Improving the master problem list: a case study in changing clinician behavior.
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Biomedical subjects
Publications and source records attributed to M S Donaldson.
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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.
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.
In a double-blind, multiclinic study, 437 patients with osteoarthritis were treated sequentially with ibuprofen, 1,800 mg/day, and placebo, or with aspirin, 3,600 mg/day, and placebo. Each treatment was given for four weeks. Considering relief of pain, ability to function, and general well-being, the patients preferred drug to placebo, usually by a statistically significant margin. Combined results showed no significant differences between ibuprofen and aspirin. Patients' evaluations of exercise-related pain, ability to perform a selected activity, and total discomfort and disability, and physicians' evaluations of discomfort and disability, all favored drug over placebo, and the differences were significant for a number of endpoints. The results indicated ibuprofen, 1,800 mg/day, offers about the same antiarthritic benefit as aspirin, 3,600 mg/day. Both drugs are superior to placebo. The incidence of gastrointestinal complaints with ibuprofen was similar to that with placebo and significantly lower than that with aspirin.
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.
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.
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.
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.
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.
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.