Licensing Instruments at CV Outcomes
Detailed instructions about how to obtain our instruments and tools for use in your projects.
- What are you licensing here?
- What exactly do I get if I license the KCCQ/KCCQ-12, the SAQ/SAQ-7, or the PAQ?
- What is the difference between the regular instruments (KCCQ and SAQ) and short form versions (KCCQ-12 and SAQ-7)?
- What are these calculation tools?
- Why can’t I just license the calculation tools without the instruments?
- How do I license these items?
- There are provisions my organization would like changed in the license agreement. How do we accomplish this?
- Where do I send the License Agreement and payment on the invoice?
- How long will it take to get a license?
- How do I pay the license fees?
- What are the “currency conversion fees”?
- Why aren’t there any prices listed for any of these items?
- Do we need to share any of our data with you as our project progresses?
- What do I do with these “zip” files?
- Why am I being asked for a “registration number” when I try to open my zip files from you?
- Why do I keep getting email reminders about my license request?
- Why does the Calculator not calculate the scores?
- What is the problem with Excel compatibility and the Calculators?
- What is this “software implementation” option?
- The specific language I need isn’t in the list of available translations.
- Are all the different translations validated? How is this done?
- Why have you switched the term of my license request to one year?
- We need more translations of the instrument we have licensed. How can we get them?
- How do license renewals work?
- Can we edit the questionnaires at all — with a logo or other information?
- I’m no longer in charge of my project that licenses your stuff. What do I need to do?
- Can these questionnaires be administered by reading the questions to patients?
- Are there administration guides or manuals?
What are you licensing here?
We have developed several validated disease-specific health-related quality-of-life instruments in the cardiovascular domain. Three are available here in a wide variety of languages: the Seattle Angina Questionnaire, the Kansas City Cardiomyopathy Questionnaire, and the Peripheral Artery Questionnaire.
All versions of our instruments have been developed through an extensive forward and backward translation process by a professional linguistic firm.
You can obtain a license to use these instruments at your institution for a defined project via our online registration system. This system not only is how you apply for a license by submitting information about your intended use of the instruments, but also is how you download your items via your custom web page once your license is in force.
You can also license several convenient, reliable data processing tools that score raw patient responses into the appropriate scale scores defined by the instruments.
What exactly do I get if I license the KCCQ/KCCQ-12, the SAQ/SAQ-7, or the PAQ?
Legally, we grant you the right to duplicate, deploy, collect, analyze and publish KCCQ, SAQ, or PAQ data within your defined project. None of our licenses are blanket site licenses.
Practically, we provide you with a downloadable zip file that contains a
- a file (in PDF format—open with Adobe Reader) with the text of the instrument
- a file (also in PDF format) containing instructions how the instrument’s scales are scored from patient responses
- a “readme” file
What is the difference between the regular instruments (KCCQ and SAQ) and short form versions (KCCQ-12 and SAQ-7)?
The short form versions of these instruments have fewer questions, so the time and effort required for a patient to complete them are less than the regular instruments. The short form versions measure health status in just as valid a fashion as the regular versions, though they omit a few of the scales:
- The KCCQ has 23 questions and reports 10 scale scores: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, and Clinical Summary Score.
- The KCCQ-12 which has 12 questions and reports 5 scale scores: Physical Limitation, Symptom Frequency, Quality of Life, Social Limitation, and Summary Score.
- The SAQ has 19 questions and reports 5 scale scores: Physical Limitation, Angina Stability, Angina Frequency, Treatment Satisfaction, and Quality of Life.
- The SAQ-7 has 7 questions and reports 4 scales: Physical Limitation, Angina Frequency, Quality of Life, and Summary Score.
The choice between the regular and short form versions depends on whether for your application you need the complete, maximally-nuanced information that the regular versions provide or whether you need a simpler, more rapid data collection process. The cost of the regular and short form versions is the same.
Please note that you should select either the regular version or the short-form version. It makes no sense to try to use them both in the same study/program.
What are these calculation tools?
