intangible costs of offshoring. Vashishtha and Vashishtha (2005) recommend looking at the Total Cost of Outsourcing rather than the savings due to wage differences. Outsourcing per se is meant to provide cost advantage as well as improvement in quality and value of the services. In case of on-shoring, the cost basis of internal and external operations is similar; so any cost advantage is only due to leveraging infrastructure and other fixed costs across multiple clients. However, in both on-shoring and off-shoring, a client organization can avail of the improvement in quality and value from a vendor who utilizes best practices and state of the art technology in the particular business activity.

Rank Two - Managing Changes in Client and Vendor Organizations due to Outsourcing

Vashishta and Vashishtha (2005) devote an entire chapter to this topic under the name of The Offshore Program Management Office (PMO). Offshore PMO's functions are further described in detail under the categories of Contract Management, Financial Management, Performance Management, Relationship Management, and Resource Management. Offshoring of non-core activities to another company in another country is fraught with risks and is bound to meet with resistance from employees and managers in both client and vendor organizations. To address such resistance, according to Carmel and Tija (2005), Change Management includes implementing measures and reward systems to motivate offshoring, creating new organizational structures to support change, educating employees and selling offshoring concept internally, funding demonstration projects, and implementing least disruptive human resource policies. Besides top management support, an offshoring champion may also be needed.

Rank Three - Addressing Myriad Training Issues for Vendors and Clients

For any outsourcing, respective vendor and client organizations have their own structure, history, culture, mission, employee profile etc. When such different organizations have to work with each other on an ongoing basis for a long term, there is a need for training and education on both sides. The requirements for training multiply in the context of offshore outsourcing - since country based differences must also be taken into account to provide relevant education and training to the employees of both organizations. These difference include differences of time zones, climate, language, political philosophy, legal and regulatory regime, culture, history, systems of measurement (e.g., MKS versus FPS). Knowledge transfer is at the root of training needs for the people in two organizations that are in an outsourcing relationship. According to Carmel and Tjia (2005), the four types of knowledge that needs to be transferred (in order of increasing difficulty of training) are: skills such as programming language; process such as harmonizing methodologies between onshore and offshore sites (for examples those pertaining to differences in CMM levels); domain such as business, scientific, algorithmic and artistic; and work/domain norms such as organizational and national culture.

Rank Four - Addressing Security Threat and Intellectual Property Protection Concerns

Data security measures take time to be understood and implemented by offshore locations. Software piracy is a legitimate concern. There are no stringent laws for intellectual property protection. Stipulations should be clearly laid out in terms of client organization's classification of the sensitiveness of various information and expected level of protection by the vendor organization. All the data that is exchanged between the client and vendor should be encrypted and relayed through a secure VPNconnection. Executives attempt to weigh cost savings against risks - "We are debating if the offshore cost savings are worth the intellectual property security risks." (Tedesco, 2004). When software and materials are written in the vendor country and then used in other countries, the laws of several countries may apply. According to Carmel and Tjia (2005), "they are like a patchwork quit, with holes." World Trade Organization - Trade Related Intellectual Property Rights (WTO-TRIPs) establish minimum standards for IP protection for the member states. Most businesses rely on the provisions of applicable international treaties and contracts to protect intellectual property.

Rank Five: Managing Across Geographical Distances, Time Zones, Cultural Differences, and Language Differences

Carmel and Tjia (2005) cover two chapters on these issues titled Overcoming Distance and Time; and Dealing with Cross-Cultural Issues. To manage distance barriers, they talk about the five centrifugal forces that make distributed software work difficult: cohesion barriers, control breakdown, coordination breakdown, communication breakdown, and culture clash. To overcome these problems, they articulate eight practical principles based on the dictum: Formalize much of what is often informal and put more effort into creating informalisms. To manage time differences due to differences in time zones, starting and ending times at work, religious and national holidays, weekends, lunch and other break hours, Carmel and Tjia (2005) describe several asynchronous, synchronous, and awareness tactics. They also recommend the use of appropriate collaborative technologies for managing distance and time differences.

