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4 Steps to Improve the Translation and Dissemination of the Results of Clinical Research INTRODUCTION The ultimate intent of clinical research is to improve hu- man health, but too often, available research evidence is not translated into practice (Berg et al., 1998; Farquhar et al., 2002; Haines and Donald, 1998~. There are a number of reasons for this including the large volume of published, and sometimes conflicting, research results; a shortage of well-conducted sys- tematic reviews; the reluctance of some physicians to use guidelines; and pressures on physicians' time. Additionally, ineffectual education about and dissemination of research re- sults, guidelines, and similar tools, and a lack of policies that foster the implementation of research results hinder transla- tion of results into clinical practice. Millions of articles are published in medical journals each year, making comprehension and implementation of available information nearly impossible, especially for busy physicians and other health professionals (Davies, 2002~. For example, a search of PubMed for publications with the term "diabetes" in the past 5 years yielded citations for 47,000 articles.) Reviews and meta-analyses of available literature have been used to address this problem, but the methodol- ogy of some traditional reviews has been criticized, and there are still too few such studies to inform the array of current medical practice (Mulrow, 1994; Bero and Jadad, 1997~.2 Furthermore, there is a need for more studies that directly compare health interventions and outcomes, such as the An- tihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial,3 and for health services research to According to a search performed in February 2003. 2 The Cochrane Collaboration and others have developed methodolo- gies to reduce errors and bias in systematic reviews so that they can be used to influence practice (Clarke and Oxman, 2003). 3 The ALLHAT recently produced articles of particular significance comparing the outcomes of using Angiotensin-Converting Enzyme Inhibi- tor or Calcium Channel Blocker versus diuretic for hypertensive therapy (ALLHAT, 2002a,b). 36 evaluate and improve clinical practice (Song et al., 2003; Tilson et al., 2003~. While conducting systematic reviews and comparative research are important tools for translating research into practice, thus addressing the second block to applying re- search to improve public health, accomplishing this goal also depends upon several other factors, including physician be- liefs, patient knowledge, institutional culture, and access to information (Haines and Donald, 1998; Farquhar et al., 2002~. See Box 4.1 for potential methods to aid in imple- menting research findings in practice. The Internet is another enabling tool for both practi- tioners and consumers in the translation of research. Over half of the adults in the United States have on-line access, and health and medicine is the fourth most popular type of content online, behind news, travel, and weather (Cyber Dialogue, 2000~. This information helps healthcare con- sumers to make more informed decisions about their health. The increased access to clinical knowledge is changing the healthcare provider-patient relationship, as many of those accessing online health information are dis- cussing the information with their doctors and asking more specific questions about their symptoms, diagnoses, and treatment (HON, 2002; Taylor and Lietman, 2001~. However, there are still many people who do not have access to the Internet, and concerns about privacy, confi- dentiality, validity, and credibility on the web must be taken into consideration. This session of the workshop focused on the translation and dissemination of research findings in order to address the current lag time between research discovery and applica- tion. Barry Wolcott discussed use of the Internet for health communication and research purposes; John Walsh provided information about the role of voluntary health associations in fostering clinical research and disseminating the findings of such research; and Stephen Katz described consensus de- velopment conferences, ClinicalTrials.gov, and dissemina-
STEPS TO IMPROVE TRANSLATION AND DISSEMINATION tion strategies at the National Institute of Arthritis and Mus- culoskeletal and Skin Diseases.4 THE INTERNET AND HEALTH COMMUNICATION Barry Wolcott, M.D., Senior Vice President of Clinical Services for WebMD Health, commented that the Internet is now the primary way that most people in the United States obtain medical information. Approximately 67 percent of adults now have online access, and in a recent survey, 55 percent of respondents indicated that they used the Internet to find health information (Taylor, 2003; Market Facts, 2002a). The respondents to the Market Facts survey spent more time using the Internet than accessing other sources when seeking health information (see Figure 4.1~. Dr. Wolcott emphasized that the Internet is a valuable tool for communication in clinical research. Consumers in another recent survey reported that they were slightly to very much more satisfied with health websites than other sources of health information such as TV news, health magazine ar- ticles, pharma websites, TV ads, and magazine ads (Market Facts, 2002b). Roughly 600,000 people a day come to WebMD look- ing for a variety of health information, according to Dr. 4 Appendix E, the report Voluntary Health Agencies and the Clinical Research Enterprise, summarizes the contributions of Voluntary Health Agencies in clinical research. 