News about CV Outcomes, Inc.

KCCQ Approved by FDA for Regulatory Submissions for Heart Failure Medical Devices

In a crucial endorsement of the validity and reliability the KCCQ, the US Food and Drug Administration has qualified the KCCQ to be used by medical device companies to support regulatory submissions for heart failure medical devices. Sponsor/investigators may use KCCQ data to establish safety and effectiveness of such devices. As detailed in the FDA annoucement, KCCQ scale scores “can be used as a component of a composite primary endpoint or secondary endpoint in a feasibility or pivotal clinical trial evaluating heart failure medical devices. The instrument can be used in superiority and non-inferiority trials evaluating out­ patients or in-patients with heart failure syndrome. For in-patient studies, post-discharge outcomes could be helpful to define the health status benefits of treatment.”

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CV Outcomes Web Site Updated

We have just updated and improved our web site. In addition to obvious cosmetic changes to the user interface, we have simplified and focused the information design. We hope that this makes it easier for visitors to the public portions of the site to find the information they need quickly.

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Shortened Version of SAQ Now Available

On September 2, 2014, Circulation: Cardiovascular Quality and Outcomes published the development of the 7-item SAQ. This shortened version of the SAQ reduces the scale from 19 to 7 items. While it does not collect the Angina Stability or Treatment Satisfaction scale, it produces extremely valid, reliable and sensitive measures of the Angina Frequency, Physical Limitation and Quality of Life domains, along with a new Summary Score. While some studies may prefer the additional domains in the full version, the shortened version markedly decreases respondent burden and is more practical for routine clinical care – a key direction for patient-reported outcomes measures, as cited in an accompanying editorial.

New CV Outcomes Web Site Now Up and Running

You have reached our new, upgraded web site for CV Outcomes. We hope you find the changes to be beneficial.

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New CVO Site Arrives This Sunday 21 September

This weekend we’re moving the CVO web site to a new system and web hosting setting. Re-engineered from the ground up, our new technologies should provide some significant benefits and a better user interface. The move will cause two important points of disruption, however:

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ISP infrastructure Revision Now Complete

Update: Our conversion to a new fiber-optic network is now complete. You should see some improvement in operations. We apologize again for any inconvenience during the change-over.

Credit Card Payment Now Available Option for Instrument Licenses

We now are able to accept payment by credit card for licenses to use the SAQ, KCCQ, and PAQ plus related calculation tools. Every new invoice generated from now on will contain instructions about payment options including credit card payments.

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CVO and CORC Lead the D2B Alliance

CVO and CORC investigators are leading efforts to reduce door to balloon times through the D2B Alliance. The D2B Alliance is a national campaign of the American College of Cardiology in collaboration with the American Heart Association, the National Heart, Lung and Blood Institute, and 33 other organizations.

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KCCQ, SAQ, and PAQ Calculators Upgraded to Support Patient Results Graphing

To assist deployment of the Kansas City Cardiomyopathy Questionnaire, the Seattle Angina Questionnaire, and the Peripheral Artery Questionnaire into clinical settings, the KCCQ Calculator, SAQ Calculator, and PAQ Calculator now can extract and graph individual patient scale scores. “At the point of care, seeing a graphical trend over time of a patients functional status can be an important factor when making therapeutic decisions,” says John Spertus, MPH MD, author of the KCCQ, SAQ, and PAQ. “The upgraded Calculators makes this easy.” Further details — including screenshots — are available here.

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Turkish Versions of KCCQ and SAQ Now Available

Drs. John Spertus and Tuncay Duruoz have collaborated to produce Turkish versions of the Kansas City Cardiomyopathy Questionnaire and the Seattle Angina Questionnaire, which are now available. “Dr. Duruoz, a rheumatologist and physiatrist at the Celal Bayar University Medical School, was instrumental in translating these instruments into Turkish,” states Dr. Spertus.

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