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Biomedical subjects

J M Douglas

Publications and source records attributed to J M Douglas.

At least 19 recordsLinked to original sources

Lichtenstein inguinal herniorrhaphy using sutures versus tacks.

The Lichtenstein hernia repair has become a popular technique for most inguinal hernias performed in the United States. One attempt to improve on this technique includes the use of a tacker instead of suturing the mesh. This study compared the feasibility and time saving for placement of mesh for open inguinal hernias with a tacker versus polypropylene suture.Thirty-four patients were prospectively randomized to undergo open hernia repair using either running 2-0 polypropylene suture or a tacker device that contained spiral titanium tacks. Patients were examined after 1 week and followed for a mean of 8 months (range 1-26 months) to record postoperative complications and technical failure rate. Mesh placement times were significantly shorter in the tacker group (9.0+/-3.5 min) than the suture group (30.9+/-9.9 min). No technical complications or recurrences were found in the follow-up period in either group.Securing mesh with the tacker is safe, and repair appears durable at short-term follow-up. Using the tacker on open inguinal hernia repairs shortens the time for mesh placement compared to suture fixation. Decreased operative time may reduce overall cost.

Adolescent↗

Profiles of grammatical morphology and sentence imitation in children with specific language impairment and Down syndrome.

The purpose of the present study was to examine the grammatical morphology and sentence imitation performance of two different groups of children with language impairment and to compare their performance with that of children learning language typically. Expressive use of tense-bearing and non-tense-related grammatical morphemes was explored. Children with specific language impairment (SLI), with Down syndrome (DS), and with typical language development (TL) were matched on mean length of utterance (MW). Performance was compared primarily on composite measures of tense, tense inflections, and non-tense morphemes, as well as on the Sentences subtest of the Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R; D. Wechsler, 1989). Exploratory analyses were completed on a set of 11 individual grammatical morphemes as a follow-up to the principal analyses. As predicted, the children with SLI performed significantly more poorly than the children with TL on all three composite measures. In addition, the DS group exhibited significantly weaker performance than did the TL group on the tense inflections and non-tense morpheme composites. Although there were no statistically reliable differences between the SLI and DS groups on any morpheme measure, the groups were not comparably weak in their use of the regular post, -ed; the irregular third person singular morphemes (e.g., has, does); the present progressive, -ing; or the use of modals. The SLI and DS groups both performed more poorly than did the TL group on the sentence imitation task.

Child↗

Relationship between human immunodeficiency virus type 1 (HIV-1)-specific memory cytotoxic T lymphocytes and virus load after recent HIV-1 seroconversion.

Human immunodeficiency virus type 1 (HIV-1)-specific memory, or precursor, cytotoxic T lymphocytes (CTL) in 14 subjects who had recently experienced seroconversion were evaluated with respect to virus set point, defined as plasma HIV-1 RNA level 6 months after seroconversion. Env-, Gag-, Pol-, and Nef-specific precursor CTL were detected in (51)Cr-release assays, using antigen-stimulated peripheral blood mononuclear cells as effectors and B cell lines infected with HIV-1-vaccinia recombinants as targets. All subjects tested had precursor CTL specific to at least 2 HIV-1 antigens. Detection of Env-specific precursor CTL was associated with a high set point (P=.0221). The number of antigens recognized tended to be greater in subjects with higher set points (rho=.45621; P=.1171). Gag-specific precursor CTL frequency correlated inversely with set point (rho=-.8478; P=.0003). Two heterozygotes for a 32-bp deletion in CCR5 had the lowest set points (P=.0220) and highest Gag precursor CTL frequencies (P=.0128). These data suggest that host factors that restrict viral replication may be important determinants of the level of HIV-1-specific precursor CTL.

Acquired Immunodeficiency Syndrome↗

Effect of condoms on reducing the transmission of herpes simplex virus type 2 from men to women.

