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Biomedical subjects

R L Coleman

Publications and source records attributed to R L Coleman.

At least 55 records · Page 3Linked to original sources

Anesthesia information management systems as a cost containment tool.

Anesthesia information management systems (AIMS) have uses that extend far beyond automatic anesthesia record-keeping. After initial experience with the development of monitoring technology, the Department of Anesthesiology at Duke University Medical Center, Durham, North Carolina, began the installation of the Arkive anesthesia information management system in 1987. The system was installed hospital-wide in 1992. AIMS played an integral role in determining the cost of pharmaceutical agents used during an anesthetic procedure. Clinicians targeted areas of high cost in which anesthetic practice could be modified. Establishment of an educational program followed by the institution of practice guidelines allowed for an annualized savings of more than $900,000 on drug costs with no effect on the quality of care provided. Future generations of AIMS need to be more fully integrated into hospital information management systems.

Anesthesiology↗

Topotecan in the treatment of gynecologic cancer.

Topotecan (Hycamtin; SmithKline Beecham Pharmaceuticals, Philadelphia, PA), a derivative of the topoisomerase I inhibitor camptothecin, was approved by the Food and Drug Administration in May 1996 for the salvage treatment of ovarian cancer. It has shown promising clinical activity in a variety of solid tumors, including cervical cancer. Phase II and III trials in patients with cisplatin-resistant ovarian cancer have been conducted using a regimen of a single 30-minute intravenous topotecan infusion (1.5 mg/m2/d) for 5 days, repeated every 21 days. Significant responses, both partial and complete, have been observed in 14% to 21% of patients, with stable disease achieved in as many as 61%. In advanced or recurrent cervical cancer, partial response or stable disease was achieved in 59% of phase II trial patients. Myelosuppression is the major dose-limiting toxicity associated with topotecan. In general, the severity of myelosuppression shows a positive correlation to the magnitude of exposure to topotecan. Support with granulocyte colony-stimulating factor may partially ameliorate myelosuppressive effects.

Antineoplastic Agents↗

Quality management in mental health. II. Managing risk of dangerousness.

In 1995 R. L. Coleman and D. E. K. Hunter described a quality management approach that produced measurable improvements in quality of care in a state-operated psychiatric hospital. Continued evolution of this approach has subsequently enabled the development and implementation of effective processes for managing risk of dangerousness among patients throughout the hospital. Supported by management principles that promote hospital-wide quality improvement, clinicians and managers produced an environment that was conducive to promoting quality. The hospital-wide quality improvement context involved integrating multiple activities designed to promote quality of care, including significant collaborations with other health care organizations. The hospital's mission as an acute care psychiatric facility has required that it focus on assessing and managing risk of dangerousness in a systematic manner. This was done through developing and utilizing a predictive risk assessment instrument and indicators for managerial oversight. This was accomplished in these steps. First, clinical leaders rated potential criteria according to estimates of their ability to predict dangerousness behavior and reviewed their estimates in relation to clinical findings. Second (and concurrently), clinicians and managers implemented procedures to monitor clinical risk and performance. Finally, outcome data were reviewed. They suggested that this approach was effective in reducing risk of dangerous behavior among patients on all psychiatric wards.

Dangerous Behavior↗

Surgical therapy of T1 and T2 vulvar carcinoma: further experience with radical wide excision and selective inguinal lymphadenectomy.

