Kaiser Permanente's "metadata-driven" national clinical intranet.

This paper describes the approach taken to build Kaiser Permanente's national clinical intranet. A primary objective for the site is to facilitate resource discovery, which is enabled by the use of "metadata", or data (fields and field values) that describe the various resources available. Users can perform full text queries and/or fielded searching against the metadata. Metadata serves as the organizing principle of the site--it is used to index documents, sort search results, and structure the site's table of contents. The site's use of metadata--what it is, how it is created, how it is applied to documents, how it is indexed, how it is presented to the user in the search and the search results interface, and how it is used to construct the table of contents for the web site--will be discussed in detail. The result is that KP's national clinical intranet has coupled the power of Internet-like full text search engines with the power of MedLine-like fielded searching in order to maximize search precision and recall. Organizing content on the site in accordance with the metadata promotes overall consistency. Issues currently under investigation include how to better exploit the power of the controlled terminology within the metadata; whether the value gained is worth the cost of collecting metadata; and how automatic classification algorithms might obviate the need for manual document indexing.

Variations in pharmacotherapy for attention deficit hyperactivity disorder in managed care.

The purpose of this study was to identify the patterns of pharmacotherapy in the treatment of children diagnosed with attention deficit hyperactivity disorder (ADHD) in a large, non-profit, group-model managed care organization from January 1997 through July 1998. We sought to determine whether children with uncomplicated ADHD use different drug therapies when compared to children with ADHD and psychiatric comorbidity. We also examined the relationships between the use of specialty mental health services and the use of various psychotropic medications for treatment of ADHD. We found that children with ADHD and psychiatric comorbidity were less likely to use psychostimulants (odds ratio [OR] = 0.71, 95% confidence interval [CI] = 0.55-0.93, p = 0.01) but more likely to use antidepressants (OR = 2.74, 95% CI = 1.95-3.86, p < 0.01), alpha adrenergic agonists (OR = 2.63, 95% CI = 1.93-3.57, p < 0.01), and other psychotropic medications (OR = 2.40, 95% CI = 1.27-4.50, p < 0.01) than children with uncomplicated ADHD (who were more likely to use stimulants only). Additionally, children with psychiatric comorbidity were more likely to use multiple psychotropic drugs (p < 0.01). The results of this study indicate that children with potentially more complex mental health needs are being treated with more varied drug therapy and/or specialty mental health care services.

Primary prevention studies and the healthy elderly: evaluating barriers to recruitment.

Although primary prevention studies are important tools in helping the healthy elderly stay healthy, recruiting from a community-based cohort of healthy elderly individuals for a primary prevention study involves numerous barriers. To better identify and understand these barriers, we conducted and evaluated a comprehensive recruitment strategy for a primary prevention study testing aspirin in an HMO population. In the recruitment phase, we identified healthy individuals (65 years of age or older) who were members of a large, group-model HMO in Oregon and Washington, and used computerized medical database screening, statistical sampling, health plan mailings, e-mail communication with primary care providers, and the experience of a well-established research clinic in an effort to enroll health elderly in this primary prevention trial. Among a random sample of 47,453 eligible patients over the age of 65, 44% responded to recruitment efforts, but only 3% were enrolled--an overall yield of slightly less than 2%. To evaluate these results, we then conducted focus groups with 225 randomly selected "eligible refusers." We determined that healthy elders were hesitant to give up their choice to use aspirin, unwilling to travel to the research center, and reluctant to risk their tenuous hold on good health to participate in a study of primary prevention. Awareness of these attitudes is an indispensable step toward designing effective recruitment strategies for primary prevention studies involving the healthy elderly.

Inhibitors of hydroxymethylglutaryl-coenzyme A reductase and risk of fracture among older women.