CONTEXT: Herpes simplex virus type 2 (HSV-2) is one of the most common sexually transmitted infections in the United States. No prospective study has shown the ability of condoms to reduce transmission of HSV-2. OBJECTIVE: To evaluate risk factors for HSV-2 acquisition and efficacy of condoms in prevention of HSV-2 transmission. DESIGN: Analysis of data from a randomized, double-blind, placebo-controlled trial conducted December 13, 1993, to June 28, 1996, of an ineffective candidate HSV-2 vaccine with 18 months of follow-up. SETTING: Eighteen clinical trial centers in the United States. PARTICIPANTS: A total of 528 monogamous couples discordant for HSV-2 infection, including an HSV-2-susceptible population of 261 men and 267 women. MAIN OUTCOME MEASURE: Acquisition of HSV-2 infection by susceptible partners, compared with those remaining free of HSV-2 with regard to demographic characteristics, sexual activity, and condom use. RESULTS: Twenty-six women (9.7%) vs 5 men (1.9%) acquired HSV-2, for a rate per 10 000 sex acts (episodes of sexual intercourse) of 8.9 vs 1.5, respectively (P<.001). In multivariable analysis, younger age (adjusted hazard ratio [HR] per 5 years, 1.57; 95% confidence interval [CI], 1.22-2.04), seropositivity for HSV-1 and HSV-2 vs HSV-2 alone in the source partner (adjusted HR, 2.34; 95% CI, 1.14-4.82), and more frequent sexual activity (adjusted HR per additional sex act per week, 1.10; 95% CI, 1.01-1.19) were associated with higher risk of HSV-2 acquisition. Condom use during more than 25% of sex acts was associated with protection against HSV-2 acquisition for women (adjusted HR, 0.085; 95% CI, 0.01-0.67) but not for men (adjusted HR, 2.02; 95% CI, 0.32-12.50). Risk of HSV-2 transmission declined from 8.5 per 100 person-years in the initial 150-day interval to 0.9 per 100 person-years in the final 150-day interval (P =.002 for trend), concurrent with a decrease in sexual activity and proportion of sex acts occurring when the source partner had genital lesions. CONCLUSIONS: Condom use offers significant protection against HSV-2 infection in susceptible women. Changes in sexual behavior, correlated with counseling about avoiding sex when a partner has lesions, were associated with reduction in HSV-2 acquisition over time. These data suggest that identification of discordant couples can reduce transmission of HSV-2, especially for heterosexual couples in which the male partner has HSV-2 infection.

Acyclovir↗

Single-dose gatifloxacin compared with ofloxacin for the treatment of uncomplicated gonorrhea: a randomized, double-blind, multicenter trial.

BACKGROUND: Treatment of gonorrhea is complicated by widespread resistance of Neisseria gonorrhoeae to antimicrobial agents of choice, including decreased susceptibility to ciprofloxacin. GOAL: To demonstrate the efficacy and safety of gatifloxacin, a novel 8-methoxy fluoroquinolone antibiotic, compared with ofloxacin in treating patients with uncomplicated gonococcal infection. STUDY DESIGN: In a double-blind, randomized (2:2:1), controlled trial, 340 men and 388 women with uncomplicated gonorrhea who were 16 years or older received a single oral dose of gatifloxacin (400 mg or 600 mg) or ofloxacin (400 mg). Primary analysis of efficacy was based on bacteriologic eradication from sites of infection. Secondary analyses examined clinical response and adverse event profiles. RESULTS: Bacteriologic eradication rates for gatifloxacin in evaluable men with urethral gonorrhea were 99% (400 mg) and 100% (600 mg) versus 100% for ofloxacin (n = 117, 122, and 55, respectively; P = ns). Eradication rates in evaluable women with endocervical gonorrhea were 99% for both 400 mg and 600 mg gatifloxacin versus 100% for ofloxacin (n = 101, 104, and 55, respectively; P = ns). Eradication rates were 100% for both rectal (n = 43) and pharyngeal (n = 31) infection across all treatment groups. All three drug regimens were well tolerated and exhibited similar clinical response profiles. CONCLUSION: Gatifloxacin is safe and effective as a single 400-mg or 600-mg dose for the treatment of uncomplicated gonorrhea. Similar efficacy rates were observed with the 400-mg and 600-mg doses. A single 400-mg dose can be recommended for treatment of uncomplicated gonorrhea.

