Qualitative Research Study on LACT Prepared for November

Qualitative Research Study on LACT Prepared for: November 30, 2005 Solomon Solutions marybeth@Solomon-Solutions. com Voice 201. 434. 0404 Mobile: 917. 601. 1273 NLM LACT Final Report © 2005 Solomon Solutions www. Solomon-Solutions. com

I. Background II. Study Objectives III. Methodology: Online Focus Group IV. Summary Conclusions V.

Background As part of an ongoing qualitative evaluation of NLM websites, the National Library of Medicine conducted one online focus group on LACT – Drugs and Lactation – a database of information on the use of prescription drugs during lactation. This qualitative study had as its objective understanding the value, usefulness, strengths, and weaknesses of the proposed database for potential users of the site (physicians, community health professionals, lactation consultants, and nursing mother. ). The online focus group on the LACT proposed database was conducted on November 21, 2005. © 2005 Solomon Solutions 3

Study Objectives The main objective of this qualitative study on LACT was to evaluate the value and usefulness to potential users of a database that addresses how pharmaceutical medications impact lactation. Additional objectives included: . Gauging the strengths and weaknesses of the content. Gaining feedback on additional content users would like to see. Understanding how users anticipate using the database. Getting reactions to the database name (LACT) Target respondents. Screening parameters for respondents were as follows: ü Mix of potential users ü Employed as professionals in the healthcare professions related to nursing and lactation, as well as lactation consultants, nursing mothers and representatives of La Leche League ü Recruited from a listserv subscriptions within the lactation community ü All were asked to spend approximately 15 -20 minutes viewing/navigating the passwordprotected database and completing three brief tasks prior to the discussion. © 2005 Solomon Solutions 5

Methodology: Online Focus Group*. Testing consisted of ONE online focus group of professionals (and some nonprofessionals) in the lactation community. . Respondents were recruited via listserv subscription, including (among others) La Leche League. . The session lasted approximately 90 minutes and was comprised of 11 participants. (See Appendix. ). The group was asked to visit LACT and given a user name and password prior to the session. They were also asked to complete a series of tasks using the database. . All participants received an incentive payment of $45. * The online focus group represents a qualitative methodology used for the purposes of ideation, brainstorming, and evaluation. Qualitative methodologies are based on a small sample size, and the findings are intended to be directional only, not projectable to the larger population. © 2005 Solomon Solutions 7

Summary Conclusions Impressions of LACT. Reactions to LACT were generally positive. . Respondents liked the idea of a database that will address the needs of the lactation community with regard to medications and other factors that impact nursing moms. . The majority of respondents had little difficulty navigating or searching for information. . Areas for improvement were primarily related to the completeness of content (i. e. , not complete enough), specifics about the drug or medication listed, and the page layout on a drug result page. . Respondents noted that they would like to see the content expanded beyond pharmaceutical medications, possibly to herbs, vitamins, and even nutrition. © 2005 Solomon Solutions 9

Summary Conclusions (cont’d. ) Strengths and Weaknesses: LACT. Strengths of the LACT database were its generally easy search functionality and useful information. . Weaknesses of the database included a lack of complete information in some areas, the absence of brand or trade names for the medications, and the absence of certain medications they expected to find (e. g. , Methotrexate). . Also mentioned was a need for a "more orderly" layout on the drug result page. . Several respondents used "Hale's book" as a reference point from which to compare LACT, which emerged somewhat lacking in content and detail. . Additionally, inclusion of links to the AAP, CBI (Center for Breastfeeding Information), and LLLI (La Leche League) were recommended. © 2005 Solomon Solutions 10

Summary Conclusions (cont’d. ) LACT. There was high anticipation for usage of LACT, as well as a strong expectation that they would recommend the database to colleagues and others in the lactation community. . The name LACT was mildly received, though suggested alternatives included Med. Lact and Lact. RX. . Also recommended was a "peer review" that would validate information in the database, though credibility and reliability were already perceived as high. Following are additional findings from the online focus group testing on LACT. © 2005 Solomon Solutions 11

Overall Findings: LACT Current information gathering practices. "Hale's book" (Medications and Mothers' Milk: A Manual of Lactational Pharmacology by Thomas Hale, Ph. D. ) was the resource most frequently mentioned as a way of getting information related to pharmaceutical medication and lactation. . Subsequently, "Hale's site" was also mentioned frequently as a resource. . Additional resources cited for getting information on lactation and medication (both online and traditional) included e. Pocrates, kellymom. com, Lactnet, La Leche League (LLLI), Micromedex, USPDI, and Pub. Med. . Some respondents also rely on google. com to conduct searches on specific topics. . Specifically, users seek information on drug safety as it relates to lactation, drug concentration in the mother, fat solubility, clinical studies and side effects, and some information on non-prescription drugs as well. . The majority of respondents reported that they seek information on breastfeeding, as well as specifically on nursing mothers, and even more specifically on nutrition related to lactation. . Non-prescription topics of interest included herbs, illegal drugs, diet pills, glue, paint, amphetamines, and vitamins. © 2005 Solomon Solutions 13