Radical wide excision and selective inguinal node dissection provide a more conservative and less morbid surgical option for women with vulvar carcinoma than en bloc radical vulvectomy with bilateral inguinofemoral lymphadenectomy. We have expanded our initial experience with this approach to 76 patients with T1 (n = 33) and T2 (n = 43) squamous carcinomas with invasion > 1 mm and clinically negative groin nodes treated between 1978 and 1994. Lateral tumors (n = 53) were more frequent than midline lesions (n = 23). Tumors were excised with a measured gross margin of 2 cm, and dissection was carried to the deep perineal fascia. The mean largest tumor dimension was 26 mm; the mean depth of invasion was 4.4 mm. Superficial inguinal lymphadenectomy, unilateral or bilateral depending on lesion location, was performed. Perioperative complications occurred on the vulva in 8% of cases and in the groin in 11%. Delayed complications, all related to groin treatment, were seen in 29%. The median follow-up interval was 38 months. Seven patients (9%) had inguinal lymph node metastases identified at their primary operation. Most received additional therapy; one has died of disease. Nine women (12%) developed recurrent disease in the vulva: all were controlled by additional resection. Four (5%) developed recurrence in a previously negative groin: three of these are dead of disease. Actuarial 4-year survival is 81%. Radical wide excision and selective inguinal lymphadenectomy can be safely offered to women with T1 and T2 vulvar cancers. Patients with known positive nodes or vulvar failure can be salvaged by further therapy. Women with unanticipated groin failure usually die of disease. These experiences are similar to those observed in more radically resected patients.

Adult↗

Contemporary quality management in mental health.

Contemporary approaches to quality management in mental health utilize methods derived from traditional quality assurance and industrial quality improvement. Quality assurance involves the use of measurable indicators to monitor and evaluate care. Sentinel event indicators refer to high risk events that require review each time they occur. Rate indicators refer to events that are reviewed in the context of trends and patterns. The process of choosing and developing indicators should involve identification of the indicator topic, the monitoring objectives, data collection mechanisms, and responsible staff. As well, indicator data must be evaluated, actions taken, and communication of results must occur. Positive results, like positive diagnostic findings, point to a probability of the presence of a quality related issue. Quality improvement methods have led to a further evolution of efforts to promote quality care. A major goal of quality management is to utilize data to improve clinical decisions. Reaching this important goal is difficult in mental health due to the uncertain relationship between interventions and outcomes of care. In the effort described,, interventions were initiated to improve decisions relating to clinical risk management and resource utilization. Administrative restructuring enabled real-time review procedures and retrospective data analysis focused on decisions related to clinical instability and on permissive and restrictive clinical decisions. Permissive decisions were defined as decisions to allow off-ward privileges for patients whose level of functioning scores suggested the need for greater restriction. Restrictive decisions involved extending hospitalization of low risk patients. Inappropriate permissive or restrictive decisions are undesirable from both risk management and quality-of-care perspectives.(ABSTRACT TRUNCATED AT 250 WORDS)

Decision Making↗

Radical hysterectomy for recurrent carcinoma of the uterine cervix after radiotherapy.

Patients with small recurrent cervical carcinomas following radiation therapy may be salvaged with radical hysterectomy rather than exenteration. Between 1953 and 1993, 50 patients underwent radical hysterectomy for persistent (n = 18) or recurrent (n = 32) cervical cancer after primary radiotherapy. The mean age of the cohort was 44 years (range, 23-70). Histologic types were squamous in 46, adenocarcinoma in 3, and adenosquamous in 1. Of 37 patients with staged disease, 24 had stage IB/IIA, 7 had stage IIB, 2 had stage IIIA, and 2 had stage IIIB. Combination radiotherapy, consisting of 40-45 Gy external-beam radiation plus brachytherapy (mean 6980 mg/hr), was performed in 32 patients (64%). In the 32 patients with recurrent lesions, the median interval from definitive radiotherapy to radical hysterectomy was 16 months (4-301), with 19 of these patients (60%) presenting within the first 24 months. Patients with persistent carcinomas underwent radical hysterectomy after a median observation interval of 2 months (1-4). A class II or III radical hysterectomy was performed in 39 (78%) cases. Pelvic and para-aortic lymph node samplings were performed in 39 patients (78%), including 33 (66%) who underwent complete pelvic lymphadenectomy. Among those sampled, 5 (13%) had metastatic nodal disease. All 5 patients died of disease at a median 13 months after surgery. Severe postoperative complications occurred in 21 patients (42%). The most common site of injury was the urinary tract, with 14 patients (28%) developing vesicovaginal or rectovaginal fistulae, 11 (22%) developing ureteral injuries, and 10 (20%) developing severe long-term bladder dysfunction. There was one postoperative death from sepsis among the entire population. Patients with abnormal preoperative intravenous pyelograms (P < 0.05), patients with recurrent presurgical lesions (P < 0.05), and patients with postoperative pelvic cellulitis (P < 0.01) were more likely to develop fistulae. The 5- and 10-year actuarial survival rates for all cases was 72 and 60%, respectively. Tumor size at radical hysterectomy was significantly associated with survival. Five-year actuarial survival in 12 of 44 patients (27%) with identifiable lesion diameters less than 2 cm was 90% compared with 64% in patients with larger lesions (P < 0.01). Prolonged disease-free survival occurred in 26 of 50 patients (52%) who had known disease status at follow-up, whereas recurrence after radical hysterectomy was seen in 24 patients (48%).(ABSTRACT TRUNCATED AT 400 WORDS)