Administration, Oral↗

Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day.

BACKGROUND: Medical therapy for genital warts remains suboptimal. The topical interferon and cytokine inducer, imiquimod, has been proved effective for the treatment of external genital and perianal warts, but there is a substantial difference in the response rates between men and women. When 5% imiquimod cream is applied three times a week up to 16 weeks, approximately two thirds of women treated with imiquimod achieve complete clearance of genital warts, whereas only about one third of men clear completely. GOAL: This study was undertaken to determine whether more frequent application of topical imiquimod cream would improve the rate of genital wart clearance in men. STUDY DESIGN: A randomized treatment trial involving adult men with biopsy-proven genital warts was conducted at nine centers in the United States and Canada using four different application frequencies. RESULTS: Complete clearance rates during the 16-week treatment period were as follows for the different imiquimod treatment frequencies: three times a week (35 %), once daily (28 %), twice daily (24%), and three times a day (27%)(P = 0.88). The four treatment groups all showed comparable reductions in the total lesion area, with a median of more than a 90% reduction in the lesion area by the end of treatment. There was a significant increase in the incidence and severity of local skin reactions including erythema, vesicle formation, ulceration, and excoriation as the dosing frequency increased from three times a week to three times a day. CONCLUSIONS: In this study, the optimal dosage regimen was the approved three times a week regimen. More frequent application (up to three times a day) did not improve clearance and was associated with an increase in local adverse events.

Adult↗

Fleeting foreskins: the misclassification of male circumcision status.

BACKGROUND: Errors in the classification of male circumcision status could bias studies linking infection to lack of circumcision. GOAL: To determine the frequency and factors associated with the reproducibility of reporting circumcision status. STUDY DESIGN: Secondary analysis of data using logistic regression modeling from a multicenter randomized controlled trial was performed. RESULTS: At follow-up assessment, 15.6% of clinician reports on circumcision status disagreed with baseline reports. Disagreement was more common if both clinicians were women than if both were men (odds ratio [OR], 2.8; 95% CI, 1.9-4.1). As compared with whites reported as circumcised (4%, 19/532 visits), the highest disagreement involved uncircumcised Hispanic (OR, 3.3; 95% CI, 1.7-6.3), white (OR, 12.2; 95% CI, 5.8-25.6), or black (OR, 17.1; 95% CI, 10.4-27.9) men. CONCLUSIONS: This is one study among a small number of studies examining the reproducibility of clinician-reported circumcision status by comparing multiple clinical examinations of the same patient. The magnitude of the misclassification discovered could bias results and indicates the need for greater accuracy in reporting circumcision status in future studies.

Adult↗

Recent concepts in fecal incontinence.

Fecal incontinence is an inability to defer release of gas or stool from the anus and rectum by mechanisms of voluntary control. It is an important medical disorder affecting the quality of life of more than 2% of the US population. The most common contributing factors include previous vaginal deliveries, pelvic or perineal trauma, previous anorectal surgery, and rectal prolapse. Many physicians lack experience and knowledge related to pelvic floor incontinence disorders, but advancing technology has improved this knowledge. Increased experience with endoanal ultrasound and endoanal magnetic resonance imaging have given us better understanding of the anatomy of the anal canal, and new techniques with muscle translocation and artificial neosphincters and neuromodulation have expanded our armamentarium of options for restoring continence.

Aged↗

Early human immunodeficiency virus (HIV) infection in the HIV Network for Prevention Trials Vaccine Preparedness Cohort: risk behaviors, symptoms, and early plasma and genital tract virus load.