37 Wolcott. Many of the site visitors are from specific patient communities, and they spend their time online reading infor- mation about their condition, in communities or in chat rooms. These online communities can provide a snapshot of particular disease groups. For example, there are postings about news reports, new drug releases, and folk remedies for specific medical conditions. Within a one-month period, WebMD recruited 50,000 people who were willing to be in research groups and filled out a 4-page questionnaire about themselves. He noted that the type of research WebMD conducts is different than clini- cal research, but pointed out that the Internet could be used for other research purposes. A growing number of people are accessing websites that provide information about clini- cal trials, and these sites could facilitate connections between researchers and potential participants. Websites can provide access to large numbers of people, can allow personalized services, and have the potential to reduce the cost of trial recruitment (DHHS OIG, 2002~. "If the goal is to recruit for an IRE, for a clinical trial, to be supportive of research, to know about clinical research, the Internet should be a major component of the marketing campaign," said Dr. Wolcott. In addition, the Internet has the potential to promote behavioral change one of the goals of WebMD. The Internet can reach large audiences and influence individual behaviors and community norms regarding health (Levy and Strombeck, 2002~.5 However, few Internet interventions have been evaluated for their effectiveness or costs. "If the goal is to recruit for an IRB, for a clinical trial, to be support- ive of research, to know about clinical research, the Internet should be a major component of the marketing campaign." Barry Wolcoff Many of the people who are online have expressed con- cerns about privacy and confidentiality, particularly con- cerning other people's access to personal information (Bernhard" et al., 2002; Cyber Dialogue, 2000; Fox et al., 2000~. Any entity using the Internet to recruit participants, provide general information about clinical research, or share health information must design systems that are sen- sitive to user concerns. The credibility of websites that provide health informa- tion is also an important issue. According to one recent sur- 5 The "VERB: It's What You Do" campaign is one example of a pro- gram that is utilizing the Internet for health promotion and disease preven- tion. As part of the youth media campaign for VERB, verbnow.com is de- signed to reach "tweens" (9-l 3 year olds) in order to increase their levels of physical activity and positive behaviors (DHHS, 2002).
38 ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Health Seekers- Source of Information Internet TV Health Mags TV Ads Pharma Sites FIGURE 4.1 Sources of Health Information Source: Dr. Wolcott presented these figures, citing Market Facts, 2002 vey, accuracy of information and trustworthiness were the two most critical concerns about the "medical Internet" (HON, 2002~.6 Anyone can have a website, so legitimate health sites must be careful to build and maintain trust, com- mented Dr. Wolcott. Most consumers use general search engines such as Yahoo rather than health portals such as WebMD to retrieve health information, which means that health site providers must make an effort to let people know that their websites exist and are valid, reliable sources of information (Taylor and Leitman, 2001~.7 THE ROLE OF VOLUNTARY HEALTH ASSOCIATIONS Voluntary Health Associations (VHAs) can play an im- portant role in the clinical research enterprise, particularly in the translation and dissemination of research. These associa- tions collaborate, convene, and consult with other entities in the clinical enterprise; attract and support researchers; edu- cate clinicians, patients, and the public; and sometimes re- cruit patients to clinical research studies. (See Appendix E, Voluntary Health Agencies and the Clinical Research En- terprise: Exploratory Focus Groups, for the results of focus group surveys with VHAs regarding their role in the clinical research enterprise.) 6 The Health on the Net Foundation has established a code of conduct for medical and health websites in order to standardize the reliability of medical arid health information on the Internet. See www.hon.ch/HONcode for more information. 