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Biomedical subjects

J C Gambone

Publications and source records attributed to J C Gambone.

At least 19 recordsLinked to original sources

Ovulation induction in women age 40 and older: the importance of basal follicle-stimulating hormone level and chronological age.

OBJECTIVES: To determine pregnancy and livebirth rates for women age 40 and older undergoing ovulation induction and to assess the impact of basal follicle-stimulating hormone (FSH) on outcome in these patients. DESIGN: Prospective, observational. SETTING: Fertility service of university medical center. PATIENTS: Infertile couples in whom the female partner was age 40 or older referred for ovulation induction therapy. INTERVENTION: Assessment of basal hormonal status; ovulation induction. MAIN OUTCOME MEASURES: Clinical pregnancy rate (PR), livebirth rate. RESULTS: Analysis of 402 cycles in 85 women age 40 and older demonstrated a clinical PR of 3.5% per cycle (95% confidence interval [CI] 1.7% to 5.3%). The livebirth rate was 1.2% per cycle (95% CI 0.1% to 2.3%). Women with a basal FSH < 25 IU/L and age < 44 years had a clinical PR of 5.2% per cycle (95% CI 2.5% to 7.9%) compared with 0.0% per cycle (95% CI 0.0% to 2.1%) in cases in which either basal FSH was > or = 25 IU/L or age was > or = 44 (P < 0.005). The prognostic importance of basal FSH and chronological age was confirmed by multivariate logistic regression analysis. The predictive value of the resulting regression equation was high (R2 = 0.94; P < 0.01). CONCLUSIONS: Pregnancy and livebirth rates are generally low during ovulation induction in women age 40 and older. In combination, basal FSH and chronological age are accurate predictors of PR, in these couples and can define a subset of patients with a more favorable prognosis. The spontaneous abortion rate in women who do conceive is high, substantially lowering the livebirth rate.

Adult

Appropriateness of hysterectomies performed for multiple preoperative indications.

OBJECTIVE: To correlate the listing of multiple preoperative indications for hysterectomy with the risk of non-confirmation of the preoperative diagnosis. METHODS: Records of 171 women undergoing consecutive hysterectomies for all indications at a large teaching hospital were reviewed for preoperative indication(s), compliance with published preoperative validation criteria for cases in which tissue pathology was not expected, and histologic verification of the preoperative diagnosis for cases in which tissue pathology was expected. Rates of confirmation (histologic verification plus successful compliance with validation criteria) of the preoperative diagnosis were compared between subgroups of cases in which single indications were listed (N = 124) or multiple indications were listed (N = 47) preoperatively. RESULTS: The rate of confirmation of single indications (115 of 124 cases, 93%) was significantly higher than the rate of confirmation of even one indication in cases in which multiple indications were listed (28 of 47 cases, 60%, P < .0001; relative risk for non-confirmation of multiple indications = 1.55). Multiple indications were more likely to be listed when tissue pathology was not expected, representing 49% of validatable indications as compared with only 18% of histologically verifiable indications (P < .0001). Overall, the rate of compliance with validation criteria (70%) was significantly lower than the rate of histologic verification (90%) (P < .01). CONCLUSION: These data suggest that listing of multiple preoperative indications for hysterectomy is associated with both decreased appropriateness, as reflected in decreased compliance with generally accepted preoperative validation criteria, and decreased diagnostic accuracy, as reflected in lower rates of histologic verification.

Female

Routine hysterectomy for large asymptomatic uterine leiomyomata: a reappraisal.

As part of an ongoing quality improvement process, the records of 104 consecutive patients undergoing hysterectomy for uterine leiomyomata were reviewed. The diagnosis was confirmed histologically in 93 cases (89%) and in eight of the remaining 11, other disease such as adenomyosis or an ovarian neoplasm was discovered. The 93 consecutive patients with a confirmed diagnosis of uterine leiomyomata were then stratified according to preoperative estimate of uterine size and actual uterine weight. The physician's clinical estimate of uterine size correlated well with specimen weight (r = 0.65, P less than .001). Intraoperative estimated blood loss correlated less well with actual change in hematocrit (r = 0.31, P = .03). Women with a uterine size estimate larger than 12 weeks' gestation were no more likely to suffer perioperative complications than were those with smaller uteri. Furthermore, there was no significant increase in mean estimated blood loss or blood transfusion in women with larger uteri compared with those with smaller uteri. We conclude that there is no increase in adverse short-term outcomes associated with hysterectomy for leiomyomata in women with uteri greater than 12 weeks' size. Therefore, hysterectomy need not be routinely recommended to asymptomatic women with larger uteri as prophylaxis against increased operative morbidity associated with future growth.

