An innovative method for clinical practice guideline contextualisation for chronic musculoskeletal pain in the South African context.

BACKGROUND: Clinical guidelines produced in developed nations may not be appropriate in resource-constrained environments, due to differences in cultural, societal, economic and policy contexts. The purpose of this article is to describe an innovative and resource-efficient method to develop a clinical practice guideline (CPG), using the CPG contextualisation approach. METHODS: The four phased contextualisation framework was applied to produce a contextualised, multidisciplinary CPG for the primary health care of adults with chronic musculoskeletal pain (CMSP) in the South African context. The four phases were: a contextual analysis, evidence synthesis, contextual integration and external evaluation. Qualitative methodology was used to investigate context factors influencing health care in this environment. A systematic review was conducted to identify current, high-quality CPGs on the topic, and to synthesise a core set of clinical recommendations from the CPGs. Consensus methods were used to integrate context information with recommendations. A multidisciplinary panel of local experts authenticated and contextualised recommendations. The resultant CPG was externally reviewed using a survey. RESULTS: The results from the contextual analysis phase indicated a wide range of contextual factors that could influence the applicability and implementability of the recommendations, including: the personal characteristics of the patient and clinician, social and environmental circumstances, healthcare interventions available, and healthcare system factors. During phase two, six existent high quality CPGs were identified and a core set of multidisciplinary recommendations were sourced from them. The contextual integration phase produced the validated recommendations, accompanied by its underpinning body of evidence and context specific information. The outcome of phase four (external review) was that the recommendations were confirmed as relevant for the intended setting. CONCLUSION: CPG contextualisation was found to be a practical approach to develop a contextualised multidisciplinary CPG for the primary health care of adults with CMSP in a South African setting. The contextualisation approach enhanced the integration of multiple stakeholder perspectives and highlighted the importance of considering clinical, social and economic complexities during CPG development. Attention to contextual information is advocated to enhance the uptake of CPG recommendations, particularly in resource constrained settings. TRIAL REGISTRATION: Health Research Ethics Committee of Stellenbosch University, South Africa (S14/01/018); the review protocol was registered on PROSPERO (registration number CRD42015022098 ).

A systematic review of collaborative models for health and education professionals working in school settings and implications for training.

CONTEXT: Collaborative engagement between education and health agencies has become requisite since the establishment of school inclusion policies in many developed countries. For the child with healthcare needs in an educational setting, such collaboration is assumed to be necessary to ensure a coordinated and holistic approach. However, it is less clear how this is best achieved. OBJECTIVES: This secondary research aimed to answer the questions: what are the reported models of best practice to support the collaboration between education and health staff and what are the implications for training strategies at an undergraduate and postgraduate level to affect these models? METHODS: Systematic review of current literature, with narrative summary. FINDINGS: Models of interaction and teamwork are well-described, but not necessarily well-evaluated, in the intersection between schools and health agencies. They include a spectrum from consultative to collaborative and interactive teaming. It is suggested that professionals may not be adequately skilled in, or knowledgeable about, teamwork processes or the unique roles each group can play in collaborations around the health needs of school children. DISCUSSION AND CONCLUSION: There is a need for robust primary research into the questions identified in this paper, as well as a need for educators and health professionals to receive training in interprofessional teamwork and collaboration beyond their traditional domains. It is suggested such training needs to occur at both the undergraduate and postgraduate levels.

Hormonal contraceptive use modulates the local inflammatory response to bacterial vaginosis.