In terms of managing cultural and language differences, Carmel and Tjia (2005) go in detail to articulate the differences and then the strategies to deal with these differences. They summarize nine orientations according to (formulated by Hofstede, Hall and other social scientists): power, relationship, uncertainty, future, time, communication, destiny, universalist, and information processing. They also cite several examples of failure in cross-cultureal communication and in language. Finally, they suggest several steps to improve cross-cultural communication. Vashishtha and VAshishtha (2005) suggest additional investment in employee training including immersion in poular culture (TV shows, movies, sports etc.) to help in bridging the cultural gap.

Rank Six: Managing Failure of Outsourcing

In case of failure of an outsourcing relationship, it is best to spell out in the original Service Level Agreement (SLA) mutually agreed steps to disengage from the relationship in a smooth manner. This is very much akin to spouses in a marriage relationship signing a pre-nuptial agreement. What are the options for the client in case of a failure? The options are find another vendor, or smoothly shift to the backup vendor. Another approach can be to have a portfolio of outsourcing vendors, so that in case of failure with one vendor, other vendors can take up the additional work at least on a temporary basis.

Monitoring Device Safety in Interventional Cardiology

Headnote
Abstract Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.

Design: The Web-based Data Extraction and Longitudinal Time Analysis (DELTA) system imports clinical data in real-time from an electronic database and generates alerts for potentially unsafe devices or procedures. The statistical techniques used are statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS).

Measurements: We selected in-patient mortality following implantation of the Cypher drug-eluting coronary stent to evaluate our system. Data from the University of Michigan Consortium Bare-Metal Stent Study was used to calculate the event rate alerting boundaries. Data analysis was performed on local catheterization data from Brigham and Women's Hospital from July 1, 2003, shortly after the Cypher release, to December 31, 2004, including 2,270 cases with 27 observed deaths.

Results: The single-stratum SPC had alerts in months 4 and 10. The multistrata SPC had alerts in months 5, 10, and 18 in the moderate-risk stratum, and months 1, 4, 7, and 10 in the high-risk stratum. The only cumulative alerts were in the first month for the high-risk stratum of the multistrata SPC. The LR method showed no monthly or cumulative alerts. The BUS method showed an alert in the first month for the high-risk stratum.

Conclusion: The system performed adequately within the Brigham and Women's Hospital Intranet environment based on the design goals. All three cumulative methods agreed that the overall observed event rates were not significantly higher for the new medical device than for a closely related medical device and were consistent with the observation that the initial concerns about this device dissipated as more data accumulated.

J Am Med Inform Assoc. 2006;13:180-187. DOI 10.1197/jamia.M1908.

Minimizing harm to patients and ensuring their safety are cornerstones of any clinical research effort. Safety monitoring is important in every stage of research related to a new drug, new medical device, or new therapeutic procedure. This type of monitoring of medical devices, under the auspices of the U.S. Food and Drug Administration (FDA), has undergone major changes over the past several decades.1-4 These changes have largely been due to a small number of highly publicized adverse events.5-13 The FDA's task is complex; the agency regulates more than 1,700 types of devices, 500,000 medical device models, and 23,000 manufacturers.3'6'14"18 In premarketing clinical trials, rare adverse events may not be discovered due to small sample sizes and biases toward healthier subjects.19 The FDA must balance this concern with the need to deliver important medical advances to the public in a timely fashion. In response to this, the FDA has shifted some of its device evaluation to the postmarket period, allowing new devices to reach the market sooner.2 This creates the potential for large numbers of patients to be exposed to a new product in the absence of long-term follow-up data and emphasizes the need for careful and thorough postmarketing surveillance.21

The current FDA policies in this area include a heterogeneous mix of voluntary and mandatory reporting.1,6'14'15,17,19'22-24 Voluntary reporting of adverse events creates limitations in significant event-rate recognition through underreporting bias, and highly variable reporting quality.25 Several state and federal agencies have implemented mandatory reporting for medical devices for specific clinical areas, and national medical societies are making strides to standardize data element definitions and data collection methods within their respective domains.26'27 Continued improvements in the quality and volume of reported data have created opportunities for timely and efficient analysis and reporting of alarming trends in patient outcomes.