Adult

Rate-based calculation of failure to progress: a proposed quality improvement method.

The rate of "failure to progress" as the indication for primary cesarean delivery used by the Joint Commission on Accreditation of Health Care Organizations is based upon the total number of cesareans performed for this indication divided by the total number of primary cesareans. This denominator includes a large number of patients who are not at risk for the diagnosis of failure to progress, including cases of malpresentation or multiple gestation in which cesarean is performed without trial of labor. Each of these variables may vary dramatically between individual physicians and institutions. Inclusion of patients not at risk for failure to progress results in a misclassification bias, which renders this rate less meaningful for purposes of comparison and trend assessment. We describe a simple method that bases the rate of failure to progress upon the population at risk for this diagnosis; that is, the total number of vaginal deliveries plus primary cesareans for failure to progress minus vaginal births after cesarean. Such a method controls for multiple differences in local practice standards and allows more meaningful assessment of trends and intra-institutional and inter-regional comparisons.

Bias

Gonadal protection and fecundity rates in cyclophosphamide-treated rats.

Premature ovarian failure and reduced fecundity are well-documented consequences of cytotoxic chemotherapy used to treat patients with malignant diseases. To investigate the ability of different hormonal agents to block the effects of cyclophosphamide (CTX) on reproductive function, sexually mature female Long-Evans rats were studied. Model development demonstrated that CTX, 6 mg/kg/day, 5 days/week for 3 weeks, was successful at inducing acyclicity and significantly reducing fertility and fecundity, with acceptable mortality, when compared to higher/lower dosages. Utilizing this model, animals were treated with CTX in combination with an inert vehicle, Lupron, 80 micrograms/kg every 24 h, Lupron, 40 micrograms/kg every 12 h, or s.c. progesterone capsules obtaining serum progesterone levels of 20-30 ng/ml. We concluded that progesterone was able to protect the gonad from the negative effects of CTX, maintaining fertility and fecundity rates not significantly different from those of untreated control animals. Lupron given every 12 h had a similar effect on fertility, but failed to protect fecundity (P less than 0.001).

Animals

Correlation between sexual abuse and somatization in women with somatic and nonsomatic chronic pelvic pain.

After a comprehensive clinical and psychological evaluation, 99 women with pelvic pain of at least 6 months' duration and normal findings at laparoscopy were divided into two groups, including 47 women with probable somatic causes of pain (group 1) and 52 women without identifiable somatic abnormality (group 2). Women without identifiable somatic abnormality (group 2) were younger, had higher mean somatization scores, and reported an earlier mean age at first intercourse, a higher number of total sexual partners, and a higher prevalence of sexual abuse before the age of 20. Within group 2 (nonsomatic pain) but not within group 1, mean somatization scores were significantly higher among women with a history of sexual abuse than among women with a negative history. When analyzed as risks for nonsomatic pelvic pain, the positive predictive value of both a history of sexual abuse and a high somatization score was 78% (relative risk compared with that of women with zero or one risk factor, 2.1; p less than 0.0001). These data suggest that the psychosocial profile of women with nonsomatic pelvic pain differs from that of women with somatic pelvic pain and that previous sexual abuse is a significant predisposing risk for somatization and non-somatic chronic pelvic pain.

Adolescent

Nongynecologic somatic pathology in women with chronic pelvic pain and negative laparoscopy.

