Medical Outcomes Trust January 1997 BULLETIN

January 1997 ~ Volume 5, Number 1

Message From the Vice President
Lyn Paget, MPH

With this issue of the Bulletin, we are taking the opportunity to highlight some of the many strides that were made in the field of health outcomes and at the Medical Outcomes TRUST during the past 12 months. The field witnessed a number of key policy decisions that will influence the agenda of health care delivery and the assessment of health care quality in this country. This year, the Health Care Financing Administration will begin to require that all Medicare managed care providers perform routine collection of functional status information from patients using a standardized patient-report survey. This policy decision followed the National Committee for Quality Assurance’s action to incorporate health outcomes information in the latest version of the Health Plan Employer Data and Information Set (HEDIS 3.0). The Joint Commission on the Accreditation of Health Care Organizations’ initiatives in performance-based accreditation is committed to including measures of functional status in its new mandates for indicators of performance measurement. The American Medical Association is developing a physician accreditation program which will standardize physician quality assessment and will include health outcomes as an element of assessment. All of these initiatives intimate a future in which integration of health outcomes measurement and standardized measures of quality from the patient’s perspective are an integral part of health care delivery.

Genuine integration of outcome information into systems of care that will permit the concept of universal adoption of health outcomes measurement to become a reality will be markedly advanced by research and development. Most promising in this research is the use of computer-adaptive technologies to enhance the precision of measures, to provide a technology for monitoring health status in individual patients, and to lower the cost and increase the efficiency of data collection. Leaders in health outcomes research are collaborating with experts in the field of educational testing to develop technologies that integrate the principles of item response theory and computer-adaptive methods with measures of health outcomes. This encouraging and exciting work will lead to more efficient and user-friendly systems of measurement.

The TRUST is approaching its fourth year of operation as a non profit, public service organization dedicated to advancing the science and use of instruments for measuring health and the outcomes of health care from the patient’s perspective. We strive to accomplish this mission through the provision of services in four principal areas: instrument distribution, publications, member services, and education. Four full-time staff are employed at the TRUST. The President serves as an unpaid volunteer. The TRUST is not affiliated with any other organization and functions as an independent, 501(c) (3) corporation. Fees are established to cover the costs associated with each service category. A nine-member Board of Trustees governs the TRUST and a six-member Scientific Advisory Committee evaluates all instruments distributed by the TRUST.

Instrument Distribution and the Scientific Advisory Committee
In September, 1995, the Scientific Advisory Committee released its Instrument Review Criteria. This document, which is publicly available, defines the eight instrument attributes the Committee takes into account in the review process and defines the criteria associated with each attribute. The Committee reviews instruments on a quarterly basis and is presently developing an addendum to the criteria to specifically address the translations of TRUST approved instruments.

All instruments distributed by the TRUST are reviewed by the Scientific Advisory Committee prior to acceptance into the TRUST. The Committee forwards its recommendation to the President and Vice President, who in turn present this information to the Board of Trustees. The Board grants final approval. Over 30 instruments have been submitted to the TRUST for consideration, and 13 instruments have completed the review process and been formally accepted. Several of the most widely used and extensively documented generic health status instruments have been approved by the TRUST, including the Quality of Well-being Scale, SF-12 Health Survey, SF-36 Health Survey, and Sickness Impact Profile. Recent instrument submissions have included several condition-specific instruments, such as the MOS HIV Health Survey and Seattle Angina Questionnaire. It is an objective of the TRUST to continue to expand the diversification of the instrument library, especially in the area of condition-specific measures.
Each month, the TRUST distributes over 100 instrument packets and close to 150 supplemental manuals and publications. Instruments are provided in a complete package for the user including the questionnaire, its scoring instruction and administration protocols, a bibliography, and several reprints of important published articles.

Publications
In March, 1997, the TRUST will publish its 20th issue of the Bulletin. The Bulletin is a bi-monthly newsletter providing technical information on the instruments distributed by the TRUST and updates in the field of health outcomes. The Monitor is a more in-depth publication offering news coverage, opinions, and research summaries in the four affinity areas of TRUST membership: research and policy, clinical practice application, health system improvement, and introduction to health outcomes. Each issue features a comprehensive review of outcomes work in a selected clinical condition or procedure, such as asthma, depression and cardiac surgery. On an annual basis, the TRUST publishes SourcePages, a resource directory for the field of health outcomes. Project profiles and a products and services guide are included in this “yellow pages” of health outcomes. Selected papers, articles, and books are included in the TRUST’s catalog of instruments and publications, and several are offered on the web site.

Membership in the TRUST
At the beginning of 1996, the TRUST introduced its membership program. This program is designed to keep clinicians, researchers, and managers updated about the health outcomes field and create opportunities for networking, collaboration and education. There are already about 900 members. Members receive services which include publications such as the Monitor (a quarterly 20-page publication), the Bulletin (a bi-monthly newsletter), and SourcePages (an annual resource directory). On-line resources have been developed for members and include Internet mail lists and a Members Room of the TRUST’s web site which provides bibliographies, reference materials, TRUST publications, and an on-line database to search for members of similar interests. “Talk to the Expert” conference calls are organized for members to spend one to two hours discussing pertinent, timely, and state-of the-art topics with the principal experts in that specialty.
Membership is available to individuals (a student rate is available) and organizations. Organizations, in addition to the privileges in the institutional and corporate member packages, receive the option to sign up 10 staff members as full professional members of the TRUST. Forty organizations are members of the TRUST.