OBJECTIVES: To compare cervical concentrations of numerous cytokines/chemokines in women with bacterial vaginosis (BV) compared with the levels detected after BV resolution and determine if hormonal contraceptive use modulates the local inflammatory response to BV. METHODS: Cervical secretions from 81 women with BV at enrollment and normal flora at one-month follow-up were analysed for 10 different cytokines/chemokines using multiplexed fluorescent bead-based immunoassays. RESULTS: BV was associated with significantly higher concentrations of IL-1 beta, tumour necrosis factor (TNF), interferon-gamma, IL-2, IL-4, and IL-10 compared with the levels detected in the presence of normal vaginal flora. Analysis of results stratified by contraceptive practice demonstrated significantly lower levels of numerous cytokines among women with BV using hormonal contraceptives compared with those women with BV not using hormonal contraceptives. Hormonal contraceptive use was also associated with a statistically significant lesser change in TNF levels between the two study visits compared with the amount of change detected between visits among women who denied their use. CONCLUSIONS: Despite increases in the levels of both pro and anti-inflammatory cytokines in the lower genital tract of women with BV, the overall balance of these two types of molecules was maintained. The character of this local inflammatory response may help explain the typical absence of overt signs of inflammation among women with BV. In addition, hormonal contraceptive use was associated with significantly lower levels of the pro-inflammatory molecules TNF, interferon-gamma, and granulocyte macrophage colony-stimulating factor in women with BV, but did not significantly reduce the levels of IL-10, a key anti-inflammatory cytokine. These results suggest the possibility of an association between hormonal contraceptive use and altered genital tract immunity.

Vestibular rehabilitation for unilateral peripheral vestibular dysfunction.

BACKGROUND: Unilateral peripheral vestibular dysfunction (UPVD) can occur as a result of disease, trauma or post-operatively. The dysfunction is characterized by complaints of dizziness, visual or gaze disturbances and balance impairment. Current management includes medication, physical manoeuvres and exercise regimes, the latter known collectively as vestibular rehabilitation (VR). OBJECTIVES: To assess the effectiveness of vestibular rehabilitation in the adult, community dwelling population of people with symptomatic unilateral peripheral vestibular dysfunction. SEARCH STRATEGY: The search included the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 1 2007, MEDLINE (1950 to 2007) and EMBASE (1974 to 2007). The date of the last search was March 2007. SELECTION CRITERIA: Randomised trials of adults living in the community, diagnosed with symptomatic unilateral peripheral vestibular dysfunction. Comparisons sought were: Vestibular rehabilitation versus control (placebo etc.). Vestibular rehabilitation versus other treatment (non-vestibular rehabilitation e.g. pharmacological). Vestibular rehabilitation versus another form of vestibular rehabilitation. Outcome measures that were considered included: frequency and severity of dizziness or visual disturbance; changes in balance impairment, function or quality of life; measure/s of physiological status with known functional correlation. DATA COLLECTION AND ANALYSIS: Both authors independently extracted data and assessed trials for quality. MAIN RESULTS: Thirty-two trials were identified and eleven were excluded because of mixed/unclear vestibular pathology, leaving twenty-one trials in the review. Included studies addressed the effectiveness of vestibular rehabilitation against control/sham interventions, non-vestibular rehabilitation interventions or other forms of vestibular rehabilitation, by comparing the subjects in each group who had significant resolution of symptoms and/or improved function. Individual and pooled data showed a statistically significant effect in favour of the vestibular rehabilitation over control or no intervention. The exception to this was when movement based vestibular rehabilitation was compared to physical manoeuvres for benign paroxysmal positional vertigo, where the latter was shown to be superior in cure rate in the short term. There were no reported adverse effects. AUTHORS' CONCLUSIONS: There is moderate to strong evidence that vestibular rehabilitation is a safe, effective management for unilateral peripheral vestibular dysfunction, based on a number of high quality randomised controlled trials. There is moderate evidence that vestibular rehabilitation provides a resolution of symptoms in the medium term. However there is evidence that for the specific diagnostic group of benign paroxysmal positional vertigo, physical (repositioning) manoeuvres are more effective in the short term than exercise based vestibular rehabilitation. There is insufficient evidence to discriminate between differing forms of vestibular rehabilitation.

Preclinical safety assessments of UC781 anti-human immunodeficiency virus topical microbicide formulations.