We offer three different optional calculation tools to automate the calculation and management of KCCQ, SAQ, and PAQ scoring. We do not “sell” them; they must be separately licensed for each project; none comes with the instruments themselves.
SAQ Calculator, KCCQ Calculator, and PAQ Calculator
These are Excel spreadsheets that provide a “form” into which you type a patient code, a date, and the patient’s raw responses to the Seattle Angina Questionnaire, the Kansas City Cardiomyopathy Questionnaire, and the Peripheral Artery Questionnaire respectively. The form restricts entered values to valid options for each question to reduce the chance of data entry errors. Once you’ve entered the data, clicking on a “Save” button transfers all the entered information plus accurately calculated scores into a new row on a second worksheet. All your patient data thus gets stored in a single “table” containing columns for the patient id, date, raw scores, and scale scores.
Beyond providing data input filtering, the Calculators also provide some very useful graphing features.
These spreadsheets thus function as simple “databases” running within the Excel spreadsheet engine. You can easily export or copy&paste data from the Calculator into other applications as neede for your purposes.
You cannot, however, modify the Calculator to add other fields, new worksheets, etc. This is to prevent users from inadvertently messing up the code that does all the work.
When you license the Calculator for a project, you get to download a zip file containing the Calculator plus a readme file.
Note finally that we have both Windows and Mac flavors of these tools because Microsoft’s implementation of Basic in Excel isn’t identical on both platforms. Choose the tool appropriate for your computer; they are not interchangeable.
SAQ SAS Code, KCCQ SAS Code, and PAQ SAS Code
These are text files (zipped along with a readme file) containing code that defines the calculations to produce scale scores from raw responses for the SAQ, KCCQ, and PAQ, respectively. This code “runs” within SAS and throws back errors if it encounters out-of-bound entries. But unlike the Calculator, it doesn’t filter data entry.
If you are already using SAS, you will know what this all means and how this works. Probably this is the tool you want, rather than the Calculator. You don’t need both, though we’re of course happy to license both if you want.
SAQ SPSS Code, KCCQ SPSS Code, PAQ SPSS Code
These are similar to the SAS Code items, but contain definitions that work within SPSS.
Why can’t I just license the calculation tools without the instruments?
The most obvious reason we only license any of the optional calculation tools as part of a license for the instruments themselves is this: until you’ve collected data via the questionnaire, you have no data to process with a calculation tool. You must license the questionnaires first. Without doing that, you will not have the appropriate version/translation of the questionnaire you need for your particular study/program.
Beyond that is a more general point. We have created the SPSS and SAS Code and the Calculator tools in order to allow licensees of our instruments an easy and reliable way to use our instruments. But at the end of the day, the fundamental intellectual properties we license to the world are the instruments themselves — the KCCQ, SAQ, and PAQ now; others to follow.
These instruments represent an investment of over $1M each in the creation and validation phases as well as our ongoing studies of clinical significance and other application-related calibrations. We license these instruments not merely to help us keep track of how they are being used, but also to help us recoup some of our costs.
Hence, if you are using the instruments, you need to license them specifically. Simply duplicating the text of the instruments from a journal article and then asking us for the scoring scheme isn’t a fair use of our intellectual property.
How do I license these items?
We have a simple, clear, step-by-step online process for this. In a nutshell, here’s what happens:
- You register at our site if you haven’t already done so; you login if you have.
- You go to the Step 1 page and proceed through a simple four-step process in which you provide us information about your project, your organization, the items you need, and then you confirm everything.
- Once you’ve submitted your request, we will review it promptly and email you any follow-up questions if necessary.
- Once everything is settled, we will approve your request and our system will send you email notifying you to return to your custom page to review the license agreement and invoice. You should print out both (two copies of the license—please sign both), and send the agreements and license fees to our address — which you’ll find in the first paragraph of your License Agreement.
- Once we’ve received the license and payment, we’ll update the status of your request to “current”. Our system will automagically notify you and you’ll be able to access and download your licensed items from your custom web page.
- If you want to modify elements of the license agreement, you can email us about your issues/concerns and we’ll work through them with you.