BACKGROUND: Inhibitors of hydroxymethylglutaryl-coenzyme A reductase (statins) increase new bone formation in rodents and in human cells in vitro. Statin use is associated with increased bone mineral density of the femoral neck. We undertook a population-based case-control study at six health-maintenance organisations in the USA to investigate further the relation between statin use and fracture risk among older women. METHODS: We investigated women aged 60 years or older. Exposure, outcome, and confounder information was obtained from automated claims and pharmacy data from October, 1994, to September, 1997. Cases had an incident diagnosis of non-pathological fracture of the hip, humerus, distal tibia, wrist, or vertebrae between October, 1996, and September, 1997. Controls had no fracture during this period. We excluded women with records of dispensing of drugs to treat osteoporosis. FINDINGS: There were 928 cases and 2747 controls. Compared with women who had no record of statin dispensing during the previous 2 years, women with 13 or more statin dispensings during this period had a decreased risk of non-pathological fracture (odds ratio 0.48 [95% CI 0.27-0.83]) after adjustment for age, number of hospital admissions during the previous year, chronic disease score, and use of non-statin lipid-lowering drugs. No association was found between fracture risk and fewer than 13 dispensings of statins or between fracture risk and use of non-statin lipid-lowering drugs. INTERPRETATION: Statins seem to be protective against non-pathological fracture among older women. These findings are compatible with the hypothesis that statins increase bone mineral density in human beings and thereby decrease the risk of osteoporotic fractures.

Trends in the prescribing of psychotropic medications to preschoolers.

CONTEXT: Recent reports on the use of psychotropic medications for preschool-aged children with behavioral and emotional disorders warrant further examination of trends in the type and extent of drug therapy and sociodemographic correlates. OBJECTIVES: To determine the prevalence of psychotropic medication use in preschool-aged youths and to show utilization trends across a 5-year span. DESIGN: Ambulatory care prescription records from 2 state Medicaid programs and a salaried group-model health maintenance organization (HMO) were used to perform a population-based analysis of three 1-year cross-sectional data sets (for the years 1991, 1993, and 1995). SETTING AND PARTICIPANTS: From 1991 to 1995, the number of enrollees aged 2 through 4 years in a Midwestern state Medicaid (MWM) program ranged from 146,369 to 158,060; in a mid-Atlantic state Medicaid (MAM) program, from 34,842 to 54,237; and in an HMO setting in the Northwest, from 19,107 to 19,322. MAIN OUTCOME MEASURES: Total, age-specific, and gender-specific utilization prevalences per 1000 enrollees for 3 major psychotropic drug classes (stimulants, antidepressants, and neuroleptics) and 2 leading psychotherapeutic medications (methylphenidate and clonidine); rates of increased use of these drugs from 1991 to 1995, compared across the 3 sites. RESULTS: The 1995 rank order of total prevalence in preschoolers (per 1000) in the MWM program was: stimulants (12.3), 90% of which represents methylphenidate (11.1); antidepressants (3.2); clonidine (2.3); and neuroleptics (0.9). A similar rank order was observed for the MAM program, while the HMO had nearly 3 times more clonidine than antidepressant use (1.9 vs 0.7). Sizable increases in prevalence were noted between 1991 and 1995 across the 3 sites for clonidine, stimulants, and antidepressants, while neuroleptic use increased only slightly. Methylphenidate prevalence in 2- through 4-year-olds increased at each site: MWM, 3-fold; MAM, 1.7-fold; and HMO, 3.1-fold. Decreases occurred in the relative proportions of previously dominant psychotherapeutic agents in the stimulant and antidepressant classes, while increases occurred for newer, less established agents. CONCLUSIONS: In all 3 data sources, psychotropic medications prescribed for preschoolers increased dramatically between 1991 and 1995. The predominance of medications with off-label (unlabeled) indications calls for prospective community-based, multidimensional outcome studies.

Effect of clinician communication skills training on patient satisfaction. A randomized, controlled trial.