One hundred eighty-three women with chronic pelvic pain were referred to a multidisciplinary chronic pelvic pain clinic after negative laparoscopy. One hundred twenty-two of them completed a thorough medical and psychologic evaluation and were followed for a minimum of six months after completion of therapy. Occult somatic pathology was diagnosed in 57 women (47%), including 19 in whom coexistent psychopathology was diagnosed. Myofascial pain was the most common somatic diagnosis, followed by atypical cyclic pain (dysmenorrhea or mittelschmerz); gastroenterologic, urologic and infectious diseases; and pelvic vascular congestion. No plausible somatic etiology was apparent in the remaining 65 (53%) of the 122 referrals. Nongynecologic somatic pathology accounted for 34 (29%) and gynecologic pathology for 23 (19%) of the referrals, only 6 (5%) of whom ultimately required hysterectomy. Women with a somatic diagnosis were found to be significantly older than the remainder of the referral population. Long-term symptomatic improvement or resolution of pain was obtained in 43 (75%) of the 57 patients with somatic diagnoses. Coexistent psychopathology was found to correlate with a poorer long-term prognosis. Our findings underscore the importance of a multidisciplinary approach to evaluating and treating chronic pelvic pain in women and confirm that hysterectomy is indicated in this setting only rarely.

Adult

The impact of a quality assurance process on the frequency and confirmation rate of hysterectomy.

A criteria-based quality assurance process for hysterectomy was instituted at a large teaching hospital. After this process was initiated, the overall frequency of hysterectomy decreased by 24%, p less than 0.001. Significant reductions were seen in hysterectomy rates for the following indications: chronic pelvic pain (77%, p less than 0.0001), recurrent uterine bleeding (46%, p less than 0.001), preinvasive disease of the uterus (55%, p less than 0.005), and severe infection (70%, p less than 0.025). Adenomyosis was the single indication for which an increase in hysterectomy rate was observed. This increase, however, was completely reversed during the last 2 years of the study. This quality assurance process also resulted in a significant increase in the histologic verification rate (i.e., 82% vs 93%, p less than 0.001). These observations suggest that using such a criteria-based process can reduce the number of hysterectomies performed and improve the accuracy of the preoperative diagnosis.

California

Nonsurgical management of chronic pelvic pain: a multidisciplinary approach.

Experience with multidisciplinary management of CPP has demonstrated the importance of ruling out and of treating nongynecologic conditions such as myofascial syndrome, irritable bowel syndrome, urethral syndrome, and psychogenic pain in women with CPP and normal laparoscopies. Moreover, current data suggest that availability of a multidisciplinary pelvic pain clinic can reduce the frequency of hysterectomy for this disorder.

Adnexal Diseases

Quality assurance indicators and short-term outcome of hysterectomy.

Fifteen gynecologic quality assurance indicators recently published by The American College of Obstetricians and Gynecologists were applied to a previously reported hysterectomy data base. Chart reviews were performed for the most recent 257 cases in the data base, representing an 18-month interval. The indicators were divided into two groups: those intended to identify morbidity and mortality and those intended to screen for appropriateness of care. Rates of actual morbidity and cases that failed to meet published criteria sets for hysterectomy were determined by chart review regardless of the presence of a quality assurance indicator. A total of 135 indicators were identified in 114 (44%) of the 257 cases, including 64 patients (25%) with morbidity indicators and 50 (19%) with appropriateness indicators. Actual morbidity was correctly identified in all 64 cases in which morbidity indicators were present. Three cases with significant morbidity were identified by chart review but not identified by the indicators, yielding positive and negative predictive values of 100 and 98%, respectively, and an overall accuracy of 99% for morbidity indicators. By contrast, 14 of the 50 cases in which appropriateness indicators were present actually failed to meet published criteria sets. An additional seven cases failing to meet criteria sets were identified by chart review and not identified by the indicators, yielding a positive predictive value of 28%, a negative predictive value of 97%, and an overall accuracy of 83% for appropriateness indicators.

California

The effects of combining norethindrone with a gonadotropin-releasing hormone agonist in the treatment of symptomatic endometriosis.

Treatment of endometriosis with gonadotropin-releasing hormone agonists (GnRH-a) is associated with side effects secondary to the induced hypoestrogenic state. In an effort to ameliorate these symptoms, 10 patients with symptomatic endometriosis self-administered the GnRH-a [D-His6(Imbzl)-Pro9-NET]-GnRH in combination with norethindrone daily for 24 weeks. Painful symptoms were significantly suppressed after therapy (P less than 0.005). Objective review of photographs taken at laparoscopy before and after therapy demonstrated significant reduction of visible implants (P less than 0.005). Vasomotor symptoms were minimized when compared with a group of 16 patients previously treated with GnRH-a alone. Bone mineral density of the distal radius assessed by single photon absorptiometry was not reduced during therapy, although lumbar spine bone density assessed by quantitative computerized tomography was minimally but reversibly reduced. No metabolic derangements were detected. The combination of norethindrone with GnRH-a is a well tolerated and effective means of treating symptomatic endometriosis.