Nonmedical industries (Toronado, HGL Dynamics, Inc., Surrey, GU; WinTA, Tensor PLC, Great Yarmouth, NR) have been using a variety of automated statistical process control (SPC) techniques for quality control purposes for many years.28"30 These systems rely on automated data collection and use standard SPC methods of varying rigor.31 However, automated SPC monitoring has not been widely deployed in the medical domain due to a number of constraints: (a) historically, automated data collection could usually only be obtained for objective data such as laboratory results and vital signs; (b) much of the needed information about a patient's condition is subjective and may be available only in free text in the medical record; and (c) medical source data, due to heterogeneity of clinical factors, typically has more noise than industrial data, and standard industrial SPC metrics may not be directly applicable to medical safety monitoring.

Within the medical domain, the most closely related clinical systems that have been developed to date are those in clinical trial monitoring for new pharmaceuticals. A variety of software solutions (Clinitrace, Phase Forward, Waltham, MA; OracleAdverse Event Reporting System [AERS], Oracle, Redwood Shores, CA; Trialex, Meta-Xceed, Inc., Fremont, CA; Netregulus, Netregulus, Inc., Centennial, CO) have been created to monitor patient data relevant to these trials. These systems rely on standard SPC methodologies and can provide real-time data monitoring and analysis through internal data standardization and collection for the trial. However, the focus of these systems is on real-time data aggregation and reporting to the FDA.

The increasing availability of detailed electronic medical records and structured clinical outcomes data repositories may provide new opportunities to perform real-time surveillance and monitoring of adverse outcomes for new devices and therapeutics beyond the clinical trial environment. However, the specific monitoring methodologies that balance appropriate adverse event detection sensitivity and specificity remain unclear.

In response to this opportunity, we have developed the Data Extraction and Longitudinal Time Analysis (DELTA) system and explored both standard and experimental statistical techniques for real-time safety monitoring. A clinical example was chosen to highlight the functionality of DELTA and to provide an overview of its potential uses. Interventional cardiology was chosen because the domain has a national data field standard,32 a recent increase in mandatory case reporting from state and federal agencies, and recent device safety concerns publicized by the FDA.

Methods

System General Requirements

The DELTA system was developed to provide real-time monitoring of clinical data during the course of evaluating a new medical device, medication, or intervention. The system was designed to satisfy five principal requirements. First, the system should accept a generic data set, represented as a flat data table, to enable compatibility with the broadest possible range of sources. second, the system should perform both prospective and retrospective analyses. Third, the system should support a variety of classical and experimental statistical methods to monitor trends in the data, configured as analytic modules within the system, allowing both unadjusted and risk-adjusted safety monitoring. In addition, the system should support different methodologies for alerting the user. Finally, DELTA should support an arbitrary number of simultaneous data sets and an arbitrary number of ongoing analyses within each data set. That is, DELTA should "track" multiple outcomes from multiple data sources simultaneously, thus making it possible for DELTA to serve as a single portal for safety monitoring for multiple simultaneous analyses in an institution.

Source Data and Internal Data Structure

A flat file representation of the covariates and clinical outcomes serves as the basis for all analyses. In addition, a static data dictionary must be provided to DELTA to allow for parsing and display of the source data in the user interface. Necessary information includes whether each field is going to be treated as a covariate or an outcome and whether it is discrete or continuous.

The system uses an SQL 2000 server (Microsoft Corp., Redmond, WA) for internal data storage, importing all clinical data and data dictionaries from source databases at regular time intervals. This database also stores system configurations, analysis configurations, and results that are generated by DELTA at the conclusion of a given time period. The user interface is Web-based and uses a standard tree menu format for navigation. DELTA'S infrastructure and external linkages are shown in Figure 1.

