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Biomedical subjects

D G Ferris

Publications and source records attributed to D G Ferris.

At least 19 recordsLinked to original sources

Reflex human papillomavirus deoxyribonucleic acid testing in women with abnormal Papanicolaou smears.

OBJECTIVE: The study examined interrelationships between sensitivity and specificity of "reflex human papillomavirus deoxyribonucleic acid testing" from liquid-based cervical cytologic specimens by means of receiver operator characteristics curves. STUDY DESIGN: A cohort study was performed on 265 women evaluated by colposcopy because of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion found on Papanicolaou smear. RESULTS: At a positive threshold of 0.2 pg/ml (1000 copies of human papillomavirus per test), human papillomavirus deoxyribonucleic acid testing detected 86% of women with cervical intraepithelial neoplasia and 93% of women with high-grade cervical intraepithelial neoplasia with a specificity of 30%. Decreasing the sensitivity of the human papillomavirus test to 1 pg/ml (5000 copies of human papillomavirus per test) improved the specificity of a positive result to 44% but decreased the clinical sensitivity to 78% for cervical intraepithelial neoplasia grade 2 or 3. Relationships between sensitivity and specificity were influenced by patient age and referral diagnosis. For example, limiting the analysis to only women with a referral for atypical squamous cells of undetermined significance found on Papanicolaou smear and a positive human papillomavirus test threshold of 0.5 pg/ml produced a sensitivity of 90% for cervical intraepithelial neoplasia grade 2 or 3 and a test specificity of 55%. CONCLUSION: Human papillomavirus deoxyribonucleic acid testing of residual cellular material from liquid cytologic specimens appears to be more appropriate for older women (>30 years old) and women with atypical squamous cells of undetermined significance, as opposed to low-grade squamous intraepithelial lesion, on their Papanicolaou smears.

Adolescent

Triage of women with ASCUS and LSIL on Pap smear reports: management by repeat Pap smear, HPV DNA testing, or colposcopy?

BACKGROUND: The purpose of this study was to determine the efficacy of a repeat Papanicolaou (Pap) smear and the Hybrid Capture tube-based (HCT) HPV DNA test for detecting cervical intraepithelial neoplasia (CIN) grade 2 or 3 in women with recent atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) Pap smear reports. METHODS: Women with a recent Pap smear report of ASCUS (n = 169) or LSIL (n = 110) had a repeat Pap smear, sampling of the cervix for HCT HPV DNA assay and a colposcopy examination. Data were evaluated using three different triage thresholds for colposcopy examination: a repeat Pap smear of persistent ASCUS or more severe dysplasia, a finding of persistent LSIL or more severe dysplasia, and a carcinogenic HPV test result. RESULTS: The sensitivity, specificity, and positive and negative predictive values for detecting CIN 2/3 were 70%, 45%, 7%, and 96% for a repeat Pap smear using an ASCUS-positive threshold and 20%, 86%, 8%, and 94% for a repeat Pap smear using an LSIL-positive threshold, respectively, when women with an initial ASCUS Pap smear were considered. HPV testing for carcinogenic viruses alone or in combination with a repeat Pap smear (using ASCUS as a positive threshold) yielded results of 50%, 67%, 9%, and 96%, respectively, and 70%, 37%, 7%, and 95%, respectively, for detecting CIN 2/3. In women with an initial LSIL Pap smear, respective values for detecting CIN 2/3 by a repeat Pap smear with an ASCUS threshold were 92%, 26%, 14%, and 96%, and for an LSIL threshold 23%, 64%, 8%, and 86%, respectively. Hybrid Capture HPV testing alone or in combination with a repeat Pap smear yielded 69%, 43%, 14%, and 91%, respectively, and 100%, 21%, 14%, and 100%, respectively. CONCLUSIONS: A Pap smear triage threshold restricted to LSIL or more severe dysplasia for women with prior ASCUS or LSIL Pap smear results was clearly ineffective for detecting high-grade cervical precancerous lesions. In contrast, when the repeat Pap smear triage threshold was expanded to include persistent ASCUS as abnormal, 83% of the women with CIN 2/3 were detected. Detection of carcinogenic HPV DNA using the HCT test was almost as sensitive for detecting CIN 2/3 as a solitary repeat Pap smear using an ASCUS or more severe positive threshold. Combining the HPV test with a repeat Pap smear did not significantly improve the sensitivity of cytology for detecting high-grade CIN. This study suggests that women with ASCUS and particularly LSIL Pap smears should be referred for a colposcopy examination until better triage methods become available.

Adult

Comparison of two tests for detecting carcinogenic HPV in women with Papanicolaou smear reports of ASCUS and LSIL.

