| RUTH S. DAY / Duke University / |
| BASIC APPROACH |
The Medical Cognition Laboratory studies how people find, understand, remember, and use medical information. The basic approach has the following characteristics.
Who
Anyone who deals with medical information, especially:
| Health Care Professionals: | Consumers: | Others: |
| --physicians | --patients | --regulators |
| --pharmacists | --caregivers | --consumer groups |
| --nurses | --professional organizations | |
| --industry | ||
| --legal system |
Medical Information
| General types of medical information include: | --drugs (prescription, over-the-counter) |
Specific content includes:
--benefits
--risks (side effects, contraindications, precautions, drug interactions)
--instructions for use
--pictograms
--drug name confusions
--medical terminology & nomenclature
--medication schedules
--health diaries
Issues include:
--“cognitive accessibility” of information (see next section)
--alternative ways to display the same information
--cognition of both providers in patients
--risks (perception, communication, minimization)
--“fair balance” of benefits vs. risks
--information load vs. cognitive load
--medical error
--health outcomes
--doctor/patient communication
--informed consent
--electronic medical records
--health literacy
Cognitive Accessibility
A key concept in this work is “cognitive accessibility” (Day, 2000). It is the ease with which people can find, understand, remember, and use medical information.
Alternative Representations
Another key concept is “alternative representations” (Day, 1988). All information can be presented in alternative ways, but each has cognitive consequences – effects on attention, comprehension, memory, and problem solving.
Information Sources
A wide range of existing medical information sources is examined, developed for use by both health care professionals and consumers, including:
--FDA-approved labeling for drugs and biologics
--medical device labeling and manuals
--patient package inserts (PPI’s)
--Medication Guides
--pharmacy leaflets
--DTC (direct-to-consumer print, TV, and internet ads)
--OTC packages
--product websites
--health information websites
--informed consent forms
--Dear Healthcare Professional letters
--clinical guidelines
Basic Methods
Research projects generally use multiple phases, especially:
- Cognitive Analyses
Evaluate the cognitive accessibility of an Original Display (an existing information source such as a drug label, pharmacy leaflet, or TV ad). Calculate quantitative measures of cognitive accessibility, compare benefits vs. risks (e.g., for “fair balance”). - Enhanced Version
Keep the same information as in the Original Display, but modify it to enhance its cognitive accessibility, based on evidence-based cognitive principles. - Cognitive Experiments
Test the effects of Original vs. Enhanced Displays of the same information on cognition and behavior using carefully-controlled laboratory methods. - Real-World Tests
Test the effects of alternative displays on cognition, behavior, and health outcomes in everyday settings (hospitals, clinics, pharmacies, home care, health databases).
Goals
1) To understand why medical information can be hard to understand, remember, and use
2) To enhance the cognitive accessibility of medical information
3) To enable people to use medical information in a safe and effective manner
4) To enhance the benefits of treatments and minimize the risks
5) To reduce medical error (by both professionals and patients)
6) To understand how cognitive processes operate in real-world situations
7) To evaluate cognitive theories generated in the laboratory, based on findings from everyday cognition research in healthcare settings
| SAMPLE GRANTS/CONTRACTS |
--When "TALLman" Lettering Comes Up Short – A Solution for Drug Name Confusions Can Create New Problems. Pearson Medical Technologies, LLC, 2008.
--Comprehension of Prescription Drug Information – Consumer Monographs. First DataBank, Inc., 2007
--Understanding the benefits and risks of prescription drugs. Arts & Sciences Research Council, Duke University, 2006.
--Effects of depression on comprehension and recall of prescription drug information. Duke University, 2006.
--Unheeded warnings: Physician comprehension of drug safety updates. Duke University, 2006.
--Perception of guestures in humans and virtual reality characters. National Science Foundation
(with Research Triangle Institute), 2006.
--Comprehension of key information in mandatory medication guides and patient package inserts. HHS/AHRQ, CERTs (with Duke Clinical Research Institute), 2002.
--Responsive virtual human technology research. National Science Foundation (with Research Triangle Institute), 2001.
