Differences between reported and actual restored caries lesion depths: results from The Dental PBRN.

OBJECTIVE: The objectives of this research were to: (1) quantify the discordance between the caries lesion depth at which dentists restored initial lesions during a clinical study ("actual depth") and the lesion depth that they reported during a hypothetical clinical scenario ("reported depth"); (2) test the hypothesis that certain practitioner, practice, patient, and caries lesion characteristics are significantly associated with this discordance. METHODS: Practitioner-investigators who perform restorative dentistry in their practices completed an enrollment questionnaire and participated in 2 consecutive studies on caries diagnosis and treatment. The first study was a survey asking about caries treatment. The second study collected data on restorations placed in routine clinical practice due to caries in patients over 19 years of age on occlusal surfaces only or proximal surfaces only. We report results on 2,691 restorations placed by 205 dentists in 1,930 patients with complete data. RESULTS: Discordance between actual depth and reported depth occurred in only about 2% of the restorations done due to proximal caries, but about 49% of the restorations done due to occlusal caries. Practice type, restorative material used and the diagnostic methods used were significantly associated with discordance. CONCLUSION: Dentists frequently restored occlusal caries at a shallower depth as compared to their reported depth, but the discordance was very small for proximal lesions. Discordance for occlusal caries was more common when radiographs were not taken or if a resin restoration was placed.

Patient-Centered Dentinal Hypersensitivity Treatment Outcomes: Results from the National Dental PBRN.

Dentinal hypersensitivity (DH) can have a significant impact on oral health and functioning, and it is a clinical symptom commonly managed by dentists during routine clinical practice. DH symptoms are typically elicited by otherwise innocuous, nonpainful stimuli applied to exposed dentin (e.g., tactile stimuli, warming or cooling temperatures or air puffs). Treatment approaches have sought to directly target the dentinal pulp tissues or close dentinal tubules via dental office care and treatment services (fluoride varnishes, glutaraldehydes, bonding agents, sealants, oxalates, or lasers) or home care services (toothpastes or dentifrices containing fluoride or potassium nitrate compounds). The purpose of this prospective multicenter cohort study was to assess how community-based dentists from the National Dental Practice-Based Research Network (National Dental PBRN) manage DH and whether the effectiveness of DH treatments can be assessed in those settings. A total of 171 dentists recruited 1862 subjects with DH from their existing patients. Dentists then recommended and provided DH treatment as appropriate. Treatment choice was at the discretion of the dentists. Patients rated their DH pain at baseline and 1, 4, and 8 wk during the course of their treatments. They used pain intensity and unpleasantness visual analog scales and 4 labeled magnitude scales and rated their satisfaction with treatment after 8 wk. Patients were provided reminders postbaseline via email, texting, or voice mail. These patient-centered outcomes served as the principal measures for the assessment of treatment because treatments sought to alleviate DH symptoms. The patients with DH who reported pain reduction from dentist-provided treatments (glutaraldehyde/HEMA [hydroxyethyl methacrylate] compounds, oxalates, and bonding agents), dentists' advice and counseling regarding oral habits and diet, and patient-applied fluoride toothpaste reported a concomitant positive rating of satisfaction with DH treatments. The results from this study support the feasibility of engaging network practices to assess the effectiveness of clinical DH treatments. Knowledge Transfer Statement: National Dental PBRN dentists provide a range of procedures to treat dentinal hypersensitivity. In this large nonrandomized study designed to assess clinical care and to capture patient-reported outcomes, about 60% of patients reported improvement in pain. This study demonstrated the feasibility of engaging network dentists and their patients to assess treatment effectiveness. Future studies will explore the feasibility of imposing randomization and measuring patient compliance with treatment in the manner that this treatment is provided.

Plasma leptin concentrations in obese children: changes during 4-mo periods with and without physical training.