BACKGROUND: The detection of cancer-associated types of human papillomavirus (HPV) in cervical specimens predicts the presence and future development of cervical intraepithelial neoplasia (CIN). The purposes of this study were (1) to determine the efficacy of a second-generation assay by hybrid capture (HC II) to detect carcinogenic HPV from residual cervical cells of a liquid-based cervical cytologic specimen, and (2) to compare the performance of this second-generation test with the first-generation hybrid capture (HCT) HPV test of material from direct cervical sampling to detect CIN in women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) Papanicolaou (Pap) smear reports. METHODS: Women with a recent Pap smear report of ASCUS or LSIL had a sampling of the cervix using either an Ayre's spatula and cytobrush or an Accellon device sampling for liquid-based cytologic system HC II HPV testing, followed by a Dacron swab sampling of the cervix for standard HCT HPV testing of the paired specimens. All women received colposcopy examinations including cervical biopsy and endocervical curettage, when indicated, to determine criterion standards for comparison. RESULTS: Paired swabs and liquid-based cervical specimens from 242 women were available for testing by standard HCT and the newer HC II HPV DNA assays. The sensitivity, specificity, and positive and negative predictive values for detecting CIN grade 2 or 3 (CIN 2/3) were 61.9%, 57.0%, 12.0%, and 94.0%, respectively, for the HCT test, and 90.5%, 29.4%, 10.9%, and 97.0%, respectively, for the liquid-based cytology HC II assay. When only women with an initial ASCUS Pap smear report were considered, the HC II test results were 88.9%, 40.3%, 9.1%, and 98.2%, respectively. CONCLUSIONS: Testing for lower genital tract carcinogenic HPV DNA using a cervical cytology liquid transport media residual sample is clinically feasible. The new HC II microplate HPV test achieved a greater test sensitivity for detecting carcinogenic HPV and correspondingly of CIN 2/3 compared with the currently available first-generation HC HPV test. Use of a liquid-based cervical cytology system combined with intermediate triage by HC II testing of residual cells for carcinogenic HPV alone may help to efficiently identify CIN 2/3 in women who have a prior screening Pap smear report of ASCUS.

Adult

Office procedures. Colposcopy.

Colposcopy is a clinical procedure to examine the epithelium of the uterine cervix and surrounding anogenital area with a magnifying instrument to detect the presence of cervical neoplasia and to identify abnormal tissue for biopsy. The procedure is enhanced by the use of chemical solutions that assist discrimination of normal tissue and abnormal lesions. Colposcopic examination and directed biopsy of the most severe focus of cervical neoplasia ensure a valid representation of the status of cervical disease. The results from the cytologic smear, histologic evaluation, and colposcopic impression collectively determine appropriate patient management.

Biopsy

Effectiveness of breast self-examination prompts on oral contraceptive packaging.

BACKGROUND: The purpose of this study was to determine if a breast self-examination (BSE) "prompt" on oral contraceptive pill (OCP) packages would improve the frequency and timing of BSE among women who use OCPs. METHODS: Women between 13 and 40 years of age who were initiating, restarting, or continuing use of OCPs completed a baseline survey that assessed health behavior and practices. All received BSE education, and then were randomized to take either OCPs with a BSE prompt or regularly packaged OCPs (without BSE prompt) for three cycles. Three months later, subjects completed a follow-up survey that assessed BSE frequency and timing. A telephone survey of randomly selected subjects conducted 6 months after the baseline survey assessed BSE compliance after discontinuation of the prompt. RESULTS: Of the 907 subjects at baseline, 49.3% performed BSE monthly but only 24.5% performed BSE during the correct time of the menstrual cycle. Among subjects who never performed BSE prior to the study, 40.3% of prompt subjects and 36.4% of the education-only subjects began BSE by the 3-month survey. Among subjects who performed BSE less than once per month at baseline, 50.9% of prompt subjects and 45.5% of education-only subjects increased the frequency of BSEs to a monthly basis by the 3-month survey. More women performed BSE during the correct time of the menstrual cycle at the 3 month follow-up survey (68.1% prompt, 62.2% education only) and 6-month survey (57.4% prompt, 48.9% education only) when compared with the baseline survey (24.7% prompt, 24.1% education only). Ninety-one percent of women in this study expressed a preference for a BSE prompt on OCP packaging. CONCLUSIONS: An increased frequency of BSE was observed when women were exposed to an OCP package prompt, particularly for women who at baseline were already partially compliant with performing monthly BSE. A small but significant improvement was observed for correct BSE timing and this effect continued after the prompt was removed, although at a reduced level. The innovative BSE prompt was overwhelmingly well received by women in this study.