7 Appendix E includes information about the characteristic of a number of Voluntary Health Agency websites. Internet Mags TV Pharma Sites TV Ads Mag Ads Percent of Total Time Spent Voluntary Health Associations use newsletters, websites, chatrooms, call centers, patient magazines, profes- sional journals, and scientific meetings, as well as health fairs and community forums, to share information with the public, patients, and health professionals. Some VHAs reach out to minorities by translating materials, placing stories in magazines with target audiences, and participating in direct outreach to communities. Several VHAs have expressed frustration about the dif- ficulties of getting, sharing, digesting, and translating exist- ing information; the lack of basic information, such as preva- lence, co-morbidities, and basic disease management needs collected about their disease; and the lack of information about indirect costs to society of particular diseases. The Alpha-1 Experience The Antitrypsin Deficiency (Alpha-l) Foundation is one VHA that has taken an active role in facilitating, translating, and disseminating clinical research relevant to Alpha-l. John W. Walsh is President and CEO of the Foundation, which is dedicated to providing leadership and resources to encour- age research about the condition. The foundation originally became directly involved in clinical research after many of its members participated in a longitudinal study that lasted for seven years. The results of the trial were not published for three years after it was completed, and the article about it was not understandable to many of the people in the Alpha- 1 community, said Mr. Walsh. The Alpha-1 model of collaboration is consumer-cen- tered and designed to stimulate research on Alpha-1 by cre- ating a true partnership with all stakeholders while maintain-
STEPS TO IMPROVE TRANSLATION AND DISSEMINATION ing focus on the participants. This model ensures that Alpha- 1 research will be conducted ethically, while leading to greater understanding, new therapies, and ultimately, a cure. Prior to the creation of the Alpha-1 Foundation, assembling and investing in the infrastructure and research for Alpha-1 was limited or nonexistent, according to Dr. Walsh. The stakeholders in clinical research are the participants, the researchers themselves, industry, and government. Clini- cal investigators serve on the Foundation's board of direc- tors and all of the scientific advisory committees with no remuneration. The government has helped people in the rare disease community to take action, hold conferences, and or- ganize responsibly; FDA, NIH, and CDC all have partici- pated in this process. The industry also plays an important role, getting discoveries into the marketplace. Thus, the Foundation incorporates all of these communities into its strategic planning process. Research Infrastructure Mr. Walsh identified a number of challenges for the Alpha-1 research community and offered his group's com- munity-centered research infrastructure as a way to confront those issues (see Figure 4.2~. Because finding a sufficiently large cohort of individu- als to participate in research is a greater challenge for re- searchers studying rare genetic conditions than for other dis- ease states, the Alpha-1 Foundation has developed a research registry, now the largest in the world for individuals with Alpha-l. The Foundation gains informed consent from reg- istry participants and recruits for additional trials. To date, the Alpha-1 registry has been used for six clinical trials, eight clinical research studies, and several surveys. Scientific conferences and workshops have helped the Foundation establish scientific credibility within the research community. For example, a workshop with the National In- stitute of Environmental Health Sciences examined environ- mental risk factors of Alpha-l. The Foundation also has at- tempted to interest new researchers in Alpha-1 projects. The 39 Foundation's Conference on Conformational Diseases: A1- pha-1 as a Paradigm brought in researchers studying Parkinson's disease, Alzheimer's, hemophilia, and cystic fi- brosis, to explore the confirmational problems related to protein. The Alpha-1 community now has researchers from other disease fields working on Alpha-l. The Clinical Resource Centers are another important building block in the research infrastructure of the founda- tion. The foundation currently collaborates with 52 centers across the country, most of which are university-based medi- cal centers. This mechanism facilitates communication be- tween investigators who are knowledgeable about Alpha-1 and those who know about the availability of potential trial participants. In addition, it provides materials to educate a broader physician population. The Alpha-1 Foundation has gathered support for trans- lational laboratories, which provide a bridge between basic science discoveries and human trials. This piece is essential to industry involvement in research on Alpha-l. The founda- tion also has established a DNA and tissue bank. The Uni- versity of Florida College of Medicine manages the bank, but the specimens are owned by the Foundation. This bank is the world's largest repository of Alpha-l-specific DNA available to the international investigator community. Research Coorclination Research coordination for the Alpha-1 Foundation is facilitated through stakeholder liaison meetings; expert ad- visory committees; FDA participation; consideration of ethi- cal, legal, and social implications; and outcome studies (see Figure 4.3~. The FDA or industry sponsors invite the foundation to participate at many points in the process, such as in sponsor meetings for product licensure or for clinical trial design. The foundation has over 250 volunteers from the scientific and medical community participating on expert advisory committees; they serve as advisors on clinical trial design within industry among their other tasks. A liaison group was | DNA and Tissue Bank ~ Translational Laboratories Research Registry Scientific Conferences and Workshops Clinical Resource Centers FIGURE 4.2 Community Centered Research Infrastructure Figures 4.2 & 4.3 were presented by Dr. Walsh.