--Usability Testing of Model Medical Device Patient Labeling. U.S. Food and Drug Administration, Center for Devices and Radiological Health, 1999.
--Optimizing Patient Comprehension through Medicine Information Leaflets. U.S. Pharmacopeia, Inc. 1998 (with Pharmacy School, University of North Carolina).
--Comprehension of Drug Information in the Elderly. National Institutes on Aging, 1988.
| PROFESSIONAL ACTIVITIES |
FDA Advisory Committees
--Drug Safety and Risk Management Advisory Committee
--Consultant and voting member at meetings for other Advisory Committees
--Sample Advisory Committee (AC) meetings and issues:
--Gastrointestinal Drugs AC, 2002 (Lotronex)
--Drug Safety & Risk Management AC, 2002 (Pharmacy Leaflets)
--Nonprescription Drugs AC, 2002 (Acetaminophen)
--Nonprescription Drugs AC, 2002 (Aspirin and NSAIDs)
--Arthritis AC, 2003 (Arava)
--Dermatologic & Ophthalmic Drugs AC, 2004 (Accutane)
--Dermatology AC, 2004 (Tazoral)
--Drug Safety & Risk Management AC, 2004 (Drug Names: Look-alikes and Sound-alikes)
--Pediatric AC, 2005 (Topical Immunosuppressants)
--Arthritis AC, 2005 (Cox-2 Inhibitors: Vioxx, Celebrex, Bextra)
--Drug Safety & Risk Management AC (Postmarket Surveillance Techniques)
--Nonprescription Drugs AC, 2006 (Comprehension Testing for Rx-->OTC Switch Drugs)
--Arthritis AC, 2007 (Arcoxia)
--Endocrinological and Metabolic AC, 2007 (Avandia)
--Gastrointestinal Drugs AC, 2007 (Tysabri)
--Drug Safety & Risk Management, 2007 (Accutane)
--Cardiac and Renal Drugs AC, 2007 (EPO)
--Cardiac and Renal Drugs AC, 2007 (Trasylol)
--Oncology Drugs AC, 2008 (EPO)
--Anesthetic and Life Support Drugs AC, 2008 (Oxycontin)
--Anesthetic and Life Support Drugs AC, 2008 (Fentanyl)
--Cardiac and Renal Drugs AC, 2008 (Contrast Agents in Ultrasound)
--Endocrinological and Metabolic AC, 2008 (Cardiology Outcomes in Diabetes Clinical Trials)
--Peripheral and Central Nervous System AC, Pediatric Drugs AC (Suicidality in Antiepileptics)
FDA Public Meetings
--Invited presentations or panel membership
--Sample meetings:
--Direct-to-Consumer Advertising of Prescription Drugs, 2003
--Direct-to-Consumer Advertising of Prescription Drugs, 2005
--Risk Communication, 2005
--Drug Name Confusions, Office of Surveillance & Epidemiology, 2008
Professional Conference & Workshop Presentations
--Presentations to professional organizations such as the Drug Information Association,
Pharmaceutical Education Association, Barnett International, Food & Drug Administration,
Renal Physicians Association, International Pharmaceutical Federation.
--National Science Foundation Chautauqua Program – Short courses on “Cognition and Teaching.” Part 1 – “Basic Cognitive Processes.” Part 2 – “Higher Mental Processes.” Courses for faculty members in all academic disciplines (e.g., physics, chemistry, biology, engineering, health sciences, psychology, sociology, political science, linguistics, public policy, philosophy, history).
--Brief versions and variations of the “Cognition and Teaching” course presented at:
Professional meetings (e.g., American Academy for the Advancement of Science, American Association for Higher Education, American Chemical Society, Lilly Foundation, Great Lakes College Association, Funds for the Improvement of Post-Secondary Education, Faculty Development Resource Association, Bush Foundation, US-Canadian Consortium on Education, State of Pennsylvania Department of Education, MacArthur Foundation, MENSA Society, Duke University Center for Science Education, )
Academic institutions, including entire faculties (e.g., Brown, Northwestern, University of Chicago, University of Dayton, Lynchburg College), cross-disciplinary group workshops (e.g., Hollins College, Denison University, LaSalle University, Catholic University of Puerto Rico, Idaho State University, Appalachian State University, Reed College, Hobart & William Smith College, Mt.Union College), and departments/schools (e.g., Montana State Physics Deparment, University of Missouri College of Agriculture);
--“Cognition in the Workplace,” short courses to IBM managers.