Adolescent

'See and treat' electrosurgical loop excision of the cervical transformation zone.

BACKGROUND: "See and treat" electrosurgical loop excision of the cervical transformation zone (ELECTZ) is an excisional surgical procedure that enables simultaneous histologic diagnosis and treatment of premalignant cervical disease, thus eliminating the need for a preliminary cervical biopsy and an additional patient visit. Indications for the procedure include an abnormal cervical Papanicolaou (Pap) smear and a colposcopic impression of cervical intraepithelial neoplasia (CIN). The purpose of this study was to assess the "see and treat" ELECTZ procedure performed by family physicians. METHODS: Women who were scheduled for colposcopic evaluation because of an abnormal cervical cytology report were enrolled from the practices of three family physician colposcopists located at three sites. The "see and treat" ELECTZ procedure was performed on patients with both abnormal Pap smear results and abnormal colposcopic findings. Procedural complications were documented. Subjects were evaluated at follow-up examinations during the first postoperative year to determine therapeutic cure. RESULTS: "See and treat" ELECTZ was performed on 48 women. The histologic results from "see and treat" ELECTZ were normal for 36.1% of subjects. When subjects with a low-grade lesion on Pap smear were considered, 40.7% had normal loop histologic findings. Of women with a preoperative colposcopic impression of low-grade lesion, 54.2% had normal histologic results, and 12% of women with a high-grade colposcopic impression had normal histologic results (P<.001). When the colposcopic impression was reported as high-grade disease, 82% of loop specimens were reported as CIN 2 or 3. CONCLUSIONS: Selective use of "see and treat" ELECTZ may be appropriate only when practiced by experienced colposcopists who are able to reliably differentiate low-grade from high-grade disease by means of colposcopy, and if cytologic and colposcopic findings unequivocally indicate high-grade cervical disease.

Adolescent

Women's use of over-the-counter antifungal medications for gynecologic symptoms.

BACKGROUND: Over-the-counter (OTC) antifungal products for vulvovaginal candidiasis (VVC) have gained tremendous popularity, as evidenced by staggering increases in sales since the products were switched from prescription-only to OTC status. The rapid escalation in the sale of these products may imply that women are using them inappropriately. The purposes of this study were to determine (1) whether women could correctly diagnose VVC and common genitourinary tract problems after reading classic case scenarios, (2) whether women could correctly select the appropriate treatment for these cases, and (3) whether a previous diagnosis of VVC by a clinician had any effect on a woman's ability to self-diagnose and self-treat VVC. METHODS: Women 16 years of age and older were recruited from medical and community sites to complete a 63-question survey instrument designed to assess their knowledge of the symptoms and signs of pelvic inflammatory disease, bacterial vaginosis, acute cystitis, vaginal trichomoniasis, and vulvovaginal candidiasis after reading classic case scenarios. RESULTS: A total of 601 women completed the questionnaire, 552 subjects and 49 medically trained women who served as a criterion standard for comparison. Of the 552 subjects, 365 reported a prior diagnosis of VCC and 154 reported no such prior diagnosis. The medically trained cohort was more accurate in diagnosing VVC (83.7% correct) than were subjects who had received a prior diagnosis of VVC (34.5% correct), and more accurate than subjects without a previous diagnosis of VVC (11.0% correct, P < .001). A greater percentage of subjects in whom VVC had been previously diagnosed, as compared with the medically trained cohort, would use OTC agents inappropriately for pelvic inflammatory disease (6.7% vs 4.3%, respectively; P = NS), bacterial vaginosis (14.6% vs 6.4%, respectively; P = .028), urinary tract infection (2.0% vs 0%, respectively; P < .001), and vaginal trichomoniasis (11.8% vs 6.6%, respectively; P = .048). CONCLUSIONS: A minority of women were able to correctly diagnose VVC from a classic case scenario. A prior clinical diagnosis of VVC had only a moderate positive effect on subjects' ability to correctly diagnose a classic case. Based on our findings, women likely use OTC antifungals inappropriately to treat gynecologic conditions that are similar but potentially more severe. Numerous adverse consequences may result from misdiagnosis. Improved patient education by health care providers and the manufacturers of OTC antifungal drugs might improve this diagnostic problem.

Adult

A neglected lesbian health concern: cervical neoplasia.

Many health care providers believe that lesbian women do not need routine Papanicolaou smears. This erroneous assumption fails to recognize that the majority of lesbian women have had prior heterosexual relationships and thus may be at risk for developing cervical neoplasia. The following case report describes a lesbian woman who denied prior heterosexual intercourse but who developed cervical intraepithelial neoplasia grade 2 (CIN 2) associated with a high oncogenic risk human papillomavirus (HPV) type. Sexual contact with multiple lesbian partners who had previous heterosexual relationships likely explains her cervical disease.