Security of patient data is currently addressed through record de-identification steps32 performed to the fullest extent possible while maintaining the necessary data set granularity for the risk adjustment models. The system is hosted on the Partners Healthcare Intranet, a secure multihospital network, accessible at member sites or remotely through a virtual private network.

Statistical Methods

DELTA uses a modular approach to statistical analysis that facilitates further expansion. DELTA currently supports three statistical methodologies: statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS). Discrete risk stratification is supported by both SPC and BUS. Periodic and cumulative analysis of data is supported by SPC and LR, and only cumulative analysis is supported by BUS.

Risk Stratification

Risk stratification is a process by which a given sample is subdivided into discrete groups based on predefined criteria. This process is used to allow providers to quickly estimate the probability of an outcome for a patient. Statistically, the goal of this process is to create a meaningful separation in the data to allow concurrent and potentially different analyses to be performed on each subset. Criteria are selected based on prior data, typically derived from a logistic regression predictive model, and the relative success of this stratification can be determined by a stepwise increase in the incidence of the outcome in each risk group. The LR method does not offer discrete risk stratification because it incorporates risk stratification on a case level.


Data Aggregation

Retrospective data analyses traditionally use the entire data set for all calculations. However, in real-time data analysis, it is of interest to monitor both recent trends and overall trends in event rates. Evaluation of recent trends will intrinsically have reduced power, because of the reduced sample size, to detect true, significant shifts in event rates.

However, such monitoring may serve as a very useful "first warning" indicator when the cumulative event rate may not yet cross the alerting threshold. This type of alert is not considered definitive but can be used to encourage increased monitoring of the intervention of interest and heighten awareness of a potential problem. In DELTA, these recent data analyses are termed periodic and can be configured to be performed on a monthly, quarterly, or yearly basis.

Statistical Process Control

Statistical process control is a standard quality control method in nonmedical industrial domains. This method compares observed event rates to static alerting boundaries developed from previously published or observed empirical data. Each industry typically requires different levels of rigor in alerting, and selection of confidence intervals (CIs) (or number of standard errors) establishes this benchmark. In the medical industry, the 95% CI is considered to be the threshold of statistical improbability to establish a trite difference. In DELTA, the 95% CI of proportions by the Wilson method is used to calculate the alerting boundaries for all statistical methods.33 The proportion of observed events is then compared to these static boundaries, and alerts are generated if they exceed the upper CI boundary. DELTA'S SPC module is capable of performing event rate monitoring on multiple-risk strata provided that criteria for stratification and benchmark event rates are included for each risk stratum. This method supports comparison of benchmark expected event rates with cumulative and periodic observed event rates.

While simple and intuitive, the SPC methodology does not support case-level risk adjustment. It is also dependent on accurate benchmark data, which may be limited for new procedures or when existing therapies are applied to new clinical conditions.

Logistic Regression

Logistic regression34 is a nonlinear modeling technique used to provide a probability of an outcome on a case-level basis. Within DELTA, the LR method allows for continuous risk-adjusted estimation of an outcome at the case level. The LR model must be developed prior to the initiation of an analysis within DELTA and is mostly commonly based on previously published and validated models.

Alerting thresholds are established by using the LR model's expected mortality probability for each case. These probabilities are then summated in both periodic and cumulative time frames to determine the 95% CI of the event rate proportion by the Wilson method. Alerts are generated if the observed event rate exceeds the upper bounds of the 95% CI of a given boundary. This method provides accommodation for high-risk patients by adjusting the alerting boundary based on the model's expected probability of death. This can be very useful when outcome event rates vary widely with patient comorbidities. A limitation of this method is that the alerts become dependent on the discrimination (measure of population prediction accuracy) and calibration (measure of small group or case prediction accuracy) of that model.

Bayesian Updating Statistics

Bayesian updating statistics is an experimental methodology pioneered in non-health care industries.35 This method incorporates Bayes' theorem36 into a traditional SPC framework by using prior observed data to evolve the estimates of risk. Alerting boundaries are calculated by two methods, both of which are considered cumulative analyses only. The first method includes previous current study data with the prior data used in the SPC method to calculate the 95% CI of the event rate proportion by the Wilson method. This means that the alerting boundary shifts during the course of realtime monitoring due to the influence of the earlier study data.