BACKGROUND: Little is known about the effects of physical training on plasma leptin concentrations in children. OBJECTIVE: We sought to determine the effects of 4-mo periods with and without physical training on leptin in obese children and to explore the determinants of leptin at baseline and in response to physical training. DESIGN: Participants were 34 obese 7-11-y-old children randomly assigned to engage in physical training during either the first or second 4 mo of the 8-mo study. RESULTS: Total body composition, visceral adiposity, and insulin were all positively correlated with leptin at baseline (P < or = 0.05); however, only fat mass was retained in the final stepwise regression (P = 0.0001, R2 = 0.57). Leptin decreased during the 4-mo periods of physical training and increased in the 4 mo after cessation of physical training (P < 0.001 for the time by group interaction). Decreases in leptin were greatest in children with higher pretraining leptin concentrations, those whose total mass increased least, and those whose insulin concentrations decreased most (P < or = 0.05); only pretraining leptin concentration (P = 0.009) and change in total mass (P = 0.0002) were retained in the final regression (R2 = 0.53). CONCLUSIONS: In obese children, leptin concentration decreased during 4 mo of physical training and increased during a subsequent 4-mo period without physical training, fat mass was highly correlated with baseline leptin, and greater reductions in leptin during 4 mo of physical training were seen in children with higher pretraining leptin and in those whose total mass increased least.

Fat distribution and hemostatic measures in obese children.

We examined the relation of general and visceral adiposity to plasma hemostatic factors [fibrinogen, D-dimer, and plasminogen activator inhibitor 1 (PAI-1)] in obese boys and girls 7-11 y of age (n = 41). Boys had significantly greater fibrinogen and D-dimer concentrations than girls (P < 0.05). whereas blacks had significantly greater fibrinogen and D-dimer concentrations than whites (P < 0.05). Univariate analyses revealed that fibrinogen was positively associated with percentage body fat (%BF) (r = 0.42, P < 0.01), subcutaneous abdominal adipose tissue (SAAT) (r = 0.40, P < 0.01), total fat mass (r = 0.42, P < 0.01), and body mass index (r = 0.41, P < 0.01). PAI-1 was positively associated with visceral adipose tissue (VAT) (r = 0.49, P < 0.01), SAAT (r = 0.32, P < 0.05), fat-free mass (r = 0.50, P < 0.01), and insulin (r = 0.61, P < 0.001). D-Dimer was positively associated with %BF (r = 0.40, P < 0.01), SAAT (r = 0.37, P < 0.05), total fat mass (r = 0.40, P < 0.01), and body mass index (r = 0.43, P < 0.01). Multiple regression analysis revealed that for fibrinogen, sex and higher %BF explained significant independent portions of the variance. For PAI-1, higher amounts of VAT and fat-free mass were significant predictors. For D-dimer, ethnicity was a significant predictor. These results suggest that general adiposity and VAT may play a role in regulating plasma hemostatic factors in obese children. Even early in childhood, adiposity is associated with unfavorable concentrations of hemostatic factors that are in turn implicated in cardiovascular morbidity and mortality later in life.

Effects of physical training and its cessation on the hemostatic system of obese children.

BACKGROUND: Physical training can improve hemostatic function in adults, thereby reducing heart disease risk, but no information is available in children on whether physical training can enhance hemostatic function. OBJECTIVE: The purpose of this investigation was to examine the effects of a physical training program on hemostatic variables in a biethnic group of obese children. DESIGN: Children were randomly assigned to 2 groups. Group 1 participated in physical training for 4 mo and then ceased physical training for 4 mo, whereas group 2 did no physical training for the first 4 mo and then participated in physical training for 4 mo. Plasma hemostatic variables [fibrinogen, plasminogen activator inhibitor 1 (PAI-1), and D-dimer) were measured at months 0, 4, and 8. RESULTS: Analyses of variance revealed no significant group-by-time interactions for the hemostatic variables. When data from both groups were combined there was a significant decrease in D-dimer after 4 mo of physical training (P < 0.05). Factors explaining individual differences in responsiveness to the physical training revealed that individuals with greater percentage fat before physical training showed greater reductions in fibrinogen and D-dimer, and that blacks showed greater reductions in D-dimer than whites (P < 0.05). Stepwise multiple linear regression showed that only higher prephysical training concentrations of fibrinogen, PAI-1, and D-dimer explained significant proportions of the variation in changes in these variables. CONCLUSIONS: In obese children, 4-mo periods of physical training did not lead to significant changes in hemostatic variables. Children with greater adiposity and concentrations of hemostatic factors before physical training showed greater reductions in hemostatic variables after physical training than did children with lesser values.