That’s it! Very simple and straightforward, as the many current licensees have told us.
There are provisions my organization would like changed in the license agreement. How do we accomplish this?
First, investigate whether we have previously issued a license to your organization. If so, we have already negotiated and fully-executed agreement language satisfactory to both of us. Please specify to us to which project this license applied — ideally by providing its URL in our online system, the name of the responsible contact at your end for that project, and the project name your group gave to that project. Using this information, we will locate that project in our system and will then simply copy&paste the verbiage from the prior license into the new one.
If this is your first project, or if your legal people insist on treating it that way, please follow the following steps. While we believe that our standard license agreement is reasonable and fair, we are open to negotiating over specific language. If you have specific MINOR changes you want to propose, we need you to identify clearly and unambiguously what those changes are, by following these steps:
- Bring up your license agreement from your project’s custom web page.
- Save that agreement to your local PC. There are several ways you can do this. You can simply copy&paste the agreement from your browser into Word. Or you can use the “Save Page” (or the equivalent in your browser) menu option to save the agreement onto your computer where you can then open it with Word.
- Open this local copy of the license agreement with Word.
- Edit into your local copy of the license agreement the language you want us to consider making sure that your edits are clearly marked by using the “track changes” feature so we can clearly and easily see them.
- Save the agreement with your edits and email the document to us.
- We will review your proposed changes and contact you for further discussion about them.
- All edits that are ultimately agreed upon will be placed in the canonical version of the agreement on your project’s web page. This is the version of the agreement that will then need to be printed out and signed. The Word versions are only for negotiation, not for execution.
If all else fails and you are simply unable to do any of these steps for some reason, you can email us and we will send you such a Word document. This should be necessary only in the most uncommon of situations.
Where do I send the License Agreement and payment on the invoice?
You should send two signed copies of your License Agreement and payment on the invoice to our address, which you’ll find in the first paragraph of the License Agreement.
How long will it take to get a license?
Because of our online system, we can process the initial steps nearly instantly. Even if we need to discuss aspects of your project, we can usually do this extremely quickly via email or phone calls.
One step that has proven to consume time in many cases is review by client organizations’ legal departments of the license agreement and negotiations about any modifications. Most clients haven’t found anything to modify, but even then if their organization requires formal review of the agreement, this can take quite a while.
The other wait is typically determined by how long it takes to generate payment for the license fees.
But once we have the license agreement and payment in hand, we can instantly turn on access to your licensed items. On rare occasions, our staff may get behind processing payments and returned license agreements, but we make every effort promptly to deliver access to items when we’ve received the materials from you.
Our system will automatically send you email notifying you that you’re good to go along with a link back to your custom web page. Go there, and you can immediately download your licensed items.
How do I pay the license fees?
Because most of our clients are large organizations with purchasing departments that typically pay by check, that is what we prefer: checks in US currency. We can also provide you with wire transfer information (ABA routing number and account number) if your organization wants to go this route.
We can also accept payment via credit card: Visa, MasterCard, Discover, and American Express. Instructions about how to submit credit card payment is on each invoice.
Also on each invoice is the EIN (US Federal tax ID) of the relevant licensing organization—either CV Outcomes, Inc. or Outcomes Instruments, LLC. Your finance department may want that.
How quickly you obtain access to your licensed stuff depends on how you send payment. We can process credit cards the same day they are faxed to us. Payment sent by post will obviously depend on transit time through the mail plus time while checks clear the banks.
In any case, once payment has cleared, we will update your project in our online system, which will then send an immediate, automated email to you letting you know that you can download your licensed items from your project’s custom web page.
What are the “currency conversion fees”?
Banks charge us 1-2% of the amount of funds to convert from a non-US currency to US currency. Previously we absorbed these costs, but we no longer are able to do so. We regretfully must add them on to international licenses now.
Why aren’t there any prices listed for any of these items?
As we’ve pointed out, we license our intellectual property to a vast spectrum of organizations and scope of projects. There is an equally vast difference in the ability to pay. The cost of licensing our instruments and tools thus depends on what you intend to do with them. And we rely on better-funded clients to help subsidize those clients with minimal resources. We believe that this approach is fair and helps advance the use of these valuable measures in multiple contexts of use.