Risk behaviors, symptoms, and virologic characteristics were studied among 103 human immunodeficiency virus (HIV) seroconverters in vaccine preparedness cohorts during 1995-1998. Overall, 83% of subjects were men who had sex with men; most reported multiple risk episodes and symptoms (84%, > or =1 symptom) during seroconversion. Acute HIV was diagnosed in only 8 of 50 who sought medical care. Median initial pretreatment plasma virus load was 25,800 copies/mL (range, undetectable-262,000 copies/mL) a mean of 4 months after seroconversion, and 9.7% had nucleoside-associated mutations; none had multidrug resistance. Semen virus load was more variable, 1.3 log(10) lower and modestly correlated (r=.28; 95% confidence interval, 0.16-0.42) with plasma among untreated men. When the plasma RNA level was <5000 copies/mL, 32% of untreated men, 13% on nucleoside regimens, and 7% on protease inhibitor-containing regimens had detectable seminal RNA. Acute HIV was seldom diagnosed, representing missed opportunities for early treatment and prevention. Most subjects had several relatively stable virus loads before initiation of antiretrovirals, indicating feasibility of assessing HIV vaccines on virus set point in efficacy trials.

Acute Disease↗

Prediction of cervical intraepithelial neoplasia grade 2-3 using risk assessment and human papillomavirus testing in women with atypia on papanicolaou smears.

OBJECTIVE: To determine whether human papillomavirus (HPV) DNA testing and risk assessment can predict cervical intraepithelial neoplasia (CIN) 2-3 on biopsies in women with atypia on Papanicolaou smears. METHODS: One hundred ninety-five consenting women were referred for colposcopy because of atypia on Papanicolaou smears between September 1997 and April 1999. Before colposcopy, women completed risk assessments and had cervical swabs collected for HPV testing using the Hybrid Capture-II assay (Digene Corporation, Silver Spring, MD). Associations of demographic and clinical variables were assessed by chi(2) analysis, and logistic regression was used to assess factors associated with CIN 2-3. The cost-effectiveness of routine colposcopy versus reflex HPV testing by either conventional or liquid-based Papanicolaou smear media was compared. RESULTS: Cervical intraepithelial neoplasia was diagnosed in 70 of 195 women (35.9%), 55 (28.2%) with CIN 1 and 15 (7.7%) with CIN 2-3. High-risk HPV types were detected in 31.3% of all subjects, 36.4% of those with CIN 1, and 93.3% of those with CIN 2-3. By logistic regression, CIN 2-3 was associated only with detection of high-risk HPV (odds ratio 110.08, 95% confidence interval 8.35, 999. 00). The sensitivity of high-risk HPV for detecting CIN 2-3 was 93. 3%, specificity 73.9%, positive predictive value 23.0%, and negative predictive value 99.3%. The cost of reflex HPV testing using conventional smear or liquid-based media was less than routine colposcopy ($4809 and $4308, respectively, versus $4875 per case detected). CONCLUSIONS: Triage based on HPV testing would result in referral of approximately 31% of patients to colposcopy and appears to be a sensitive and cost-effective alternative to colposcopy.

Adult↗

The extent of undiagnosed HIV infection among emergency department patients: results of a blinded seroprevalence survey and a pilot HIV testing program.

This study was performed to determine the rate of previously undiagnosed HIV infection among patients presenting to an urban emergency department (ED) and to assess the feasibility of routinely offering voluntary HIV testing in this setting. HIV serostatus was determined anonymously among consecutive acute medicine and trauma ED patients (aged 18-55) who had blood drawn as part of their medical care. Excess serum was aliquoted and coded with an anonymous study code. Before performing HIV testing, the number of persons with previously reported HIV infection was determined by linkage with the state HIV/AIDS reporting registry. Concurrent with the blinded HIV serosurvey, ED patients were offered voluntary HIV testing in a pilot program. Overall, 76 of 2,155 (3.5%) adult ED patients in the blinded survey were HIV-seropositive, 15 of whom (0. 7% of those tested, 20% of those HIV-seropositive) had no infection previously reported to the state HIV/AIDS registry. In the pilot program, six of the 156 (3.8%) individuals who underwent voluntary HIV testing were HIV-seropositive, including three of 53 (5.6%) individuals without prior HIV testing. Of the six HIV-seropositive subjects, one was previously diagnosed, while five of the remaining 155 (3.2%) represented previously undiagnosed infections. Overall, 3. 5% of ED patients from whom blood was obtained for other reasons tested positive for HIV antibody, 20% of whom were previously undiagnosed. Implementation of the voluntary testing program uncovered newly diagnosed infection among 3.2% of those tested. An ED may be an important setting for routinely offering HIV testing, especially for patients who have not been previously tested for HIV.