BACKGROUND: Although substantial resources have been invested in communication skills training for clinicians, little research has been done to test the actual effect of such training on patient satisfaction. OBJECTIVE: To determine whether clinicians' exposure to a widely used communication skills training program increased patient satisfaction with ambulatory medical care visits. DESIGN: Randomized, controlled trial. SETTING: A not-for-profit group-model health maintenance organization in Portland, Oregon. PARTICIPANTS: 69 primary care physicians, surgeons, medical subspecialists, physician assistants, and nurse practitioners from the Permanente Medical Group of the Northwest. INTERVENTION: "Thriving in a Busy Practice: Physician-Patient Communication," a communication skills training program consisting of two 4-hour interactive workshops. Between workshops, participants audiotaped office visits and studied the audiotapes. MEASUREMENTS: Change in mean overall score on the Art of Medicine survey (HealthCare Research, Inc., Denver, Colorado), which measures patients' satisfaction with clinicians' communication behaviors, and global visit satisfaction. RESULTS: Although participating clinicians' self-reported ratings of their communication skills moderately improved, communication skills training did not improve patient satisfaction scores. The mean score on the Art of Medicine survey improved more in the control group (0.072 [95% CI, -0.010 to 0.154]) than in the intervention group (0.030 [CI, -0.060 to 0.1201). CONCLUSIONS: "Thriving in a Busy Practice: Physician-Patient Communication," a typical continuing medical education program geared toward developing clinicians' communication skills, is not effective in improving general patient satisfaction. To improve global visit satisfaction, communication skills training programs may need to be longer and more intensive, teach a broader range of skills, and provide ongoing performance feedback.

Practical methods to increase use of advance medical directives.

OBJECTIVE: To compare the effectiveness of two means for increasing the use of advance medical directives: written materials only versus written materials and an educational videotape. DESIGN: Population-based, randomized controlled trial with 3-month follow up. SETTING: Kaiser Permanente Colorado Region, a not-for-profit group-model health maintenance organization. PARTICIPANTS: A population-based sample of all 1,302 members aged 75 years and older who used the Franklin Medical Office, excluding 55 persons who died or disenrolled during the study period or were identified by their physicians as blind or cognitively impaired. INTERVENTIONS: All subjects were mailed a 10-page cartoon-illustrated educational pamphlet on patient choices, a selection of Colorado advance medical directive forms, and a guide to their completion; 619 subjects also were mailed a 20-minute videotape on advance directives. Both groups had access to a study nurse for assistance in completing and placing advance medical directives. MEASUREMENTS AND MAIN RESULTS: The main outcome measure is the proportion of subjects who placed a directive in their medical record for the first time. Placement rates increased almost identically, from 21.2% to 35.0% in the written materials-only group and from 18.9% to 32.6% in the group receiving the videotape (95% confidence interval for difference -0.04, 0.04, p =.952). CONCLUSIONS: In an elderly population with a substantial baseline placement rate, mailing of written materials substantially increased placement of an advance directive in the medical record, but the addition of a videotape did not. Mailing the video did increase the use of treatment trials and made patients more aware of reasons not to use advance directives.

A patient-initiated system for preventive health care. A randomized trial in community-based primary care practices.

OBJECTIVE: To test the effectiveness of a patient-initiated, touch-sensitive computer system (TSCS) for improving screening rates for cancers of the breast, cervix, colon and rectum, and oral cavity. DESIGN: One-year, randomized, controlled trial with primary care practice as the unit of analysis. SETTING: Sixty primary care practices, randomly recruited from 329 nonteaching practices in a southeastern state. SUBJECTS: Random sample of the medical records of 50 male and female adult patients before intervention and 50 adult patients after intervention in each practice and a random sample of 507 TSCS users. INTERVENTIONS: Touch-sensitive computer system and a registered nurse who served as liaison to the study practices. The TSCS provided patient-specific preventive service recommendations and facilitated work flow to increase the completion of these interventions. MAIN OUTCOME MEASURE: Average change, adjusted for health maintenance examination (HME) and use of the TSCS, in the proportion of eligible patients undergoing screening mammography, clinical breast examination, digital rectal examination, fecal occult blood test, flexible sigmoidoscopy, Papanicolaou smear, and oral cavity examination. RESULTS: We observed a significant increase in the completion of screening mammography (6.6%; P < or = 0.5) and clinical breast examination (6.1%; P < or = .01) in women 50 years of age and older, particularly for those who had an HME during the study year. CONCLUSIONS: Patients who have HMEs are more likely to receive cancer screening; however, a computer-based system for preventive services can contribute to improvement in screening. Among those patients who did not have an HME, TSCS users had higher rates of breast cancer screening than nonusers.