We also endeavor to scrupulously determine what are appropriate “market” prices for our stuff, and always seek to provide great value for your investment.
Note: occasionally people have worried that simply putting through a request somehow obligates them to follow through with paying for a license. We don’t actually understand how that misunderstanding arises, but no request is ever finalized until both parties have signed the agreement and the invoice is paid. Anyone who decides that they don’t want to proceed any time before that point can simply cancel their request. There is no “obligation” simply from putting through a request.
That said, we do not offer “guesstimates” or other “quotes” based on incomplete information that people might subsequently expect us to honor despite substantive changes in the nature of the project. We price all projects based on the specifics of the project. Hence we only entertain definite requests with defined parameters. If your project is too tentative to provide reliable details, then please contact us later when your plans finalize.
Do we need to share any of our data with you as our project progresses?
At this point, we’ve not added any such requirements to our license agreements. Obviously many of our largest client applications involve proprietary drug and device development where the collected data are tightly protected by the client. However, as investigators and analysts, we are certainly interested in seeing develop a broad and deep pool of accumulating data using these instruments. We can also provide contract analytic and manuscript writing services, and we’d consider price breaks on license fees in return with access to data under the right circumstances. If this direction sounds interesting to you, please email John Spertus to discuss this.
What do I do with these “zip” files?
Zip is a compression mechanism that combines and shrinks files to make them easier to move across the Internet. We use it because it is a commonly used “standard” that most people know how to deal with.
When you download one of our zip files, save it to the hard drive on your computer. Then “decompress” it using one of these tools:
- WinZip (if you’re using Windows)
- Stuffit Expander (if you’re using a Mac)
- gunzip (if you’re using Linux or unix—but in that case, you’ll already know exactly what you’re doing)
Once you’ve decompressed the zip file, you’ll see a folder containing whatever it is that you’ve licensed.
Why am I being asked for a “registration number” when I try to open my zip files from you?
If you are seeing this, the problem is that you don’t have a proper zip utility installed on your computer. That zip utility is asking you for registration information before it wants to do its job. This message has nothing to do with our package. To use our materials requires no additional registration number, code, key, etc.
Maybe this analogy will make this clear: we provide you with corn in a can; our instruments and tools are the corn, and the zip file is the can. The can needs to be opened in order for you to get to the corn, and to open the can, you need a proper can opener. The zip utility is the can opener.
You can choose to install on your computer any one of a number of different freeware/shareware/commercial zip utilities; we provide you with links to a couple in the prior FAQ. Most people’s computers already have some zip utility, but if yours doesn’t, you need to install one by obtaining it from one of the zip utility vendors.
Once you’ve done that, you’ll have no problem with our packages.
Why do I keep getting email reminders about my license request?
Our system checks every night to identify license requests that we have approved but that we haven’t yet activated because we’re waiting to receive payment on the invoice. The first reminder email goes out three weeks after the license is approved, and the system sends out reminders every two weeks subsequently until the invoice is paid or the request is cancelled.
If you’ve sent the invoice off to your financial/purchasing department and you email us explaining that this is the case, the reminders will still come automagically every two weeks until your financial/purchasing department has finished its job. We hope that you don’t find this annoying; in fact, it has frequently been the case that these reminders uncover lapses in communication between different departments or other causes for things falling between the cracks. We find that this system works well, and we hope that you think it does, too.
Why does the Calculator not calculate the scores?
The KCCQ, SAQ, and PAQ Calculators are Excel spreadsheets, which means that they “run inside” Microsoft Excel. These calculators do their magic via code in the spreadsheet that Excel executes.
Excel provides you with a “security” option that allows you to turn off execution of code (a “macro” is what they call it) in spreadsheets. If you have your copy of Excel set this way, the Calculator will not work. How you set these security settings depends on what version of Excel you have, but in general, you have to set the macro security option at “medium” or “low”.