Adolescent↗

Conceptual and methodological challenges in discourse assessment with TBI speakers: towards an understanding.

The primary objective of this paper is to review theoretical and methodological literature pertaining to the clinical evaluation of discourse abilities in speakers who have sustained traumatic brain injury (TBI). A brief history of the study of discourse impairment in this population is followed by consideration of the following issues: (1) sampling (genres selected, the physical setting in which sampling takes place, the relationship between speakers, elicitation techniques, presence of recording devices, the number of samples required, and transcription); (2) measurement; (3) the relationship between sampling and measurement; (4) other approaches to discourse assessment (self and close other report); (5) consideration of the criterion of 'normal' which clinicians should employ; (6) the relationship between discourse impairment and measures of executive function; and (7) the relationship between discourse impairment and seventy of injury. Recommendations arising from a critical review of these domains are made for both clinical practice and research.

Brain Injuries↗

Correlates of depression in adults with severe traumatic brain injury and their carers.

Although it is generally accepted that social support plays a role in the maintenance of psychological well-being, there has been relatively little direct investigation of the role that social support may play in affecting post-injury depressive symptoms and mediating the effects of traumatic brain injury (TBI). Consequently, social support was selected as the framework within which to investigate possible indicators of depression in adults with severe TBI and their carers. The authors were interested in the degree of association between social support and the criterion variable of depression in the context of demographic and disability-related variables that have been identified as significant correlates of depression. Thirty-five adults with severe TBI (PTA > 7 days) and their primary carers participated in the study. Time post-injury ranged from 3.5-10 years and all the participants were living in the community. Fifty-seven per cent of the adults with TBI and 60% of their carers were classified as showing significant symptoms of depression. As hypothesized, social support contributed significantly to the prediction of depression. In particular, strong-tie support appeared to be an important indicator of well-being for both the participants with TBI and their carers.

Adaptation, Psychological↗

Diclofenac sodium (Voltaren) reduced exercise-induced injury in human skeletal muscle.

PURPOSE: To examine the effects of prolonged systemic administration of diclofenac sodium (Voltaren), a nonsteroidal anti-inflammatory drug, on objective indices of exercise-induced muscle damage in humans. METHODS: Fifty-four volunteers (mean age, 26.4 yr; range, 18-35) participated in this randomized double-blind, placebo-controlled trial. To achieve steady-state tissue levels, either placebo or diclofenac was orally administered two times a day for 27 consecutive days. A strenuous 20-min stepping exercise program, about which the subjects were unfamiliar, was conducted on day 15. Creatine kinase (CK) activities were measured immediately before the exercise session and on days 16, 18, and 27. Vastus lateralis muscle samples were obtained immediately before exercise and on day 27 for subsequent histological characterization of muscle inflammation. RESULTS: The preexercise muscle samples revealed no difference in muscle damage between the two groups. However, the postexercise muscle samples showed that the diclofenac-treated group demonstrated less muscle tissue damage than placebo-treated subjects (P = 0.002). The administration of diclofenac also resulted in a significant lowering of post-/pre-exercise CK ratios on days 18 (P = 0.03) and 27 (P = 0.02) compared with the placebo group, an indirect finding that supports the possibility of diclofenac reducing exercise-induced muscle damage. CONCLUSION: These findings demonstrate preadministration of diclofenac (in accordance with tissue half-life pharmacokinetics) significantly reduces quantitative indices of exercise-induced skeletal muscle damage in human muscle.

Administration, Oral↗

Comparative prevalence of infection with Trichomonas vaginalis among men attending a sexually transmitted diseases clinic.

