Reducing loss-to-follow-up among women with abnormal Pap smears. Results from a randomized trial testing an intensive follow-up protocol and economic incentives.

OBJECTIVES: This study evaluates the efficacy of two interventions designed to reduce loss-to-follow-up among women with abnormal Pap smears. METHODS: The two interventions were evaluated in two large public hospitals using a randomized 2 x 2 factorial design. One intervention involved an intensive follow-up protocol that relied on multiple attempts (mail and telephone) to contact the patient. The second intervention provided patients with economic vouchers to offset out-of-pocket expenses associated with the follow-up visits. Loss-to-follow-up was addressed by medical chart reviews and telephone interviews. RESULTS: The study population (n = 1453) was primarily Hispanic, married or otherwise living with a significant other, relatively young in age, and with no source of payment for health care. Overall, 30% of the total sample was loss-to-follow-up (i.e., no return visits). Among patients assigned to the control condition, loss-to-follow-up was 36.1% compared with 27.8% for the intensive follow-up condition, 28.8% for the voucher condition, and 29.0% for the intensive follow-up plus voucher condition. Both intervention conditions significantly improved follow-up rates. The odds ratio for intensive follow-up was 1.56 compared with 1.50 for the voucher intervention. The combined intervention condition (intensive follow-up x voucher program) did not have a significant effect after taking into account the main effects of the two interventions. Correlates of loss-to-follow-up included age (younger women had lower return rates), race/ethnicity (African American women had lower return rates), live-in relationship (women who were not married or living as married had lower return rates), and severity of the abnormal Pap smear (less severe abnormalities were associated with lower return rates). CONCLUSIONS: Both interventions were associated with moderate reductions in loss-to-follow-up in this underserved population. The implications of these findings are discussed relative to implementing cervical cancer control programs within state and local health departments.

Conservative management of options for patients with dysplasia involving endocervical margins of cervical cone biopsy specimens.

OBJECTIVE: Our purpose was to study the feasibility of conservatively managing selected cases of dysplasia involving endocervical cone margins. STUDY DESIGN: A retrospective review of patients conservatively managed after being found to have squamous cell dysplasia involving the endocervical margins of their cervical cone biopsy specimens. In phase I patients who had cold-knife conization with positive endocervical margins underwent repeat Papanicolaou smears and colposcopy, with biopsies and endocervical curettage as indicated. Those found free of disease were followed up with frequent Papanicolaou smears. In phase II patients with dysplasia to the endocervical resection edges on loop electrical excision procedure biopsy specimens were followed up with frequent cytologic studies. RESULTS: In phase I, 31 patients with positive endocervical margins on cold-knife conization and no evidence of dysplasia on reevaluation were followed up for 1 to 18 years. Dysplasia was detected in one patient during cytologic surveillance. In phase II, 11 patients were followed up for 12 to 31 months; only one patient has dysplasia. CONCLUSION: Selected patients with squamous cell dysplasia at endocervical cone biopsy margins may avoid additional surgery.

Nonsurgical management of unruptured isthmic ectopic pregnancy: preliminary experience.

Five unruptured isthmic tubal pregnancies diagnosed at laparoscopy were treated with either methotrexate/citrovorum factor rescue (MTX/CF) (n = 4) or observation alone (n = 1). Entry criteria required that the ectopic be fully visualized, no greater than 3 cm in diameter, with intact serosa, and without active bleeding. Treatment selection was based upon preoperative levels of beta-hCG with MTX/CF given to subjects exhibiting a plateaued or rising pattern and observation alone given those with falling levels. Subjects were followed with serial measurements of beta-hCG, complete blood counts, and liver function tests. In all subjects the ectopic pregnancy resolved without further surgery. Time to resolution (first day of treatment to undetectable beta-hCG) ranged from 12 to 55 days. Of the five subjects studied, follow-up hysterosalpingograms in four demonstrated tubal patency on the side of the ectopic gestation.

Nonsurgical management of unruptured ectopic pregnancy: an extended clinical trial.

Unruptured tubal pregnancies diagnosed at laparoscopy were treated with either methotrexate/citrovorum factor (MTX/CF) (n = 21) or observation (n = 5). Entry criteria required that the ectopic pregnancy be visualized, less than or equal to 3 cm in diameter, with intact serosa and no active bleeding. Treatment selection was based upon preoperative levels of beta-human chorionic gonadotropin (beta-hCG), with MTX/CF given to subjects exhibiting a plateaued or rising pattern and observation alone given to those with falling levels. Twenty-five of 26 ectopic pregnancies resolved without need of laparotomy. Two subjects received blood transfusions and one required a second operation for intra-abdominal bleeding. In both cases, fetal cardiac activity was noted pretreatment on ultrasound. The authors conclude the following: (1) MTX/CF may be safely used to treat selected unruptured ectopic pregnancy; (2) many ectopic pregnancies resolve spontaneously; and (3) ectopic pregnancies that form fetal elements, as evidenced on ultrasound, should not be managed medically.

