Prioritizing Evidence-based Interventions for Dissemination and Implementation Investments: AHRQ's Model and Experience.

BACKGROUND: The Agency for Healthcare Research and Quality (AHRQ) is mandated to implement patient-centered outcomes research (PCOR) to promote safer, higher quality care. With this goal, we developed a process to identify which evidence-based PCOR interventions merit investment in implementation. We present our process and experience to date. MATERIALS AND METHODS: AHRQ developed and applied a systematic, transparent, and stakeholder-driven process to identify, evaluate, and prioritize PCOR interventions for broad dissemination and implementation. AHRQ encouraged public nominations, and assessed them against criteria for quality of evidence, potential impact, and feasibility of successful implementation. Nominations with sufficient evidence, impact, and feasibility were considered for funding. RESULTS: Between June 2016 and June 2018, AHRQ received 35 nominations from researchers, nonprofit corporations, and federal agencies. Topics covered diverse settings, populations, and clinical areas. Twenty-eight unique PCOR interventions met minimum criteria; 16 of those had moderate to high evidence/impact and were assessed for feasibility. Fourteen topics either duplicated other efforts or lacked evidence on implementation feasibility. Two topics were prioritized for funding (cardiac rehabilitation after myocardial infarction and screening/treatment for unhealthy alcohol use). CONCLUSIONS: AHRQ developed replicable criteria, and a transparent and stakeholder-driven framework that attracted a diverse array of nominations. We identified 2 evidence-based practice interventions to improve care with sufficient evidence, impact, and feasibility to justify an AHRQ investment to scale up practice. Other funders, health systems or institutions could use or modify this process to guide prioritization for implementation.

Creation of a Composite Score to Predict Adnexal Torsion in Children and Adolescents.

STUDY OBJECTIVE: To create a composite score to predict adnexal torsion in children and adolescents. DESIGN: A prospective cross-sectional study. SETTING: Emergency department of a tertiary care children's hospital. PARTICIPANTS: Three hundred twenty-four female participants aged 6-21 years who presented to the emergency department with lower abdominal pain and underwent ultrasound or computed tomography imaging. INTERVENTIONS: Collection of possible clinical and radiologic predictors of torsion. MAIN OUTCOME MEASURES: The primary outcome was a composite score to predict adnexal torsion. We used χ2 analyses to identify possible risk factors. The classification and regression tree decision method was used to identify risk factor cutoff points. Independent risk factors were combined into a composite score. Receiver operating characteristic curve analyses were used to assessed score performance. RESULTS: Of 324 participants with abdominal pain, 241 underwent imaging, and 6.6% (16 of 241) had torsion. Duration of pain, intermittent pain, nausea, and absence of arterial or venous flow were not associated with torsion. Vomiting (P = .05 in premenarchal subjects; P < .001 in menarchal subjects), adnexal volume (P = .008 in premenarchal subjects; P < .001 in menarchal subjects), and adnexal volume ratio (P = .04 in premenarchal subjects; P < .001 in menarchal subjects) were independent predictors of torsion. These predictors were incorporated into a composite score. No torsions were identified with a score of less than 2. There was an increasing risk of torsion for each 1-point score increase. CONCLUSION: Independent predictors of torsion can reliably be combined into a composite score to identify children and adolescents at risk for adnexal torsion. This score might aid in improving triage and management of these challenging patients.

Provider Adherence to Syphilis Testing Recommendations for Women Delivering a Stillbirth.