The nonnucleoside reverse transcriptase inhibitor UC781 is under development as a potential microbicide to prevent sexual transmission of human immunodeficiency virus type 1 (HIV-1). Two gel formulations of UC781 (0.1% and 1.0%) were evaluated in a range of preclinical safety assessments, including systemic absorption analysis following topical application in the pig-tailed macaque models for vaginally and rectally applied topical microbicides. High-sensitivity high-performance liquid chromatography analysis of serum samples showed that no systemic absorption of UC781 was detected after repeated vaginal or rectal application of either product. However, high levels of UC781 were detectable in the cervicovaginal lavage samples up to 6 h after product exposure. Both formulations were safe to the vaginal microenvironment, even with repeated daily use, as evidenced by colposcopy, cytokine analysis, and lack of impact on vaginal microflora. By contrast, rectal application of the 1.0% UC781 formulation caused an increased expression of numerous cytokines not observed after rectal application of the 0.1% UC781 formulation. These results provide additional support for the continued development of UC781 formulations as anti-HIV microbicides.

Susceptibility of vaginal bacteria to metronidazole and tinidazole.

In vitro antimicrobial susceptibility testing was performed on 470 vaginal isolates from women with bacterial vaginosis and three species of Lactobacillus, to metronidazole and tinidazole using the agar dilution method. There was no significant difference observed in the inhibitory activity of either drug to any of the isolates tested.

Preclinical safety and efficacy assessments of dendrimer-based (SPL7013) microbicide gel formulations in a nonhuman primate model.

Three gel formulations (1%, 3%, and 5% [wt/wt]) of SPL7013, a dendrimer known to have antiviral (anti-human immunodeficiency virus and anti-herpes simplex virus) activities, completed a range of preclinical tests in the pigtailed macaque models for vaginally and rectally applied topical microbicide safety assessments. The vaginal safety profile of the 3% SPL7013 gel formulation was equal to that of the 1% formulation but was superior to that of the 5% formulation. The 3% SPL7013 gel was further evaluated for rectal safety and for antichlamydial efficacy with cervical challenge with Chlamydia trachomatis. This first-generation dendrimer-based product was shown to be safe to the vaginal and rectal microenvironments with repeated daily use. However, a single intravaginal application of the 3% (wt/wt) SPL7013 gel did not provide protection from the acquisition of cervical chlamydial infection.

The sensitivity of three commonly used outcome measures to detect change amongst patients receiving inpatient rehabilitation following stroke.

OBJECTIVE: To investigate the sensitivity of three commonly used functional outcome measures to detect change over time in subjects receiving inpatient rehabilitation post stroke. DESIGN: Subjects were assessed within one week of admission and one week of discharge from an inpatient rehabilitation facility. Several parameters of sensitivity were calculated, including floor and ceiling effects, the percentage of subjects showing no change and the effect size of the change between admission and discharge. SETTING: The medical rehabilitation ward of an inpatient rehabilitation facility. SUBJECTS: Seventy-eight subjects receiving inpatient rehabilitation following a first or recurrent stroke. MEASURES: Five-metre walk, comfortable pace (gait speed), the Berg Balance Scale and the Motor Assessment Scale. RESULTS: Sixty-one subjects had complete admission and discharge data. Gait speed and the Berg Balance Scale were both sensitive to change and demonstrated large effect sizes. The Motor Assessment Scale item five also showed a large effect size and was able to detect change amongst lower functioning subjects. The other items of the Motor Assessment Scale were less useful, in particular, the effect sizes for upper extremity change scores were small (d=0.36-0.5) and the majority of subjects (44.3-63.9%) showed no change over time on these measures. CONCLUSION: Gait speed, the Berg Balance Scale and the Motor Assessment Scale item five were sensitive to change over time in this sample.

Microbiologic response to treatment of bacterial vaginosis with topical clindamycin or metronidazole.