Adult

Physician office laboratory education and training in primary care residency programs.

OBJECTIVE: To assess the status of office laboratory residency education and training in family practice, internal medicine, obstetrics and gynecology, and pediatric residency programs. DESIGN: A single mailed survey to 1299 residency programs from December 1992 to February 1993. PARTICIPANTS: Primary care residency directors from 507 (39%) of 1299 programs. INTERVENTIONS: A 27-item survey of residency-based office laboratory practices, education, training, and resources. MAIN OUTCOME MEASURES: Differences between specialties in provision and quantity of office laboratory education and training, presence of a residency-based office laboratory, laboratory classification under the Clinical Laboratory Improvement Amendments, and available laboratory tests. RESULTS: Of those responding, office laboratories were present in 89% of family practice, 19% of internal medicine, 29% of obstetrics and gynecology, and 24% of pediatrics residency programs. Laboratory training was available at 60% of family practice, 16% of internal medicine, 15% of obstetrics and gynecology, and 30% of pediatrics programs. The median number of hours of formal skills training was 10 hours for family practice residency programs but less than 2 hours for the other specialties. Only 25% of the programs reported educational assistance from pathologists. Merely 4% of the programs had postassessment examinations and 2% awarded certificates of achievement. A majority of family practice programs performed waivered tests and physician-performed microscopy tests, but moderately complex tests were performed in less than 50% of family practice programs. CONCLUSIONS: Family practice residency programs provide more office laboratory training for residents than other specialties. There is a need for improved residency training in the basics of office laboratory practice.

Curriculum

Office laboratory diagnosis of vaginitis. Clinician-performed tests compared with a rapid nucleic acid hybridization test.

BACKGROUND: The traditional diagnosis of vaginitis incorporates patient symptoms, clinical findings observed during vaginal examination, and laboratory analysis of vaginal fluid. The purpose of this study was to evaluate routine clinician-performed office laboratory diagnostic techniques for women with abnormal vaginal symptoms, and to compare these results with those obtained by a DNA hybridization test for Trichomonas vaginalis, Gardnerella vaginalis, and Candida species. METHODS: The study included 501 symptomatic women who were between the ages of 14 and 67 years. Three vaginal specimens were obtained for saline wet mount, potassium hydroxide (KOH) prep, amine "sniff", pH, and nucleic acid hybridization (T vaginalis, G vaginalis, and Candida sp) tests. Clinicians and medical technicians independently evaluated the wet mount, KOH prep, amine, and pH tests. A medical technician processed the DNA tests according to manufacturer's protocol. RESULTS: Of 499 subjects for whom complete data were available, vulvovaginal candidiasis was diagnosed in 20.0%, vaginal trichomoniasis in 7.4%, and bacterial vaginosis in 52.1%. Fourteen percent of subjects had multiple vaginal infections. The sensitivity and specificity of clinician microscopically diagnosed vulvovaginal candidiasis, vaginal trichomoniasis, and bacterial vaginosis were 39.6% and 90.4%, 75.0% and 96.6%, and 76.5% and 70.8%, respectively. The sensitivity and specificity of the DNA probe diagnosis of the same types of vaginitis were 75.0% and 95.7%, 86.5% and 98.5%, and 95.4% and 60.7%, respectively. When only women with multiple vaginal infections were considered, the percentages of correct clinician diagnoses for vulvovaginal candidiasis, vaginal trichomoniasis, and bacterial vaginosis were 49.3%, 83.6%, and 59.7%, respectively. For the DNA probe test, the percentages of correct diagnoses were 72.9%, 92.9%, and 90.0%, respectively. CONCLUSIONS: Primary care clinicians demonstrated a high specificity but low sensitivity when identifying vaginal trichomoniasis and vulvovaginal candidiasis by microscopic techniques. Correct microscopic diagnosis of bacterial vaginosis was even more difficult for clinicians, as was the diagnosis of multiple vaginal infections. Clinicians were not as accurate as the DNA probe test in diagnosing vaginal infections. Clinicians need more education in the laboratory diagnosis of vaginitis. Clinicians should carefully scrutinize each microscopic slide, systematically examine the slide for each type of vaginitis, and consider specimen pH and the presence of leukocytes, Lactobacillus organisms, or amine odor as additional clues to infection.

Adolescent

Electrosurgical loop excision of the cervical transformation zone: the experience of family physicians.

