Search Site:
MARC-30: Prospective Multicenter Study of Bronchiolitis Admissions
FAQs
Posted here are questions that were asked of the EMNet Coordinating Center, which we thought might be of general interest.
If you do not find an answer to your question here, please send us an email, and we will try to have an answer for you as quickly as possible.
General FAQs
Subject Enrollment FAQs
Form FAQs
Visit Form
Daily Inpatient Form
Follow-up Form
Registry
NPA Specimen FAQs
Q: What kind of training is required?
A: Training will take place over the phone during a 2-hour training conference call (all study staff). The training calls are available in October (multiple options). The training calls will be supplemented by PowerPoint presentations. Also, all study personnel will be trained on how to collect a nasopharyngeal aspirate by watching a video that we have prepared for this purpose. All study personnel must watch this video prior to beginning work on the study.
Q: What level of practitioner should people involved in data collection be?
A: This is a structured interview and chart review, so anyone who has been trained can do it. We find that college-age people and older are best, just because of the dynamics of interaction with parents. Some sites choose to rely on undergraduate research assistants or medical students, while others rely on respiratory therapists and nurses. Still others rely on doctors (e.g., colleagues of the site PI, residents, fellows). It depends largely on the type of staff you have available at your hospital.
Q: What ICD-9 codes can we use to check the number of bronchiolitis patients we see in a year?
A: You should use ICD-9 code 466.xx.
Q: How will we be paid? Is a contract necessary?
A: Since this is a federally funded study, a legal agreement with each site is necessary. The type of contract that we will use is called a Purchased Service Agreement (PSA) will be signed by MGH and an official at your institution.
Q: What about secondary analyses – are site investigators allowed to write manuscripts?
A: Yes! We encourage you to pursue any and all secondary analyses that interest you. The primary analyses will describe the virology of severe bronchiolitis and the development of a tool to help physicians determine which children with bronchiolitis can be safely sent home and which should be admitted. There are, of course, many other directions you could go with the vast amount of data that we will collect. Throughout all of our studies, we at EMNet have always encouraged investigators to publish secondary analyses using network data. In fact, since 1997, more than 325 different EMNet investigators have published almost 400 peer-reviewed publications/abstracts! Please check out the Publications section of the EMNet website (www.emnet-usa.org) for more details. You can access our secondary analysis proposal page at the following address: www.emnet-usa.org/Coordinating_Center/SAPF.cfm. This is not a list of papers, but rather an opportunity for you to propose a paper based on whatever aspect(s) of the data interest you the most. EMNet statisticians will perform the analysis for you and the entire team will work on your national presentation and then manuscript publication.
Q: How do I report a protocol deviation?
A: Please report via email all protocol deviations to Tate Forgey. Please include the subject number, the date of the deviation, and a brief description of the event. Sites are responsible for submitting protocol deviations to their local IRB.
Q: How long must we keep paper documents on file?
A: Please keep all paper documents until all data are submitted, the database is closed, and your IRB is notified of the study's closure.
Q: Are there inclusion and exclusion criteria?
A: Yes, inclusion and exclusion criteria are listed in the "Detailed Protocol" on the website.
Inclusion criteria: Age younger than 2 years; physician-diagnosis of bronchiolitis; ability of the parent/guardian to give informed consent.
Exclusion criteria: Interviewed for bronchiolitis study during an earlier hospital admission; parent/guardian does not agree to the collection of the NPA specimen or possible future use of the specimen; patient transferred to a participating site hospital >48 hours after the time of admission at another hospital.
Q: Can someone other than the site PI obtain consent from a legal guardian/parent?
A: Yes. Sites should follow their site-specific rules on who can obtain informed consent.
Q. If a parent refuses the nasopharyngeal aspirate, can we include them in the study by completing the forms without the aspirate?
A. If a parent refuses the nasal aspirate, we will not include them in the study. This is, after all, a study on the virology of severe bronchiolitis. The parent must consent to the nasopharyngeal aspirate to participate in this study.
Q: Will informed consent from doctors and nurses be required?