The other alerting method is based on the evolution of the updated risk estimates represented as probability density functions (PDFs). In each period, a new PDF is generated based on the cumulative study event rate and baseline event rate. Alerting thresholds are generated by the user specifying a minimum percentage of amount of overlap of the two distributions (by comparison of central posterior intervals).37 The first comparison PDF is the initial prior PDF, and the second is the previous period's PDF. BUS supports discrete risk stratification.

This method was included in DELTA because it tends to reduce the impact of early outliers in data and complements the other monitoring methods used in the system. It also may be particularly helpful in situations in which limited preexisting data exist. However, the method is dependent on accurate risk strata development and on the methods used for weighting of the prior data in the analysis.

User Interface

The user interface is provided via a Web browser and was developed in the Microsoft.NET environment, running Microsoft US 5.0 Web Server (Microsoft Corp.). Each data set is represented as a separate folder on the main page, and all analyses for that set are nested under that folder (Fig. 2). At the initiation of an analysis, the user designates the analysis period and starting and stopping dates and selects the statistical module and the outcome of interest. Data filters can be applied to restrict the candidate cases for analysis. Covariates used for risk stratification are selected. Last, periodic and cumulative alerts for the statistical method selected can be activated or suppressed based on user preferences. An analysis configuration can be duplicated and modified for convenience in configuring multiple statistical methods to concurrently monitor a data source.


The results screen of DELTA serves as the primary portal to all tables, alerts, and graphs generated from an analysis. Tabular and graphical outputs of the data and specific alerting thresholds by risk strata are available, and an export function is included to allow researchers to perform further evaluation of the data.

Clinical Example

As an example of the application of DELTA to real-world data, an analysis of the in-hospital mortality following the implantation of a drug-eluting stent was performed. The cardiac catheterization laboratory of Brigham and Women's Hospital has maintained a detailed clinical outcomes database since 1997 for all patients undergoing percutaneous coronary intervention, based on the American College of Cardiology National Cardiovascular Data Repository data elements.32

For risk stratification, the University of Michigan risk prediction model38 was used since it provides a concise method of comparing all three of DELTA'S statistical methods using one reference for previous experience. The previous experience of event rates for all risk strata from this work is listed in Appendix 1. A logistic regression model with risk stratification scores is listed in Appendix 2. The logistic regression model developed from the data was used to create a discrete risk scoring model. Based on the mortality of patients in the study sample at various risk scores, these data were divided into three discrete risk categories, and the compositions of those categories are listed in Appendix 2.

A total of 2,270 drug-eluting stent cases were performed from July 1, 2003, to December 31, 2004, at our institution, and the outcome in terms of in-hospital mortality was analyzed. These data were retrospectively evaluated in monthly periods for each of the three statistical methodologies. There was a total of 27 observed deaths (unadjusted mortality rate of 1.19%) during the study. Local institutional review board approval was obtained. Risk stratification of these cases by the University of Michigan model is listed in Table 1 and demonstrates increasing in-hospital mortality risk with 0%, 0.9%, and 23% mortality risk in the low-, medium-, and high-risk strata, respectively.

An alternative data set was generated by taking the clinical data above and changing the procedure date from the eight cases with the outcome of interest in the last five periods. The procedure dates were changed by random allocation into one of the first 13 periods. The duration of the monitoring was then shortened to 13 periods. This was done to illustrate alerts when cumulative event rates clearly exceeded established thresholds. The overall event rate for this data set is 1.71% (27/1,583), and the risk stratified event rates were 0% (0/446), 1.3% (14/1,095), and 31% (13/42) for the low-, medium-, and high-risk strata, respectively.