Adenocarcinoma↗

Familial aggregation of carcinoma of the endometrium.

OBJECTIVE: Our purpose was to describe histologically verified endometrial carcinoma and other cancer types manifested through three generations in a pedigree, where these findings do not fit any classic hereditary cancer syndrome. STUDY DESIGN: Our family study protocol used detailed patient interviews whenever possible and questionnaires with permission forms that, when signed, enabled retrieval of pertinent medical-genetic and pathologic study documents. RESULTS: Endometrial carcinoma was histologically verified in five women through three consecutive generations. The triad of obesity, hypertension, and diabetes mellitus was not observed. Primary carcinomas of both the endometrium and ovary and endometrium and lymphoma were documented in two relatives in the direct genetic lineage of the pedigree. CONCLUSION: An aggregation of endometrial carcinoma in families, even when classic hereditary cancer syndrome identification is lacking, nevertheless merits surveillance and management strategies targeted to putative high-risk family members.

Endometrial Neoplasms↗

Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 gp120 subunit vaccine combined with MF59 adjuvant with or without muramyl tripeptide dipalmitoyl phosphatidylethanolamine in non-HIV-infected human volunteers.

A phase 1 study of 42 non-human immunodeficiency virus type 1 (HIV)-infected volunteers was initiated to determine the safety and immunogenicity of an HIV subunit vaccine consisting of recombinant envelope gp120 derived from HIVSF2 (rgp120SF2) combined with a novel adjuvant, MF59, with or without the immunomodulator muramyl tripeptide dipalmitoyl phosphatidylethanolamine (MTP-PE). All injections contained adjuvant MF59, and subjects were grouped according to MTP-PE dose. Injections were given on days 0, 30, 180, and 365. The vaccine was well tolerated with limited local and systemic reactions. These immunizations induced rgp120SF2-specific binding antibodies that persisted > or = 24 weeks. After three immunizations, all subjects receiving the antigen developed neutralizing antibodies to HIVSF2, and serum from 67% of these subjects also cross-neutralized HIVMN. ELISA-reactive antibodies to the HIVSF2 V3 region and strong lymphoproliferative responses to HIVSF2 envelope proteins were detected in all rgp120SF2-immunized subjects.

AIDS Vaccines↗

DNA flow cytometric analysis of clinical stage I endometrial carcinomas with lymph node metastases.

