May 21st, 2004

Louisiana State University Health Science CenterMs. Ellen M. FoxProgram CoordinatorPulmonary/Critical Care Medicine1901 Perdido StreetSuite 3205New Orleans, LA 70112-1393

SPECIFIC AIMS OF THE QA-ASTHMA PROJECT-LSU-NEW ORLEANS1. Identification and Significance of the Problem

Many outstanding problems in the area of clinical medicine would seem well suited to the application of computer technology, especially the advanced information technology provided by computerized clustering and pattern techniques.

Computer software technology is being seen as an increasingly more feasible way to devise tools to aid in the management of patient care. Physicians and providers of care are also interested in methods, tools, and techniques that can involve the patient in monitoring his or her own care. By engaging the patient as an equal partner in disease management the patient obtains education on the particular disease and its treatment. One of the cutting edge software technologies is the area of computerized clustering techniques. The trend in “intelligent” medical systems has been away from diagnostic systems and toward systems for the overall planning and achievement of goals related to quality of care and cost containment in health care delivery. This change in focus is a result of many factors, including medical cost problems, the Medicare funding crisis, problems in delivering care to under, or uninsured, the malpractice crisis, product liability lawsuits, and the increasing control by the (FDA) Food and Drug Administration over the software medical diagnostic industry. [Muscarello & Valenta, 1995; Applied Knowledge Inst., 1990]

Engagement of chronic disease patients in the planning and management of their care should offer significant increases in quality of care with savings in the costs associated with disease management. [NAEPP, 2000] There are numerous chronic diseases, which could serve as foci for study. This project will concentrate on one of the most pressing problems—Asthma in adults.

1a. Medical Focus of the ProjectAsthma is a chronic and debilitating respiratory disease afflicting over 14-million Americans

with thousands of new cases added each day. Air becomes trapped in the lungs, with the ability to breath out compromised to various degrees. Like bronchitis and emphysema, it causes a tightening of the chest and difficulty in breathing. Asthma’s symptoms are not always present. They come in episodes, set off by various environmental or emotional “triggers,” such as foods, chemicals, pollutions, pollen, animal dander, tobacco smoke, exercise, and emotional stress.

During an asthma episode, lung muscle spasms and swelling bronchial tissues narrow the lung, as airways become clogged with excess mucus. Stale air is trapped in the bottom of the lungs, forcing one to use the top portion to gasp for air. For some, asthma is a mild annoyance, with moderate episodes consisting of short incidents of breathlessness and wheezing. For others with severe cases, asthma becomes a life-threatening condition where the lung airways become so narrow and clogged that breathing is impossible, requiring immediate emergency medical intervention.

According to the (NHLBI) National Heart, Lung, and Blood Institute all levels of Asthma have increased more than 75% since 1980. Today, Asthma is one of the top reasons for hospitalization of children. It causes children to miss more than 10-million school days a year and

adults to miss 3-million days at work. It is responsible for more than 2.7 million medical visits a year, and this year responsible for more than 5,637 deaths in 1995, more than twice as many as in 1981.

The emphasis on today’s Asthma treatment is prevention and control. The best way to achieve such control is by closely monitoring the underlying factors that produce the “triggers” that stimulate asthma attacks. Physicians and clinicians have always been an active part of the asthma solution – in the best-case scenario monitoring Asthmatics on a regular basis. Traditionally, the Asthmatic individual has not been an active partner in the control of this disease, relying instead on the advice and counsel of medical experts for the solution.

To achieve control over this disease, Asthma needs to be monitored closely—every day if necessary. For the Asthmatic person, this is not as hard as it might sound, and the payoff can be enormous. Studies have shown that people who learn to monitor their Asthma, and communicate their opinion have a higher overall quality of life, fewer emergency room visits, and lost days from work or school.