Enlarged peroneal process with peroneus longus tendon entrapment.

A 50-year-old man was treated conservatively for chronic bilateral ankle pain for several years. Plain radiographs obtained following exacerbation of symptoms showed bilateral enlarged peroneal processes. CT and MRI demonstrated bony detail of the unusual processes and also showed isolation of the peroneus longus tendons and associated tendinitis and partial tears.

Meconium-stained amniotic fluid-associated infectious morbidity: a randomized, double-blind trial of ampicillin-sulbactam prophylaxis.

OBJECTIVE: To evaluate the efficacy of intrapartum prophylactic administration of ampicillin-sulbactam in reducing intraamniotic infection and postpartum endometritis in patients with meconium-stained amniotic fluid (AF). METHODS: Patients with intrapartum meconium-stained AF were randomized to receive either ampicillin-sulbactam or normal saline (placebo) intravenously at the time of diagnosis of meconium and every 6 hours until delivery. The outcomes of the two groups were compared with respect to intra-amniotic infection and postpartum endometritis. RESULTS: During the study period, 332 patients with meconium-stained AF were approached for participation, and 120 patients met inclusion criteria and were enrolled. Patient demographics, labor, and delivery characteristics were similar. Ampicillin-sulbactam reduced the incidence of intra-amniotic infection from 23.3 to 6.7%, (P = .02; relative risk [RR] 0.48, 95% confidence interval [CI] 0.22-0.98). The incidence of postpartum endometritis was also reduced, but the difference was statistically nonsignificant (8.3 versus 16.7%, P = .16; RR 0.64, 95% CI 0.30-1.33). CONCLUSION: Prophylactic intravenous ampicillin-sulbactam significantly reduces intra-amniotic infection in patients with meconium-stained AF.

Patient use of a computer for prevention in primary care practice.

A computerized health information system for prevention can provide an efficient way to enhance the doctor-patient interaction and provide patient-specific education materials. A computer system called HealthTouch was developed by family physicians and placed in 29 randomly selected primary care practices in Virginia for 1 year. Data were collected from three sources: randomly selected patients' charts, the HealthTouch data base, and patient telephone interviews. Data from these sources were combined, and frequency distributions and comparisons of responses by demographic attributes were analyzed using the chi-square statistic. During the study year, 9799 adult patients used the HealthTouch system. HealthTouch users were younger, on average, than the overall patient population, and the majority (89%) were either very satisfied or satisfied with the system. Computers are effective tools to collect, organize, and store patient information about prevention.

Blood pressure and atrial natriuretic peptides correlate throughout the day.

Vessel dilator consisting of amino acids (a.a.) 31-67 and atrial natriuretic factor (ANF) composed of a.a. 99-126 of the 126 a.a. ANF prohormone circulate in humans and have potent vasodilatory properties. To determine whether these atrial natriuretic peptides are directly related to blood pressure in healthy normotensive humans, we recently had the unique opportunity to examine the circadian rhythms of vessel dilator, ANF, and blood pressure in seven individuals in 1988 and again in 1993. The changes in mean arterial pressure and systolic and diastolic blood pressure in these individuals during this 5-year hiatus allows comparison in the same individual, if circulating concentrations of atrial natriuretic peptides directly correlate with naturally occurring changes in blood pressure. In both 1988 and in 1993 vessel dilator and ANF each had significant (p < 0.001) circadian rhythms with their peak concentrations at 4:00 AM being nearly twice their concentrations at 4:00 PM. Mean arterial pressure, systolic blood pressure, and diastolic blood pressure also had significant circadian rhythms with peaks and troughs that were exactly opposite to those of ANF and vessel dilator. A significant inverse correlation between 24-hour averages of mean arterial blood pressure and 24-hour averages of vessel dilator (p = 0.05) and ANF (p = 0.02) was also found. These data suggest that vessel dilator and ANF are important for the maintenance of blood pressure within the normotensive range.

Use of prostate-specific antigen for prostate cancer screening in primary care practice.