40 ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Expert Advisory | Stakeholder Liaison Committees Meetings FDA Ethical, Legal, and Participation Social Implicat ons Outcome Studies FIGURE 4.3 Community Centered Research Coordination established to work with the FDA and NIH on Alpha- 1 clini- cal trial design. The Foundation recommends that the federal government, in collaboration with the private sector, establish a center to provide resources for communities to develop components for building a research program; for example, how to establish registries and DNA banks properly, with appropriate ethics considerations, under HIPAA compliance. This resource cen- ter would help the Clinical Research Enterprise to optimize its efficiency by creating tools that would assist the public and voluntary health agencies in their work with the federal gov- ernment and with other clinical research activities. TRANSLATION AND DISSEMINATION OF THE RESULTS OF CLINICAL RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH Consensus Development Conferences Stephen Katz, M.D., Ph.D., Director of the National In- stitute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), noted that for approximately 25 years, NIH has been utilizing Consensus Development Conferences to devise strategies to disseminate information. These conferences have been sponsored by the NIH Office of Medical Applications of Research and are conducted four to five times per year, when the knowledge base about an issue is sufficient to anticipate that the medical and scientific community can reach consen- sus on a particular issue. The subject is usually one of consid- erable public health importance, such as normal calcium in- take levels or the criteria for total joint replacement. Public involvement in the conferences is absolutely es- sential, not only for identifying what issues are important to the public but also for interpreting some of the information, said Dr. Katz. The conferences are advertised widely. Be- fore they take place, invitations are mailed directly to 20,000-100,000 individuals, a website announcement is posted one year in advance,8 and the conference notice is ~ This information is available at the NIH Consensus Development Pro- gram website: consensus.nih.gov. published in the Federal Register. In addition, there is a pub- lic news release two weeks prior to the conference. The conferences are webcast while they are taking place, and a draft statement is posted on the website on the last day of the conference. A final statement is posted 4-6 weeks afterward. In addition, there is a press conference on the last day of the meeting. After the consensus conference, final statements are mailed directly to individuals to whom the information is relevant and to others who have expressed interest. For ex- ample, the Consensus Development Conference on Diagno- sis and Treatment of Early Melanoma would specifically tar- get oncologists, dermatologists, and plastic surgeons to receive materials. The conferences also produce articles that are published in journals popular within the communities that would be impacted by the conclusions. Those who at- tend the conferences can receive 10-15 continuing medical education (CME) credits; after the conference, individuals can take online CME exams for one credit. Dr. Katz noted that the Office of Medical Applications and Research Advisory Committee is exploring how best to assess the translation and impact of this type of knowledge on behavioral change. ClinicalTrials.gov The NIH, through the National Library of Medicine (NLM) and in collaboration with the Food and Drug Admin- istration (FDA), has developed ClinicalTrials.gov to provide information about clinical trials for a wide range of diseases and conditions. In accordance with the FDA Modernization Act of 1997,9 work on the project to launch the site began in September 1998; the website was launched in February 2000. Currently, it contains approximately 7,100 clinical studies sponsored by the NIH, other federal agencies, and the phar- maceutical industry. The website receives over 3 million page views per month and hosts approximately 9,000 visi- 9P.L.105-115, 1997.