Overall Findings: LACT Challenges in Finding Information. The challenges encountered in finding useful information included reports of "not enough" information, or information that is missing important details. "data is usually lacking or sparse. ” (Daniel) “There simply isn't enough research and what is there is often contradictory. Also the PDR that cautions every drug for breastfeeding mothers and the FDA website which follows closely without references or clinical/research citations. ” (Cathy) . Respondents reported that they handle these challenges by presenting the data that IS available and extrapolate from it. In other cases, their need to find information goes unmet. “I give mothers a copy of the information I have and suggest they discuss with their HCP. ” (Mary) © 2005 Solomon Solutions 14

Overall Findings: LACT Impressions of LACT. Initial reactions to LACT, based on pre-discussion review of the database, were generally positive, and users were particularly pleased that a useful database would be available to them. . Strengths of the LACT database, based on initial impressions, were that it was "easy to search" (though one respondent disagreed), "useful, " and impressive. “Overall I found the monographs useful and complete and objective. ” (Sharon) "Impressed! it seems to contain the published data & studies … I think that it is significant advance- it’s similar to a Hale online and then some. ” (Daniel) "I was impressed that each entry I found actually had more references and was more detailed than Hale. I was really excited. it just wasn't nearly as complete as Hale, because it mostly did prescription drugs (although I did find Aspirin). ” (Melissa) © 2005 Solomon Solutions 15

Overall Findings: LACT Weaknesses and Areas for Improvement. Respondents encountered several challenges, however. Some had difficulty finding complete information, such as brand names and certain medications. “You need to add ALL the trade names to each drug listing main page … Methotrexate was not there. ” (Nancy) “It was easy to search except that in the real world many physicians use brand names and the database did not reference those completely. There were significant drugs missing like metronidazole. ” (Sharon) . One respondent felt that the information on LACT did not compare favorably to the information provided by the Hale book and site. "no Hale information, which is quite useful … the L 1 -L 5 rating, theoretic infant dose, his charts of T 1/2 PHL PK MW Vd etc … maybe a summary of what the drug is, what it is used for, common side effects. ” (Cathy) © 2005 Solomon Solutions 16

Overall Findings: LACT Weaknesses and Areas for Improvement (cont'd. ). There were a few comments on the layout, unrelated to content. “… I'd set left hand column/tool bar a little more narrow. . . ” (Anna) “I would have liked to have seen an orderly layout identifying the drug, common name for recognition then maybe list something about what it's used for and how it's metabolized. After that, the information from the research would be logical from my clinical perspective. After that the safety summary and then the other rating pieces that were there. ” (Nanette) “The ‘browse’ feature was somewhat confusing -- there was a point in the search where there were boxes to check, but no ‘search’ button, but then I realized that the names were hot-links that would send me to the page. ” (Margaret) . Also related to layout was a recommendation that an abstract or summary (currently showing up at the bottom of the page) be presented at the top of each drug result page. “… I strongly STRONGLY recommend that the summary statement be on the top. If lay people are reading this, they may read about one adverse event and freak out. Everyone doesn't have to know about every little study. ” (Melissa) © 2005 Solomon Solutions 17

Overall Findings: LACT Target Audience. Some respondents questioned whether the database would be exclusively for a professional audience or for the general public. The target was not entirely clear, based on their own usage of the database. "My understanding is that this is meant for health care professionals and completeness is an asset. " (Sharon) “if non professionals will be using it, maybe a page about how aspects affect milk/plasma, half life, peak, oral bioavailabiltiy, etc. . . ” (Anna) “It is targeted/ oriented MORE towards professionals who can interpret medical studies" (Daniel) . Respondents did, however, agree that it could benefit professionals and non-professionals alike, though one questioned whether it should be available to non-professionals. “I think anyone can benefit from it. I think most lay people who would use it would probably be the types to use the information with prudence and guidance. " (Anna) “This kind of a database can be a problem in a lay person's hands. It's a lot of information and there are never any promises; even with amoxicillin. " (Nanette) © 2005 Solomon Solutions 18

Overall Findings: LACT Content Development. Respondents suggested expanding content with over-the-counter medications, as well as anything that would circumvent the need to use a variety of other resources. “As an office clinician with an EMR, I am looking for ‘one stop shopping’ a place to go that has everything as I don't have time to go to one resource then reference a second or a third. I need as much information as I can get at one place. " (Nanette) “Industrial chemicals are problems and over the counters would be a good expansion. I find radioisotope exposures very difficult to answer since there are so many variables. ” (Sharon) © 2005 Solomon Solutions 19