To compare the frequencies, concentrations, and antimicrobial susceptibilities of vaginal microbes isolated from women with bacterial vaginosis (BV) before and after therapy, 119 nonpregnant women aged 18 to 45 with clinical and Gram stain evidence of BV were randomized to receive intravaginal clindamycin or metronidazole. Vaginal swabs were collected at baseline and 7 to 12 days, 35 to 45 days, and 70 to 90 days following therapy for quantitative vaginal culture. For the 99 women completing all four visits, statistical analyses were performed comparing differences in vaginal microflora between the two treatment arms and between visits in the same treatment group. Antimicrobial susceptibility testing using the agar dilution method was performed for anaerobic gram-negative rods. Although both therapies resulted in decreased colonization by Gardnerella vaginalis and Mycoplasma hominis, only metronidazole treatment resulted in a significant decrease in the frequency and concentration of Prevotella bivia and black-pigmented Prevotella species. Of the 865 anaerobic gram-negative rods evaluated for susceptibility, only 3 (0.3%) were resistant to metronidazole, whereas clindamycin resistance increased significantly for P. bivia and black-pigmented anaerobic gram-negative rods persisting following clindamycin therapy. Clindamycin-resistant subpopulations of P. bivia and black-pigmented Prevotella species emerged 7 to 12 days after therapy even among women colonized initially by clindamycin-susceptible strains. These resistant subpopulations persisted at high frequencies (42 to 50%) 70 to 90 days following therapy. The two topical agents for treatment of BV have differing microbiologic effects on the vaginal microflora. The emergence of clindamycin-resistant anaerobic gram-negative rods following therapy is of concern.

Effect of transport time, temperature, and concentration on the survival of group B streptococci in amies transport medium.

The impact of transport time and temperature on survival of group B streptococci (GBS) in Amies transport medium was evaluated. Viability of 10 or more CFU of GBS was maintained for 4 days at 24 or 3 degrees C. However, there was a significant decrease in viability for GBS held at 30 degrees C for 4 days.

Diversity of surface protein expression in group B streptococcal colonizing & invasive isolates.

BACKGROUND & OBJECTIVES: The classification of group B streptococcal (GBS) isolates is based on the capsular polysaccharides (Ia-VIII), and antigenic characterization of clinical isolates is augmented by the detection of various surface-localized protein antigens. In our laboratory, all GBS isolates are routinely analysed for the alpha trypsin-resistant and the beta trypsin-sensitive c protein antigens, as well as other trypsin-resistant proteins R1, R3, and R4, as well as BPS. The purpose of this work was to study diversity of protein expression in colonizing isolates (vaginal and rectal sites) from nonpregnant women and from invasive isolates (blood or CSF) from mothers and their less than seven day old newborn infants. METHODS: A total of 289 invasive isolates and 2660 colonizing isolates were collected between 1993-2002. All isolates were tested for polysaccharide serotype and cell surface-expressed protein profile by double immunoprecipation in agarose using monospecific antisera. RESULTS: Among the 289 invasive isolates, 89.6 per cent expressed one or more trypsin-resistant proteins; 93 per cent of the colonizing isolates expressed one or more of these proteins. Overall, the most common surface protein expression profile by GBS serotype was: alpha in type Ia; alpha plus beta in type Ib; alpha and R4 in type II; R4 in type III; and co-expression of R1 plus R4 in isolates of type V. BPS was found in five (1.7%) invasive isolates, alone in two isolates and with other proteins in three isolates. Among 2660 colonizing isolates, BPS was found alone in 15 (0.6%) and in 57 additional isolates with other proteins. Among the total isolates, BPS was found predominantly in serotype Ia isolates, also expressing R1. Uncommon protein profiles of known serotypes included 11 type III isolates expressing alpha plus beta. Among 72 nontypable colonizing isolates, expression of R1 plus R4 was the commonest (33.3%) profile. INTERPRETATION & CONCLUSION: The GBS surface proteins and the common serotypes were distributed comparably in colonizing and invasive isolates. Trypsin-resistant, alpha and alpha-like proteins, R1 and R4 were the most prevalent. The phenotypic diversity of the surface-localized protein antigens of GBS is intriguing, and genotypic analysis will permit consensus in nomenclature from laboratory to laboratory.

