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Biomedical subjects

M S Carey

Publications and source records attributed to M S Carey.

11 recordsLinked to original sources

Surgery as sole treatment for serous borderline tumors of the ovary with noninvasive implants.

OBJECTIVES: The objectives were to describe the clinical characteristics and prognosis of surgically treated patients with stage II and III serous borderline tumors of the ovary with noninvasive implants. MATERIALS AND METHODS: From 1990 to 2000, 16 patients with stage II and III ovarian serous borderline tumors and noninvasive implants were diagnosed and prospectively followed at our center. All patients underwent surgical treatment including staging and their pathology was reviewed. Fifteen patients had thorough surgical staging by laparotomy, while one patient was staged laparoscopically. No patient was treated with adjuvant therapy (radiation or chemotherapy) after surgical treatment and none were lost to follow-up. RESULTS: The mean age at diagnosis was 42 years (range 26-59). Fourteen patients were treated by abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and multiple peritoneal biopsies, while 2 patients were treated conservatively for fertility preservation. Two patients underwent pelvic and para-aortic lymph node dissection. Fifteen of 16 patients had ovarian surface involvement with tumor. All patients but 2 had clinical evidence of extraovarian disease at the time of surgery. The mean duration of follow-up was 60.7 months (range 2-134 months). Thirteen patients (81%) are alive without evidence of disease. Four patients (25%) required subsequent surgery for recurrent disease and all are still alive. Two patients have been treated with chemotherapy (paclitaxel/carboplatin) for progressive borderline disease, while an additional patient was treated after first relapse with chemotherapy for an invasive recurrence. CONCLUSIONS: Carefully staged patients with advanced serous borderline tumors of the ovary and noninvasive implants have a good prognosis without adjuvant therapy.

Adult↗

General health and psychological symptom status in pregnancy and the puerperium: what is normal?

OBJECTIVE: To identify normative changes in psychological and physiologic health status associated with pregnancy and the puerperium. METHODS: Self-administered surveys containing Ware's Short Form-36 and Derogatis's Brief Symptom Inventory were completed by 393 pregnant women during their third trimester. Of those, 253 completed the same survey during the puerperium. Results were compared between periods and with those of samples of women from standardized community samples. RESULTS: On the Short Form-36, pregnant women in the third trimester had significantly poorer levels of functioning (P<.01) than community controls with regard to bodily pain (51.86 versus 79.61), physical functioning (62.91 versus 89.12), social functioning (74.0 versus 84.06), vitality (47.24 versus 58.04), and functional limitations resulting from physical health problems (45.0 versus 86.73) subscales. Those differences persisted into the puerperium. Compared with pregnancy, scores on social functioning and functional limitations caused by emotional problems decreased during the puerperium. Women reported improved perceptions of their general health in the puerperium compared with community controls (80.22 versus 74.80). On the Brief Symptom Inventory, pregnant women reported significantly higher levels of emotional distress on the three global measures and on the somatization (0.75 versus 0.35), obsessive-compulsive (0.70 versus 0.48), and hostility (0.59 versus 0.36) subscales than controls; those changes normalized in the puerperium. CONCLUSION: Pregnancy and the puerperium are associated with significant changes in psychological and physiologic health status. Documentation of those changes is important if the Short Form-36 and Brief Symptom Inventory are to be used in health outcomes research with this population.

Adult↗

Progress of clinical oncology guidelines development using the Practice Guidelines Development Cycle: the role of practitioner feedback.