Correlates of individual differences in body-composition changes resulting from physical training in obese children.

BACKGROUND: No studies have been reported in children that assess correlates of body-composition changes in response to a physical training intervention. OBJECTIVE: The hypothesis studied was that variation in diet and physical activity would explain a significant portion of the interindividual variation in the response of body composition to physical training. DESIGN: The participants were 71 obese children aged 7-11 y (22 boys, 49 girls; 31 whites, 40 blacks). Body composition was measured by dual-energy X-ray absorptiometry, physical activity by a 7-d recall interview, and diet by two, 2-d recalls. The children underwent 4 mo of physical training. RESULTS: The mean attendance was 4 d/wk, the mean (+/-SD) heart rate for the 40-min sessions was 157 +/- 7 beats/min, and the mean energy expenditure was 946 +/- 201 kJ/session. On average, the percentage body fat decreased significantly in the total group, and total mass, fat-free soft tissue, bone mineral content, and bone mineral density increased, but there was a good deal of individual variability. Multiple regression models indicated that in general, more frequent attendance, being a boy, lower energy intake, and more vigorous activity were associated with healthier body-composition changes with physical training. Ethnicity was not retained as a correlate of the change of any component of body composition. CONCLUSIONS: In obese children, age, vigorous activity, diet, and baseline percentage body fat together accounted for 25% of the variance in the change in percentage body fat with physical training.

Body-composition measurement in 9-11-y-old children by dual-energy X-ray absorptiometry, skinfold-thickness measurements, and bioimpedance analysis.

We compared, in 9-11-y-old children (n=43), three measures of body composition: dual-energy X-ray absorptiometry (DXA), skinfold thickness, and bioimpedance analysis (BIA). The intraclass correlation coefficient (ICC), Bland-Altman procedure, and Spearman rank correlation were used to determine test-retest reliabilities of the three methods and to compare methods. For DXA measurements, the rank correlation between fat-free soft tissue and fat-free mass (FFM) was > 0.99, indicating that bone mineral content did not provide independent information. Thus, subsequent analyses used the two-compartment model (ie, fat mass and FFM) for all three techniques, focusing especially on values for percentage of fat. The test-retest reliabilities for all methods were high (ICCs > 0.994 and no significant differences between trials 1 and 2). The range of individual differences from trial 1 to trial 2 and Bland-Altman limits of agreement suggested that the reliability was greatest for DXA, followed by BIA and skinfold-thickness measurement. The percentage of fat values for the three methods were highly intercorrelated (all Spearman r values > 0.83). However, there was a systematic tendency (P < 0.01) for DXA values (mean: 23.98) to be higher than those derived from skinfold-thickness measurements (mean: 21.05) and BIA (mean: 21.52). The variance in percentage of fat values for BIA was significantly smaller than that for the other two techniques. These findings, along with rather large limits of agreement derived from the Bland-Altman procedure, suggest that the methods should not be used interchangeably.

Correlates of children's bicycle helmet use and short-term failure of school-level interventions.

To test the utility of school-level interventions for child bicycle safety and to identify social and behavioral factors associated with children's bicycle helmet use, a two-level intervention was conducted in two suburban elementary schools. Children (N = 209) and parents (N = 125) in school 1 and in school 2 (children, N = 470; parents, N = 364) were surveyed regarding bicycle injuries and helmet use. Children and parents in schools 1 and 2 received literature about bicycle safety and discount coupons for helmet purchase. School 1 was then the target of an intensive safety campaign, including meetings with the school safety committee and the PTA and a classroom presentation to children emphasizing helmet use. Ten months later the same survey was again administered. Children in school 1 were more likely at posttest to believe that helmets were protective (P = .003) but did not differ on other variables. Logistic regression showed that sibling helmet ownership, parental helmet use, and lower parental perceived social barriers to helmet use were independently associated with children's reported helmet use and with parental intent for the child to use a helmet at posttest.

Exercise in sickle cell anemia: effect on inflammatory and vasoactive mediators.

