Measuring quality of care at the end of life.

Caring for patients at the end of life presents a series of quality-of-care problems to the health care system. In the past, concern has focused on overaggressive treatment of dying patients. Given rapid changes in the financing and delivery of care, it is time to focus on a range of quality problems and address ways to improve care and achieve outcomes desired by patients and their families. We provide a framework for conceptualizing such a task. This article addresses the purposes of measurement, definition of the patient population, timing of measurement, use of surrogates in measurement, scope of services to be evaluated, and the choice of measures. It emphasizes the necessary links between quality measurement and quality improvement.

Continuity of care: a reconceptualization.

Although continuity of care is considered an essential feature of good health care, researchers have used and measured continuity in many different ways, and no clear conceptual framework links continuity to outcomes. This article of offers a reconceptualization and definition of continuity based on agency theory. It posits that the value of continuity is to reduce agency loss by decreasing information asymmetry and increasing goal alignment. Three decades of empirical literature on continuity were examined to assess whether this model would provide greater clarity about continuity. Some authors measured improved information transfer, but more appeared to assume that continuity would lead to better information. Most authors appeared to have assumed that goal alignment was present and did not measure it. The model of continuity based on agency theory appears to provide a useful conceptual tool for health services research and policy.

Effects of long-term passaging of BTI-Tn5B1-4 insect cells on growth and recombinant protein production.

The BTI-Tn-5B1-4 insect cell line from Trichopulsi ni has enabled better secretion and higher productivity of recombinant proteins in the baculovirus expression system. An early passage stock of this cell line is compared here to the commercially available "High Five" cell line stock. The early passage Tn5B1-4 cells grew to over 11 x 10(6) cells/mL and expressed 2.5-fold more recombinant secreted alkaline phosphatase (SEAP) than the High Five cells. While the specific productivity on a cell number basis was only slightly higher, the early passage Tn5B1-4 cells maintained this productivity at higher cell densities, increasing their volumetric productivity to 50 microg/mL under elevated oxygen conditions. We propose that the difference in these two stocks of cells is the length of time they have been cultured, 130 total passages for the early passage versus 360 passages for the High Five cells. This conclusion is supported by the facts that the early passage Tn5B1-4 cells are smaller in diameter by 4 micron, smaller in cellular protein content (206 versus 270 microg of protein/10(6) cells), have an increased propensity to clump in suspension culture, and are less susceptible to dispersion of these clumps by dextran sulfate compared to the High Five cells.

Low-cost serum-free medium for the BTI-Tn5B1-4 insect cell line.

The BTI-Tn5B1-4 insect cell line, commercially available as the High Five cell line (Invitrogen), supports higher levels of recombinant protein production compared to existing insect cell lines. Proprietary serum-free media such as ExCell 405 (JRH Biosciences), Express Five (Life Technologies), IS BAC (Irvine Scientific), and CCM3 (HyClone) are available which were developed specifically for a suspension culture of High Five cells. While these media are highly optimized, a lower cost alternative is desirable for large-scale protein production which is also serum-free and supports good cell growth (>5 x 10(6) cells/mL) and recombinant protein production (>50 mg/L of secreted protein). The amino acid and carbohydrate metabolism of the Tn5B1-4 cells was first examined. It was found that asparagine was nearly depleted during batch growth in Ex-Cell 405, without limitations in glutamine, other amino acids, or glucose. Alanine also accumulated to about 35 mM during growth. We then extended the formulation techniques for medium development used for Spodoptera cell lines to the Tn5B1-4 cell line. A medium based on IPL-41 basal medium, Hy-Soy protein hydrolysate (Quest, International), yeastolate ultrafiltrate, a lipid-sterol emulsion, and Pluronic F-68 was developed. Dextran sulfate (100 microg/mL) was used to induce a single cell suspension culture. This medium is denoted as ISYL and performs best when supplemented with a 2.5% lipid-Pluronic F-68 mixture. Supplementation with additional aspargine in a 1.5% lipid-Pluronic F-68 mixture did not improve growth, suggesting that a lipid was growth-limiting and not an amino acid. Ex-Cell 405 and ISYL with 2.5% lipid-Pluronic F-68 supplement supported virtually identical growth rates, extent of growth (ca. 6.0 x 10(6) cells/mL) in an 80% oxygen atmosphere, and supported production of SEAP (secreted human alkaline phosphatase) at a volumetric level of about 65-70 mg/L. Thus, the less expensive ISYL medium can deliver acceptable performance and may be suitable for large-scale insect cell cultures.