Expert Witness Testimony
National Transportation Safety Board and Food & Drug Administration. Understanding warnings:
Do pictograms help? 2001.
U.S. Congress, House of Representatives, Committee on Energy and Commerce. DTC ads for prescription drugs – What do people understand and remember? Hearing on direct-to- consumer advertising of prescription drugs. May 8, 2008.
U.S. Congress, Senate Committee on Aging. DTC ads for medical devices – What do people understand and remember? Hearing on direct-to-consumer advertising of medical devices. September 17, 2008.
Consulting
Formal and informal consulting for various “stakeholders” in the pharmaceutical, medical device, and general medical communities, such as the U.S. Food and Drug Administration, the U.S. Pharmacopeia, Blue Cross Blue Shield, American College of Physicans, National Consumers League, information vendors, industry, hospitals, physician practices, foundations, and professional organizations. Examples include:
--Proposed rule for physician labeling: Cognitive aspects. Food and Drug Administration, CDER Live, Satellite Video Conference, 2001. Also, format design for final rule.
--Migraine triggers: Design for a heath condition diary. Glaxo, Inc. (Note: resulted in a patient-physician brochure, Charting Your Route to Relief: A Personal Migraine Management Program, in use from 1994 to present.)
--Multiple medication schedules to enhance patient compliance. Individual physicians.
--Auto-injectors for drug delivery. Dey, Inc. (Note: redesigned Patient Package Insert for EpiPen® for severe allergic reactions, subsequently packaged with the product)
--Electronic medical records -- design/development/testing for cognitive accessibility. Duke University Medical Center.
--Risk assessment/perception/management and patient safety. FDA, Center for Drug Evaluation and Research.
| PAPERS/ PRESENTATIONS |
Overview of Research Approach & Major Findings
Day, R.S. Comprehension of prescription drug information: Overview of a research program.
Proceedings of the American Association for Artificial Intelligence. Argumentation for
Consumer Healthcare, 2006. (www.aaai.org)
Key Concept Paper
Day, R.S. Alternative representations. In G.H. Bower (Ed.), The Psychology of Learning and
Motivation. New York: Academic Press, 1988, 22, 261-305. (Note: includes research on
alternative displays for multiple medication schedules.)
Early/mid 1990’s
Day, R.S. Reducing medication mistakes in the elderly. Cognitive Aging Conference, 1990.
Day, R.S. Alternative displays: Effects on memory and problem solving for drug information. Glaxo, Inc, 1994.
Day, R.S. Deadly drugs vs. medical miracles: Understanding prescription medications. North Carolina Cognition Conference, 1994.
Day, R.S. Cognitive analysis of Zantac information: Text and pictorial problems. Glaxo, Inc., 1995.
Day, R.S. Understanding, remembering and using drug interaction information. Psychonomic Society, 1995.
Day, R.S. Deadly drugs vs. medical miracles: Understanding prescription medications. North Carolina Cognition Conference, 1996.
Day, R.S. Memory and problem solving in pharmacology. Medical pharmacology course, Duke University Medical School, 1996, 1997.
Day, R.S. Memory and problem solving in pharmacy. Pharmacy School, University of North Carolina, 1996.
Day, R.S. Memory for drug information. Pharmacy School, University of North Carolina., 1996.
Day, R.S. Understanding drug information: Recent studies. Thailand Pharmacy Delegation, 1996.
Day, R.S. Cognitive problems in everyday pharmacy practice. Senior Pharmacy Administration Staff, Duke University Medical Center, 1996.
Day, R.S. Ways to display drug information: Effects on memory, comprehension, and decision making. Medical Practice Board, Duke University Medical Center, 1997.
Day, R.S. Everyday cognition. Science and Technology Group, Trent Associates, Duke University, 1998.