OBJECTIVE: To assess overall adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommended guidelines for syphilis testing among women who delivered a stillbirth and compare it with other tests recommended for stillbirth evaluation. METHODS: We used MarketScan claims data with 40 million commercially insured and 8 million Medicaid enrollees annually to estimate prenatal care and follow-up testing among women who had stillbirths between January 1, 2013, and December 24, 2013. Stillbirth was identified if women had any International Classification of Disease, Ninth Revision codes related to a stillbirth outcome. Among women with stillbirths, we estimated the proportions of women who received prenatal care and prenatal syphilis testing within 280 days before stillbirth, and testing at the time of stillbirth (syphilis testing, complete blood count, placental examination and autopsy) using Physician's Current Procedural Terminology codes. RESULTS: We identified 3672 Medicaid-insured women and 6023 commercially insured women with stillbirths in 2013. Approximately, 61.7% of Medicaid-insured women and 66.0% of commercially insured women had claims data indicating prenatal syphilis testing. At the time of stillbirth, Medicaid-insured and commercially insured women had similar rates of syphilis testing (6.5% vs 9.3%), placental examination (61.6% vs 57.8%), and complete blood count (31.9% vs 37.6%). Autopsies were too infrequent to be reported. Approximately, 34.6% of Medicaid-insured women and 29.7% of commercially insured women had no syphilis testing either prenatally or at the time of stillbirth. CONCLUSIONS: Syphilis testing among women after stillbirth was less than 10%, illustrating limited adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommendations. Such low prenatal and delivery syphilis testing rates may impact the number of stillbirth cases identified as congenital syphilis cases and reported to the national surveillance system. Our results emphasize the need to improve syphilis testing to improve diagnosis of syphilitic stillbirths, identify women with syphilis infection, and provide treatment to these women to avoid syphilis-related adverse outcomes.

Impact of Post-visit Contact on Emergency Department Utilization for Adolescent Women with a Sexually Transmitted Infection.

STUDY OBJECTIVES: To understand Emergency Department (ED) utilization patterns for women who received sexually transmitted infection (STI) testing and explore the impact of post-visit telephone contact on future ED visits. DESIGN, SETTING, PARTICIPANTS: We performed a secondary analysis on a prospectively collected dataset of ED patients ages 14-21 years at a children's hospital. INTERVENTIONS AND MAIN OUTCOME MEASURES: The dataset documented initial and return visits, STI results, race, age and post-visit contact success (telephone contact ≤7 days of visit). Logistic regression was performed identifying variables that predicted a return visit to the ED, a return visit with STI testing, and subsequent positive STI results. RESULTS: Of 922 women with STI testing at their initial ED visit, 216 (23%) were STI positive. One-third (315/922) returned to the ED, 15% (141/922) returned and had STI testing, and 4% (38/922) had a subsequent STI. Of 216 STI-positive women, 59% were successfully contacted. Of those who returned to the ED, age ≥ 18 and Black race were associated with increased STI testing at a subsequent visit. Successful contact reduced the likelihood of STI testing at a subsequent ED visit (OR 0.28, 95% CI 0.01-0.8), and ED empiric antibiotic treatment had no effect on subsequent STI testing. CONCLUSION: Contacting women with STI results and counseling them regarding safe sex behaviors may reduce the number of ED patients who return with symptoms or a new exposure necessitating STI testing. The high STI prevalence and frequent return rate suggest that ED interventions are needed.

Adolescent patient preferences surrounding partner notification and treatment for sexually transmitted infections.

OBJECTIVES: Important barriers to addressing the sexually transmitted infection (STI) epidemic among adolescents are the inadequate partner notification of positive STI results and insufficient rates of partner testing and treatment. However, adolescent attitudes regarding partner notification and treatment are not well understood. The aim was to qualitatively explore the barriers to and preferences for partner notification and treatment among adolescent males and females tested for STIs in an emergency department (ED) setting and to explore the acceptability of ED personnel notifying their sexual partners. METHODS: This was a descriptive, qualitative study in which a convenience sample of 40 adolescents (18 females, 22 males) 14 to 21 years of age who presented to either adult or pediatric EDs with STI-related complaints participated. Individualized, semistructured, confidential interviews were administered to each participant. Interviews were audiotaped and transcribed verbatim by an independent transcriptionist. Data were analyzed using framework analysis. RESULTS: Barriers to partner notification included fear of retaliation or loss of the relationship, lack of understanding of or concern for the consequences associated with an STI, and social stigma and embarrassment. Participants reported two primary barriers to their partners obtaining STI testing and treatment: lack of transportation to the health care site and the partner's fear of STI positive test results. Most participants preferred to notify their main sexual partners of an STI exposure via a face-to-face interaction or a phone call. Most participants were agreeable with a health care provider (HCP) notifying their main sexual partners of STI exposure and preferred that the HCP notify the partner by phone call. CONCLUSIONS: There are several adolescent preferences and barriers for partner notification and treatment. To be most effective, future interventions to prevent adolescent STIs should incorporate these preferences and address the barriers to partner notification. In an ED setting, using HCPs to provide partner notification of STI exposures is acceptable to adolescent patients; however, the feasibility of this type of program needs further exploration.