Adult

Pathophysiology and management of endometrial hyperplasia and carcinoma.

Endometrial cancer is currently the commonest pelvic malignancy affecting American women, most of whom share the same pathophysiologic basis, that is, unopposed estrogenic stimulation. The initial result of hyperestrogenism is the development of endometrial hyperplasia, which is reversible in most cases by appropriate hormonal therapy. Persistent stimulation eventually leads to atypical hyperplasia with nuclear atypia and invasive carcinoma. Because there is no cost-effective screening method for the detection of endometrial hyperplasia and carcinoma, it is essential to survey the high-risk population with appropriate diagnostic techniques. After diagnosis, therapy should be individualized based on pathologic findings (cell type and histologic grade) and extent of disease (International Federation of Gynaecologists and Obstetricians stage, depth of myometrial invasion, and pelvic and para-aortic lymph node status). Recent studies suggest that sex hormone receptors and nuclear DNA ploidy patterns provide useful prognostic information independent of histologic grade.

Adenocarcinoma

Demographic and historic variables in women with idiopathic chronic pelvic pain.

A comprehensive historic, demographic, and medical questionnaire was administered to 106 women referred to a multidisciplinary clinic for evaluation of idiopathic chronic pelvic pain and to 92 age-matched, pain-free control patients presenting for routine annual examination. Although racial distribution, mean gravidity and parity, and rates of elective abortion were similar in both groups of respondents, spontaneous abortion was reported significantly more frequently among women with pelvic pain. Patients in the study group were also more likely to be on active military duty, to have undergone previous nongynecologic surgery, and to have sought treatment for unrelated somatic complaints. Finally, although the mean ages at first intercourse were similar, women with idiopathic pelvic pain reported a higher total number of sexual partners and were significantly more likely to have experienced previous significant psychosexual trauma. These findings confirm that predisposing psychosocial variables are important in the pathogenesis of idiopathic pelvic pain and emphasize the significance of multidisciplinary evaluation and management.

Abortion, Spontaneous

Validation of hysterectomy indications and the quality assurance process.

Hysterectomy is one of the most commonly performed major operations in the United States. Despite efforts to explain its high incidence, the perception remains that a significant number of hysterectomies are unjustified. More indications are listed for hysterectomy than for any other major operation. A quality assurance process is presented that requires the surgeon to select preoperatively one designated indication for each hysterectomy performed. The pathology report is expected to verify the surgical indication in 66% of the cases. The other 34% of hysterectomy specimens are not expected to show tissue pathology based on the listed indication. For these cases, predetermined validation criteria must be satisfied in the surgeon's preoperative note. Applying the process in this series of 584 consecutive hysterectomies, 93% (N = 396) of the "pathology expected" indications were verified by the pathology report and 98% (N = 188) of the "no pathology expected" indications were validated by the surgeon's preoperative note. The process of using a single designated indication and reviewing only two documents (the pathology report and the surgeon's preoperative note) has greatly simplified the quality assurance process. This system enables a quality assurance committee to monitor easily the appropriateness of hysterectomy indications for their institution. Information obtained from this process can influence changes regarding the acceptability of certain indications. As a result of this study, adenomyosis, because of its low (38%) verification rate, is no longer considered a reliable preoperative indication for hysterectomy at San Diego Naval Hospital.

California

Consumer advocacy, elective surgery, and the "golden era of medicine".

The process of medical quality assurance evolved logically from the consumer advocacy movement of the past decades. This process has fundamentally altered the personal and legal relationship between patients and physicians. The need for development and adoption of a medically, ethically, and fiscally sound standard of elective surgical practice is clear and immediate. A system that may be used to evaluate the appropriateness of elective surgical procedures is proposed.

Consumer Advocacy