Results

Statistical Process Control

Single Risk Stratum

The single risk stratum SPC was configured with no risk stratification covariates. The static alert boundary was a 2.07% (upper 95% CI of 100/5,863). Periodic evaluations ranged from 0% to 4.5%. Period 4 exceeded the boundary with a 3.4% (5/148) event rate and period 10 with a 4.5% (5/110) event rate. Cumulative event rates ranged from 0.9% (2/ 213) to 1.7% (10/587). No cumulative evaluations had an event rate that exceeded the boundary. The cumulative evaluation is depicted graphically in Figure 3.

Periodic evaluations of the alternative data set ranged from 0% to 4.7%. Period 4 exceeded the boundary with a 4.7% (7/150) event rate, period 7 with a 2.6% (3/117) event rate, period 8 with a 2.6% (3/117) event rate, and period 10 with a 4.5% (5/110) event rate. Cumulative event rates ranged from 0.9% (2/213) to 2.4% (12/490). Periods 4 through 11 had event rates exceeding the 2.07% threshold and generated alerts and ranged from 2.1% to 2.4%.

Multiple Risk Strata

Alerting thresholds were calculated for the low-, medium-, and high-risk strata by using the upper 95% CI of the proportion of the event rates of each stratum in the University of Michigan data. The thresholds were 0.3% (1/1,820), 1.7% (50/ 3,907), and 44% (49/136), respectively.


There were no events in the low-risk stratum, and no alerts were generated. In the moderate-risk stratum, the periodic observed event rates ranged from 0% to 2.7%. The alerting boundary was exceeded with rates of 2.7% (2/75) in period 5, 2.6% (2/78) in period 10, and 1.9% (2/108) in period 18. The cumulative observed event rates ranged from 0.7% to 1.3% and never exceeded the upper alert boundary. In the high-risk stratum, the periodic observed event rates ranged from 0% to 100%. The alerting boundary was exceeded with rates of 100% in periods 1 (1/1), 7 (1/1), and 10 (3/ 3), and by a rate of 50% (4/8) in period 4. The cumulative observed event rates ranged from 16.7% to 100%. The alerting boundary was exceeded by a rate of 100% (1/1) in period 1.

Evaluation of the alternative data set was performed periodic and cumulative alerts. There were no events in the low-risk stratum, and no alerts were generated. In the moderate-risk stratum, the periodic observed event rates ranged from 0% to 3.6%. The alerting boundary was exceeded with rates of 3.6% (3/84) in period 3, 2.1% (2/95) in period 4, 2.7% (2/ 75) in period 5, 2.5% (2/81) in period 7, and 2.6% (2/78) in period 10. The cumulative observed event rates ranged from 0.7% to 2.0% and exceeded the alerting boundary in periods 3 through 11. In the high-risk stratum, the periodic event rates ranged from 0% to 100%. The alerting boundary was exceeded with rates of 100% in periods 1 (1/1), 7 (1/), and 10 (3/3) and by a rate of 55.6% (5/9) in period 4. The cumulative observed event rates ranged from 16.7% to 100%. The alerting boundary was exceeded by a rate of 100% (1/1) in period 1.

Logistic Regression

Alerting thresholds were calculated on a periodic basis using the expected probability of death for the cases in their respective periods, and the 95% upper CI ranged from 4.9% (1.02/ 112) to 7.1% (2.51/110). Cumulative-based upper alerting boundaries ranged from 2.3% (29.86/1,835) to 5.7% (1.66/ 115). The overall expected cumulative event rate was 1.75% (39.7/2,270).

Periodic event rates ranged from 0% to 4.5%, and no alerts were generated. The two highest periodic event rates of 3.4% (5/148) in period 4 and 4.5% (5/110) in period 10 had upper alerting boundaries of 5.8% (2.98/148) and 7.1% (2.51/110), respectively. Cumulative event rates ranged from a 0.9% (2/213) to 1.7% (10/587) event rate, and the cumulative upper 95% CI was well above the observed event rate throughout the evaluation and shown in Figure 4.