According to Dr. John Jay Shannon, associate chairman for Respiratory and Intensive Care Medicine, Department of Internal Medicine, Cook County Hospital, Chicago, IL, “We have experienced significant increases in Asthma patients traffic at Cook County that follow a rapidly growing nationwide trend. For example, between 1/1/96-12/31/97: there were 4,150 admissions to the hospital for Asthma, and (COPD) chronic obstructive pulmonary disease exacerbation.” Estimating the costs of Asthma is one way to measure its health burden. Using a hospital industry average of $2,000 per day, with a minimum of a two-day hospital stay per Asthma patient, Cook County Hospital has incurred an estimated $16,600,000 in direct Asthma patient medical costs. Other Cook County Hospital figures also show a rise in Asthma patients in other areas. Ambulatory visits to Cook County Hospital's Adult Asthma clinic from 1994-1999, omitting 1996 are as follows (Figures provided by Cook County Hospital, 11/2000):

1994-16731995-16131997-22231998-21271999-2758

A2. Technical ObjectivesThe goal of the project is to develop an innovative survey instrument that will assess an asthma patient’s status, opinions and attitudes to help control and prevent Asthmatic episodes. The information gathered by the instrument will be used by the patient’s physician to monitor and treat the disease, and open new avenues of communication and shared understanding.

The project will focus on inner-city minority (African-American), adult patients, for example, as in a large urban hospital (Cook County Hospital, Chicago, IL.) These patients will have a high likelihood of suffering quality of life impediments, and are hospitalized and treated in the emergency room at a high frequency. They are also least likely, due to education and socio-economic status, to be able to use existing methods of patient education and self-management. This may be achieved using the latest computer software and hardware technologies to develop an integrated system, which would achieve the following sub goals relating to NAEPP goals:1. Define and develop patient self-monitoring instrument. The formulation and

establishment of such an instrument tied to treatment protocols and provider standards would allow for consistency, predictability, and reliability in the planning, monitoring, and allocation of health care services, while allowing the provider organization to meet budgetary and cost-containment goals. A specific practice area or domain of expertise must be used for an initial effort. The area of chronic asthma monitoring has been chosen. This domain is amenable to representation in a survey instrument, experts are readily available and willing to

work, and the domain is one of interest and importance to those involved in health treatment & cost planning.

2. Monitor adherence to established standards by patients and individual practitioners. The patient and physician will work together in monitoring the course of treatment. Regular, close scrutiny of treatment delivery patterns would identify individual patients whose symptoms or measures were outside established norms with regard to adherence to the treatment regimen. This will reduce the numbers of emergency room visits and hospitalizations.

3. Increasing patient knowledge and ownership of the disease and treatment. The use of the instrument will provide a simple cost-effective method of educating patients, a simple means of communication about the disease between patient and practitioner, and a means whereby the patient increasingly takes a more effective role in ownership and treatment of the disease.

4. Increasing quality of life. By allowing patients to understand and take control of their conditions, the patient will be able to reduce activity limitations, lost work days, and lost school days.

5. Assist staff in treatment planning. Such an instrument would be a valuable tool in assisting physicians and nursing staff in the delivery of treatment plans (including asthma care according to NAEPP guidelines), especially those incorporating infrequently used or costly diagnostic or hospital inpatient procedures.

6. Assist in monitoring trends in patient groups. Data obtained through use of the survey would allow the physician or nurse to monitor trends in a patient’s condition and progress, as well as trends over patient populations.

A2a. Project Proposal - Designing (QA) Qualitative Asthma MethodologyThe project goal is to design a QA-method (Qualitative Asthma method) medical

methodology and survey instrument, focusing on capturing, measuring, and storing subjective patient attitudes and opinions on issues pertaining to asthma healthcare for the purpose of communicability, education and shared understanding of the asthmatic human experience. The subjective QA-information will be integrated with a relational database using a variety of statistical patient data (clinical data) to form an asthma longitudinal patient care record. A QA-historical file is created for identifying and exploring patterns and clusters (related to disease status, symptoms) among asthma participants. QA-method will have the capability of understanding both quantitatively and qualitatively, an individual participant’s profile, by viewing the participant as a member of a particular QA-asthma factor group. QA’s power is grounded in the value of the participant; producing a stable contextually intact interpretation of the participant’s point-of-view that can be observed, measured and studied. The asthmatic person now becomes an interactive partner with the doctor and clinician in controlling and preventing asthmatic episodes, resulting in real healthcare ownership, and improved quality-of-life.

