Adenovirus Study

FAQ

Research Questions and Answers

Question: Are the birth date really necessary? Would birth year and month be adequate?

Question: We have several collections of adenovirus isolates from our various laboratories and studies. Would you be interested in including these in the surveillance study?

Question: The Adenovirus Information Form asks if the patient was hospitalized when the isolate was obtained. We often have DFA or culture obtained in the ED and then the patient is admitted. Even though the sample was obtained in the ED, wouldn't you consider the patient hospitalized if they are admitted at the same visit?

Question: The forms ask when the "isolate was obtained". Does this mean when the sample was collected and/or received by the lab? The isolate may not be obtained until a number of days later.

Question: Some of our specimens from which we have isolated adenovirus were sent to us from outside facilities-other hospitals, private laboratories, etc. We have no access to patient records and won't be able to find out whether the patient has had a transplant, etc. What should we do for these individuals as far as completing the information sheet?

Question: How should I handle adenovirus-positive specimens referred to our lab from other institutions? Though we have had two such isolates recently, I do not have access to all of the needed clinical and demographic information. Do you want these with the limited information available?

Question: How do I submit invoices?

Question: What, if anything, am I allowed to tell my collogues about which adeno types are in our population? I know we shouldn't be sharing typing results on individual patients--or can we do this? Let me know the etiquette here.

Question: Are the birth date really necessary? Would birth year and month be adequate?

Answer: While month and year might substitute for other purposes such as calculating age, we wish to use birth date, gender, and year to assess for receiving multiple specimens from the same patient over time. If we receive the same Adv serotype/genotype from the same patient over a period of time for multiple clinical events, this is consistent with a chronic infection and we'd wish to epidemiologically consider the isolates as statistically non-independent. We would thus likely not use all this person's isolates in our multivariable modeling.

We plan to, after a period of months, screen the study data for such potentially non-independent isolates, and query the sites to learn is such isolates are from the same patient (eg. are your specimens AU0103 and AU0145 from the same patient?)

If your IRB desires, we are pleased to sign a data use agreement regarding protecting the birthdate data.

Question: We have several collections of adenovirus isolates from our various laboratories and studies. Would you be interested in including these in the surveillance study?

Answer: For this study's purposes, we should receive only your Adv isolates (and data) you have collected since IRB approval. However, we are interested in the other isolates. I suggest you hang onto them until we adapt new molecular typing strategies here. We are holding a molecular typing meeting in about a week and moving towards a gene sequencing typing strategy. Soon we expect to have things worked out such that we can systematically approach your and others' archived specimens.

Question: I looked in the containers and there are 10 vials in each. The form also has room for 10 isolates. This implies that once we have 10 isolates, we should ship the box to you, rather than at a specified time, such as once a month. Does that fit your plans?

Answer: You have the option to send us several months of specimens in one shipmen which will save us shipping and administrative costs. If you only have 3 samples, you can wait until you have a couple of months worth (10 or more samples). The containers hold 30-50 tubes. We are experimenting a bit regarding the supply logistics. Some sites will quickly deplete their supplies, others will be slow to do so.

Question: The forms ask when the "isolate was obtained". Does this mean when the sample was collected and/or received by the lab? The isolate may not be obtained until a number of days later.

Answer: We desire to capture the date the culture sample was collected from the patient.

Answer: Do the best you can on the forms...The better your data, the better our risk factor analyses will be. We will reassess the questionnaire content after about 12 months.

Answer: Not if we can't complete a significant portion of the questionnaire data

Question: How do I submit invoices?

Answer: The process is really pretty simple. All you need do is fax us an invoice for payment. After you clear your IRB, you may begin collecting adenovirus isolates for this study. You may bill us $584.40 for each month in which you collect a specimen. Here is a sample invoice. Please list each month separately. You may fax such an invoice to her at:

Cindy Rohret cindy-rohret@uiowa.edu
Administrator
Department of Epidemiology
University of Iowa
200 Hawkins Drive , C21 GH
Iowa City , IA 52242
Tel 319 384-5015
Fax 319 384-5004

Answer: I see no problem with sharing our research findings with your clinicians. In fact making our epidemiological findings useful to others is a central theme of what we are trying to do. We just can't release the research findings as a patient's clinical laboratory report.

I think it appropriate if you point your clinicians to your site's web page, and as your IRB permits, interpret the results for them. Sharing the epidemiological information will likely generate more enthusiasm for asking your laboratory for Adv culture/detection.