STEPS TO IMPROVE TRANSLATION AND DISSEMINATION tors daily according to Dr. Katz's presentation. Currently 8,250 websites link to ClinicalTrials.gov.~° The website designers met with many groups while de- signing and developing the system. In addition, before the site was launched, they conducted focused testing with 60 individuals from 19 voluntary health associations. ClinicalTrials.gov provides a single point of access for reli- able trial-related information and is searchable through a vari- ety of mechanisms. It also provides resources for understand- ing the risks and benefits of participating in clinical trials. Patients use the site to find out about the availability of trials, clinicians to improve medical practice, researchers for evi- dence-based medicine, sponsors for patient recruitment, and public policy makers to explore areas of research sunnort. said Dr. Katz. Clinical research sponsors prepare and submit data ac- cording to a set of standard data elements, often using a web- based protocol registration system to create, update, and re- lease trials to ClinicalTrials.gov. For each trial, the purpose, eligibility, location, and contact information are presented, as are the number of patients required and whether the study is filled or not. Site visitors can search for particular terms as well as closely related terms. For example, when the term "cancer" is entered, the site also searches for"neoplasm," "tumors," and "malignancies." The site recognizes spelling errors and allows the user to search within results, and users have the ability to browse by condition, sponsor, and other criteria. ClinicalTrials.gov also provides links to other relevant sites. For instance, a search for rheumatoid arthritis would provide links to the Arthritis Foundation, the American College of Rheumatology, and the American Association of Orthopedic Surgeons. Currently, all NIH trials are listed on ClinicalTrials.gov; trials sponsored by pharmaceutical and bioengineering com- panies may be listed with greater frequency in the futures Dissemination at NIAMS Dr. Katz listed a number of challenges to translating and disseminating knowledge. Those challenges include: . translating knowledge into behavior change of health care providers and the public; · making information available to all Americans (this includes disseminating information at an understandable lit- eracy level, and sensitivity to culture and vulnerable popula- tions); ID According to results of a Google web search performed on January 6, 2003. 1l CenterWatch also has a trial registry available at http:// www.centerwatch.com/patient/trials.html. The site provides a listing of many industry-sponsored trials. In addition, many websites provide infor- mation about trials for specific conditions or that meet other criteria. mation; and 41 making information available in many forms; knowing when and how to communicate the infor- · providing enough valid information. The NIAMS garners input on its information develop- ment strategies from a number of sources. The Institute has an Ad Hoc Advisory Group on Information Dissemination and Communications, a subcommittee of the NIAMS Advi- sory Council, which started about six years ago. In addition, NIAMS interacts with 67 voluntary and professional organi- zations as well as patient representatives current and former clinical study patients from the NIH on a regular basis. NIAMS translates and disseminates the results of this clinical research through printed materials, the Institute website, other outreach, and collaborations (see Box 4.2~. In addition to other dissemination tools, NIAMS has an inquiry phone line in both English and Spanish (1-877-22-NIAMS). Over the past five years, NIAMS has nearly doubled its ex- penditures on public health education and information dis- semination, to a total of three million dollars a year. ENGAGING PROVIDERS IN HEALTH INFORMATION DISSEMINATION Ken Getz, M.B.A., President of CenterWatch, asked the panel members to identify ways to better engage the health provider community in dissemination of information to the
42 "The general public wants to be educated, wants to be aware, and we need to focus resources on this issue." public. Mr. Walsh commented that the Alpha-1 Foundation is committed to funding dissemination of research results. The foundation initiated a process to update a standard of care document and worked with the American Thoracic So- ciety and the European Respiratory Society to convene a writing group of 30 or 40 investigators for the task. The A1- pha-1 community also played a role in the development of AlphaNet, a disease management entity that has invested several hundred thousand dollars in the development of a comprehensive disease management program that the foun- dation will be implementing and making available to physi- cians. The Alpha-1 Clinical Resource Centers, which operate in most states in the United States, connect general practitio- ners who have Alpha-1 patients with specialists who can pro- vide specific treatment and research information. The cen- ters also follow several Alpha-1 patients. Dr. Wolcott said that more research is needed about how to engage health care practitioners in lifetime learning. The cost of this research will be far less than the delays in imple- menting good clinical research, he commented. TARGETING MESSAGES Sometimes the willingness and the eagerness of the pub- lic to learn best practices is proportionately greater than that of the physicians who are "in the trenches" seeing patients. commented Dr. Wolcott. He noted that because of demands on clinicians' time and other pressures, it is difficult to get their attention. One way to get an NIH Consensus Report into the hands of physicians is to restate it so that it becomes a list of questions that patients ask their physicians about treatment, he suggested. Mr. Walsh noted that the Alpha-1 Foundation has de- veloped screening models that involve the