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Background Mycoplasma genitalium (MG) causes symptomatic urethritis in men, and can infect alone or together with other sexually transmitted infection (STI) agents. Methods The prevalence of MG and other STIs was determined in 1816 men with symptomatic urethritis. Resistance of MG to macrolides and fluoroquinolones was determined by sequencing; the impact of recent antimicrobial usage on the distribution of MG single or mixed infections was determined. Results Overall, prevalence of MG infection was 19.7% (358/1816). Fifty-four percent (166/307) of MG infections occurred alone in the absence of other STI agents. Men with single MG infection self-administered or were prescribed antibiotics more often in the 30 days prior to enrollment than subjects with urethritis caused by MG coinfection (P < .0001). Higher rates (96.7%) of infection with macrolide resistance in MG were identified in men who had taken macrolides prior to enrollment (P < .03). Overall, 88.9% (303/341) of 23S ribosomal RNA (rRNA) genes contained mutations responsible for macrolide resistance; 89.5% (308/344) of parC and 12.4% (42/339) of gyrA genes had mutations responsible for fluoroquinolone resistance. Approximately 88% (270/308) of MG had combined mutations in 23S rRNA and parC genes; 10.4% (32/308) had mutations in all 3 genes. Conclusions MG was the single pathogen identified in 11% of men with symptomatic urethritis. Overall, nearly 90% of MG infections were resistant to macrolides and fluoroquinolones. Men who took macrolides in the 30 days prior to enrollment had higher rates (97%) of macrolide-resistant MG. Resistance was associated with numerous mutations in 23SrRNA, parC, and gyrA genes.

To compare clinical outcomes and treatment patterns among patients with moderate vs severe RA following biologic DMARD initiation.Biologics-naive patients with moderate to severe RA [Clinical Disease Activity Index (CDAI)10] who initiated a biologic DMARD were selected from the Corrona registry (2001-13). CDAI, functional status [modified HAQ (mHAQ)] and patterns of drug use were compared at 1 and 2 years post-initiation between patients with moderate (CDAI10⩽22) vs severe (CDAI22) baseline disease activity.A total of 1596 patients (817 severe, 779 moderate) had ⩾1 year of follow-up and 1269 (635 severe, 634 moderate) had ⩾2 years of follow-up. Patients with severe vs moderate baseline disease activity experienced greater improvements in disease activity [mean change in CDAI -18.9 vs -6.0 at year 1; -21.0 vs -7.1 at year 2 ( P0.0001)] and physical function [mean change in mHAQ -0.2 vs -0.1 ( P0.0001) at year 1; -0.2 vs -0.1 ( P = 0.0013) at year 2]. Greater proportions of patients with moderate vs severe disease activity achieved remission (CDAI ⩽2.8) [22.7 vs 15.8% ( P = 0.0003) at year 1; 25.9 vs 20.9% ( P = 0.0396) at year 2] or low disease activity (CDAI10) [60.1 vs 41.2% at year 1; 66.7 vs 49.4% at year 2 ( P0.0001)]. Most patients remained on the original biologic drug (70% at year 1;62% at year 2).With biologic therapy, RA patients with higher baseline disease activity achieved greater improvements in measures of disease activity than those with lower levels of disease, but less often achieved the common targets of remission or low disease activity.

Antibodies against reduction modifiable protein (anti-Rmp Abs) can block complement-dependent killing of Neisseria gonorrhoeae by otherwise bactericidal Abs. An anti-lipooligosaccharide bactericidal monoclonal Ab (mAb) 2C7, a gonococcal vaccine candidate Ab, attenuates vaginal colonization by gonococci in BALB/c mice. Here we show that anti-Rmp Abs block the efficacy of mAb 2C7 in mice in a dose-dependent manner. Anti-Rmp Abs also counteract 2C7-mediated enhancement of C3 deposition on gonococci in vivo. The mouse model will prove useful to study how blocking Abs influence the efficacy of gonococcal vaccines. Preexisting anti-Rmp Abs will be an important consideration in evaluating the efficacy of gonococcal vaccine candidates.