1999
Day, R.S. Cognition experiments: Optimizing patient comprehension through medicine information leaflets. In A.G. Hartzema, S. Tolleson-Rinehart, B.L. Sleath, and R.S. Day,
Optimizing patient comprehension through medicine information leaflets. Rockville, MD: U.S. Pharmacopeia, 1999, 60-176.
Day, R.S. Comprehension and memory for information in MedCoach pharmacy leaflets. U.S. Pharmacopeia, 1999.
Day, R.S. Drug information pictograms: If a picture is worth 1,000 words, which words are they? North Carolina Cognition Conference, 1999.
Day, R.S. Useful patient information. National Drug Information Stakeholders Meeting, U.S. Pharmacopeia, 1999.
Day, R.S. Cognitive aspects of drug information: Implications for patients and professionals. Micromedex, Inc., 1999.
2001
Day, R.S. Understanding pictograms: A comprehensive approach. U.S. Food and Drug Administration, Center for Biologics, 2001.
Day, R.S. Mapping the flow of events in a medical clinic: Implications for cognition and behavior. Mission St. Joseph Research Institute, 2001.
Day, R.S. Using an electronic medical record: Effects on the cognition and behavior of providers. Duke Clinical Research Institute, Duke University, 2001.
Day, R.S. Understanding warnings: Do pictograms help? National Transportation Safety Board and U.S. Food and Drug Administration, 2001.
2002
Day, R.S. Cognitive Accessibility of Drug Benefits vs. Risks: Hardcopy, TV, and Internet. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 2002.
Day, R.S. Fair Balance of Benefits vs. Risks: Cognitive Aspects. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 2002.
Day, R.S. Everyday cognition: Research in the Laboratory vs. Real World – Medical cognition. American Psychological Association Distinguished Speaker Series in Cognitive Science,
2002.
Day, R.S. Drug-device labeling: Maximizing comprehension & use. Drug Information Association Annual Meeting. 2002.
Day, R.S. Star Trek Jet Injector: Comprehension problems and solutions for a hypothetical medical device. Drug Information Association Annual Meeting, 2002.
Day, R.S. Consumer comprehension of educational materials: Key cognitive principles. Invited Address, U.S. Food & Drug Administration, Drug Safety & Risk Management Advisory
Committee, Meeting on Pharmacy Leaflets, 2002.
Day, R.S. Drug-device combinations: Enhancing labeling comprehension & use. Barnett International Conference, 2002.
Day, R.S. Comprehension and problem solving: Hypothetical drug-device combinations. Barnett International Conference, 2002.
2003
Day, R.S. Using human factors & cognitive principles to enhance labeling comprehension. Drug Information Association, 2003.
Day, R.S. Effective risk communication for providers, patients, & the general public. Drug Information Association Annual Meeting, 2003.
Day, R.S. Rare and serious events: Labeling comprehension. Invited Address, Arthritis Advisory Committee, U.S. Food and Drug Administration, Center for Drug Evaluation and
Research, 2003.
Day, R.S. Understanding drug labeling. National Public Radio, Peoples Pharmacy, 2003.
Day, R.S. Understand Rx drug information: TV ads, internet, hardcopy. U. S. Food and Drug Administration, Center for Drug Evaluation and Research, Public Meeting on Direct-to-
Consumer Advertising of Prescription Drugs, 2003.
2004
Day, R.S. Comprehension and communication of benefits and risks: Implications for stakeholders. Pharmaceutical Education Association Conference on Assessing Benefit, Risk, and Benefit-Risk Balance, 2004.
Hubal, R.C., Guinn, C.I., Sparrow, C.C., Studer, I.J., Day, R.S., and Visscher, W.A. A synthetic character application of informed consent. American Association for Artificial Intelligence,
Dialogue Systems for Health communication, 2004. New York: ACM Press.
2005
Day, R.S. Providing vs. communicating risks: Cognitive principles & experiments. Pharmaceutical Education Association, 2005.
Day, R.S. Alternative representations: Drugs, dance, and the law. Southern Society for Philosophy and Psychology, 2005.
Day, R.S. Communication vs. comprehension of risks. Toxicology Forum, Aspen Institute, 2005.