distribution of test kits. He further commented that connecting a patient with a physician and going to a local newspaper or the local cable TV station to promote public interest in their story is a useful way to disseminate information. "The general public wants to be educated, wants to be aware, and we need to focus resources on this issue," he said. It may help to have new standards of care, but press and media involvement are im- portant to get the message across, he noted. FUNDING FOR RESEARCH TRANSLATION Hugh Tilson, M.D., Dr.P.H., Senior Advisor to the Dean of the University of North Carolina School of Public Health, ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE identified himself also as the chair of the national steering committee of the Agency for Healthcare Research and Qual- ity-funded Centers for Education and Research on Thera- peutics. He noted, from the perspective of his latter role, that the lack of money to fund research about the translation and dissemination of information regarding clinical trials is a major impediment. Research questions such as the weight- ing of evidence and the extent to which evidence should drive practice need to be answered for effective application of re- search results. He noted the importance of identifying a re- search agenda on effective methods for translating research into practice, as well as the need for an aggressive cross- agency program to encourage multiple agencies to invest money in this much-needed research. An audience member then asked Dr. Katz how much NIAMS spends on research that identifies effective means of translation. He responded that NIAMS does not spend a lot of money on this issue, because although it is a fruitful area for pursuit, it is a generic problem for research. There are paradigms that have to be developed, which is one of the pursuits of the Office of Behavior and Social Science Re- search. The education research that NIAMS has funded has focused primarily on the area of rheumatology. Dr. Wolcott noted that WebMD conducts consumer and marketing research that provides insight about what works, what doesn't work, and how to improve operations. Chang- ing health behaviors is part of WebMD's product, so this information is central to its mission. WebMD also owns Medscape, which provides information services for physi- c~ans. "What happens now," said Dr. Wolcott, "is we have huge research and development operations throughout the clinical research enterprise that generate lots of new, excit- ing findings, but the marketing of these discoveries is dis- connected... No publicly held company would operate that ``What happens now is we have huge research and development operations throughout the clinical research enterprise that gener- ate lots of new, exciting findings, but the marketing of these dis- coveries is disconnected... No publicly held company would op- erate that way; they would build the cost into the expenses for research and development." Barry Wolcoff way, they would build the cost into the expenses for research and development." NEGATIVE CLINICAL RESEARCH RESULTS When an audience member commented about the lack of reporting about research demonstrating negative results,
STEPS TO IMPROVE TRANSLATION AND DISSEMINATION "Orphan or rare disease communities are starving for new thera- pies. People understand that not everything will work and appreci- ate honest communication on progress of research activities." aloha Walsh Dr. Katz pointed to the negative findings of the Women's Health Initiative regarding hormone therapy. He commented that much healthcare practice is not based on strict evidence like the reviews from the Cochrane Collaboration, adding that many of the clinical studies reported in the literature are driven by companies, which do not want to publish negative results. The NIH is trying to find out whether something can be learned from negative studies reported to the FDA, he said. From a consumer perspective, the knowledge that re- search is being done is very important, said Mr. Walsh, and knowing what has worked and what has not worked is even more important. When a study supported by the Alpha-1 Foundation regarding use of a transgenic aerosol showed that the intervention did not work, the company that developed the aerosol, the Alpha-1 Foundation, and the investigators involved reported the negative results. This action earned them much credibility with the community. "Orphan or rare disease communities are starving for 43 new therapies. People understand that not everything will work and appreciate honest communication on progress of research activities," he said, adding that it is important to emphasize the positive lessons from each study and that work will continue on the problem. Reporting all results will help to keep the community engaged, he said. Dr. Wolcott com- mented that the general population is more interested in negative results than is the medical community. News orga- nizations take their leads about what is medical news from the traditional medical journals, which tend not to publish negative results. SUMMARY High-quality clinical research is not very useful if its findings are not implemented in practice. The Internet is one promising tool for communicating the findings of health re- search and could be used for other research purposes. Build- ing a community-centered research infrastructure and facili- tating community-centered research also can aid in the translation and dissemination of research. Consensus Devel- opment Conferences, ClinicalTrials.gov, and dissemination strategies that include public input are important elements for translation and dissemination implemented at NIH. Pri- vate companies, government entities, and voluntary health associations all have roles to play in the translation and dis- semination of research results, as evidenced by the comments of Dr. Wolcott, Dr. Katz, and Mr. Walsh.
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