Objective To determine whether depression has a temporal association with RA disease activity, treatment persistence and response to therapy. Methods We performed a systematic review encompassing an electronic database search of all published literature since the availability of biologic response modifiers (beginning in 1998) investigating the impact of depression on downstream RA disease progression and treatment. Results Only seven articles that evaluated temporal relationships between depression and RA outcomes comprising disease activity, treatment persistence and response to therapy, were included in the review. Results from these studies suggest that depression may exacerbate pain and disease activity and decrease the efficacy of pharmacological (i.e. biologic and non-biologic DMARDs) and some non-pharmacological (e.g. cognitive behavioural therapy) RA treatments. Conclusion Given the available evidence, depression probably has a temporal influence on RA disease progression and treatment. However, it is unclear whether these observed effects are due to a response tendency on patient-reported outcomes created from negative cognitive perceptions, immunologically mediated processes that increase inflammation or behavioural changes that lead to decreased physical activity and a greater sensitivity to pain.

Background: The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites. However, little is known about how to effectively promote self-management in this population.Purpose: The objectives were first to determine the feasibility of conducting a randomized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects.Methods: Participants for this pilot study were recruited from a community health center, an elder program, and a community-wide database developed by the community health center, in collaboration with other agencies serving the community, by surveying households in the entire community. Participants were randomly assigned to an intervention (n = 15) or a control (n = 10) condition. Assessments were conducted at baseline and at 3 months and 6 months postrandomization. The intervention consisted of 10 group sessions that targeted diabetes knowledge, attitudes, and self-management skills through culturally specific and literacysensitive strategies. The intervention used a cognitivebehavioral theoretical framework.Results: Recruitment rates at the community health center, elder program, and community registry were 48%, 69%, and 8%, respectively. Completion rates for baseline, 3-month, and 6-month assessments were 100%, 92%, and 92%, respectively. Each intervention participant attended an average of 7.8 out of 10 sessions, and as a group the participants showed high adherence to intervention activities (93% turned in daily logs, and 80% self-monitored glucose levels at least daily). There was an overall Group × Time interaction (p = .02) indicating group differences in glycosylated hemoglobin over time. The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8% (95% confidence intervals = −1.1%, −0.5%) compared with the change in the control group (p = .02). At 6 months, the decrease in the intervention group remained significant, −0.85% (95% confidence intervals = −1.2, −0.5), and the decrease was still significantly different from that of the controls (p = .005). There was a trend toward increased physical activity in the intervention group as compared to that of the control group (p = .11) and some evidence (nonsignificant) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants. Adjusting for baseline depressive scores, we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment (p = .02).Conclusions: Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research. This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a randomized clinical trial.

Population laboratories with complete clinical information on episodes of care are needed to support research on the quality of care delivered to cancer patients. Data resources within the Cancer Research Network (CRN) may overcome many of the limitations of existing cancer databases, but their potential clinical value depends on the stability of the enrolled population. To assess this issue, we studied the retention rates among survivors of the 132 580 patients diagnosed with cancer from January 1, 1993, through December 31, 1998, who were enrolled at five health maintenance organization sites participating in the CRN. Enrollees were followed from cancer diagnosis through death, disenrollment, or the end of follow-up (i.e., December 31, 1999). The retention rate among survivors for all cancers combined at 1 and 5 years after cancer diagnosis was 96.0% (95% confidence interval [CI] = 95.9% to 96.1%) and 83.9% (95% CI = 83.4% to 84.3%), respectively. The proportion of enrollees diagnosed with cancer who remained enrolled and available for evaluation suggests that the CRN is well-suited for studies of the quality of care for cancer patients, survivorship, and long-term outcomes.

The relationships between host factors, viral shedding, illness severity, and antibody response in respiratory syncytial virus (RSV)-induced bronchiolitis are poorly defined. These relationships were prospectively evaluated in 77 infants hospitalized with RSV bronchiolitis in multicenter, double-blind, placebo-controlled trials of RSV immunoglobulin therapy. Severity of illness was influenced by age and host risk factors but was not influenced by RSV neutralizing antibody titer or by the amount of virus in nasal secretions at enrollment. Virus recovery in nasal secretions was variable but was highest at enrollment. Viral shedding was not influenced by primary diagnosis, antibody titer, age, or duration of acute respiratory illness before enrollment. In intubated patients, the amounts of virus recovered in nasal secretions and endotracheal aspirates were highly correlated. A serum neutralizing antibody response was seen in 64% of subjects who received placebo. The response was not influenced by age, primary diagnosis, amount of virus recovered, or severity of illness but was suppressed by preexisting antibody.