PURPOSE: To present an update on the development of oncology practice guidelines (PGs) using the Practice Guidelines Development Cycle (Cycle), and to present the results of surveys of oncologists on the first 10 guidelines from the Cancer Care Ontario Practice Guidelines Initiative. METHODS: Practitioners' opinions about guidelines in development were sought using a mail survey method with systematic follow-up. Practitioners were identified by cancer center representatives. Survey packages included evidence-based recommendations (EBRs) and a one-page, nine-item feedback questionnaire. Data were collected between February 1995 and February 1996. RESULTS: Nine hundred fourteen surveys that pertained to 10 guidelines were mailed to 423 practitioners in Ontario. Practitioners included 112 medical oncologists/hematologists, 34 radiation oncologists, 195 surgeons, and 82 practitioners from other medical specialities. One hundred practitioners were located in cancer centers and 323 had community-based practices. The overall response rate by practitioner was 72% and by survey questionnaire, 70%. For the five questionnaire items that assessed guideline quality, approval ratings ranged from 86% to 92%. For the 10 recommendations, 77% ( 63% to 82%) of respondents agreed that the EBR could be approved as a PG. Response and approval rates were consistent across medical specialities and locations of practice. CONCLUSION: The process of obtaining practitioner feedback in the development of PGs is both feasible and useful. The high response rates to the survey indicate that it is possible to obtain broad participation in evidence-based guidelines development throughout Ontario. The changes made to the EBRs in response to feedback suggest that practitioners' opinions can be valuable in shaping evidence-based guidelines.

Evidence-Based Medicine↗

Pharmaceutical fingerprinting: evaluation of neural networks and chemometric techniques for distinguishing among same-product manufacturers.

The present study was undertaken to evaluate several computer-based classifiers as potential tools for pharmaceutical fingerprinting by utilizing normalized data obtained from HPLC trace organic impurity patterns. To assess the utility of this approach, samples of L-tryptophan (LT) drug substance were analyzed from commercial production lots of six different manufacturers. The performance of several artificial neural network (ANN) architectures was compared with that of two standard chemometric methods, K-nearest neighbors (KNN) and soft independent modeling of class analogy (SIMCA), as well as with a panel of human experts. The architecture of all three computer-based classifiers was varied with respect to the number of input variables. The ANNs were also optimized with respect to the number of nodes per hidden layer and to the number of hidden layers. A novel preprocessing scheme known as the Window method was devised for converting the output of 899 data entries extracted from each chromatogram into an appropriate input file for the classifiers. Analysis of the test set data revealed that an ANN with 46 inputs (i.e., ANN-46) was superior to all other classifiers evaluated, with 93% of the chromatograms correctly classified. Among the classifiers studied in detail, the order of performance was ANN-46 (93%) > SIMCA-46 (87%) > KNN-46 (85%) = ANN-899 (85%) > "human experts" (83%) > SIMCA-899 (78%) > or = ANN-22 (77%) = KNN-22 (77%) > or = KNN-899 (76%) > SIMCA-22 (73%). These results confirm that ANNs, particularly when used in conjunction with the Window preprocessing scheme, can provide a fast, accurate, and consistent methodology applicable to pharmaceutical fingerprinting. Particular attention was paid to variations in the HPLC patterns of same-manufacturer samples due to differences in LT production lots, HPLC columns, and even run-days to quantify how these factors might hinder correct classifications. The results from these classification studies indicate that the chromatograms evidenced variations across LT manufacturers, across the three HPLC columns and, for one manufacturer, across lots. The extent of column-to-column variations is particularly noteworthy in that all three columns had identical specifications with respect to their stationary-phase characteristics and two of the three columns were from the same vendor.

Chemistry, Pharmaceutical↗

Good outcome associated with a standardized treatment protocol using selective postoperative radiation in patients with clinical stage I adenocarcinoma of the endometrium.

In 1982, a treatment protocol was instituted for the management of patients with clinical stage I adenocarcinoma of the endometrium. All pertinent historical, operative, and pathologic findings were reviewed by a multidisciplinary committee and 384 patients were prospectively assigned to either high- or low-risk categories. Patients were excluded from the study if they had clinically apparent extrauterine disease, clear cell or serous histologies, or microscopic ovarian metastasis. Patients were considered high-risk if they had one or more of the following factors: grade 3 tumor differentiation, myometrial invasion > 50% of the total wall thickness, pathologic cervical involvement, or adenosquamous histology. Two-hundred twenty-seven (59%) low-risk patients were followed without further treatment after surgery, while pelvic radiation was recommended for 157 (41%) high-risk patients. The 5-year relapse-free survival rates in the low- and high-risk groups were 95 and 81%, respectively. There were no treatment-related deaths. Severe or life threatening chronic radiotherapy complications occurred in 6 (5%) patients. Multivariate Cox analysis identified the following significant prognostic factors: grade, myometrial invasion, cervix involvement, and age. This treatment protocol represents a safe and effective method of managing patients with carcinoma of the endometrium and spares the need for radiation therapy in the low-risk patient.