A: This is up to your institution, but it should not be necessary. If your IRB insists on getting consent from doctors and nurses, we strongly urge you to consider oral consent. For example, saying to the doctor or nurse something like "By answering this question, you are consenting to research..." would be preferable to having them read through and sign a 6-page consent form. We anticipate that most physicians will be happy with the oral consent and would not want to read through an extensive written consent. Also, since there is no harm to them (we are asking them simple questions), oral consent should be fine.
Q: How many patients are we required to enroll?
A: Each site is required to enroll ~10 patients per month. Each site will have monthly enrollment goals, as determined by the EMNet Coordinating Center. Please remember that you need to enroll at least 50% of consecutive, eligible patients.
There are various situations that could arise. For example, assuming you are supposed to enroll 10 patients, what should you do if you are able to enroll only 7 ward (non-ICU) patients? In this case you should try to enroll 3 ICU patients that month. Remember the maximum ICU enrollment is 4 per month. What if you get another ward patient and you already have 8 ward patients? Stop at 8 ward patients. Your registry is closed to ward patients at that point. You should be looking to enroll a total of 10 patients (ward + ICU). Once you reach the 10 patients you are done for the month. If you have any questions/concerns, please do not hesitate to contact EMNet staff to discuss your situation.
Q: Do we have to start recruiting subjects on the first day of each month?
A: Sites can begin their recruitment each month as their schedule permits. We encourage you begin recruiting subjects as early as possible each month so that you can meet the monthly recruitment goals.
Q: How should your site handle enrollment of patients transferred from outside institutions? Are they even eligible?
A: Patients are eligible if they were transferred to your hospital within 48 hours of the time of admission to the floor of the non-site hospital. To be eligible, the patient cannot have been transferred from a different m30 site, which would be highly unusual. Assuming both of these criteria are met, you can treat the child like a new patient. Please see the transfer enrollment guidelines for additional information.
Q: What happens if a patient arrives from the clinic without clinic data?
A: Obtain any info from the clinic charts and use ED data where needed.
Q: We enrolled a subject who was initially seen at another ED and then transferred to our ED before being admitted. When answering the questions for the pre-admission chart review, do you want us to use the vitals from the 1st ED visit and then use both ED visits to answer the remaining questions?
A: You may use the vitals from your own ED to complete the initial bronchiolitis severity questions (Q49-55 on the visit form). If the patient was at the first ED form more than 12 hours before being transferred to your ED, please try to obtain the vitals from the first ED.
Q: What happens if the ward registry is closed and someone from the ward is transferred into the ICU? Should you enroll another ward patient that month?
A: Assuming that the site already had 8 ward and 2 ICU patients the above scenario would put that site at 7 ward and 3 ICU patients and that is fine – 10 in one month. There are other possible scenarios that are not as easy, but if something comes up let the EMNet Coordinating Center know and they will help you figure out the best plan of action.
Keep in mind that a site could catch up on another ward patient the following month.
Q: Using the same transfer scenario as above, when would the clock begin for the transferred patient?
A: The clock starts when the child is admitted to the ICU. The site will gather the ED data by chart review as they would for a hospital-to-hospital transfer.
Q: What happens if an enrolled patient from the ward is transferred into the ICU?
A: They become an ICU patient.
Q: What are the rules for enrolling a patient in the ED?
A: 1) Patient must be admitted to the medical floor at some point during hospital stay
2) Patient may be enrolled if they are in the ED and being cared for by the inpatient team
These rules should exclude observation only patients that are cared for by ED staff in the ED.
Q: Should we enroll children who acquire bronchiolitis while in the hospital?
A: No, please exclude children with nosocomial bronchiolitis.
Q: Many forms ask for admission time. Which time would you like recorded: the time the decision was made to admit the patient, the time the order was put in to admit the patient, or the time the patient was transported to the floor?
A: Please record the time the patient was transported to the floor.
Q: Question 24 asks if the child's immunizations are up to date? How delayed can be considered as normal (e.g., if postponed by recurrent infections)?