Improving sexually transmitted infection results notification via mobile phone technology.

PURPOSE: To improve adolescent notification of positive sexually transmitted infection (STI) tests using mobile phone technology and STI information cards. METHODS: A randomized intervention among 14- to 21-year olds in a pediatric emergency department (PED). A 2 × 3 factorial design with replication was used to evaluate the effectiveness of six combinations of two factors on the proportion of STI-positive adolescents notified within 7 days of testing. Independent factors included method of notification (call, text message, or call + text message) and provision of an STI information card with or without a phone number to obtain results. Covariates for logistic regression included age, empiric STI treatment, days until first attempted notification, and documentation of confidential phone number. RESULTS: Approximately half of the 383 females and 201 males enrolled were ≥18 years of age. Texting only or type of card was not significantly associated with patient notification rates, and there was no significant interaction between card and notification method. For females, successful notification was significantly greater for call + text message (odds ratio, 3.2; 95% confidence interval, 1.4-6.9), and documenting a confidential phone number was independently associated with successful notification (odds ratio, 3.6; 95% confidence interval, 1.7-7.5). We found no significant predictors of successful notification for males. Of patients with a documented confidential phone number who received a call + text message, 94% of females and 83% of males were successfully notified. CONCLUSIONS: Obtaining a confidential phone number and using call + text message improved STI notification rates among female but not male adolescents in a pediatric emergency department.

Point-of-care tests for sexually transmissible infections: what do 'end users' want?

BACKGROUND: Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. METHODS: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. RESULTS: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. CONCLUSIONS: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.

Blind evaluation of the microwave-accelerated metal-enhanced fluorescence ultrarapid and sensitive Chlamydia trachomatis test by use of clinical samples.

Accurate point-of-care (POC) diagnostic tests for Chlamydia trachomatis infection are urgently needed for the rapid treatment of patients. In a blind comparative study, we evaluated microwave-accelerated metal-enhanced fluorescence (MAMEF) assays for ultrafast and sensitive detection of C. trachomatis DNA from vaginal swabs. The results of two distinct MAMEF assays were compared to those of nucleic acid amplification tests (NAATs). The first assay targeted the C. trachomatis 16S rRNA gene, and the second assay targeted the C. trachomatis cryptic plasmid. Using pure C. trachomatis, the MAMEF assays detected as few as 10 inclusion-forming units/ml of C. trachomatis in less than 9 min, including DNA extraction and detection. A total of 257 dry vaginal swabs from 245 female adolescents aged 14 to 22 years were analyzed. Swabs were eluted with water, the solutions were lysed to release and to fragment genomic DNA, and MAMEF-based DNA detection was performed. The prevalence of C. trachomatis by NAATs was 17.5%. Of the 45 samples that were C. trachomatis positive and the 212 samples that were C. trachomatis negative by NAATs, 33/45 and 197/212 were correctly identified by the MAMEF assays if both assays were required to be positive (sensitivity, 73.3%; specificity, 92.9%). Using the plasmid-based assay alone, 37/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 82.2%; specificity, 92.9%). Using the 16S rRNA assay alone, 34/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 75.5%; specificity, 92.9%). The overall rates of agreement with NAAT results for the individual 16S rRNA and cryptic plasmid assays were 89.5% and 91.0%, respectively. Given the sensitivity, specificity, and rapid detection of the plasmid-based assay, the plasmid-based MAMEF assay appears to be suited for clinical POC testing.

Point-of-care testing improves accuracy of STI care in an emergency department.