Alerting thresholds for the alternative data set based on the upper 95% CI ranged from 4.9% (1.02/112) to 7.5% (3.2/ 117) in the periodic analysis and from 2.6% (28.17/1,583) to 5.7% (1.66/115) in the cumulative analysis. The overall expected event rate was 1.78% (28.17/1,583).

Periodic event rates ranged from 0% to 4.7%, and no alerts were generated. The two highest periodic event rates of 4.7% (7/150) in period 4 and 4.5% (5/110) in period 10 had upper alerting boundaries of 6.2% (3.56/150) and 5.1% (2.51/110). Cumulative event rates ranged from 0.9% (2/ 213) to 2.4% (12/490) and were well below the alert boundaries through the evaluation.


Bayesian Updating Statistics

The upper alert boundary varied from 0.2% to 0.3%, from 1.5% to 1.7%, and from 40.2% to 44.4% in the low-, medium-, and high-risk strata, respectively. From all strata, the only alert generated was in the high-risk stratum period 1 with an observed event rate of 100% and an upper alert boundary of 44.4% (49/136).

There was a trend toward lower event rates in the PDFs of all risk strata, as illustrated for the high-risk stratum cases in Figure 5. At no time in any strata did the posterior CI overlap fall below the user-specified 80% criteria.

The upper alert boundaries in the alternative data set were the same as the real data set. However, in the moderate-risk stratum, the observed event rates of 1.73% (4/231) in period 3, 1.84% (6/325) in period 4, 2.0% (8/400) in period 5, 1.73% (10/576) in period 7, and 1.71% (14/818) in period 10% exceeded the alert boundaries that ranged from 1.65% to 1.74% for those periods.

The trend toward lower event rates in the PDFs of all risk strata in the real data set was not found in the alternative data set. At no time in any strata did the posterior CI overlap fall below the user-specified 80% criteria.

Discussion

The DELTA system satisfied all prespecified design requirements and performed all analyses and graphical renderings within two seconds each on the hospital Intranet.


The SPC method triggered periodic alerts in both single- and multiple-risk strata analyses. This method also triggered the first period's cumulative alert in the multiple-risk strata, but this can be considered a periodic equivalent alert. Otherwise, there were no cumulative event rate alerts detected by the SPC method. The LR method generated no alarms in either the periodic or cumulative evaluations. The BUS method generated an alert only in the first period of the high-risk stratum. While all BUS alerts are considered cumulative, the alert was generated from one case with a positive outcome for that period.

The alternative data set event rate was elevated manually to generate alarms. The single stratum SPC method alerted to event rates exceeding the threshold for periods 4 through 11. The multistrata SPC method revealed that the event rate increase of concern was in the moderate-risk group, alerting from periods 3 through 11. The LR method generated no periodic or cumulative alerts in the alternative data set. The BUS method agreed that the elevation was primarily of concern in the moderate-risk stratum by generating cumulative alerts in periods 3, 4, 5, 7, and 10.

Periodic alerts are very sensitive measures of elevated event rates but generally lack the statistical power to make a conclusive decision about the safety of a device. These alerts would serve to heighten surveillance and possibly reduce the interval of evaluation for the new device but would not, in and of themselves, be sufficient to recommend withdrawal of the device. The discrepancy between SPC and LR periodic alerting was because LR attempts to adjust the alerting threshold based on the expected outcome of a given case. If there were an increase in the event rate for a period, SPC would trigger an alert as the rate exceeds the static threshold. However, if the LR model expected the cases to have that outcome, then the method would likely not alert because the alert threshold would be adjusted based on that expectation. The cumulative alerts for this analysis were consistent across statistical methods, and the alerts in the first period were due to a very low number of examined cases. In the alternative set, the LR method has no cumulative alerts, and this could be due to the fact that the events were expected by the model.

In phase 3 randomized controlled trials, there are no previous data to use as a benchmark, and a common method of determining the threshold of stopping the trial is to initially place the threshold at a very statistically improbable number (such as five or six standard errors from an estimated allowable rate) and gradually reduce the allowable error as the volume of data grows. The allowable rates are generally established by expert consensus and are manually generated on a trialby-trial basis.