You’ll know that you need to reset your copy of Excel if, when you launch the Calculator, you don’t see a dialog asking whether you want to “enable macros” in this spreadsheet. You do want to enable macros, so allow them. If you don’t, the Calculator will not work.
What is the problem with Excel compatibility and the Calculators?
There is one issue:
- Macs: Microsoft decided to drop support for Visual Basic for Applications (VBA) in Office 2008. This is a characteristically vile Microsoft decision, the intent of which is to push users to Windows from OSX. The Calculators do their magic via VBA programming, so this compatibility problem cannot be fixed. Microsoft has chosen to market crippleware, and there is nothing we can do about this.
In any case, this compatibility problem derives simply and directly from Microsoft’s labored attempts to maintain its oppressive monopolist status. It is shipping crippleware. The best approach you should take is do not “upgrade” your Microsoft operating system or applications!
What is this “software implementation” option?
If you are a software vendor (a commercial web site, electronic medical record developer or other system creator/integrator) who wants to deploy one of our quality-of-life instruments in your data management system to sell/license/rent to your clients, then licensing this “item” is what you need to do.
If on the other hand you are a physician, hospital, provider network, or research organization and you simply want to create a software solution for your internal use within your specific project, then you don’t need to license the “software implementation” item.
The specific language I need isn’t in the list of available translations.
Over time, we have added new translations as specific studies and contracts warrant. Validating a new translation is an expensive and time-consuming proposition, so we haven’t been able simply to do all languages all at once.
If you have a specific project that needs a language that we don’t currently provide, please register your project via our instrument licensing system and email us about your needs. We’ll be glad to work with you on this.
However, please note that we do not ever allow individuals to undertake their own translations. Each translation we offer has been created by a professional linguistic firm using a complicated and expensive process of forward- and backward-validations. Ad hoc translations by individuals would invalidate the instrument and thus are prohibited.
Are all the different translations validated? How is this done?
In our effort to support the field of patient-centered outcomes research, we acquire and license translations of our instruments, including the Seattle Angina Questionnaire, the Kansas City Cardiomyopathy Questionnaire and the Peripheral Artery Questionnaire. Often these translations are initially sponsored by industry for use in clinical trials and, occasionally, these are sponsored by CV Outcomes to support international research.
Prior to posting or supporting a translation, CV Outcomes works with translators to insure accurate translations. Although translation is admittedly a fine art, and regional variations in language use often render some translations appropriate in certain settings and awkward in others, CV Outcomes works to ensure the following:
- An original US English version of the translation is provided to the translating service.
- Native speakers independently perform a forward and backward translation.
- A series of iterations reconciling the translations are conducted, often involving the author, Dr. John Spertus MD MPH, to reconcile issues relating to the clinical intent of the original instrument.
- When groups of languages are being simultaneously translated, international harmonization is performed.
- Often, an independent evaluation by a past-President of the American Society of Linguistics, sponsored by Dr. Spertus, reviews the resulting translation for additional comments.
- Once the penultimate translation is completed, pilot testing with small groups of physicians and patients from the region of interest is generally conducted for additional input.
- Upon satisfactory pilot testing, the instrument is deemed to be a valid translation.
- Occasionally, re-verification of the instrument’s validity with data from its initial applications is also conducted, if data is provided by the sponsor and resources are available to perform such work.
- Only one translation is supported by the CV Outcomes website and it is intended that this translation will be used in all studies involving patients from the region of interest so that comparability across studies is maintained.
- All licenses are provided `as is’ and while every possible attempt to ensure accuracy of the translations has been made, no other warranty is available.
- The majority of currently available translations have been performed by the MAPI Institute in Lyons, France and more details about the translation process can be obtained directly from them.
- The CV Outcomes website may also provide additional information about the psychometrics and clinical validity of its instruments.
Why have you switched the term of my license request to one year?