The QA-methodology and instrument will be grounded in Q methodology. Subjectivity, in the lexicon of Q methodology, means nothing more than a person’s communication of his/her point of view. As such, subjectivity is always anchored in self-reference, and does not render it inaccessible to rigorous examination. Within this context, self-referent subjectivity of this sort is pure behavior, and it is at issue anytime an individual remarks, “It seems to me…or, I really feel…or, in my opinion. In speaking thus, an individual is saying something meaningful about personal experience, and what Q methodology provides is a systematic means to examine, and reach measurable understanding about such individual personal experience and what it means.

PHASE 1Qualitative Technologies, Inc. and its co-founders have been working on tools, survey

instruments, and methodologies to be used in the education, marketing, and delivery of medical

systems, education, and treatment management for over 10 years. Prototypes of similar methods have been developed and tested for feasibility.

The past knowledge engineering process has yielded a preliminary version of the basic methodology to be used in designing and delivering the instrument. Existing methods and tools for presenting survey instruments, analyzing data, and creating patient factor groups do not automatically store data for ease of access. There is no access to clinical data (which is stored on departmental computer systems.) Further work on the design and testing of the survey instrument specifically for asthma patients is necessary. This would entail additional time spent in the knowledge acquisition process. This will entail meetings to be held with relevant hospital staff, the consultant, and especially patients for purposes of further delineating variables, statements, and measures to be used in the instrument.

The proposed Phase I research project would involve the investigation and building of a prototype assessment instrument to assist in the self-monitoring of patient status. This will allow the patient to be a co-manager of the disease with the practitioner. The patient will be empowered to participate in treatment for quality, efficiency, and proper utilization. The standard of care analysis can be done based on many factors including diagnosis, patient variables, service rendered, physician specialty, etc.Uses of patient self-monitoring assessment survey instrument

The uses of such an instrument and the establishment of methods of measuring care would include:

1) Tracking of changes in patient symptoms or status;2) Adjustment of patient treatment plan;3) Post auditing of treatments and services;4) Peer review and evaluation5) Planning the overall allocation and delivery of health care services.

Data UsedThe input data used for development of the survey instrument would include public health

data on asthma, historical data, physician profile data, and other sources of available data. This data can be made available by the participating departments at Cook County Hospital, which maintains its own database of case data. However, the major source of information for the building of the instrument will be patient and provider interviews and focus groups related to the issues of patient disease status, assessment, and management. The initial prototype would be limited to one practice area, Asthma. Once the method’s overall performance has been proven in that area it can be expanded to include other chronic diseases such as cardio-respiratory, diabetes, emphysema, and heart.

It must be specifically noted that the proposed prototype will be developed using the available resources at Cook County Hospital, Chicago, IL. When the prototype has been implemented and tested for functional, user, and content acceptability consideration will then be given to expansion, first to other Chicago area asthma practices and then on a state and regional level and finally at the national level. This expanded testing would be done during Phase II of the project. We are currently discussing the assistance of faculty and students at both Cook County Hospital and the University of Illinois at Chicago, for assistance in designing and carrying out the validation process. Review of the Domain Expertise will be done by participating physician and nursing members of Cook County Hospital.Cost Projections

Cost projections can be made based on a number of factors including such areas as diagnosis, treatment plan, or cost centers. Closer management of the disease by patients should provide an important capability in the area of health care service allocation and planning under the constraints of cost-containment.

PHASE 2The principle objective of the Phase 2 project will be to design and develop a fast, effective

and accurate online, interactive web-based software, system that can capture, measure and analyze subjective opinions and attitudes of Asthmatic individuals for the purpose of building more effective health care treatment and treatment ownership. As the list of problems and challenges previously mentioned demonstrates, most of the limitations of the current manual Q-method stem from a lack of ability to handle large problems and diverse audiences, separated by time, location and distance. Today, approximately 700 qualitative researchers use manual Q-method worldwide, conducting surveys in person, and are limited to small problems and audiences. (QA) Qualitative Asthma will be a technological application leap into the 21st Century, serving the needs of participants numbering in the millions, across innumerable locations, geographic distances and time zones.