The benefits of incorporating previous information into the development of alerting thresholds include the ability to develop and establish explicit rules for alerting thresholds. This methodology could then be applied in an objective manner to a wide variety of monitoring applications. This removes the need for an expert consensus to develop the thresholds.

However, this objective methodology has limitations. The accuracy of the alerting boundaries is dependent on the source data. In the case of this clinical example, the University of Michigan Bare-metal Stent Study mortality data and model were established as the benchmark. DELTA then considered mortality event rates statistically significantly above that baseline to be abnormal and of concern. This becomes important when assessing the external validity of the benchmark data with regards to applicability in a different patient population. In addition, applying multiple concurrent statistical methodologies to a monitoring process is meant to guard against specific vulnerabilities that one methodology might have to these types of confounding.

Statistical process control is only concerned with the overall event rate in the benchmark source population to establish alerting boundaries, and these are static throughout the analysis. This is the least sensitive to subpopulation variations between the study and baseline populations. Including multiple-risk strata in the analysis increases the sensitivity to finding problems in a specific risk group but requires the user to ensure that the study subpopulations using the risk stratification criteria are representative of the source subpopulations. Similar proportions and relative event rate risks between the source data and study data support the use of stratification in this clinical example.

Logistic regression is the most susceptible method to population differences because it provides a case-level estimation based on a number of risk factors. In a number of studies, these models have degraded predictive ability at the case level in disparate populations and as the time from the model's development increases.39 In the example, the population's event rate was 1.19% and the LR model's expected event rate was 1.75%. This shows that the LR model overpredicted mortality for this population.

Bayesian user statistics carries many of the same benefits and drawbacks of using the aggregate source population's event rate to establish alerting thresholds but allows for the movement of these thresholds by changing study event rates. This method is the most capable in determining a significant shift in a short period of time.

Overall, the results of the example analysis support that the in-hospital mortality following implantation of a drug-eluting stent was acceptably low over the time period studied when compared with the University of Michigan Bare-metal Stent Study benchmark data. The prototype system currently in use at Brigham and Women's Hospital Cardiac Catheterization Laboratory is in a testing and evaluation phase, and as such, clinicians do not consult the system directly. An evaluation of the current user interface will be conducted to assess DELTA'S acceptability in the clinical environment by different health care providers. However, the preliminary results of our testing are encouraging: the DELTA system shows promise in filling a need for automated real-time safety monitoring in the medical domain and may be applicable to routine safety monitoring for hospital quality assurance and monitoring of new drugs and devices.

References
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Further Readings

1. Medical device and user facility and manufacturer reporting, certification and registration; delegations of authority; medical device reporting procedures; final rules. Fed Regist. 1995;60:63577-606.

2. Postmarket surveillance. Final Rule. Fed Regist. 2002;67:5943-42.

3. Center for Devices and Radiologie Health Annual Report Fiscal Year 2000. January 2001. Accessed at http://www.fda.gov/cdrh/ annual/fy2000/annualreport-2000-5.html on January 18,2005.

4. Cook DF. Statistical Process Control for continuous forest products manufacturing operations. Forest Products Journal. 1992; 42(7/8):47-53.

5. Grigg N, Walls L. The use of statistical process control in food packaging: preliminary findings and future research agenda. British Food Journal. 1999;101(9):763-84.

6. Tornado, HGL Dynamics, Inc. Surrey, GU.

7. US DOT Federal Railroad Administration. Developed Wheel and Axle Assembly Monitoring System for Improved Passenger Train Safety. RROO-02 March 2000.

8. WinTA, Tensor PLC, Great Yarmouth, NR.

9. Clinitrace, Phase Forward, Waltham, MA.

10. OracleAdverse Event Reporting System (AERS), Oracle, Redwood Shores, CA.

11. Trialex, Meta-Xceed, Inc., Fremont, CA.

12. Netregulus, Netregulus, Inc., Centennial, CO.