> F.A.Q.

Q: Why choose the LCSS?
    · It may be best to use the LCSS versus other measures because there are no confounding areas to distract from the primary purpose of assessing a new agent (essentially, using areas not altered by a new agent).

Q: What are the desired outcomes for relative QL according to the FDA?
   · Increased survival, increased QL.
   · Increased survival, no detriment to QL.
   · No survival difference, but increased overall QL.
   · No survival difference, but difference in average symptom burden or specific symptoms.

Q: What is the difference in measuring clinical benefit versus QL in terms of symptoms?
   · Clinical benefit = increased pain + increased performance status (only).

Q: How soon can permission to use the LCSS be obtained?
   · Permission can be expedited by using overnight mail.
   · The license fee for this trial should be sent (check made payable to Quality of Life Research Associates) along with the signed agreement form and a summary of the protocol. (A confidentiality form is generally signed.)
   · If the LCSS is appropriate for your research aims, as deemed from your protocol synopsis by one of the developers, and the signed agreement form and license fee have been received for use of the copyrighted LCSS in the trial of interest, then the signed LCSS agreement will be returned.

Q: Can our lawyer amend the agreement form specific to our company?
   · Yes. An electronic copy of the agreement form can be sent to you, but it is not one that can be completed on line.
   · However, if you save it as a word file, amend it, and then send a draft as an attachment to an e-mail message, Dr. Hollen will be glad to review it.
   · Dr. Hollen's signature is the one generally on the agreement form, and it represents all of our associates.

Q: You are requesting study data that we may not be able to release for some time. Is this a problem?
   · Please note on the agreement form that our group is only interested in the LCSS data, not treatment variables. However, if there is still a concern, please discuss this with Dr. Hollen.

Q: You are also requesting sociodemographic and disease-related data for the patient. What if these are limited in our study?
   · Our group accepts whatever patient and disease-related variables you have collected (rather than our group specifying these). We just need to be able to describe your sample in relation to the data for the LCSS.
   · We are also interested in the data for the translations, if any are used or developed by your company as a sponsor. From our "norms document" and our previously published "norms article" (both sent in the LCSS packet), you can see the direction our group is going with securing more normative data for the LCSS.

Q: Is a faxed version of the Agreement Form acceptable?
   · No, an original signature is needed.

Q: Does LCSS-QL accept credit cards?
   · Unfortunately, our group does not accept credit cards.
   · Please note that the process can be expedited by overnight mail.

Q: What address should we use in returning the LCSS Agreement Form or in preparing a Confidentiality Agreement?
    
    Patricia J. Hollen, PhD, RN, FAAN
    Quality of Life Research Associates, LLC
    548 Worthington Drive
    Charlottesville, VA 22903  USA

Q: Has your group determined the magnitude of a clinically significance difference for the LCSS patient scale?
   · Yes. Please contact Dr. Hollen.

Q: Are published norms available to use as a reference group for patients?
   · Yes. Please see the LCSS bibliography for norms for patients with non-small cell lung cancer and contact Dr. Hollen for norms for patients with mesothelioma.

Q: Where can we obtain information about formatting the patient cards?
   · The LCSS packet, obtained through the order form (see webpage), includes this information.

Q: Does the formatting of the patient scale have to be on separate cards versus 1-2 pages?
   · At this time, the format for this copyrighted scale must remain as the original - each question using a visual analogue scale and also on a separate card.
   · The rationale of the developers is that 1) the patient needs to focus on one card at a time, instead of trying to weigh one symptom against the other; and 2) the published psychometric properties of feasibility, reliability, and validity have been obtained for this original format.
   · However, we now have the results of testing a numerical scanned form with printing on 1-2 pages. The psychometric properties are not affected when changed from the VAS single card format; thus, you have a choice of format.
   · The LCSS format on cards has been working for many multisite trials on six continents over the past decade. These trials have been sponsored by major pharmaceutical companies as well as academic institutions. In addition, this format has been used by many other cancer centers and oncologic groups.
   · If your PI still has a concern, please have him or her contact either Dr. Hollen or Dr. Gralla.