OBJECTIVES: We aimed to examine the impact of a point-of-care (POC) test on overtreatment and undertreatment of sexually transmitted infections (STIs) by comparing treatment patterns for gonorrhoea (detected with nucleic acid amplification testing (NAAT)) with trichomoniasis (detected by POC test) for young women seen in an emergency department (ED). METHODS: We reviewed the database of a quality improvement (QI) project that aims to improve follow-up care for STIs in the ED. Data included the test result and antibiotic given (if any) during visits by women age 14-21 for whom an STI test was ordered. We generated Shewhart control charts and compared overtreatment and undertreatment rates for gonorrhoea and trichomoniasis using χ(2) testing. RESULTS: Of 1877 visits over 18 months, 8.8% of women had gonorrhoea and 16.5% had trichomoniasis. Overtreatment was higher for women with gonorrhoea than trichomoniasis (54% vs 23%, p<0.001). Overtreatment for gonorrhoea decreased from 58% to 47% (p<0.01) and overtreatment for trichomoniasis decreased from 24% to 18% (p<0.01), which corresponded to improvements in patient follow-up for the QI project. Undertreatment was higher for women with gonorrhoea than trichomoniasis (29% vs 21%, p=0.03), and did not change over time. CONCLUSIONS: A POC test improves the accuracy of STI care in an ED compared with NAAT testing. An unanticipated benefit of QI efforts to improve patient follow-up is the observed decrease in antibiotic use in the ED. Given the ability of gonorrhoea to develop antibiotic resistance, future efforts should focus on development of an accurate POC test for gonorrhoea.

Gynecologic knowledge is low in college men and women.

STUDY OBJECTIVE: Although men may influence women's reproductive choices, little is known about men's knowledge regarding gynecologic matters (eg, sex, anatomy, and contraception). This study aimed to evaluate the level of gynecologic knowledge among college students, particularly to investigate the differences in knowledge between men and women. DESIGN, SETTING, PARTICIPANTS: We administered a survey to assess knowledge of sex, contraception, and female anatomy to college students at a Midwestern university during the spring 2010 semester. INTERVENTIONS AND MAIN OUTCOME MEASURES: The survey included demographic and behavioral questions, 9 general gynecology knowledge items, and 11 female anatomy items. A total gynecology score was generated by summing the correct responses to 20 items. RESULTS: The 236 respondents included 98 men and 138 women (aged 18-36 years). Women scored higher than men on 19 of 20 individual items, with mean total scores of 13.4 vs 10.1 (P < .01). There was a trend for gynecologic knowledge to be higher among those who reported having had been STI tested (P = .13), and whose parents had discussed anatomy with them (P = .07). In multivariable modeling, being male was associated with lower mean knowledge scores, whereas increasing age and having a parent who discussed anatomy were associated with greater knowledge scores, even while controlling for having a gynecologist parent, multiple sexual partners, and prior STI testing. CONCLUSIONS: College men have lower gynecologic knowledge than women. Increasing age and having a parent who discussed anatomy with them served as predictors of higher knowledge scores. Because men influence women's reproductive choices, efforts to increase men's knowledge are needed.

Clinical evidence for the role of Trichomonas vaginalis in regulation of secretory leukocyte protease inhibitor in the female genital tract.

BACKGROUND: Secretory leukocyte protease inhibitor (SLPI) is responsible for regulating inflammatory damage to and innate and adaptive immune responses in the vaginal mucosa. Depressed cervicovaginal SLPI levels have been correlated with both Trichomonas vaginalis infection and poor reproductive health outcomes. METHODS: We measured levels of SLPI in 215 vaginal specimens collected from adolescent and young adult females aged 14-22 years. Log-transformed SLPI values were compared by analysis of variance or by an unpaired t test before and after adjustment for confounding effects through the propensity score method. RESULTS: Females receiving hormonal contraceptives and those with an abnormal vaginal pH had lower SLPI levels as compared to their peers. After propensity score adjustment for race, behavioral factors, hormonal use, and other sexually transmitted infections (STIs), SLPI levels were lower in females with a positive T. vaginalis antigen test result, a vaginal pH >4.5, vaginal leukocytosis, and recurrent (vs initial) T. vaginalis infection, with the lowest levels observed in those with the highest T. vaginalis loads. CONCLUSIONS: The SLPI level was reduced by >50% in a T. vaginalis load-dependent manner. Future research should consider whether identifying and treating females with low levels of T. vaginalis infection (before they become wet mount positive) would prevent the loss of SLPI and impaired vaginal immunity. The SLPI level could be used as a vaginal-health marker to evaluate interventions and vaginal products.

Abnormal vaginal pH and Mycoplasma genitalium infection.