The aim of this study was to determine the response of inflammatory and vasoactive mediators to 3 consecutive days of exercise in African-American women with and without sickle cell anemia (SCA). Circulating inflammatory mediators [C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor alpha (TNFalpha)] were measured before, and vasoactive mediators [endothelin-1 (ET-1), nitric oxide metabolites (NOx)] before and after each exercise bout in ten subjects with SCA and ten controls. Exercise did not affect ET-1, IL-6 or CRP concentrations (p >.05). TNFalpha was higher in SCA than controls (p < or = .0005) at all times; however, the response pattern was similar for the groups: no change from day 1 to day 2, but a decrease from day 2 to day 3 (p < or = .05). NOx increased significantly after exercise (p < or = .0001) but returned to baseline by 24 h afterward. On the 3rd day, NOx increased after exercise in SCA but not in the controls (p < or = .05). In conclusion, exercise did not cause a harmful inflammatory response in these individuals with SCA. However, NOx increased after exercise on all 3 days in SCA but appeared attenuated after 2 days in controls.

Effect of physical training on total and visceral fat in obese children.

PURPOSE: Children with high levels of total body fat mass (TFM) and visceral adipose tissue (VAT) have elevated levels of certain risk factors for coronary artery disease and non-insulin-dependent diabetes mellitus. We tested the hypothesis that controlled physical training, without dietary intervention, would have a favorable impact on VAT and percent body fat (%BF) in obese children. METHODS: A volunteer sample of 74 obese children, 7-11 yr of age, accepted random assignment to physical training or control groups. Before and after 4 months of intervention, measurements were obtained for VAT, TFM, %BF, daily physical activity, and cardiovascular fitness. The intervention involved 4 months of controlled physical training 5 d x wk(-1), 40 min per session, at a mean heart rate (HR) of 157 beats x min(-1). The estimated energy expenditure (EE) per training session was 925+/-201 kJ. RESULTS: Compared with the control group, the physical training group declined significantly in %BF (delta = -2.2%) (P < 0.01), TFM (delta = -3.1%) (P < 0.01), and subcutaneous abdominal adipose tissue (delta = - 16.1%) (P < 0.05), and increased significantly in fat-free mass (delta = +6.1%) (P < 0.05) and moderate-to-very hard physical activity (delta = +14.1%) (P < 0.05). The increase in VAT was significantly less in the physical training group (delta = +0.5%) as compared with that in the control group (delta = +8.1%) (P < 0.05). CONCLUSIONS: This study showed that during physical training obese children: 1) were capable of participating in a substantial amount of high intensity physical training over a 4-month period: 2) accumulated significantly less VAT as compared with nonexercising controls; and 3) experienced other beneficial changes in total and regional body composition.

Children's dietary recalls: the salience of entree and liking for foods on accuracy and order of reporting.

This study investigated the impact of entree and liking for foods on the accuracy and order of reporting on children's school lunch recalls. Data were collected during a series of studies to investigate children's lunch recalls from a cognitive processing approach to understand better how children remember what they have eaten. Fourth-grade children from four schools were randomly selected, observed eating lunch, and interviewed the same (n = 89) or next (n = 148) day. Foods were classified as matches (observed and reported eaten), omissions (observed but not reported eaten), or phantoms (not observed but reported eaten), and corresponding rates were calculated. Statistical analyses included z tests and permutation tests. For same- and next-day recalls, children were more likely to report entree than other meal components earlier in the interview. For next-day recalls, the phantom rate for the remaining items was lower for children who reported entrees accurately versus inaccurately. For items liked "a lot" compared with items "not liked a lot," match rates were higher for next-day recalls, and phantom rates were lower for both same- and next-day recalls. Because entree and liking for foods appear to play salient roles in children's dietary recalls, these results provide guidance regarding the development of specific prompts to increase the accuracy of children's dietary recalls.

Cardiovascular (CV) responsivity and recovery to acute stress and future CV functioning in youth with family histories of CV disease: a 4-year longitudinal study.