Needs-based health promotion program serves as HMO marketing tool.

A needs assessment survey was originally conducted at the George Washington University Health Plan in 1981 and repeated in 1983 for evaluation and redirection. The survey resulted in a program which attempted to address the perceived needs of its members. The response, not only of the patients, but also of both the HMO clinical and marketing staffs, resulted in further program development, and established role for health promotion in HMO marketing, and a model of preventive care teaching in ambulatory primary care medicine.

HMO members and clinicians rank health education needs.

Before expanding a health education program, the staff of the George Washington University Health Plan conducted a needs assessment of members. Patients in the HMO's adult care and parents in pediatric waiting areas answered survey questions, and a random sample of members was polled by mail. Patients rated their interest in a list of 45 topics, and plan clinicians chose from the same list topics which "would be of greatest help in your practice." Anxiety/stress was the most popular topic among patients and those who responded by mail. Depression, physical fitness, CPR, and nutrition also rated high. Only 4 topics appeared among the top 10 choices of both plan members and clinicians. After discussion of the patients' choices, the clinicians were asked, several weeks later, to rate the topics again. Clinicians' choices in the second round much more closely approximated the choices of the members. The most frequently chosen method of instruction was "written material," although videotape and other, more expensive media were also listed. When seminars geared to the members' top choices in the survey were offered, the response was so enthusiastic that additional seminars--a total of 12 in 6 weeks--were held.

Fibromyalgia syndrome improved using a mostly raw vegetarian diet: an observational study.

BACKGROUND: Fibromyalgia engulfs patients in a downward, reinforcing cycle of unrestorative sleep, chronic pain, fatigue, inactivity, and depression. In this study we tested whether a mostly raw vegetarian diet would significantly improve fibromyalgia symptoms. METHODS: Thirty people participated in a dietary intervention using a mostly raw, pure vegetarian diet. The diet consisted of raw fruits, salads, carrot juice, tubers, grain products, nuts, seeds, and a dehydrated barley grass juice product. Outcomes measured were dietary intake, the fibromyalgia impact questionnaire (FIQ), SF-36 health survey, a quality of life survey (QOLS), and physical performance measurements. RESULTS: Twenty-six subjects returned dietary surveys at 2 months; 20 subjects returned surveys at the beginning, end, and at either 2 or 4 months of intervention; 3 subjects were lost to follow-up. The mean FIQ score (n = 20) was reduced 46% from 51 to 28. Seven of the 8 SF-36 subscales, bodily pain being the exception, showed significant improvement (n = 20, all P for trend < 0.01). The QOLS, scaled from 0 to 7, rose from 3.9 initially to 4.9 at 7 months (n = 20, P for trend 0.000001). Significant improvements (n = 18, P < 0.03, paired t-test) were seen in shoulder pain at rest and after motion, abduction range of motion of shoulder, flexibility, chair test, and 6-minute walk. 19 of 30 subjects were classified as responders, with significant improvement on all measured outcomes, compared to no improvement among non-responders. At 7 months responders' SF-36 scores for all scales except bodily pain were no longer statistically different from norms for women ages 45-54. CONCLUSION: This dietary intervention shows that many fibromyalgia subjects can be helped by a mostly raw vegetarian diet.

Planning for program effectiveness in quality assurance.

Quality assurance programs are now a fact of life in health care institutions, yet the effectiveness of these programs in improving care is unproven. Reports of quality assurance activities rarely discuss "remedy implementation" or the outcome of such attempts. Effectiveness does not flow naturally from sound methodology or documentation but is the most challenging part of the program. This article examines reasons for this difficulty, and the authors recommend strategies for improving problem resolution and increasing the influence of the program in the organization. They urge attention to program implementation and emphasize active participation by clinicians, patients, administration, and staff. This broad representation promotes examination of a wide range of patient care issues as well as medical audits, allows the program to enlist support for change, and enables the program to anticipate and make timely contributions to the decisions of policymaking groups.

Confidentiality on the information highway: balancing the needs of individual patients and society.

State and federal agencies, professional associations and business coalitions are actively promoting the development of regional or statewide health database organizations (HDOs). One of the key missions of HDOs is the public release of aggregated healthcare data and analyses to facilitate improved patient care. In 1992 and 1993 a committee appointed by the National Academy of Sciences' Institute of Medicine studied the implications of HDO formation in a landmark report. The committee's recommendations on how to assure accuracy and completeness of data, minimize potential harm from released data and guarantee appropriate protections for individually identifiable data are summarized and interpreted in the following article.