Twenty-one (8%) of 264 consecutive evaluable patients with clinical stage 1 endometrial carcinoma had histologic evidence of pelvic and/or para-aortic lymph node metastases. DNA flow cytometry was performed on both the primary tumor and nodal metastasis. Seventeen of 21 sets could be analyzed. Overall, 11 (65%) of the primary carcinomas were aneuploid. Nine of 17 (53%) had consistent ploidy patterns when the primary tumor and lymphatic metastasis were compared. The remaining 8 (47%) had aneuploid primaries with diploid nodal metastases. Five (83%) of the 6 patients with diploid primary tumors were alive without evidence of disease compared to 3 of 11 (27%) patients with aneuploid tumors (P < 0.05). Other predictors of disease outcome included tumor histology, lymph vascular space invasion, and depth of myometrial invasion. Ploidy status of the lymphatic metastasis was not important in terms of overall survival. All 8 patients with para-aortic nodal metastases had aneuploid primary carcinomas compared to 4 (44%) of 9 patients with pelvic node involvement only (P < 0.01). Mean survival was 31 months for patients with para-aortic node metastases compared to 51 months for patients with only pelvic node metastases. Comparison of survival curves among these two groups demonstrated a significant survival advantage in patients with regional nodal metastases (P = 0.032). S-phase fraction of both the primary tumor and lymphatic metastasis did not correlate with survival or predict disease outcome. DNA index of the primary tumor, as a continuous variable, was inversely proportional to survival, demonstrating poorer survivorship with incremental increases of DI. Ploidy status of the lymph node metastasis was an inconsistent reflection of the primary tumor's expression and behavior and, therefore, little additional information was gained by knowledge of the lymphatic ploidy status.

Adult↗

Intraoperative radiographs to confirm the adequacy of lymph node resection in patients with suspicious lymphangiograms.

Between June 1991 and October 1992, we used presurgery lymphangiograms and intraoperative radiographs to identify and remove suspicious nodes in the pelvic and para-aortic chains of 19 patients with bulky pelvic cancers. Surgery comprised extraperitoneal exploration using a midline vertical or paramedian "J" incision. After grossly enlarged nodes were removed, an intraoperative anterior-posterior (AP) abdominal radiograph was obtained. The exposure field approximated the 24-hr delay AP LAG radiograph. Both films were compared in the operating room to confirm removal of abnormal nodes. Initial resection removed all suspicious nodes in 16 of 19 cases. Additional dissection resulted in successful node excision in the other 3 patients. Most of these "missed" nodes were behind or between vessels. The median number of nodes sampled was 15 (range 2-47). Bilateral sampling was performed in 15 cases. Metastatic tumor was present in 14 patients (74%) who had from 1 to 8 positive nodes. Of the 5 negative specimens, all contained lipogranulomata; two had extensive fatty replacement, 2 contained Müllerian inclusions, and 1 had reactive follicular hyperplasia which could be accountable for the radiographic abnormalities. Extracapsular extension was noted in 12 of 14 metastatic samplings. Radiotherapeutic treatment planning was then tailored to lymph node status and the location of positive nodes. Combined use of preoperative LAG and intraoperative films is useful in ensuring that complete resection of abnormal nodes has been accomplished. Whether removal of gross lymph node metastases enhances survival requires further study.

Adult↗

Promoting quality through managed care.

Managed care organizations will be able to promote quality care as well as control costs by utilizing quality management approaches and practice guidelines. By so doing, organized systems of care could promote adherence to standards of quality and appropriateness. Focusing on systems of care is a major component of the quality improvement process and fits well with the development and utilization of practice guidelines. Practice guidelines, as well as risk management, quality assurance, and quality improvement techniques, can help reduce undesirable variation in practice patterns and prevent problems from occurring. Guidelines may be based on different levels of explicitness ranging from subjective judgment to specific outcomes and patient preferences. The use of guidelines and quality improvement mechanisms will enhance the effectiveness of clinical decision making and enable managed care organizations to work productively with physicians to promote quality.

Humans↗

The staff psychiatrist and the Joint Commission survey.

The psychiatrist on a hospital's medical staff has a major role in maintaining the quality standards established by the Joint Commission on Accreditation of Healthcare Organizations and in preparing for its accreditation survey. The authors review the medical staff's role in quality assurance activities, including development of clinical indicators, monitoring of clinical data, peer review of problems, and planning for improved care. Other areas of hospital operation requiring the attention of the medical staff are the functioning of the medical executive committee, hospital bylaws, and procedures for granting, denying, and amending clinical privileges.