Blood pressure (BP) and heart rate (HR) data obtained during supine rest, in response to and recovery from four laboratory stressors in a baseline year were used to predict supine resting BP and HR values obtained during each of four consecutive annual follow-up evaluations. Subjects were 385 normotensive youth [95 African American (AA) males, 106 AA females, 92 European American (EA) males, 92 EA females] (mean age 12.7+/-2.6 at baseline year) with a positive family history of cardiovascular disease (CVD). During the baseline evaluation subjects were presented with four laboratory stressors (namely, postural change, video game challenge, social competence interview, and parent--child conflict discussion). The BP and HR values taken during each of the laboratory stressors and during the post stressor recovery periods were converted to z-scores which were averaged to yield aggregate measures for systolic and diastolic BP and HR responsivity and recovery. The data obtained during the baseline evaluation were subsequently used to predict the follow-up values of supine resting BP and HR. The prediction models were fairly consistent across each of the 4 follow-up years. Responsivity or recovery accounted for up to 6% of the total variance after accounting for baseline values. Within the prediction models responsivity or recovery accounted for 4--56% of the variance. The predictive value of the derived models did not decline from one annual evaluation to the next over the length of the study. CV recovery may supplement resting and responsivity in the prediction of future development of CVD

Ototoxicity after high-dose chemotherapy with cyclophosphamide, thiotepa and carboplatin followed by stem cell transplantation in patients with breast cancer.

Our purpose was to determine the risk of ototoxicity in breast cancer patients receiving a myeloablative regimen consisting of cyclophosphamide 6000 mg/m2, thiotepa 500 mg/m2 and carboplatin 800 mg/m2 (CTCb) followed by stem cell transplantation. Fourteen consecutive patients with breast cancer were treated with high dose chemotherapy consisting of the CTCb regimen followed by stem cell transplantation. A pretransplant complete hearing study was obtained which consisted of hearing case history, audiometry and tympanometry. In addition, DPOAE (Distortion Product Otoaccoustic Emissions) was done to evaluate measurable changes in the cochlear (outer hair cell) functioning. Pre-transplant, all patients had no clinical evidence of hearing impairment and hearing studies were normal. Eleven patients had hearing studies and a telephone interview posttransplant. One patient was lost to follow-up and two patients died. One of the 11 patients tested had an abnormal post-transplant hearing study but none of them had clinically detectable hearing impairment. In our prospective study of breast cancer patients treated with the CTCb regimen, we did not observe clinically detectable hearing impairment in any of the patients tested.

Body composition in women with sickle cell disease.

INTRODUCTION: Adults with sickle cell disease (SCD) have increased morbidity and low perceived health status, similar to patients with other chronic conditions. These patients may be sedentary due to exercise intolerance, physical incapacity due to sickle cell-related complications or medical conservatism. Obesity is an indicator of low health status and overall well-being in the general population, and we hypothesize that adults with SCD will have a high total body fat (%BF). The purpose of this study was to assess body composition in women with SCD using dual-energy X-ray absorptiometry (DXA). METHODS: Baseline medical examination, laboratory assessments, and seven-day activity recall to estimate energy expenditure (EE) were obtained for 22 women with SCD. BMI was calculated and whole body DXA was performed [fat mass (FM), fat-free soft tissue (FFST), and bone mineral content (BMC)]. Descriptive statistics were obtained and associations between body composition indices, total hemoglobin (Hb), treatment with hydroxyurea (HU), and EE were determined. RESULTS: Patient age was 30.5+/-9.3 years and total Hb was 8.85+/-1.92 g/dL (mean+/-SD). Mean body mass index (BMI) (22.6 kg/m2) was in the 'acceptable' range, while DXA measurement of mean % fat (32.6%) indicated obesity. Fat-free mass (FFM) was 40.0+/-5.62 and bone mineral density (BMD) was 1.13+/-0.14 g/cm2 (mean+/-SD). There were no correlations between body composition indices and total Hb, HU, or EE. CONCLUSIONS: This is the first report of high levels of adiposity, low FFM, and low BMD in normal weight women with SCD. The findings were not affected by total Hb, EE, HU. Further studies are needed to better define body composition, body composition determinants, and their impact on overall health status in adults with SCD.

Noninvasive detection of Chlamydia trachomatis in men: a comparison of two immunoassay tests.