OBJECTIVE: To examine prostate-specific antigen (PSA) as a screening test in randomly selected primary care practices. DESIGN: Chart abstractions of a random selection of 552 men (age, > or = 50 years) and physician and practice-level surveys. SETTING: Fifty-eight randomly selected, nonteaching, non-governmental, primary care practices in a 43-county area in Virginia. MAIN OUTCOME MEASURES: Documented evidence of PSA screening for asymptomatic male patients and physician self-report on regular (annual or biannual) use of PSA screening. RESULTS: Of 496 asymptomatic men, 123 (25%) seen in a 1-year period had documentation of PSA screening. Sixty (50%) of 120 asymptomatic men with documentation of a health maintenance examination had a PSA screening, whereas only 63 (17%) of 376 men without health maintenance examination had a PSA screening (chi 2, P < .001), after adjusting for race, insurance status, and age. Comparison of PSA screening use before and after the November 1992 publication of the American Cancer Society guidelines on PSA screening revealed that PSA screening after the publication date was 26%, compared with 19% before the data (P = .045), adjusting for health maintenance examination and the length of time for which the patient was eligible for screening. Logistic regression on physician self-report of regular vs not regular PSA use found an odds ratio of 6.12 (95% confidence interval, 1.28 to 29.30) for influence of the guidelines and 0.96 (95% confidence interval, 0.93 to 0.99) for the proportion receiving Medicaid or uninsured in the practice. CONCLUSIONS: Despite controversy over PSA as a screening test, PSA screening has now spread substantially in primary care practice.

Temporal (circadian) and functional relationship between atrial natriuretic peptides and blood pressure.

Long-acting natriuretic peptide, vessel dilator, and atrial natriuretic factor consisting of amino acids (a.a.) 1 to 30, 31 to 67, and 99 to 126 of the 126-a.a. atrial natriuretic factor (ANF) prohormone, respectively, circulate in humans and have potent vasodilatory properties. To determine if these atrial natriuretic peptides are directly related to blood pressure in clinically healthy normotensive humans, we obtained 24-h profiles of vessel dilator, long-acting natriuretic peptide, ANF, and blood pressure in 10 men in 1988 and 11 men in 1993 (seven men were studied twice) to compare circulating concentrations of atrial natriuretic peptides with naturally occurring changes in blood pressure. Overall, vessel dilator, long-acting natriuretic peptide, and ANF each had significant (p<0.001) circadian rhythms, with peak concentrations late during sleep (at 04:00 h) being nearly twice their concentrations in the afternoon and evening. This high-amplitude circadian change allowed for the refinement of normal limits for ANF peptides by computing 3-hourly tolerance intervals (chronodesms) against which to compare time-specified single samples for normality. Systolic, diastolic, and mean arterial blood pressure also had significant circadian rhythms (p<0.001) with peaks and troughs that were exactly opposite those of the ANF peptides. In addition to this inverse temporal relationship, there was a significant inverse correlation between absolute values for blood pressure and each ANF peptide (p<0.001), implying a functional relationship. These data suggest that in addition to other well-established neurochemical factors, the ANF peptides (vessel dilator, long-acting natriuretic peptide, and ANF) are important for the maintenance of blood pressure and modulation of its circadian rhythm.

Alternating irradiation and chemotherapy in stage III A and B nonsmall cell lung cancer: report of a cancer and Leukemia Group B phase II study 8636.

PURPOSE: A pilot trial testing the feasibility of chemotherapy and radiotherapy was done in Stage III A and B nonsmall cell lung cancer. The schedule was designed to be consistent with the laboratory model of Looney and Hopkins. METHODS AND MATERIALS: Treatment began with thrice-per-day radiotherapy for 3 days (16.2 Gy/nine fractions), followed by chemotherapy (cis-platinum 100 mg/m2 day 10, and vinblastine 4 mg/m2 days 10 and 12). A second cycle started on day 22, a third on day 43, and a fourth on day 64. We treated three cohorts. The first cohort received three cycles of radiotherapy alone, (48.6 Gy). The second cohort received three completed cycles, and the third received three completed cycles and a fourth radiotherapy course (64.8 Gy). Patients were evaluated for toxicity, protocol compliance, response, and survival. RESULTS: The patients in the first cohort experienced no toxicity. Fifty-six percent (56%) of the patients treated in cohort 2 experienced severe or life-threatening myelosuppression as did 82% of those in cohort 3. Nonhematologic toxicity was not severe; one case of Grade 3 esophagitis, one of reversible adult respiratory distress syndrome, and one radiation pneumonitis. We closed the trial after accrual to the third cohort because of significant myelosuppression. CONCLUSION: This schedule is too myelosuppressive to be used without modification.