Gearing up for health data in the information age.

This workshop summary focuses on public disclosure--the publication of provider-specific (but non-person-identified) information to improve health care and the delivery of health services. It also summarizes participant discussions about quality-of-care research in health database organizations, as well as issues related more broadly to the creation of a health data infrastructure.

Metabolic vitamin B12 status on a mostly raw vegan diet with follow-up using tablets, nutritional yeast, or probiotic supplements.

BACKGROUND: Pure vegetarian diets might cause cobalamin deficiency due to lack of dietary intake. It was hypothesized that a population following a vegan diet consuming mostly raw fruits and vegetables, carrot juice, and dehydrated barley grass juice would be able to avoid vitamin B12 deficiency naturally. METHODS: Subjects were recruited at a health ministers' reunion based on adherence to the Hallelujah diet for at least 2 years. Serum cobalamin and urinary methylmalonic acid (MMA) assays were performed. Follow-up with sublingual tablets, nutritional yeast, or probiotic supplements was carried out on subjects with abnormal MMA results. RESULTS: 49 subjects were tested. Most subjects (10th to 90th percentile) had followed this diet 23-49 months. 6 subjects had serum B12 concentrations <147 pmol/l (200 pg/ml). 37 subjects (76%) had serum B12 concentrations <221 pmol/l (300 pg/ml). 23 subjects (47%) had abnormal urinary MMA concentrations above or equal to 4.0 microg/mg creatinine. Sublingual cyanocobalamin and nutritional yeast, but not probiotic supplements, significantly reduced group mean MMA concentrations (tablet p < 0.01; yeast p < 0.05, probiotic > 0.20). CONCLUSIONS: The urinary MMA assay is effective for identifying early metabolic cobalamin deficiency. People following the Hallelujah diet and other raw-food vegetarian diets should regularly monitor their urinary MMA levels, consume a sublingual cobalamin supplement, or consume cobalamin in their food.

The importance of measuring quality of care at the end of life.

Although designed to respond to acute illness, the current health care system must increasingly provide care for people living longer with chronic diseases. Evaluation of the quality of this care must utilize appropriate measurements, study populations, and outcomes. Current quality measures and major studies of quality of care are highlighted. A framework for measuring quality of care is outlined.

Accountability for quality in managed care.

BACKGROUND: It is often difficult to understand where responsibility lies for monitoring and improving quality in managed care. From 1996 through 1998 a group of individuals convened by the Institute of Medicine's (Washington, DC) National Roundtable on Health Care Quality developed a model of accountability for the quality of care provided by managed care organizations (MCOs). Each of three overarching forms of accountability (professional, market, and regulatory) has a set of tools for imposing accountability and-because accountability relationships are not self-enforcing-sanctions for failures of accountability. PROFESSIONAL ACCOUNTABILITY: Fiduciary relationships in medicine are an essential part of any quality accountability mechanism, and it will be important to maintain the strength of the professional model in the changing health care system. Yet it is not easy to preserve the strength of the professional model in an MCO environment in which professionals are not dominant, and there is likely to be increasing pressure to weaken their autonomy. MARKET ACCOUNTABILITY: The primary assumption of market accountability is that consumers will select options based on perceived value to them and will make new choices based on their information and experience. Market accountability requires choice among competing providers and information to inform choice. In health care, however, individuals rarely have the information they need and often do not have choice. Accountability for quality generally has not been a major feature in contracts. REGULATORY ACCOUNTABILITY: There is a widespread perception of defects in a market-based health care system. Many believe there is a need for a regulatory structure to correct market failures. The use of regulation to impose accountability for quality requires that a regulatory framework, penalties for violations, and effective enforcement mechanisms are all established. PUBLIC GOODS: The model of accountability for quality in managed care does not promote public goods such as education, research, public health, or care for the uninsured. Indeed, the locus of responsibility to the community when markets fail to supply these public goods is controversial. Nevertheless, such responsibility should be considered by MCOs and policy makers. COLLABORATION TO IMPROVE QUALITY OF CARE: Given market-driven models of health care financing and delivery, it might be feasible and desirable to encourage collaboration among MCOs to improve quality, whether at the national or local market level. The health professions in general, and the medical profession in particular, are and must be accountable to society for providing leadership in the development of knowledge about effective medical care, in defining high-quality care, and in advocating for and improving the quality of care. CONCLUSION: Establishing effective accountability for quality involves multiple entities and many different kinds of accountability relationships. The three forms of accountability interact, and all operate at once.