OBJECTIVE: Although established in women as a common cause of vaginal discharge, the prevalence of Trichomonas vaginalis (TV) in men compared with other classic urethral pathogens has not been well characterized. To assess this issue, the authors compared the prevalence of Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), and TV in consecutive men attending a sexually transmitted diseases (STD) clinic. METHODS: From June 1, 1998 to July 27, 1998, 454 consecutive men presenting to the Denver Metro Health Clinic with a new problem were tested for GC by urethral swab culture, for CT by polymerase chain reaction of urine, and for TV by urine sediment culture. RESULTS: GC, CT, and TV were detected in 23 (5.1%), 34 (7.5%), and 13 (2.8%) of men, respectively. There were significant differences by age for both CT (11.3% in men younger than 30 years versus 3.3% in men 30 years and older, P < 0.05) and TV (0.8% in men younger than 30 years versus 5.1% in men 30 years and older, P < 0.05). In 50 men 30 years or older with symptoms of urethral discharge, TV prevalence (12.0%) rivalled that of GC (12.0%) and CT (14.0%). In 45 men 30 years and older with nongonococcal urethritis, the prevalence of TV and CT were each 13.3%. Multivariate logistical regression analysis showed the presence of discharge and nongonococcal urethritis in men 30 years and older to be an independent predictor of TV. CONCLUSIONS: TV is common in men attending sexually transmitted disease clinics, especially in those 30 years or older, in whom it may account for as much urethritis as GC or CT. These findings suggest that in older men with nongonococcal urethritis, diagnostic evaluation, empiric treatment, and partner management should include the possibility of TV infection.

Adult↗

The effect of treating sexually transmitted diseases on the transmission of HIV in dually infected persons: a clinic-based estimate. Ad Hoc STD/HIV Transmission Group.

BACKGROUND: The effect of sexually transmitted disease (STD) treatment on HIV transmission is a topic of considerable current interest and controversy. GOAL: To assess the potential effect of STD treatment on HIV transmission in persons who are dually infected with STD and HIV. STUDY DESIGN: Using data from eight STD clinic sites in the United States, the authors estimate the actual achievable reduction in HIV transmission by multiplying the prevented fraction associated with treatment of STDs (set at an average of 0.8) by the maximum potential reduction in HIV transmission achieved by treating STDs (using an average relative risk of 3.0 for increased HIV transmission in the presence of STDs). Subgroup analysis assessed infection proportions for genital ulcer disease, nonulcerative STDs, and any STD by sex, ethnicity, age, and sexual orientation. RESULTS: The maximum achievable reduction in HIV transmission from dually infected persons to their partners is approximately 33%. The actual achievable reduction is approximately 27% (range, 10.0-38.1%) at the eight clinic sites. If each of the 4,516 dually infected persons in this cohort experienced a single sexual exposure with an uninfected person, 28 HIV infections would occur in the absence of STD treatment whereas 16 infections would occur with STD treatment. CONCLUSIONS: The estimate of a 27% reduction provides a qualitative assessment of the potential impact of STD treatment on HIV transmission in the absence of any other behavioral intervention. Identification of dually infected persons in STD clinics is an important mechanism for targeting interventions to a social milieu with high risk for HIV infection and other STDs.

Adult↗

Does measured behavior reflect STD risk? An analysis of data from a randomized controlled behavioral intervention study. Project RESPECT Study Group.

BACKGROUND: Many studies measure sex behavior to determine the efficacy of sexually transmitted disease (STD)/HIV prevention interventions. GOAL: To determine how well measured behavior reflects STD incidence. STUDY DESIGN: Data from a trial (Project RESPECT) were analyzed to compare behavior and incidence of STD (gonorrhea, chlamydia, syphilis, HIV) during two 6-month intervals. RESULTS: A total of 2879 persons had 5062 six-monthly STD exams and interviews; 8.9% had a new STD in 6 months. Incidence was associated with demographic factors but only slightly associated with number of partners and number of unprotected sex acts with occasional partners. Many behaviors had paradoxical associations with STD incidence. After combining behavior variables to compare persons with highest and lowest risk behaviors, the STD incidence ratio was only 1.7. CONCLUSION: Behavioral interventions have prevented STD. We found people tend to have safe sex with risky partners and risky sex with safe partners. Therefore, it is difficult to extrapolate the disease prevention efficacy of an intervention from a measured effect on behavior alone.

Adolescent↗