Over the years, we have found that there are two basic types of projects using our instruments:
- Fixed-enrollment, time-delimited clinical trials and other studies
- Open-ended, ongoing, increasing-enrollment registries and other operational programs
While the former type of project has constrained parameters that can be specified at the beginning of the project, the latter does not. For these ongoing operational programs, we issue one-year license terms where pricing is based on enrollment size (the number of patients studied) at the point of annual renewal. If you put through a request for this sort of program but input a longer term than one year, we will simply change that and email you why.
We need more translations of the instrument we have licensed. How can we get them?
We are happy to work with you to add more translations. To do so, we need this information:
- The specific license that you want to modify. Best is to provide the URL of your project’s web page. Next best is to provide the exact name of your project as you requested it. If you’re not the person who requested the license and is the designated contact person for the license, then either have that person contact us or at least provide us with that name and email address.
- The total enrollment size with this change in your recruitment plans. n=what? We need the integer value. “No change” is not adequate since we have frequently found that enrollment was increased after all.
- The specific translations/versions that you need. The names of countries where you’re recruiting are not sufficient. We need the exact names of the translations you need from the list always available here.
- The change in end date if you need more time.
Without all this information, we really can’t move forward, so please provide it in your first communication.
We will then update your project with an amendment to your license agreement and, as needed, another invoice. Once the amendment is fully-executed and the invoice is paid (if applicable), we will enable download of the new versions.
How do license renewals work?
A month before your license will expire, our online system will begin sending you reminder emails that you need to renew the license or else discuss with us the status of your use of your licensed items — for example, that your work will complete by the end of the license.
Presuming that you need to continue to continue your license, you will find a link to “request a renewal” on your project’s web page. Clicking that link brings up a simple form that asks for updated details about your project of which the most important is the enrollment data — that is, the number of patients that you are studying with our instruments. Complete that form and submit it back to our online system. We will review your request and likely contact you for any clarifications. Then we will generate a new agreement and invoice available on your renewal’s new custom web page. You access that agreement and invoice and process them as with the initial license.
Can we edit the questionnaires at all — with a logo or other information?
In general, we strongly suggest not trying to alter the questionnaires in any fashion, as there is a significant risk that while trying to do so, you will inadvertently alter the questionnaire itself in a fashion that would invalidate it and thus any data you collect with it. That is why we distribute the questionnaires in protected PDFs.
If you have a compelling reason to want to proceed, then you should email us with specifics about what you’re trying to accomplish, and we will email you Word versions that you can open and edit. (This of course assumes that you have already secured a license to use the instruments at all.) However there are several key restrictions:
- You may not remove or alter the copyright notice present in the footer of every page.
- You may not change any of the text in the questionnaire.
- You may not alter any of the formatting in the questionnaire.
- Whatever you try to add must not be so large that it alters the layout of the questionnaire otherwise.
I’m no longer in charge of my project that licenses your stuff. What do I need to do?
It is absolutely essential that we have a consistent, reliable contact person at your end with whom we can communicate about all issues concerning your license. Thus if you are changing jobs, shifting responsibilities in your organization, going on maternity leave, or otherwise will not be able to continue to fulfill that role, then this is what needs to happen:
- Identify who at your organization will take your place.
- Make sure that your replacement registers at our web site just as you once did. Point them to this FAQ so they know how to do this.
- Email us to let us know of the impending switch so that we can replace you with the new person in your project in our online system, which will then give your replacement access to your project’s web page.
Please do not just disappear, which forces us to try to track down someone at your organization who knows what is going on.
Can these questionnaires be administered by reading the questions to patients?
Yes, though rather uncommon, this approach has been used numerous times. Particularly in cases of visual or literacy problems, a native-speaking staff person can read the questions to a patient and record the patient’s answers either in person or over the phone.
Are there administration guides or manuals?
The questionnaires themselves are fully self-documented, with clear instructions embedded within the questions. All that needs to be done is to give the questionnaire to patients and let them answer it. Since the process is just that simple, there is really nothing else to include in a manual — so we provide none.
As to the much more complicated issues of study protocol — how often to administer the questionnaires, to whom, and how to analyze the resulting data — those issues depend entirely on the questions you’re trying to answer by doing your study or program. No manual can possibly address such matters in a generic fashion.