Background: Increased concentrations of high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation, are associated with increased risk for coronary heart disease. Because of its relationship to inflammation, hs-CRP has considerable biologic variation. This study was carried out to characterize CRP variation and to compare it to another risk factor, total serum cholesterol.Methods: One hundred thirteen individuals were scheduled to have five measurements each of hs-CRP and total cholesterol carried out at quarterly intervals over a 1-year period. Variations of hs-CRP and total cholesterol were characterized, and classification accuracy was described and compared for both.Results: The relative variation was comparable for hs-CRP and total cholesterol. When classified by quartile, 63% of first and second hs-CRP measurements were in agreement; for total cholesterol it was 60%. Ninety percent of hs-CRP measurements were within one quartile of each other. This relationship was not altered by the use of log-transformed hs-CRP data.Conclusion: hs-CRP has a degree of measurement stability that is similar to that of total cholesterol.

Over a 20-year period in a population of otherwise healthy children, respiratory viruses have been cultured from nasal wash specimens from each child with a clinically significant respiratory illness. Since efforts are underway to develop vaccines for prevention of illness due to parainfluenza virus (PIV) type 3, the epidemiologic characteristics of PIVs were reviewed, and the population size necessary to demonstrate vaccine efficacy was estimated. A population of 1429 children was followed through early childhood. PIVs were isolated from 286 samples, 17.4% of positive viral cultures. PIV-3 was the most common: 10% of the children had at least one symptomatic, culture-proven PIV-3 infection. PIV-3 was endemic during the study period, while the other two PIVs, PIV-1 and -2, caused biennial flu epidemics. Only four PIV-related hospitalizations were seen. The efficacy of a PIV-3 vaccine could be demonstrated in a trial of 600 carefully monitored children vaccinated by 3 months and followed to 15 months of age.

Live attenuated, cold-adapted (ca) monovalent and bivalent influenza A vaccines were evaluated in seronegative infants (ages 6-18 months) in a double-blind placebo-controlled trial to assess safety and immunogenicity. A total of 182 seronegative subjects received a single intranasal dose (10(6.2) TCID50) of ca A/Kawasaki/9/86 (H1N1) or ca A/Los Angeles/2/87 (H3N2), both as a bivalent vaccine, or placebo. Respiratory and systemic symptoms did not differ between groups after vaccination. Hemagglutination antibody seroconversions (> or = 1:8) to H3N2 exceeded 90%. In contrast, seroconversions to A/Kawasaki/9/86 (H1N1) were significantly less frequent in bivalent ca vaccine recipients (31%) than in monovalent ca H1N1 recipients (83%) (P < .002). During a subsequent H3N2 epidemic, nasal washes were cultured for viruses from any subject with respiratory illness. H3N2 infections documented by virus isolation were reduced by 65% in ca H3N2 recipients compared with placebo or ca HIM recipients (P = .01).

Although the incidence of Bordetella pertussis infections had decreased significantly since the introduction of widespread vaccination, an increase in the number of cases has occurred recently. In an attempt to define the seroepidemiology of pertussis in Nashville, antibody levels to pertussis toxin (PT) and filamentous hemagglutinin (FHA) were measured by ELISA in 585 serum samples from healthy 1- to 65-year-old subjects. Data were analyzed by smooth curve fitting and by comparison of trends in PT and FHA titers across age groups. The results demonstrated a peak in PT and FHA titers in the 4-6 year age group, concurrent with the administration of booster doses of diphtheria-tetanus toxoid-pertussis vaccine. A second larger peak was noted in the 13-17 year age group. These data suggest that pertussis infection is frequent during the adolescent years.

Forty-one cystic fibrosis (CF) patients and 89 family members were immunized in a double-blind randomized 3-year trial with either intranasal live cold-adapted (ca) influenza A vaccine or the recommended intramuscular trivalent inactivated (triv) influenza vaccine. Local, respiratory, and systemic symptoms after vaccine were infrequent and did not differ between vaccine groups. CF patients did not differ from family members in immune response to either vaccine. Although antibody responses tended to be higher after triv vaccine, > or = 85% of subjects had mean hemagglutination inhibition antibody titers > or = 1:32 to influenza H1N1 and H3N2 after the first dose of either vaccine. Infection with influenza H3N2 viruses circulating during this study occurred with comparable low frequency in CF patients after ca (14 infections/100 subject-years of observation) or triv vaccine (10 infections/100 subject-years of observation). Influenza A ca vaccines appear to be safe, immunogenic alternatives to influenza A inactivated vaccines for CF patients and their families.