Education
Each spring the TRUST presents the State-of-the-Art Health Outcomes Conference for an international audience. The May 1997 conference will be held in San Francisco, CA. Its agenda will consist of plenary sessions, 20 breakout sessions, a networking luncheon, exhibits, receptions, and post-conference specialty seminars. Conference sessions will provide illustrative, practical information on the application of health outcomes measures in research, clinical practice, population monitoring, patient satisfaction, and performance measurement. Four sessions on methods will also be offered.

Professional training courses of one or two full days are offered by the TRUST with both introductory and advanced curricula. These courses are designed for groups of 25 to 40 and are taught by a minimum of 2 instructors. Courses are held throughout the U.S. and may be customized for an organization’s on-site training.

The TRUST’s newly established web site offers complete, on-line, up-to-date information for individuals seeking resources in health outcomes and a description of TRUST services. We receive approximately 1,500 visitors each week and the site is continuously updated. Available instruments and TRUST publications as well as membership programs, training courses, and the annual conference are all included on the site. An individual may learn about the TRUST and its objectives, order an instrument packet, become a member, register for a course, or access a variety of resources and pertinent information while visiting the TRUST’s web site.

As we head into 1997, the TRUST will continue with a very ambitious agenda. Our first three years have been intensely industrious, and we are inspired by the level of activity of this small organization as well as by the growing interest and support we receive. An open invitation is continuously extended for input and suggestions. Your thoughts are welcomed and encouraged as we continue to operate with a commitment to public service and a mission to achieve universal measurement of health outcomes.

The Medical Outcomes Study
HIV Health Survey (MOS-HIV)

The Medical Outcomes TRUST is pleased to announce the recent approval of the Medical Outcomes Study HIV Health Survey (MOS-HIV), now available through the TRUST. The principal developer of the MOS-HIV is Albert W. Wu, MD, MPH, at Johns Hopkins University.
The MOS-HIV is a brief, comprehensive health status measure-based on items from the Medical Outcomes Study, that has been used extensively in studies of HIV/AIDS since its development in 1987. The MOS-HIV was one of the first disease-targeted measures available for this population, and is widely used in clinical trials and other research and evaluation studies. It has been shown to discriminate among groups of patients that differ clinically from one another, to predict future outcomes, and to be responsive to differences among groups and clinically important changes over time.

Development of the MOS-HIV was prompted by the need for a brief instrument for use in multicenter AIDS clinical trials. The dimensions represented in the SF-20 (Stewart et al) were the starting point of the instrument. Additional concepts important in HIV/AIDS (energy/fatigue, cognitive functioning, health distress, and quality of life) were added from the MOS item pool to create a 30-item form. In a subsequent version of the MOS-HIV, 5 additional items were added to better assess general health perceptions and pain, and response choices for physical functioning and role functioning items were altered to reflect extent rather than duration of limitation.

The questionnaire contains 35 questions that measure 10 dimensions of health: general health perceptions, pain, physical functioning, role functioning, social functioning, energy/fatigue, mental health, health distress, cognitive function, and quality of life. A single item is also included to assess health transition. Subscales of the MOS-HIV are scored as summated rating scales on a 0-100 scale; higher scores indicate better health. In addition to these subscales, two summary scores can be generated: Physical Health Summary and Mental Health Summary scores. The instrument takes approximately 5 minutes to complete, and can be self-administered or given as a face-to-face or telephone interview.

The MOS-HIV in Clinical Trials
The MOS-HIV Health Survey has been used extensively to examine the impact of clinical interventions on health-related quality of life. Richard Berzon, DrPH, Assistant Director, Health Economics and Outcomes Research at Bayer Pharmaceuticals, has been involved with several such studies and he described an application of the MOS-HIV Health Survey for the Bulletin.

In a clinical trial designed to examine the treatment impacts of two drugs to prevent cytomegalovirus (CMV) disease, an infection frequently diagnosed among patients with HIV, the MOS-HIV was incorporated as a measure of health-related quality of life. This international, multi-site study included approximately 800 patients who completed the MOS-HIV at baseline and every three months thereafter. According to Dr. Berzon, the MOS-HIV was selected as an appropriate measure for three reasons: (1) it offered the potential for rapid adaptation to other cultures, (2) well-documented psychometric data had been published, and (3) it was readily available. The objective in using the MOS-HIV was to look at patients’ health-related quality; and specifically to evaluate energy, psychological well-being, self perception of health, vitality, and distress regarding one’s health state, in addition to looking at clinical end points. The focus in clinical trials has changed significantly with illnesses such as HIV and cancer. “In the past, the primary endpoint in a clinical study was survival, but with chronic diseases such as HIV, the primary endpoint is a combination of the clinical impact and the impact on health-related quality of life,” states Dr. Berzon. These factors pay an integral role in a patient’s level of participation in his or her own recovery, as well as effect compliance with medications, and other health promoting practices.