Q: Should our own vendor prepare the spiral-bound patient cards?
   · Yes, but our group will provide an example.

Q: How is the patient scale presented within the case report form?
   · The patient scale is reproduced on one page with boxes (for the mm) for the case report form.

Q: How have quality checks been maintained in previous trials?
   · CRAs spot-check the study coordinator's (data manager's) measurement for accuracy to be sure that someone is not transposing numbers. All of this is stated in the manual.

Q: May we reproduce the LCSS Manual for our Investigator's Meeting?
   · Yes, this permission is included in the license fee.

Q: What copyright information is required for use on the patient/observer scales and manual?
   · Copyright 1995 Reproduced by permission of Quality of Life Research Associates, LLC.

Q: Are there available electronic versions of the patient & observer scales?
   · Yes, for the observer scale.

Q: Do you have a standard description for the LCSS for the protocol and is it available electronically?
   · Yes, it can be obtained from Dr. Hollen.

Q: Can only the patient scale be used for a trial?
   · Yes, the observer scale is optional. An evaluator may choose to use only the patient scale or may elect to add the observer scale to provide context to the subjective perceptions of the patient. This health professional form combines the patient's perceptions, taken from the patient interview, with the observer's contextual knowledge (e.g., important information for understanding the patient's perception of pain for some research aims).
   · If the observer form is not used, then it is important to have obtained such data using another form (e.g., type of pain medication).

Q: How many versions has the LCSS had since first developed?
   · The first generation LCSS was a 7-item instrument. The current second-generation 9-item measure has two additional items (appetite and fatigue).
   · The "illness version" was created because the word "cancer" is too extreme for some countries.
   · A "meso version" is also available for mesothelioma.

Languages

Q: What literacy level is needed in foreign countries?
   · The LCSS has not been tested for readability in any of the foreign countries. However, the pilot-testing process, where patients complete the scale on their own and then explain each question back in their own words to the in-country investigator to show comprehension and misunderstandings, does provide some indication of the readability level.
   · Each translation has undergone this process with seven patients with lung cancer from that country. If there is difficulty by any of the patients, then this is considered by the reconciliation panel.
   · A study coordinator/data manager should actually demonstrate how to mark the visual analogue scale (VAS) and can explain words as needed. Because this is a self-report scale, the patient needs to complete the scale on his/her own. The response is just a short vertical mark. Generally, if patients are "trained" with the example question and the study coordinator/data manager does not proceed until the patient understands, then there has been no difficulty.
   · At the study initiation meeting, the study coordinator/data manager is oriented to the process of "training" patients in completing the patient scale.
   · Certainly, a second example could be used or even more if needed, as long as they are not the questions from the scale. Also, study coordinators/data managers have used terms that the patient understands such as a "true 0" or "true 100" to explain the extremes, and that is perfectly fine.
   · Originally, the selection criterion for patients was included as a base of 2nd grade reading level. If a patient can be read a question and then explain back in his/her own words the correct meaning, then literacy would not be needed. The problem will be with staff taking the time to do this, versus just reading the questions and assuming comprehension.

Q: What selection criteria are needed for the observers?
   · Consistency in the selection of the observers is needed.
   · In the past, observers have been Registered Nurses with prior oncology nursing experience.
   · A few physicians practicing as data managers also have been used as observers.

Q: There seems to be some controversy as to when the LCSS should be administered. What is the standard procedure?
   · Standard procedures for both the patient and observer scales have been outlined in the manual.
   · The LCSS manual addresses administration, telephone procedure, scoring, and coding in detail.
   · The telephone procedure should be done only when it is impractical to administer in person and the patient has had an initial face-to-face assessment in which the visual analogue scale was demonstrated and an example question was comprehended by the patient.

Q: What are the critical factors as rationale for why "before" versus "after" seeing the physician?
  · Primarily, one methodological factor - potential of bad news for this rapidly progressive disease, even the value of a lab test.