This ICR is approved consistent with revised supporting statement, revised instruments, and AHRQ memo of September 4, 2009 and July 13, 2009. Given the small size of this focus group study and its qualitative/exploratory nature, AHRQ agrees that caution should used in interpreting the study results and drawing any causal inferences from them. Should AHRQ publish or otherwise disclose the results of this study, AHRQ will disclose all study limitations, including threats to its internal and external validity.
The approval is also on the understanding that this focus group study is one part of a larger study. Specifically, the results from this focus group study are intended to inform the development of a draft survey instrument which AHRQ anticipates subjecting to additional focus group and pilot testing. AHRQ may submit the request for that additional focus group and pilot testing under AHRQÂs generic pretesting clearance, with final approval contingent on the extent to which the generic clearance is appropriate for that request. Lastly, AHRQ agrees to submit a full clearance request for the final larger study, which all of this focus group and pilot testing will inform. When AHRQ submits the request for further focus groups/pilot testing and for the final larger study, AHRQ should provide a report on the results from the prior studies that informed them (e.g. the supporting statement for the draft survey instrument should explain clearly how the results of this focus group fed into the instrument, while the supporting statement for the final larger study should explain clearly how the results of the further focus groups/pilot tests have informed it).
AHRQ is reminded that all materials respondents will be seeing as part of studiesÂe.g. recruitment letters, consent forms, etc. -- should be included as part of ICR submissions in order to be considered complete.
Inventory as of this Action
Requested
Previously Approved
10/31/2010
12 Months From Approved
332
0
0
134
0
0
0
0
0
This proposed data collection is a qualitative study to preliminarily identify issues that relate to the misuse and overdosing of over-the-counter (OTC) acetaminophen. Acetaminophen is the most widely used analgesic and antipyretic drug in the U.S. When appropriately used, it is a very safe agent. However, a single large overdose, or several supratherapeutic dosages in a short period of time, has been associated with acute liver failure, which can occur with dosages over 250 mg/kg over a 24-hour period, or > 12 g in an adult. Toxicity from acetaminophen has been on the rise in the past 3 decades, and is now the most common cause of acute liver failure in the U.S., surpassing viral hepatitis. Because this study is exploratory, the data collection will employ convenience samples of individuals from different segments of the population. Parents of young children, adolescents, adults and health providers will be included. Populations that have not been previously evaluated in the U.S. including ethnic minorities and older adults will be recruited. The results of this qualitative phase will provide an understanding of the issues of relevance and will be used to develop a comprehensive survey.
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Semi-structured interviews with Pharmacists