This investigation compared a rapid enzyme immunoassay test and an enzyme-amplified immunoassay test with culture for the noninvasive detection of Chlamydia trachomatis urethritis in men. Urine specimens from 108 male subjects were evaluated for the presence of C trachomatis antigen, using the Kodak Surecell Chlamydia rapid enzyme immunoassay test and IDEIA Chlamydia enzyme-amplified immunoassay test. The test results were then compared with urethral C trachomatis culture and urethral Gram's stain analyses. Performance characteristics of the two tests were similar. The rapid chlamydial enzyme immunoassay test demonstrated several clinical advantages. Appropriate use of these tests may decrease patient morbidity and clarify organism etiology for enhanced specific medical care of urethritis in men.

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.

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.

The efficacy of liquid-based cervical cytology using direct-to-vial sample collection.

BACKGROUND: Previous studies of liquid-based cervical cytology (LBCC) have used a split sample collection technique that creates a potential negative bias for its evaluation. Thus, the full diagnostic potential of LBCC has not been established. The purpose of our study was to determine rates of specimen adequacy and cervical cytologic and histologically confirmed diagnoses obtained with a liquid-based Papanicolaou (Pap) test using a direct-to-vial sample collection technique and compare these results with those obtained using the conventional Pap test (CPT). METHODS: A total of 1004 nonpregnant women aged 18 years or older with an intact cervix had Pap tests collected with an Ayre spatula and cytobrush, and the sample was placed in a preservative solution. The specimens were processed as thin layer Pap tests according to the manufacturer's specifications. Another group of 2110 women with a similar patient profile had a CPT collected immediately preceding the initiation of the trial. The subjects in each group consisted of an equal percentage of women presenting for a routine Pap test or a colposcopy examination. We compared the distributions of diagnostic categories between the groups using a chi-square test. RESULTS: A significantly greater percentage of satisfactory Pap tests were obtained using LBCC (84.0%) compared with the CPT (60.5%, P < .001). Fewer satisfactory but limited by (SBLB, 14.8%) and unsatisfactory (1.2%) Pap tests were reported using LBCC compared with the CPT (35.7% and 3.8%, respectively, chi2 = 170.7, P < .001). A significantly greater percentage of low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL) Pap test results were reported using LBCC (7.4% and 3.7%, respectively) compared with the CPT (1.7% and 1.7%, respectively, chi2 = 74.4, P < .001). The predictive value of a positive LBCC test (93.9%) was similar to that for a positive CPT (87.8%) when compared with histology results. CONCLUSIONS: Compared with the CPT, LBCC detected a significantly greater percentage of satisfactory Pap tests and significantly reduced the number of unsatisfactory and SBLB tests. Four times the percentage of LSIL and twice the percentage of HSIL Pap test results were obtained using LBCC compared with the CPT. These findings demonstrate that LBCC significantly improves the adequacy of Pap tests and may increase the rate of detection of cervical neoplasia compared with the CPT.

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.

PIP: The inclusion of a breast self-examination (BSE) "prompt" on oral contraceptive (OC) packaging resulted in an increased frequency of this critical breast cancer preventive practice. 907 women 13-40 years old from 7 health care sites in the US were recruited without knowledge of the goals of the study and given a general health promotion pamphlet and a BSE demonstration. 601 of these women were randomly assigned to receive 3 prompt-included OC packets; the remainder received unmarked OCs. The marked OC packets printed a reminder of the ideal time for BSE (7 days after menstrual period) beneath the first row of pills. At baseline, 49.3% of all subjects had performed BSE at least once in the preceding 3 months, while 21.5% had never done so. The interventions were most effective among women who were at least partially compliant with BSE at baseline (50.9% of prompt subjects and 45.5% of education-only subjects increased BSE frequency to monthly), but there was a 40% increase in frequency among women new to this regimen. The percentages of women performing BSE at the proper time of the cycle increased from baseline levels of 24.7% in the prompt group and 24.1% in the education-only group to 68.1% and 62.2%, respectively. These improvements in the frequency and timing of BSE persisted, although at a reduced level, 3 months after completion of the special OC packets. Finally, 91.2% of women who received the prompt indicated they would like this to be a regular feature of their OC packaging and 80.3% said it had reminded them to perform BSE.

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.