The medical treatment of unruptured ectopic pregnancy with methotrexate and citrovorum rescue: preliminary experience.

Seven women with unruptured tubal pregnancies diagnosed on laparoscopy were treated with methotrexate and citrovorum rescue. Criteria for inclusion in the study were that the level of human chorionic gonadotropin (hCG) be plateaued or rising, that the ectopic pregnancy not exceed 3 X 3 cm, that the tubal serosa be intact, and that there be no active bleeding. The women were followed with serial measurements of hCG, complete blood counts, and liver function tests. All women responded to a single course of therapy. The median time to resolution (from the first day of treatment to when the hCG was undetectable) was 31 days (range, 5 to 50 days). Follow-up hysterosalpingograms were available for five women. Four women demonstrated tubal patency, and one showed a unilateral occlusion on the side of the ectopic. One woman was found to have an intrauterine pregnancy prior to the scheduled time of hysterosalpingogram.

Percutaneous drainage of pelvic abscesses: management of the tubo-ovarian abscess.

Percutaneous drainage of 35 pelvic abscesses secondary to pelvic inflammatory salpingitis are reported. Two methods of drainage were used: simple aspiration and catheter drainage. The success rate of aspiration drainage was 94 per cent, while catheter drainage yielded a 77 per cent success rate. The differences between pelvic abscess drainage and other types of percutaneous drainage are presented. The role of percutaneous drainage in the treatment of pelvic inflammatory disease is also discussed.

A comparison of piperacillin and clindamycin plus gentamicin in women with pelvic infections.

The efficacy and safety of piperacillin were compared with those of clindamycin plus gentamicin in 74 women with obstetric or gynecologic infections (such as endometritis, salpingitis and septic abortion). Thirty-five of the patients in the group treated with piperacillin and 33 of the patients in the group treated with clindamycin plus gentamicin were clinically cured. Clinical failure occurred in two patients in the group treated with piperacillin (salpingitis in one and endometritis in the other patient) and relapse of salpingitis occurred in one. Three patients who were given clindamycin plus gentamicin (all with salpingitis) did not respond to therapy. The most frequently isolated organisms were Neisseria gonorrhea and Bacteroides species. Adverse clinical experiences and the results of laboratory tests were fewer in the group treated with piperacillin than in the patients who received the combination regimen; in neither instance was treatment discontinued because of these effects. Thus, piperacillin was as safe and effective as a combination of clindamycin plus gentamicin.

Urodynamic effects of a vaginal pessary in women with stress urinary incontinence.

The manner in which a vaginal pessary restores urinary continence is poorly understood. This report provides an explanation. Following placement of the vaginal pessary, detailed urodynamic studies in a group of 12 women with stress urinary incontinence demonstrated consistent and significant (p less than 0.005) increase in urethral functional length and urethral closure pressure under varying stressful conditions, when compared with prepessary studies. Postpessary stress testing also became normal (p less than 0.005). Prepessary and postpessary simultaneous voiding urethrocystometry and instrumented uroflowmetry demonstrated absence of obstruction to free flow of urine. Clinically, 10 of 12 patients became continent. Characteristic postpessary urodynamic alterations and Q-tip test changes provided an objective explanation that the vaginal pessary restored continence by stabilizing the urethra and urethrovesical junction to allow proper pressure transmission and by actively increasing urethral resistance to escape of urine under resting and stressful conditions.

Use of an information retrieval service in an obstetrics/gynecology residency program.

The need for a more effective and timely method of keeping a department's faculty and house staff knowledgeable of current developments and research is recognized. A program utilizing the clinical librarian as a member of the patient care team has been developed by the staff of the Department of Obstetrics and Gynecology and the Medical Library Department, UCLA Medical Center. The objectives, methodology, and costs of the program are described. At the completion of one year evaluation of the program indicates successful achievement of the objectives. Utilization of library literature search services by the Department of Obstetrics and Gynecology increased 12 percent after the program initiation.

Laparoscopic tubal sterilization using thermal coagulation.

A technique using a low-voltage, rechargeable battery pack and a cautery hook assembly for thermal coagulation and division of the fallopian tube under laparoscopic visualization has been evaluated in 393 patients. The procedure is quick, easy to perform, and electrically safe. The gross extent of the burn to the fallopian tube by thermal coagulation and division was compared with that done by high-frequency unipolar electrocoagulation and division. The difference in the mean total gross tubal burn produced by the 2 methods is not statistically significant. The variance of total tubal burn in individual cases within each group is significantly greater in the electrocoagulation group. The authors assume that pregnancy rates in patients undergoing thermal coagulation and division will be no different than those reported in patients in the electrocoagulation and division group. Two hundred of the patients have been followed from 12 to 33 months and no method-failure pregnancies have occurred.