Characterization of vaginal & rectal colonization with multiple serotypes of group B streptococci using multiple colony picks.

BACKGROUND & OBJECTIVES: There is paucity of information on vaginal and rectal colonization with multiple serotypes of group B streptococci (GBS). As part of an ongoing cohort study evaluating the natural history of vaginal and rectal colonization by GBS, the colonization with multiple serotypes was studied in 102 non-pregnant women aged 18-30 yr. METHODS: Up to ten separate colony picks of beta-haemolytic streptococci (total 1515 isolates) were selected from vaginal and rectal primary culture plates. The colonies were identified as GBS, and their capsular polysaccharides (CPS) serotypes determined using monospecific rabbit antisera for types Ia-VIII by double immunodiffusion in agarose (DID). A colony dot immunoblot (DB) assay, using monospecific rabbit antisera to purified type polysaccharides conjugated to tetanus toxoid, was developed to serotype efficiently the multiple colony picks of GBS. RESULTS: The CPS serotype distribution, examining only the 177 "a" or first colony picks from the 102 patients, was 30.5 per cent for Ia; 28.2 per cent for type III; 15.3 per cent for type II; and 13.6 per cent for type V. Only 2.8 per cent were nontypeable. Eighty of the 102 patients (78.4%) were colonized with only one serotype; 20 (19.6%) had two serotypes and two patients (2%) had three serotypes in their vaginal and/or rectal paired cultures. Overall, 91.9 per cent of the culture sites colonized with one to three CPS types (from the total number of colonies picked) were identified with a minimum of three colony picks. In 75 patients with vaginal/rectal pairs the GBS serotype concordance of only the "a" colony was 89.3 per cent and concordance decreased to 80 per cent when the serotype concordance of the total colony picks was analyzed. INTERPRETATION & CONCLUSION: In conclusion, there was a relatively high prevalence of serotype nonconcordance in this population, and 21.6 per cent of patients had multiple GBS serotypes.

Safety and efficacy evaluations for vaginal and rectal use of BufferGel in the macaque model.

BACKGROUND: The nonhuman primate model allows for safety and efficacy testing of topical microbicide products. GOAL: The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of BufferGel (ReProtect, Inc.). STUDY DESIGN: The safety of repeated product applications was evaluated by microflora, pH, vaginal colposcopy, and rectal lavage. To test efficacy in preventing chlamydia, infection was documented by culture and nucleic acid amplification tests. RESULTS: Repeated vaginal or rectal applications of BufferGel were not associated with significant changes in microflora. BufferGel use had a transient acidifying effect on vaginal and rectal pH. Colposcopic observations remained relatively normal in all test animals. A slightly increased incidence of epithelial desquamation was noted after rectal product use compared with the control group. BufferGel did not prevent cervical or rectal chlamydial infection. CONCLUSION: BufferGel has an acceptable safety profile after repeated vaginal and rectal use, but does not prevent chlamydial infection in the macaque models.

The antimicrobial treatment of subacute endometritis: a proof of concept study.

OBJECTIVE: Our purpose was to evaluate the antimicrobial therapy effect on clinical and laboratory findings among women at risk for endometritis. STUDY DESIGN: A prospective antimicrobial treatment trial of 153 women was performed to characterize subacute endometritis and to determine the treatment effect on endometritis resolution. RESULTS: After antimicrobial treatment, significant reductions occurred in abnormal bleeding (60% vs 29%), mucopurulent cervicitis (20% vs 6%), uterine tenderness (20% vs 6%), and histologic endometritis (38% vs 4%), all P<.001. In women with prior pelvic inflammatory disease (PID), endometritis was present in 43% with and 28% without current Chlamydia trachomatis or Neisseria gonorrhoeae. In women without prior PID, endometritis was present in 23% with and 12% without current C trachomatis or N gonorrhoeae (P=.002 for trend). CONCLUSIONS: In women without a clinical diagnosis of PID, antimicrobial therapy decreased abnormal clinical findings and histologic endometritis. Prior PID is additive with current cervical infection as a risk for endometritis.