STUDY OBJECTIVE: Mycoplasma genitalium (MG) is a sexually transmitted pathogen linked to female morbidity, but testing for MG is not standardized. We aimed to determine which point-of-care (POC) vaginal tests could predict MG infection. DESIGN, SETTING, PARTICIPANTS: A cross sectional study recruited sexually active adolescent women, aged 14-22 y (n = 217) from an urban medical center. INTERVENTIONS AND MAIN OUTCOME MEASURES: Vaginal swabs were POC tested for pH, amines, clue cells, sialidase, and Trichomonas vaginalis (TV). MG was detected by research-use-only transcription mediated amplification (TMA) assay. Presence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) were confirmed using TMA. Three criteria were required for diagnosis of clinical BV: pH > 4.5, presence of amines, and >20% clue cells. Associations were assessed using logistic regression (LR). RESULTS: TMA detected MG in 30 (14%), CT in 49 (23%), and NG in 21 (10%) of the samples tested. POC vaginal tests were positive for TV in 21%, amines in 52%, clue cells in 33%, sialidase in 22%, pH > 4.5 in 56%, and clinical BV in 19% of the samples tested. Using LR, pH > 4.5 was a predictor of MG (odds ratio 4.4, P < .05). Of 131 women without clinical BV or TV, 25% of those with pH > 4.5 had MG, compared to 9% of those with pH ≤ 4.5 (P = .02). CONCLUSIONS: Until standardized, approved testing for MG is available, pH may be a useful indicator to suspect MG, especially in the absence of BV and TV.

Accuracy and trust of self-testing for bacterial vaginosis.

PURPOSE: Two point-of-care tests are available to detect bacterial vaginosis (BV), a common vaginal condition. This study aimed to (1) compare the accuracy of two self-performed BV tests with clinician-performed BV tests and with clinical diagnosis of BV; and (2) compare trust of results for self-performed BV testing with clinician-performed BV testing. METHODS: Participants (14-22 years old) in a study assessing self-testing for Trichomonas vaginalis were also asked to perform a self-test for BV (using a pH or sialidase test). Results were compared with clinician-performed tests and with clinical diagnosis of BV (defined by modified Amsel criteria). A two-item subscale from a larger acceptability scale was used to assess trust at baseline, after testing, and after discussion of results. RESULTS: All 131 women performed self-BV testing correctly. Agreement between self- and clinician-performed tests was good (κ: .5-.7) Compared with clinical diagnosis of BV, self-pH was 73% sensitive and 67% specific, and self-sialidase was 40% sensitive and 90% specific. Trust in self-performed BV testing was lower than trust in clinician-performed BV testing at baseline, but increased after testing and discussion of results. CONCLUSIONS: Young women can perform self-tests for BV with reasonable accuracy, which could increase testing when pelvic examinations are not feasible. Trust in self-testing increased after experience and after discussion of test results. Although the pH test is available over the counter, young women may continue to rely on clinicians for testing.

Improving notification of sexually transmitted infections: a quality improvement project and planned experiment.

BACKGROUND AND OBJECTIVE: Inadequate follow-up of positive sexually transmitted infection (STI) test results is a gap in health care quality that contributes to the epidemic of STIs in adolescent women. The goal of this study was to improve our ability to contact adolescent women with positive STI test results after an emergency department visit. METHODS: We conducted an interventional quality improvement project at a pediatric emergency department. Phase 1 included plan-do-study-act cycles to test interventions such as provider education and system changes. Phase 2 was a planned experiment studying 2 interventions (study cell phone and patient activation card), using a 2 × 2 factorial design with 1 background variable and 2 replications. Outcomes were: (1) the proportion of women aged 14 to 21 years with STI testing whose confidential telephone number was documented in the electronic medical record; (2) the proportion of STI positive women successfully contacted within 7 days. RESULTS: Phase 1 interventions increased the proportion of records with a confidential number from 24% to 58% and the proportion contacted from 45% to 65%, and decreased loss to follow-up from 40% to 24%. In phase 2, the proportion contacted decreased after the electronic medical record system changed and recording of the confidential number decreased. Study interventions (patient activation card and study cell phone) had a synergistic effect on successful contact, especially when confidential numbers were less reliably documented. CONCLUSIONS: Feasible and sustainable interventions such as improved documentation of a confidential number worked synergistically to increase our ability to successfully contact adolescent women with their STI test results.