WHAT IS Q-METHOD?Q-entails a method for the scientific study of human subjectivity. Subjectivity, in the lexicon of Q methodology, means nothing more than a person’s communication of his/her point of view. As such, subjectivity is always anchored in self-reference, and does not render it inaccessible to rigorous examination. Within this context, self-referent subjectivity of this sort is pure behavior, and it is at issue anytime an individual remarks, “It seems to me…or, I really feel…or, in my opinion. In speaking thus, an individual is saying something meaningful about personal experience, and what Q methodology provides is a systemic means to examine, and reach measurable understanding about such individual personal experience and what it means.

Toward this end, the respondent’s frame of reference is preserved. Q-studies, from conception to completion, adhere to the methodology axiom that subjectivity is always self-referent. As Kent State University’s Steven Brown, said, (1986:58) “Only subjective opinion are at issue in Q, and although they are typically unproven, they can be shown to have structure and form, and it is the task of Q- technique to make this form manifest for the purpose of observation and study.”

Q-Sort’s will be a major new decision support software tool, capable of integrating its power of impressive subjective study, understanding, and analysis capabilities that can integrate with large-scale relational databases/data marts. As a methodology, Q-sort embraces a distinctive orientation toward the systematic study of human subjectivity. Defined as such by a particular logic of inquiry, as by technical specifications, this orientation can sometimes clash with conventional “R” methodology approaches to the measurement and study of subjective phenomena such as opinions, attitudes, and values from an expressive viewpoint.

The principle of Q’s subjective contextuality is tied to self-reference, and also to Q’s premise as a method of impression, as opposed to expression. Since the impression versus expression distinction lies at the heart of the difference between Q and R method’s, it’s important to elaborate briefly.

Under methods of expression (R method), respondents are measured for traits, attitudes, and the like from the external point of view. The respondent’s own view on the matter at issue is of little interest, or is seen as having little significance. With the Q-method of impression, on the other hand, the personal, individual significance of the test stimuli is of primary importance. When responding to them, the subject assigns scores (weights) in terms of some relevant condition that bears, in one way or another, on his/her internal frame of reference.

It’s important to steer a middle course between Q and R method. Distinctiveness, is often taken to imply superiority, and whether it’s intended or not, researchers, such as myself are convinced of Q’s virtuosity. While important differences between Q & R exist, and while these differences almost inevitably give raise to contention over, which is right, and which cause is therefore just. I know from personal experience that vigorous efforts towards methodological elucidation share a very thin line with self-righteous and pretentious forms of methodological evangelism. On the other hand, there is little to be gained from neglecting entirely the distinctiveness of the two methods in the interest of avoiding undue contentiousness in the service of advocacy. The following simple example lets us see the distinctiveness of Q and R methods. Both Q & R are excellent methods within their own context; one is not superior over the other.

The importance of contextuality in Q method versus R method is made in the following example: Suppose four stimuli, arrayed below in the left-hand column, form a mini scale of political values, and that subjects A and B complete the scale by responding in a yes/no fashion in the same way as shown.

Yes No(1) Human rights A, B(2) Property rights A, B(3) Communism A, B(4) Fascism A, B

Their identical responses would seem to indicate a possible shared, “liberal” ideology however, if we change the behavioral task, and ask them to rank order (Q) the items vis-à-vis one another, the results could well be the following:

A B(Most Agree With) 1 2 2 1 3 4 (Least Agree With) 4 3 In terms of political values, individual A is now clearly of the political Left, whereas B is closer to the Right. Two people passing as ideological twins on the yes-or-no (R method), upon closer scrutiny, afforded by a slight, but significant methodological alteration are actually political opponents. In this fashion, contextuality clarifies what by definition and design is unclear at the outset of the Q-study. Respondents themselves, apart from the researcher’s preconception, they define the world about them.

Qualitative Technologies, Inc.David R Donohue, MA