Overall Findings: LACT Searching and Navigation. Not all expectations were met when it came to searching. Several respondents needed more information to round out the picture. Offering features such as a browsing capacity and printable formats (easy to share) would benefit users in this capacity. "sometimes a mom calls with incomplete drug name and I don't know which one she is talking about so a alphabetical browse feature would be helpful. " (Mary) “not as comprehensive and not organized in a way to share easily with a mother. " (Cathy) . On the other hand, the database was perceived as a highly reliable, credible, and accurate resource. "Yes, reliable and accurate. And nothing's perfect. It's still worth saying that lexapro is better than celexa-- just have to caution lay people using this. Mom can switch to lexapro. " (Melissa) "I would definitely use this as a reliable resource and recommend it for other health care providers. " (Sharon) © 2005 Solomon Solutions 20

Overall Findings: LACT Currency/Updates. The issue of how frequently the database would be updated emerged, with respondents preferring updates every three months minimum. “I would say every 3 months (journals are out every month) so new information can be added on as soon as possible. " (Molika) "Like any other database updates should be continuous with some way to track the last date of update. " (Sharon) "I think there needs to be a date of when it was updated. " (Mary) © 2005 Solomon Solutions 21

Overall Findings: LACT Database Name: LACT. The name LACT alone did not resonate with this group. Many suggested alternative names, such as "LACTrx, " "Lact. Med, " and "Med. Lact. " “LACT just says breastfeeding to me. How about LACTRx? " (Daniel) “OK, Med. Lact? www. Medlact. gov. " (Melissa) © 2005 Solomon Solutions 22

Overall Findings: LACT Peer Review. Respondents stated that the ideal peer review for LACT would include physicians (pediatricians, internists), nurses, pharmacists, and other health professionals in the lactation community. . Some also suggested a collaboration with CBI (Center for Breastfeeding Information). "Ideal peer review would include ABM members, IBCLCs and LLL Leaders. ” (Cathy) “Yes, since this isn't a money-making endeavor, could something be done to collaborate with Hale or the CBI -- that's a good resource. ” (Margaret) © 2005 Solomon Solutions 23

Overall Findings: LACT Other Issues. The idea of a "teaching module" within the database did not resonate significantly with this group of respondents. . Peer review was an important element in the database. . Also important was the necessity to maintain the database as a free resource, whether to professionals, non-professionals, or both. . The inclusion of photographs of pills in the database was a very low priority and not generally perceived as a necessity (or particularly relevant) to respondents. . Links, on the other hand, were perceived as highly relevant and useful elements to include in the database. . Most respondents expected to find LACT via links on Google, Lact. Net, AAP, and other related sites. . There was high anticipation for using LACT in the future when it becomes available. Following is a series of recommendations that emerged from the results of this online focus group. © 2005 Solomon Solutions 24

Recommendations A few recommendations that emerged from this focus group included the following: . Expand content to include details on each medication listed (e. g. , drug safety, clinical trials, side effects, etc. ). . Include over-the-counter medications, as well as pharmaceuticals, if possible. . Redesign the results page layout in such a way that a summary or abstract precedes the rest of the detail on the page. . Also include non-medication items, such as glue and other inhalants, herbs, vitamins, and some foods. . Clarify the "aim" of the site (i. e. , target audience). If non-professionals are included, create content that is easily searchable and accessible, using "lay" language throughout the database. . Link to other relevant sites, such as CBI (Center for Breastfeeding Information) or LLL (La Leche League) to increase exposure and include the non-professional lactation community. Following is a respondent profile of participants in this online focus group. © 2005 Solomon Solutions 26

I. Background II. Study Objectives III. Methodology: Online Focus Group IV. Summary Conclusions V. Overall Findings: LACT VI. Recommendations VII. Appendix: Respondent Profile © 2005 Solomon Solutions 27

Appendix: Respondent Profile - LACT # Name Gender City, State Occupation 1 Anna F Sebring, FL Nursing student 2 Cathy F College Station, TX IBCLC, Research associate 3 Daniel M Bronx, NY Neonatologist 4 Margaret F Silver Spring, MD Lactation consultant 5 Mary F Antioch, CA La Leche League leader 6 Melissa F Massachusetts Internist, Massachusetts Breastfeeding Coalition 7 Molika F Melbourne, Australia Pharmacist 8 Nancy F San Diego, CA Neonatologist 9 Nanette F Hillsboro, OR Private pediatrics and lactation 10 Sharon F Rochester, NY Clinical pharmacist, National Lactation Study Center 11 Susan F Fairview, NC Perinatal support specialist © 2005 Solomon Solutions 29