The feasibility of an outcome approach to quality assurance--a report from one HMO.

Recent federal legislation has contained the stipulation that participating health maintenance organizations (HMOs) include a quality assurance program which stresses health outcomes. This provision was ostensibly directed at correcting alleged abuses in HMOs serving the urban poor. One version of the outcome method was employed for an 18-month period at an urban HMO caring for 2,000 Medicaid subscribers. The program involved comparing diagnostic accuracy and therapeutic outcomes for clinical conditions relevant to the study population with ideal standards established by the HMO. Three conditions were selected: contraception, depression, and hypertension. The results revealed widespread underdiagnosis (44-74%) in each condition and unacceptable therapeutic outcomes in two. Data collection was hampered by shifts in geography and financial eligibility among the denominator population and low response rates (38-63%) to telephone and mail surveys. Applying the general project guidelines to specific conditions proved considerably more difficult than anticipated. Further refinement of this approach to quality assessment must occur before its widespread use is feasible. Its effectiveness in improving quality remains to be seen. This experience raises doubts regarding the wisdom of legislating a specific outcome approach to quality assessment before feasibility and effectiveness have been demonstrated in organized health settings.

Medicare: a strategy for quality assurance, II: Site visits.

The second of a series of articles on the Institute of Medicine study on a quality review and assurance program for Medicare, this article recapitulates the findings of site visits conducted between October 1988 and May 1989. The issues and concerns raised by site visit hosts, as listed in the IOM report, are discussed in detail. For example, concerns about QA methods include those regarding the duplication of quality review and assurance efforts, the value of education and feedback of quality-of-care information, disclosure, dealing with the very poor practitioner, and improving average practice. Most problems of quality and QA identified by the organizations visited are those of "systems" rather than individual providers, which itself is an important finding.

Measuring the quality of health care: state of the art.

BACKGROUND: September 12-13, 1996, in Washington, DC, the Institute of Medicine, as part of its Special Initiative on Health Care Quality, held an invitational conference to illustrate exemplary quality measurement and to discuss the results. Patient reports, innovative uses of outcome measures for quality improvement, risk adjustment, assessment in integrated health plans and health care settings, clinical guidelines, and projects on disseminating information on quality measurement techniques and tools were among the topics represented. IMPROVING MEDICATION USE: Brent James described studies undertaken to reduce adverse drug events (ADEs). When implementing any measurement system where error is a possible factor, it is important to emphasize identifying problems for the purpose of learning, not judgment. Lucian Leape agreed that staff involved must feel that the purpose of the study is to examine system problems, not individuals' mistakes. David Classen described a nonproprietary computerized disease-management program designed to reduce ADEs in infectious diseases. "A QUALITY VISION": Robert Brook said that the relationship between cost or resources devoted to care and quality is not well understood and is certainly not simple. He also said that although investments in measurement strategies are needed to make them better, that doesn't mean we shouldn't attempt to use the measurements we have now. CLOSING ADDRESS: Mark Chassin said that the presentations at the conference provided evidence that should allow us to conclude beyond a reasonable doubt that quality can be measured-with a degree of scientific precision equal to that of most of the measures used to take care of patients every day.

Medical student instructional costs in a primary care clerkship.

Using a variety of techniques, such as logs kept daily by the faculty, direct observation, and on-site interviews, the authors determined the instructional costs of a required third-year primary care clerkship based in an ambulatory care setting. Included in the analysis were labor costs of both faculty members and nonfaculty personnel, space and materials, and general university overhead. Total instructional costs were $54.20/student/day. If other third-year clinical clerkships generate equivalent costs, the direct instructional costs of clerkships for third-year medical students would be in excess of $11,500/student/year. The study results imply that ambulatory-based teaching of medical students generates considerable costs and thus requires support from student tuition, federal or state government, or other sources.

Medicare: a strategy for quality assurance, V: Quality of care in a changing health care environment.

This article, the fifth and final in a series, provides a retrospective wrap-up of an Institute of Medicine (IOM) study to develop a strategy for quality review and assurance in Medicare. Portions of that report were adapted for four articles in QRB in January, March, August, and October 1991. This final article reflects on selected developments in the period since the IOM report first appeared, particularly those involving other IOM activities, in the context of certain of the findings, conclusions, and recommendations of the IOM study committee on Medicare quality assurance.