BACKGROUND: Electrosurgical loop excision of the cervical transformation zone (ELECTZ) is an excisional surgical procedure for treatment of premalignant cervical disease and the abnormal transformation zone by wire loop electrodes. The purpose of this study was to describe and assess the clinical experiences and complications of family-physician-performed ELECTZ and ELECTZ conization. METHODS: Women who were scheduled for the ELECTZ or ELECTZ conization procedures were enrolled in the study between March 1992 and March 1993, inclusive. Subjects were recruited from the practices of six family physician colposcopists located at five sites. The ELECTZ and ELECTZ conization procedures were performed on patients with abnormal Papanicolaou (Pap) smears or abnormal histologic results and abnormal colposcopic findings. Procedural complications were documented. Subjects were serially assessed during the first postoperative year by Pap smears, colposcopy, and, when necessary, by biopsy to determine therapeutic cure. RESULTS: Of 198 subjects enrolled in the study, 148 women were assessed at least once in follow-up by Pap smear and colposcopy. Only 7.6% of women were defined as treatment failures by subsequent histologic assessment. Women treated by ELECTZ conization were older (32.2 vs 25.1 years, P = .02), were more likely to develop posttreatment cervical stenosis (25.9% vs 3.8%, P = .001), and were more likely to have the postoperative squamocolumnar junction positioned in the endocervical canal (32.4% vs 8.7%, P = .002) than were women treated by ELECTZ: Loop excision specimen margins demonstrated dysplasia for 27 (13.6%) subjects. Significant operative bleeding (> 25 mL) was noted in 6.8% of subjects. Histologic thermal artifact was reported for 9.6% of specimens. One case of microinvasive cancer and one case of invasive cancer were identified unexpectedly by ELECTZ conization. CONCLUSIONS: Electrosurgical loop excision of the cervical transformation zone and ELECTZ conization may be safely and effectively performed in office settings by family physicians. Complications and treatment failure rates for the ELECTZ and ELECTZ conization procedures were similar to those experienced by other clinicians.

Adolescent

Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream.

BACKGROUND: Treatment options for bacterial vaginosis are numerous. The purpose of this study was to compare the efficacy of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream for the treatment of bacterial vaginosis using traditional clinical and laboratory methods, as well as a new DNA probe test. We also determined the percentage of patients receiving each treatment who developed posttreatment vaginal candidiasis, a potential complication of treating bacterial vaginosis. METHODS: One hundred one women in whom bacterial vaginosis was diagnosed by standard criteria were randomly assigned to receive: oral metronidazole 500 mg twice daily for 1 week, 0.75% metronidazole vaginal gel 5 g twice daily for 5 days, or 2% clindamycin vaginal cream 5 g once daily for 7 days. Women with coexisting vulvovaginal candidiasis or vaginal trichomoniasis were excluded. Tests of cure by vaginal saline wet prep and potassium hydroxide microscopic examinations, Gram's stain, pH and DNA probe tests for Gardnerella vaginalis and Candida species were scheduled 7 to 14 days following treatment. RESULTS: There were no statistically significant differences in cure rates for oral metronidazole (84.2%), metronidazole vaginal gel (75.0%), or clindamycin vaginal cream (86.2%) (chi 2 = 1.204, df = 2, P = .548) using traditional clinical and laboratory criteria. Cure rates were lower based on DNA testing, indicating that Gardnerella vaginalis may remain after a clinical cure. This would explain cases of recurrent disease. Posttreatment vulvovaginal candidiasis was experienced by 12.5% of subjects treated with oral metronidazole, 14.8% of subjects treated with clindamycin vaginal cream, and 30.4% of subjects treated with metronidazole vaginal gel (chi 2 = 2.607, df = 2, P = .272). CONCLUSIONS: Oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream achieved nearly equivalent cure rates for the treatment of bacterial vaginosis. Patients treated with these agents experienced similar rates of posttreatment vulvovaginal candidiasis, but those using the intravaginal products reported being more satisfied with the treatment.

Administration, Intravaginal

Vaginal intraepithelial neoplasia III detected after hysterectomy for benign conditions.

Because primary vaginal cancer is rare, many experts discourage routine cytologic sampling of the vaginal vault following hysterectomy for benign circumstances. The following report describes a case of vaginal intraepithelial neoplasia III (VAIN III) detected by a vaginal vault Papanicolaou smear obtained from an asymptomatic 57-year-old woman 23 years after she had a total abdominal hysterectomy for a benign condition. As VAIN III is a true vaginal cancer precursor, the innocent disregard of recommended screening practices averted significant morbidity and possibility mortality for this otherwise healthy woman.

Carcinoma in Situ