Adenocarcinoma↗

Conservative surgery for recurrent or persistent carcinoma of the cervix following irradiation: is exenteration always necessary?

Between 1960 and 1988, 47 patients had conservative surgery for postradiation recurrent or persistent cervical carcinoma. Forty-two patients with nonmetastatic disease and available follow-up information were divided into 3 groups based on the extent of disease and type of surgical procedure. Group 1 contained 13 patients with smaller tumors prior to radiation (FIGO Ib and IIa), and recurrent or persistent disease confined to the cervix and/or vaginal vault. Group 2 consisted of 20 patients presenting with more advanced disease than those in Group 1, at the time of either radiation or surgery. Surgical resection of disease was accomplished in both Groups 1 and 2 by either radical vaginal or abdominal hysterectomy. The 8 patients in Group 3 required extended Wertheim operations to encompass locally advanced disease involving the bladder base and/or parametrium. One patient could not be categorized. The 5-year estimated relapse-free survivals for each group were 84, 49, and 25%, respectively. The relapse-free survival of Group 1 was significantly better (P = 0.003) than that of Group 3. Major complications occurred in 4 patients belonging to Group 1 (31%), 10 in Group 2 (50%), and 6 (including two treatment-related deaths) in Group 3 (75%). The most common complication was fistula formation in 11 patients (26%). Radical hysterectomy can be offered as an alternative to exenteration in carefully selected patients.

Adult↗

Baclofen, a new antispastic drug. A controlled, multicenter trial in patients with multiple sclerosis.

A double-blind, five-week, multicenter trial was conducted to compare the effect of baclofen, a unique amino acid derivative, with that of placebo in the treatment of 106 patients with spasticity secondary to multiple sclerosis. A spasticity assessment method that included a neurological examination, physicians' clinical impressions of changes during treatment, and a patient's self-evaluation was used to determine efficacy. This method showed baclofen (70 to 80 mg daily maximum, titrated) is effective relative to placebo in relieving symptoms of spasticity, such as flexor spasms, pain and stiffness, resistance to passive joint movements, and tendon stretch reflexes. Patient self-evaluation results also showed a significant reduction in clonus. Side effects were generally mild and transient.

Adolescent↗

Developing optimum drug regimens.

In clinical pharmacological trials the determination of the optimum regimen for a drug using the technique of response surface analysis is proposed as being more advantageous than traditional analyses of dose response relationships. Major considerations in favour of this technique are that the optimum regimem can be identified with a minimum of human experimentation, and unacceptable regimens are eliminated from the study early, at a substantial saving of time and money.

Drug Administration Schedule↗

Effect of delayed implantation on differentiation of the extra-embryonic endoderm in the mouse blastocyst.

Delayed implanting blastocysts recovered from both ovariectomized and lactating pregnant mice were examined for the presence of primitive endoderm. One or more of three different criteria were used to identify this tissue which was found to be present in nearly all such blastocysts, regardless of the length of time for which their implantation had been delayed. Furthermore, the tissue appeared to differentiate in blastocysts from ovariectomized females at approximately the same postcoital stage as in those from sham-operated controls. Formation of the parietal endoderm layer was not observed in a single instance during delay, but began approximately 10 h after it had been terminated by injecting ovariectomized females with oestradiol benzoate. Cells in mitosis were found both at longer intervals after the onset of implantation delay and at shorter intervals after its termination than reported previously. It is concluded that, contrary to what might have been anticipated from certain earlier studies, there seem to be no obvious advantages in using delayed implanting rather than nondelayed blastocysts for investigating initial steps in differentiation of the primitive endoderm. Delayed blastocysts may, nevertheless, be of value in elucidating factors controlling the differentiation or onset of migration of parietal endoderm cells.

Animals↗