Low prevalence of Chlamydia trachomatis infection in non-urban pregnant women in Vellore, S. India.

OBJECTIVE: To determine the prevalence and risk factors for Chlamydia trachomatis (CT) infection in pregnant women and the rate of transmission of CT to infants. METHODS: Pregnant women (≥28 weeks gestation) in Vellore, South India were approached for enrollment from April 2009 to January 2010. After informed consent was obtained, women completed a socio-demographic, prenatal, and sexual history questionnaire. Endocervical samples collected at delivery were examined for CT by a rapid enzyme test and nucleic acid amplification test (NAAT). Neonatal nasopharyngeal and conjunctival swabs were collected for NAAT testing. RESULTS: Overall, 1198 women were enrolled and 799 (67%) endocervical samples were collected at birth. Analyses were completed on 784 participants with available rapid and NAAT results. The mean age of women was 25.8 years (range 18-39 yrs) and 22% (95% CI: 19.7-24.4%) were primigravida. All women enrolled were married; one reported >one sexual partner; and six reported prior STI. We found 71 positive rapid CT tests and 1/784 (0.1%; 95% CI: 0-0.38%) true positive CT infection using NAAT. CONCLUSIONS: To our knowledge, this is the largest study on CT prevalence amongst healthy pregnant mothers in southern India, and it documents a very low prevalence with NAAT. Many false positive results were noted using the rapid test. These data suggest that universal CT screening is not indicated in this population.

MRSA: rare in the vagina.

STUDY OBJECTIVE: To determine the prevalence of vaginal Staphylococcus aureus and methicillin-resistant S. aureus (MRSA) in sexually active adolescent women. DESIGN: A prospective surveillance study. PARTICIPANTS: Patients included 315 sexually active young women (ages 13-24) undergoing routine pelvic examination and wet mount testing in an urban teen health center. MAIN OUTCOME MEASURES: Prevalence of vaginal S. aureus and MRSA. RESULTS: S. aureus was present in 16 samples for a point estimate of 5.1% (95% CI: 2.6%-7.5%). MRSA was detected in two samples, giving a vaginal prevalence estimate of 0.6% (95% CI: 0.0% -1.5%). No differences were detected in the prevalence of S. aureus by age or race, although no cases of S. aureus were observed in those under age 15. CONCLUSION: The prevalence of MRSA in a sample of sexually active adolescents was as rare as reported in other populations. It is unlikely that vaginal MRSA is a reservoir for community acquired infections.

Acceptability of self-testing for trichomoniasis increases with experience.

OBJECTIVES: Self-testing and point-of-care (POC) tests could improve the detection of sexually transmitted infections (STIs) in adolescents. This study aimed to (1) validate a scale measuring acceptability of self-testing for trichomoniasis, (2) compare acceptability of self versus clinician testing using a POC test for trichomoniasis, (3) examine changes in acceptability after experience and review of results, and (4) examine predictors of acceptability. METHODS: Women (14-22 years old) performed the POC test and completed surveys assessing acceptability of self and clinician testing at baseline, after testing, and after discussion of results. Factor analysis examined scale structure; changes in mean scale scores were assessed with mixed models. Generalised linear models examined predictors of acceptability. RESULTS: Of 247 participants, 54 (22%) had a positive POC test for trichomoniasis. Factor analysis confirmed four acceptability subscales: trust of results, confidence, comfort, and effects of testing. At baseline, trust and confidence were higher, and comfort was lower, for clinician versus self testing. For self-testing, all subscale scores increased from baseline to after testing, and trust increased from after testing to after discussion. Trust of self and clinician results was not significantly different after discussion. A positive attitude towards home testing predicted higher self-test acceptability on all subscales. Tampon use was associated with increased self-test comfort at baseline. Concordance between self and clinician results predicted increased trust of self testing after discussion. CONCLUSIONS: Many young women lack confidence in their ability to self-test for trichomoniasis. Allowing women to try a POC test and review the results with a clinician increases acceptability of self-testing.

Biomarkers to distinguish surgical etiologies in females with lower quadrant abdominal pain.