Optimization of media for detection of hydrogen peroxide production by Lactobacillus species.

A healthy vaginal ecosystem has been shown to be protective against the acquisition of human immunodeficiency virus and gonorrhea, and women who are colonized with H(2)O(2)-producing lactobacilli are more likely to maintain a normal vaginal flora than women with lactobacilli that do not produce H(2)O(2). The purpose of this study was to formulate a testing medium that better supports the growth and detection of H(2)O(2) by a broader range of lactobacilli than a published, widely used agar formulation (TMB). The new medium (TMB-Plus) consists of brucella agar base, 3,3',5,5'-tetramethylbenzidine, horseradish peroxidase, starch, vitamin K, hemin, magnesium sulfate, manganese sulfate, and horse serum. To validate the new formula, 256 vaginal isolates and ATCC strains were inoculated onto TMB-Plus and, for comparison, onto TMB. Growth was enhanced for 69% of the isolates on TMB-Plus, and 48% had enhanced color production. The percentage of H(2)O(2)-positive isolates increased from 71% on TMB to 79% on TMB-Plus. Formulations using Rogosa or MRS agar base in combination with peroxidase and a chromogen did not support the growth of all of the strains of Lactobacillus, and fewer H(2)O(2)-producing strains were detected on these formulations than on TMB-Plus. This new medium better supports the growth of a wider range of Lactobacillus strains isolated from the vagina and enhances the color production of H(2)O(2)-producing strains.

Factors associated with acquisition of, or persistent colonization by, vaginal lactobacilli: role of hydrogen peroxide production.

To identify factors that predict sustained colonization by vaginal lactobacilli, microbiologic, behavioral, and demographic data were obtained from 101 nonpregnant women at baseline and at 4 and 8 months. A total of 272 isolates of lactobacilli were identified to the species level by use of whole chromosomal DNA homology to type strains. The predominant lactobacilli were the species Lactobacillus crispatus (38%) and L. jensenii (41%). Of 57 women initially colonized by H(2)O(2)-producing L. crispatus or L. jensenii, 23 (40%) remained colonized over 8 months, compared with 1 (5%) of 21 women colonized by other H(2)O(2)-producing species or by H(2)O(2)-negative strains (P=.01). Frequency of sexual intercourse (> or =1 sex act per week) was associated with loss of colonization with H(2)O(2)-producing lactobacilli (P=.018), as was antibiotic use (P< or =.0001). Other behavioral and demographic characteristics did not predict sustained colonization. The production of H(2)O(2) is closely linked with species and is a predictor for sustained long-term colonization of the vagina.

Comparison of clindamycin phosphate vaginal cream with triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

BACKGROUND: Triple sulfonamide vaginal cream has been used to treat bacterial vaginosis for many years. There are few studies in which triple sulfonamide cream has been compared with newer regimens. GOAL: To compare the efficacy and safety of clindamycin phosphate vaginal cream with that of triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. STUDY DESIGN: In this double-blind, randomized multicenter study, nonpregnant women 16 years of age or older with symptomatic bacterial vaginosis were assigned to receive either 2% clindamycin phosphate vaginal cream or triple sulfonamide vaginal cream for 7 days. Follow-up visits were conducted 5 to 10 days and 25 to 39 days after completion of treatment. RESULTS: Clinical cure or improvement at 25 to 39 days was noted in 55 (69.6%) of 79 assessable participants who received clindamycin vaginal cream and in 33 (41.8%) of 79 women who received triple sulfonamide vaginal cream (P < 0.0001). Most of the difference between the treatment groups was noted in women with a history of bacterial vaginosis. Among women without a history of bacterial vaginosis, clindamycin and triple sulfonamide creams had similar efficacy. Evaluation of Gram-stained vaginal smears correlated with clinical outcome. Most patients in both treatment groups reported an improvement in symptoms. No significant difference was observed between the treatment groups in the incidence of adverse events. CONCLUSION: Clindamycin 2% vaginal cream is more effective than triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

An association of cervical inflammation with high-grade cervical neoplasia in women infected with oncogenic human papillomavirus (HPV).