Distraction osteogenesis. A comparison of corticotomy techniques.

The left hindlimbs of 15 adult mongrel dogs were lengthened using the Ilizarov external fixator. Five dogs were assigned to each of three separate groups: (I) corticotomy; (II) osteotomy with multiple drill holes and an osteotome; (III) osteotomy with an oscillating saw. Distraction began on postoperative day seven and continued at a rate of 0.25 mm every six hours for 26 days. The regenerate segments were evaluated with weekly radiographs and Dual Energy Photon X-ray (DEPX) beginning at day seven. Barium perfusion studies and histologic preparations were also performed after the dogs were killed. Periosteal callus formation was apparent in all groups at two weeks, and endosteal callus appeared in Groups I and II at three to four weeks. Perfusion studies at the end of the distraction period demonstrated vessels bridging across the regenerate gap in Groups I and II. Vessels bridging the gap were diminished in the oscillating-saw Group III specimens. During the distraction period, the appearance and length of the regenerate bone was similar for each group radiographically and by DEPX scanning. No histologic differences were seen in Groups I and II. Three of the four tibias cut with the oscillating saw did not consolidate at ten weeks. A simple transverse osteotomy yields regenerate bone that is indistinguishable from the technically more difficult corticotomy. Use of the oscillating saw may lead to delayed consolidation.

Treatment of radiation exposure and contamination.

For treatment of radiation accident victims, procedures for handling trauma patients must be modified to ensure proper care and prevent contamination of hospital facilities and personnel. The radiation accident management plan should be instituted in advance. Exposure and contamination victims are treated differently. Exposed patients have sustained either partial or whole-body exposure but do not carry radioactive material; contaminated patients have also been exposed, but they have radioactive material either externally or internally and thus are continually exposed to radiation until the contaminant is removed. The treatment area and personnel must be protected with use of isolation, clean transfer techniques, and appropriate attire. After clothing has been removed, the patient's medical condition is assessed, stabilized, and treated. Samples from the affected areas, eyes, nose, and mouth are obtained for analysis and planning definitive treatment. For external contamination, the skin is washed with normal saline or mild detergent. Treatment of internal contamination is based on the isotopes involved and may include saturation of the crucial organ, dilution therapy, isotope displacement, or use of chelating agents. After a survey to ensure that no residual contamination remains, the patient is transferred to a care unit. Effects of exposure are seen over periods ranging from days to weeks to years, depending on the total dose received. Knowing the dose allows clinicians to predict what effects may ultimately occur.

Microencapsulation studies on aminophylline involving spherical crystallization, spheronization and drug loading on to non-pareil seeds.

Aminophylline was formulated as small spherical cores for subsequent coating in an attempt to develop a competitor microencapsulated product to the commercial available sustained-release tablet, Phyllocontin. Optimum spherical crystallization conditions yielded cores of loosely adhering crystals of active, with highly irregular surface morphology and poor mechanical strength during pan coating. Aqueous spheronization yielded satisfactory cores in high yield when microcrystalline cellulose and liquid paraffin were used. However, application of large amounts of controlled-release coatings based on Eudragit RL and RS failed to produce a product with retarded drug dissolution comparable to the commercial product. Drug loaded non-pareils were easily formed, but required application of about 20 per cent Eudragit RL/RS coating to achieve adequate prolonged-release properties. Application of 10 per cent hydrogenated castor oil/ethylcellulose based coating gave acceptable in vitro release only if the microcapsules formed were tableted and annealed. All products investigated rapidly discoloured during storage and none were considered to represent a realistic alternative to tableting technology for the production of a sustained-release oral dosage form of aminophylline.