A: If the immunizations are obtained within 2 weeks of the due date, we consider the immunizations up to date.
Q: Question 26 asks if the child stopped breathing during this illness.
Is this same as apnea, or something more severe (i.e. need for
resuscitation)?
A: This is the parent's view of "stopped breathing." If a parent thinks there child has stopped breathing, the answer is yes. True apnea will only be able to be observed by physicians.
Q: Who is supposed to fill out the Daily Inpatient Form, and to whom are questions 4-8 directed?
A: Although the questions are asked daily, with “notes” recorded to left of the vertical line, questions 4-8 should be completed (finalized) only once. The final response to these questions should be recorded on the final day of the hospital stay – when further data collection is not possible. The attending > fellow > senior resident / Nurse Practitioner> intern should answer this question once. The hypothesis that we will test is: once the parent and the attending physician think the child has improved, he/she will not regress clinically.
Q: How do I fill in the hospital day # on the Daily Inpatient Form? When do we fill out the Daily Inpatient Form? Am I required to complete a Daily Inpatient form for hospital day # 0?
A: The day the patient is admitted to the hospital is hospital day #0. Hospital day # is based on hospital admission date, and not calculated based on hours following admission.
Examples:
If the patient is admitted at 11:00 on Wednesday, you enroll the patient at 15:00, and you complete the Daily Inpatient Form at 09:00 on Thursday, you should list the hospital day # on the form as “1.”
If the patient is enrolled at 23:00 on the same day he/she is admitted (hospital day #0), once the clock strikes midnight it is hospital day #1.
One may have a hospital day #0 Daily Inpatient Form if the child was discharged on the same day he/she was admitted and you are able to obtain data from the 20 hours prior to hospital discharge (i.e., you review data from the ED visit in combination with data from the admission). You are not required to complete a Daily Inpatient Form if the total time from ED arrival to hospital discharge is less than 20 hours.
Example:
If the patient arrived in the ED at 21:25 on 12/1, was admitted at 04:35, and discharged at 20:40 the same day, one could look at the information over the course of the pre-admission ED visit and the admission to complete the Daily Inpatient Form.
Q: Our first patient was admitted the evening of 11/4, and we enrolled the patient the next day (11/5), which would be hospital day # 1. Do we need a Daily Inpatient Form completed on hospital day #1 if this is the day of enrollment?
A: You should complete a Daily Inpatient From on hospital day #1 even if you enrolled the patient on day #1. We want to capture data from the time the patient arrived at the hospital. Even though you enrolled the patient on day #1 (11/5), there should be data from hospital day #0 (11/4) for you to use to complete the form. You may use data from the pre-hospital visit (ED or clinic visit), if available, when completing questions about trends on the hospital day #1.
Q: Can we use ED data when answering questions about trends on the Daily Inpatient Form?
A: You may use data from the ED or clinic visit prior to admission when completing questions about trends on the Daily Inpatient Form.
Q: How should we answer questions on the Daily Inpatient Form about oxygenation if the child has a baseline oxygen need?
A: If a child has a baseline oxygen need, please note this in the Comments section of the Daily Inpatient Form.
Q: Do we need to keep filling out daily inpatient forms if a child admitted for bronchiolitis is being kept in the hospital for reasons unrelated to bronchiolitis?
A: After a subject is in the hospital for one week, please look at the child's clinical data to determine if the child's continued hospitalization is prompted in large part by bronchiolitis. If the child is being kept in the hospital for reasons that are not in large part related to bronchiolitis, please email Tate Forgey. We will discuss the situation and make a decision about whether or not you need to continue filling out daily inpatient forms on a case-by-case basis.
Q: What is the window of time during which the follow-up phone call may be made?
A: The calls may be made between 8 and 14 days after the patient’s discharge from the hospital. Beginning calls on the 8 th day (i.e., closer to the time you last saw them) should improve your chances of reaching the patient. Please do not call before the 8-day mark to make sure that all patients have a full 7 days of follow-up. Calls made after 14 days will be considered ineligible and follow-up data collected from an ineligible call will not be usable.