Previous reports of genital conditions, such as nonspecific genital infection/sore or vaginal discharge associated with cervical cancer (L. A. Brinton et al., J. Natl. Cancer Inst. (Bethesda), 79: 23-30, 1987; C. J. Jones et al., Cancer Res., 50: 3657-3662, 1990), suggest a possible link between either genital tract inflammation or changes in bacteria flora consistent with bacterial vaginosis (BV) and cervical cancer. To test whether changes in vaginal bacterial flora or the degree of cervical inflammation are associated with women having a human papillomavirus (HPV) infection or with women infected with oncogenic HPV having high-grade cervical lesions (high-grade squamous intraepithelial lesions or cancer), we conducted a case-control study of women <50 years old enrolled in the Costa Rican natural history study of HPV and cervical neoplasia. To test whether BV and inflammation were associated with HPV DNA positivity, Analysis 1 was restricted to women with no or mild (low-grade or equivocal) cytological abnormalities, and the degree of inflammation and Nugent score (a measure of BV) were compared between women infected (n = 220) and not infected (n = 130) with HPV. To test whether BV and inflammation were associated with high-grade lesions, Analysis 2 was restricted to women infected with oncogenic HPV, and the degree of inflammation and Nugent score were compared between women with (n = 95) and without (n = 158) high-grade cervical lesions. In Analysis 1, BV and cervical inflammation were not associated with HPV infection. In Analysis 2, BV was not associated with high-grade lesions. However, we found a marginally significant positive trend of increasing cervical inflammation associated with high-grade lesions in oncogenic HPV-infected women, (P(trend) = 0.05). Overt cervicitis was associated with a 1.9-fold increase in risk of high-grade lesions (95% confidence interval, 0.90-4.1). The results of this study suggest that cervical inflammation may be associated with high-grade lesions and may be a cofactor for high-grade cervical lesions in women infected with oncogenic HPV.

Evaluation of the Affirm Ambient Temperature Transport System for the detection and identification of Trichomonas vaginalis, Gardnerella vaginalis, and Candida species from vaginal fluid specimens.

The objective of this study was to measure the performance of the Affirm Ambient Temperature Transport System (ATTS) over time and to estimate the length of time the system can preserve a vaginal specimen containing the three common organisms causing vaginitis: Trichomonas vaginalis, Candida species, and Gardnerella vaginalis (one of the causative agents of bacterial vaginosis). Women with symptoms of vaginitis presenting to one of three clinical centers were evaluated over a 4- to 8-week period. Four simultaneously obtained swabs were collected and tested by the Affirm VPIII assay at time zero with and without a preservative reagent, at 24 h with reagent, and at either 48 or 72 h with reagent. For each of the three organisms, Trichomonas, Gardnerella, and Candida, positivity at each time point was evaluated and compared to that at reference time zero with and without the ATTS. A total of 940 specimens were obtained from the three clinical sites. Eight hundred three were positive for one or more of the three organisms. Gardnerella had the highest overall positive rate (62%), followed by Candida with 18% and Trichomonas at 9%. The percent sensitivity versus control for Trichomonas ranged from 100% at time zero with and without reagent to 91% by 72 h. Gardnerella and Candida sensitivity remained at 100% for each time period. The Affirm VPIII ATTS system performed within 10% of the control swab (no transport reagent) at all four time points (0, 24, 48, and 72 h) for Trichomonas, Gardnerella, and Candida.