Berzon recommends that when using a quality of life survey in a study in which patients have a terminal illness, and there is a strong likelihood that certain patients may become increasingly impaired over time, one should consider logistical issues with that change in circumstance at the start of trial. In this particular study for example, patients who had experienced CMV complications such as blindness completed the survey through an interview conducted by a caregiver. Berzon cautions that this methodology should be considered thoroughly in the planning of a trial since evidence tells us that surrogates perform well reporting the domains of health which they are able to observe, yet not as well with those such as emotional well-being which are less apparent through observation. He recommends at the start of the trial to obtain baseline values for both the surrogate and the patient to look at correlations and the extent to which there is variability between the two and adjust accordingly.

Dr. Berzon illustrated the value of measures such as the MOS-HIV in clinical trials by describing some of the complexities of patient care and treatment choices. Collecting this type of data at the point of drug evaluation brings greater opportunity for informed treatment choices between patient and health care provider. Many issues are effected by health-related quality of life factors, including the level of compliance with a certain treatment and the likelihood that a patient will participate in his or her own recovery. Complexities of illnesses such as HIV are underscored by the differences in individual responses to treatment and Clinical Application.

Measuring Health Status Among
Individuals with Multiple Sclerosis

At the Mellen Center for Multiple Sclerosis Treatment and Research , several studies are underway to evaluate treatments for Multiple Sclerosis (MS) from the patients’ perspective. In an interview with the Bulletin, Deborah Miller, PhD, of the Mellen Center indicated that “this is a very interesting time for MS. For so long now there have been no available treatments to alter the course of this disease, and now there are two on the market with one more that has been approved. Many clinical trails are underway and standardized measures will become only more important with these new treatment developments.”

The Mellen Center and Dr. Miller are involved in an initiative sponsored by the National MS Society to develop a MS-specific questionnaire of health outcomes. Four clinic sites from the Consortium of MS Centers (two in the U.S. and two in Canada) are participating in a cross-sectional study of 300 subjects to evaluate a modular designed questionnaire with generic and disease specific items. In the course of the study, detailed neurological and cognitive evaluations were conducted for each patient, and a final report will be delivered to the National MS Society this month. This report will include recommendations for a core set of measures to be included in the self-administered MS questionnaire.

Dr. Miller is also conducting a study to evaluate the outcomes of an outpatient rehabilitation program at the Mellen Center in which she was looking to compliment individual patient goal attainment scaling with a standardized measure of health. Her experience with traditional measures of functional status in rehabilitation proved to be ineffective due to the significant level of disability characteristic of this particular patient population. Aiming to demonstrate the efficacy of the weekly group rehabilitation program, and with an interest in monitoring patients over time, she decided to incorporate the SF-36 Health Survey.

The study included five groups totaling 40 patients who participated in a weekly four-hour rehabilitation therapy program at the Mellen Center. Patients were significantly disabled, met the technical criteria for social security disability, were dependent in at least two personal care activities, were living in the community, and had a fairly high level of cognitive impairment. The SF-36 was administered at the end of the first treatment period, at the end of a six-week break from treatment, and at the end of the second phase of treatment. Analysis of study data is underway, but in her interview with the Bulletin, Dr. Miller discussed several anecdotal points of interest noted during the course of the study.

In general, patients reported that the items of the questionnaire were more relevant than other questionnaires they had completed. Declines were noted in physical functioning among most patients, but emotional adjustment was found to be good. In social and role functioning, the data suggests that patients normalize their social activities and although their level of functioning might be significantly restricted compared to the general population, only slight limitation was reported. She cautions that results must be examined within the context of the physical impairment and how that impairment lines up with reported functioning. In analysis of her own study data, she believes that length of disability will impact one’s assessment of their health status.

She found that those patients with a long-standing disability had difficulty with the four-week time frame of certain items. “These patients have been disabled for ten years, on average, and see very little change in a four-week time frame,” she indicated. In addition, items which were anchored in the concept of “normal” were at times problematic for the study participants (such as “during the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities...”). Dr. Miller reports no other significant issues with this study, but did remark that large print self-administration forms work well, and that she would expect that computer touch screen with a limited number of response choices per screen would be the ideal mode of administration.

After this project is completed, Dr. Miller is interested in developing profiles for the SF-36 component and profile scores that are dependent upon level of MS-specific disability. She recognizes the challenge that this presents because “the most widely accepted measure of MS-disability, the Expanded Disability Status Scale (EDSS) is heavily dependent on ambulation ability that does not fully reflect the visual, bladder, and upper extremity symptoms caused by the disease”. The health status of MS patients is as likely to be affected by these symptoms as by ambulation ability. For that reason, it will be necessary to utilize a more comprehensive measure of MS disease severity than the EDSS allows to develop meaningful profiles. Dr. Miller may be reached at the clinic at (216) 444-8605.