Accreditation↗

The use of decision analysis in quality assessment.

Now that major efforts are being made to develop clinical indicators, it is also imperative that participants in quality assurance programs have useful mechanisms to review data derived on the basis of these indicators. The decision tree is one means of conceptualizing clinical problems in a manner that can enhance both the development and review of clinical indicators. The decision tree can assist in presentation of clinical decisions and outcomes. When applied to specific clinical indicator data, such as a failure to order diagnostic tests, or to a trend of failure to follow a standard protocol for admissions, decision trees and decision analysis can assist in the review of quality and appropriateness of care. Both individual cases and trends lend themselves to decision analysis, which can help determine the decisions likely to be appropriate. When numerical data are available, decision analysis can provide quantitative evaluations of clinical and quality assurance data.

Decision Support Techniques↗

Warfarin dosage requirements: prospective clinical trial of a method for prediction from the response to a single dose.

We have previously described a model for predicting individual daily maintenance dosage (MD) requirements of warfarin 24 h after the administration of a single dose. This model relies on measurement of the initial anticoagulant response as the 24 h percentage fall in plasma clotting factor VII activity. It permits prediction of the individual MD given the size of the initial dose, a baseline and desired maintenance value of the prothrombin ratio, and a baseline and 24 h plasma level of factor VII activity. We now present the results of a prospective clinical trial of the method. Data from 65 patients were suitable for analysis. The mean daily MD of warfarin was 4.0 mg (range 1-10 mg). There was a moderately strong linear relationship between predicted and actual MDs of warfarin (r = 0.66, P less than 0.001). Actual vs predicted MDs in individual patients were not significantly different. The mean difference was 0.39 mg. The results of this prospective trial suggest that our model predicts warfarin MD requirements with reasonable accuracy. Nevertheless, the accuracy of the model is not sufficient to replace careful clinical and haematological monitoring of each patient commencing warfarin therapy.

Adolescent↗

Depth-dose curves for 90Sr and natural and depleted uranium in Mylar.

Strontium and uranium are common sources used to calibrate personal dosimeters and survey meters for beta radiation. Since the absorbed dose rate of low-penetrating beta radiation decreases significantly with increased depth in tissue or dosimeters, it is necessary to describe the dose rate accurately as a function of depth. Complete depth dose information from zero to 1000 mg/cm2 is currently unavailable for strontium and uranium. This paper describes the generation of accurate depth-dose curves in Mylar for 90Sr and slabs of natural and depleted uranium from 0 to 1000 mg/cm2, utilizing an extrapolation chamber. The absorbed dose rate produced by natural uranium was found to decrease from 235 mrad/hr at a depth of 7 mg/cm2 to 43 mrad/hr at 300 mg/cm2 to 4.8 mrad/hr at 1000 mg/cm2. The dose rate produced by depleted uranium was found to decrease from 205 mrad/hr at 7 mg/cm2 to 34 mrad/hr at 300 mg/cm2 to 2.3 mrad/hr at 1000 mg/cm2. A 1-mCi extended area 90Sr source (encapsulated in 50 mg/cm2 AG) was found to produce an absorbed dose rate of 16,997 mrad/hr at 57 mg/cm2, 5000 mrad/hr at 300 mg/cm2, and 27.1 mrad/hr at 1050 mg/cm2. Doses to deep organs have been determined historically at depths ranging from 300 to 1000 mg/cm2. The results of this study show that 90Sr and uranium produce significant absorbed dose rates at a depth of 300 mg/cm2. Thus, if doses for deep depths are determined at 300 mg/cm2 for mixed beta-gamma exposures, the dose will be overestimated due to the presence of the beta component. The depth-dose curves generated in this study can be used by dosimeter processors to normalize the response of their dosimeters to the shallow (7 mg/cm2) and deep (1000 mg/cm2) depths defined by the U.S. Nuclear Regulatory Commission.

Calibration↗