Q: How should follow-up with non-English-speaking people be handled?
A: If the person with whom the initial visit interview is performed does not speak English as a first language, please note this to the left of the vertical line with that person’s contact information. This will flag you to the possibility that you may have to use a bilingual research staff person or your hospital’s interpreter services for the call. The follow-up forms have been translated into Spanish to assist Spanish-speaking researchers in making the follow-up calls. If you attempt a follow-up call with anyone who does not speak English or Spanish, please use a hospital interpreter. If your hospital does not have such an interpreter service, you could call an outside interpreter service, such as Pacific Interpreters out of Portland, OR (http://www.pacificinterpreters.com/). Please note that any charges for this service will need to be covered by your site stipend; the EMNet Coordinating Center will not pay for this interpreter service.
Q: Does follow-up need to be done on children who are admitted for bronchiolitis, but are subsequently determined to have a major medical disorder that requires a prolonged hospital stay unrelated to bronchiolitis?
A: After a subject is in the hospital for one week, please look at the child's clinical data to determine if the child's continued hospitalization is prompted in large part by bronchiolitis. If the child is being kept in the hospital for reasons that are not in large part related to bronchiolitis, then you do not need to make a follow-up call for this subject. Please email Tate Forgey if this occurs.
Q: How long do I keep calling a parent whose child still has a cough that is not "all better"?
A: If you are still calling the parent at 7 weeks, you should tell the parent to seek medical attention for their child's cough and then stop calling.
Q: How should I handle situations where a parent's response to a question on the follow-up form about medications prescribed conflicts with what is documented in the chart?
A: Please record the parent's response. If a parent reports that their child is not taking a medicine prescribed at discharge, they may not have filled the prescription.
Q: When is the Registry open?
A: The Registry is open during the recruitment period. Once your site reaches 10 patients the registry is closed for the month. The Registry period differs for ward patients versus ICU patients; they are independent of one another. At the time of day you reach 8 ward patients the registry for ward patients will close so that if another ward patient comes in it will not affect the percentage of patients you enrolled (You must enroll at least 50% of consecutive, eligible patients). Once you get 2 ICU patients the registry will close for ICU patients. For example, if you begin recruiting patients on Nov. 1 st and finish enrolling ward patients at 9AM on Nov. 6th, the registry for all ward patients was open for 6 days and closed as of 9AM on the 6th. The idea applies for the ICU registry and therefore if your site finishes enrolling 2 ICU patients at 4PM on Nov. 8th, the ICU registry was open for 8 days and closed at 4PM on the 8th. There are many other situations that could arise, so if you have any questions please contact EMNet staff and we will be happy to work with you on this issue.
Q: I know that I am going to be short-staffed on certain days this month. May I temporarily close my Excel registry during this period?
A: If you know that you will be short-staffed on certain days in the month (e.g., study staff are away at a mandatory training), you may close the registry even if you have not met your monthly enrollment goal. You may then re-open the registry later in the month. You may close and re-open the registry only once in any given month. Important: you must keep your registry open in one week intervals (minimum) if you have not met your monthly enrollment goal.
Q: How long should we wait after a previous suctioning before collecting the sample?
A: Please wait 1-2 hours.
Q: What should you do if you can only collect the sample from a single nostril?
You may only be able to collect the sample from a single nostril if an ICU patient's nares are occupied by ET tubes or feeding catheters. Please instill 1 cc in the available nostril and then suction up 2 ccs from the sterile cup. (The procedure therefore uses 1 less cc of saline than normal for the two-nostril NPA collection procedure.) When the specimen is collected from one nostril, please record this fact on both the vial and sample shipment log. On the sample shipment log, please put an asterisk next to the sample with an explanation of the asterisk at the bottom of the sample log.
Q: Some of the tubes of viral transport media (VTM) in my refrigerator have frozen on the mid-level setting. Is it okay to use the VTM after it has been frozen?
A: Yes, you can still use the VTM after it has been frozen.
| ©2010 EMNet | Last Updated:01/04/10 ee |