Hubal, R.C. and Day, R.S. Informed consent procedures: An experimental test using a virtual character in a dialog systems training application. Journal of Biomedical Informatics.
Special issue on Dialogue Systems for Health Communication, 2005, 39, 532-540.
Day, R.S. Risk information: What do patients understand and remember? Drug Information Association Annual Meeting, 2005.
Day, R.S. Comprehension of benefits vs. risks: Medication guides & patient package inserts. Duke Clinical Research Institute, Research Conference, 2005.
Day, R.S. Comprehension of benefits & risks: Rx TV ads & medication guides. Visiting Professor Lecture Series, U.S. Food & Drug Administration, Center for Drug Evaluation
and Research, 2005.
Day, R.S. Risk communication: How serious is "serious”? U.S. Food & Drug Administration, Public Meeting on Risk Communication, 2005.
Day, R.S. Comprehension of benefits vs. risks: Fair balance in DTC? U.S. Food & Drug Administration, Public Meeting on Direct-to-Consumer Advertising of Prescription Drugs.
2006
Day, R.S. Understanding Treatments: Patients and Physicians. Renal Physicians Association, 2006.
Day, R.S. Did they get it? Factors that affect consumer comprehension of benefits vs. risks in Rx TV and print ads. Drug Information Association, DTC Meeting, 2006.
Day, R.S. What did they say? Understanding & remembering health information. The Forest at Duke Retirement Community, 2006.
Day, R.S. Comprehension of prescription drug information: Overview of a research program. American Association for Artificial Intelligence, 2006.
Hubal, R. and Day, R.S. Understanding the frequency and severity of side effects: Linguistic, numeric and visual representations. American Association for Artificial Intelligence, 2006.
Day, R.S. Communication healthcare information: Consumers, patients, physicians. Health Sector Advisory Council, Fuqua School of Business, Duke University, 2006.
Day, R.S. From DTC to DHCP: Common problems in risk communication. Drug Information Annual Meeting, 2006.
Day, R.S. Benefits vs. Risks in Rx Drug Ads: What do people understand & remember? National Consumers League, conference on Research Approaches in Direct-to-Consumer Advertising of Prescription Drugs, 2006.
Day, R.S. Understanding drug ads: Cognitive research and implications. Food Drug and Law Institute, 2006.
Day, R.S. Cognitive accessibility of OTC drug information. Nonprescription Drug Advisory Committee, U.S. Food and Drug Administration, 2006.
Day, R.S. Comprehension and memory for TV drug ads. Psychonomic Society Annual Meeting, 2006.
2007
Day, R.S. Memory in the real world: Benefits and risks of prescription drugs. Joint meeting of the Experimental Psychology Association (Britain) and the Psychonomic Society (U.S.), 2007.
Day, R.S. Cognitive accessibility of consumer tools. Invited Address, Blue Cross and Blue Shield Association, 2007.
Day, R.S. “Everyday Cognition: Comprehension and Memory for Prescription Drug Information.” Invited Address, Southeastern Psychological Association Annual Meeting.
Day, R.S. Memory Failures in the Real World: What Were Those Side Effects?! Psychonomic Society Annual Meeting, 2007.
2008
Day, R.S. Understanding drug ads: Cognitive research & implications. Staff briefing, U.S. House of Representatives, 2008.
Day, R.S. Everyday cognition: Comprehension and memory for prescription drug information. Invited Address, Southeastern Psychological Association, 2008.
Day, R.S. DTC Drug Ads: What Do People Understand & Remember? Expert Witness Testimony, U.S. House of Representatives, Committee on Energy and Commerce, Hearing on Direct-to-Consumer Advertising, 2008.
Day, R.S. DTC Ads for Rx Drugs: What Do People Understand & Remember? U.S. House of Representatives, Committee on Energy and Commerce, hearing on direct-to-consumer
advertising of prescription drugs, 2008.
Day, R.S. DTC Ads for Medical Devices: What Do People Understand & Remember? U.S. Senate, Committee on Aging, hearing on direct-to-consumer advertising of medical devices,
2008.
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