PIP: A new technique, utilizing thermal coagulation provided by a low 6 voltage rechargeable battery pack and disposable cautery hook assembly, was used in performing laparoscopic tubal sterilization on 393 patients during 1975-1977 and found to be a safe and effective procedure. No major complications or burns occurred. 51% of the patients were followed for 12-33 months and no pregnancies attributable to method failure occurred. In order to assess the degree of burn damage resulting from thermal coagulation as compared to burn damage associated with high frequency unipolar electrocautery, 10 patients had the right tube cauterized by thermal coagulation and the left tube by electrocautery. Surgical specimens from both tubes were histologically examined. No significant differences in total gross burn area were observed; however, variation in the degree of individual burns was greater for the high frequency electrocoagulation specimens. For patients interested in the possibility of tubal reanastomosis this variation might be crucial. The surgical procedures involved in using thermal coagulation are described and a table presents the gross burn measurements for both the electrocoagulation and thermal coagulation specimens.

Obtaining drug exposure histories during pregnancy.

One hundred fifty-three pregnant patients were included in this study to verify the amount of drugs ingested during their pregnancies. The results demonstrate that, unknown to the physician, pregnant patients take a variety of pharmacologic agents. The patient's medical record is considered grossly inadequate in documenting an accurate assessment of a patient's exposure to drugs taken during pregnancy. Drug histories were obtained utilizing the hospital pharmacist drug history interview and home diary. Validity testing of the pharmacist's drug history and of the medical record history was not performed. The patient's compliance for utilizing the home diary for drugs or chemicals taken during their pregnancy was 83% (127 patients). It was shown that the usual methods of drug history documentation will identify only 30% of the actual drug exposure to the fetus.

The DES story.

During the last 6 years, there has been a marked increase in the incidence of vaginal and cervical clear cell adenocarcinomas occurring in young females. A relationship between maternal ingestion of synthetic estrogens occurs in about 75% of these cases. DES was used in a variety of pregnancy complications between 1940 and 1970 with the peak years being 1945 through 1960. There is no explanation for the increased number of cases occurring in patients whose mothers did not ingest synthetic estrogens. The number of women who took these drugs during pregnancy and their at-risk daughters is unknown. Vaginal adenosis is an associated finding in about 90% of the vaginal and 30% of the cervical adenocarcinomas. The reported incidence of adenosis in DES-exposed offspring varies from 30 to 90%. Gross cervicovaginal abnormalities occur in about 20% of the exposed patients. The relationship between adenosis and clear cell adenocarcinoma is not clear; however, many investigators feel adenosis is a precursor. Both adenosis and the clear cell tumors are of Müllerian origin, and it appears that any dose of synthetic estrogens ingested prior to the 18th week of pregnancy alters the normal embryogenesis of the vagina.

Intrauterine contraception with the copper T-200 and the Dalkon shield in nulligravid women.

A randomized, prospective study design compares the small Dalkon shield and the Copper T 200 (T Cu 200) intrauterine contraceptive devices in nulligravid women in the same clinic population during a 12-month period. This prospective study demonstrates statistically significant differences in the accidental pregnancy, expulsion and medical removal rates between the two devices. In nulligravid patients the T Cu 200 had lower event rates than the small shield in the categories of accidental pregnancy and medical removals for bleeding and pain.

Value of screening procedures for the detection of vaginal adenosis.

This study describes the use of routine vaginal iodine staining and other screening procedures for the detection of vaginal adenosis in 3871 postpubertal female patients. Iodine staining identified 65 patients with nonstaining areas in the vagina. Colposcopy verified the presence of vaginal adenosis in 11 of the 65 patients. Directed biopsies confirmed the diagnosis in 10 patients. The iodine staining procedure detected vaginal adenosis in only 1 patient who did not have a positive history of DES exposure or coexisting physical findings. Iodine staining of the vagina has little value as a screening procedure for the detection of vaginal adenosis. Based on these findings, a careful medical history and vaginal examination are recommended as the most productive routine screening procedures for vaginal adenosis. Evaluation and followup of those patients with a history of DES exposure in utero or physical findings suggestive of vaginal adenosis should include vaginal Papanicolaou smears supplemented by colposcopy at 6-month to 1-year intervals. Colposcopically directed biopsies of all abnormal areas should be obtained.

Training and function of a women's health-care specialist, a physician's assistant, or nurse practitioner in obstetrics and gynecology.

Serious manpower shortages exist in the United States. Proposed corrective measures indicate the need for nonphysicians to provide medical care for well or worried well patients. We have tested this proposed solution in the field of obstetrics and gynecology using allied health personnel to provide health maintenance services to well women, and feel that the experiment has been a success. Using principles of pattern recognition allied health workers recognize normal and abnormal findings. Patients with abnormalities are referred to the supervising physician for diagnosis and therapy. Allied health workers can also perform technical health-maintenance tasks such as inserting intrauterine devices and obtaining Pap smears. This article describes the historical evolution of our allied health personnel workers, called women's health-care specialists (WHCS), the selection and training of students, functions and levels of performance of the specialists, and the future role of such individuals in obstetrics and gynecology. We feel that with appropriate preparation of the physician, co-workers, and patients, the integration of the WHCS into the health-care system is both desirable and appropriate and will offer significant advantages to the patient and the practicing obstetrician-gynecologist in either the clinic or private practice setting.