OBJECTIVES: Lower abdominal pain is a common complaint in girls and young women presenting to a pediatric emergency department (PED). An extensive evaluation may be required to exclude surgical emergencies such as appendicitis and ovarian torsion. However, clinicians and families prefer to limit invasive procedures and radiation exposure. The literature suggests that serum biomarkers such as the cytokine interleukin-6 (IL-6) can predict ovarian torsion in adults, while the membrane glycoprotein cluster of differentiation-64 (CD64) has been linked with bacterial infections and sepsis. Therefore, the study objective was to assess whether plasma IL-6 or neutrophil CD64 surface levels would assist clinicians in distinguishing surgical diagnoses (ovarian torsion and appendicitis) from nonsurgical diagnoses in young females with lower abdominal pain. METHODS: This study was a prospective, cross-sectional, pilot study of young females presenting with lower abdominal pain. Demographics, clinical and laboratory data, and final diagnoses were recorded. Plasma IL-6 and neutrophil CD64 were quantified. Nonparametric Kruskal-Wallis test was used to detect significant differences in IL-6 and CD64 values between surgical and nonsurgical patients. Further analysis was done to detect differences among the surgical patients (appendicitis vs. ovarian torsion). A bivariate analysis using the Wilcoxon rank sum was used to test for significant differences in IL-6 and CD64 by selected clinical factors. RESULTS: There were 112 female subjects ages 6 to 21 years enrolled. Final diagnoses were grouped as appendicitis (n = 38, 34%), ovarian torsion (n = 15, 13%), and nonsurgical (n = 59, 53%). Surgical cases had significantly higher levels of IL-6 compared to nonsurgical cases (p < 0.0001), and appendicitis patients had significantly higher CD64 indexes compared to ovarian torsion patients (p = 0.007). The clinical characteristics of fever of ≥38°C (p = 0.0002) and constant pain (p = 0.02) were significantly associated with elevated IL-6. Fever of ≥38°C (p = 0.02) was significantly associated with a higher CD64 index. CONCLUSIONS: Interleukin-6 was significantly elevated in surgical patients compared to nonsurgical patients in this sample of young females, and CD64 was significantly elevated in appendicitis patients compared to ovarian torsion patients. These data suggest that with larger sample sizes and future confirmatory studies, these biomarkers may be useful in the evaluation of young women with lower quadrant abdominal pain.

Using a rapid communication approach to improve a POC Chlamydia test.

Chlamydia trachomatis is a common sexually transmitted infection in young women. Available point-of-care (POC) diagnostic tests perform poorly, but development of new devices can be costly and time consuming. We explored the feasibility (user friendliness) and test characteristics (sensitivity and specificity) of a new prototype device to detect Chlamydia in adolescent women by using small numbers of subjects and rapid communication with the manufacturer. We compared cervical POC test results to the gold standard (cervical nucleic acid amplification testing). We also assessed the accuracy of the POC test on self-collected vaginal swabs by comparing results to cervical nucleic acid amplification test and to the cervical POC test. We frequently reviewed user experience and test results with the manufacturer. The results showed the feasibility and accuracy of the device. Feasibility--initial device malfunctions were identified and corrected. This device would be easy to use in a nonclinical setting, as it is self-contained and the color change for some specimens was dramatic and immediate. Accuracy--initial prototypes demonstrated low sensitivities (38%) for vaginal and cervical swabs. After feedback, the company developed new prototypes with improved sensitivity (80%). However, the increased sensitivity was accompanied by a high percentage of indeterminate results and false positives that lowered specificity.

Adolescent Sexually Transmitted Infections: A Community Epidemic.

Women under 25 years of age have higher rates of sexually transmitted infections (STIs) than other populations. Providing follow-up for adolescents with an STI is especially challenging in emergency departments (EDs). In our ED, we discovered that a significant number of adolescents with an STI did not receive adequate treatment, and 25% of those with an STI who were treated remained unaware of their infection. These deviations from ideal care are problematic because adolescents with untreated STIs are at risk for pelvic inflammatory disease and infertility. Those who were treated but unaware of their infection are unable to take steps to avoid re-infection, including partner treatment. We hypothesized that an improved system to handle STI test results would reduce the burden on ED staff and increase the proportion of adolescents receiving appropriate follow-up. This intervention has the potential to significantly address the STI epidemic in our community.