Patient preferences for HIV service delivery models; a Discrete Choice Experiment in Kisumu, Kenya.

Novel "differentiated service delivery" models for HIV treatment that reduce clinic visit frequency, minimize waiting time, and deliver treatment in the community promise retention improvement for HIV treatment in Sub-Saharan Africa. Quantitative assessments of differentiated service delivery (DSD) feature most preferred by patient populations do not widely exist but could inform selection and prioritization of different DSD models. We used a discrete choice experiment (DCE) to elicit patient preferences of HIV treatment services and how they differ across DSD models. We surveyed 18+year-olds, enrolled in HIV care for ≥6 months between February-March, 2019 at four facilities in Kisumu County, Kenya. DCE offered patients a series of comparisons between three treatment models, each varying across seven attributes: ART refill location, quantity of dispensed ART at each refill, medication pick-up hours, type of adherence support, clinical visit frequency, staff attitude, and professional cadre of person providing ART refills. We used hierarchical Bayesian model to estimate attribute importance and relative desirability of care characteristics, latent class analysis (LCA) for groups of preferences and mixed logit model for willingness to trade analysis. Of 242 patients, 128 (53.8%) were females and 150 (62.8%) lived in rural areas. Patients placed greatest importance on ART refill location [19.5% (95% CI 18.4, 10.6) and adherence support [19.5% (95% CI 18.17, 20.3)], followed by staff attitude [16.1% (95% CI 15.1, 17.2)]. In the mixed logit, patients preferred nice attitude of staff (coefficient = 1.60), refill ART health center (Coeff = 1.58) and individual adherence support (Coeff = 1.54), 3 or 6 months for ART refill (Coeff = 0.95 and 0.80, respectively) and pharmacists (instead of lay health workers) providing ART refill (Coeff = 0.64). No differences were observed by gender or urbanicity. LCA revealed two distinct groups (59.5% vs. 40.5%). Participants preferred 3 to 6-month refill interval or clinic visit spacing, which DSD offers stable patients. While DSD has encouraged community ART group options, our results suggest strong preferences for ART refills from health-centers or pharmacists over lay-caregivers or community members. These preferences held across gender&urban/rural subpopulations.

Implementing a digital system for contact tracing and case investigation during COVID-19 pandemic in San Francisco: a qualitative study.

During the COVID-19 pandemic, many health jurisdictions deployed digital informatics systems to support "manual" case investigation and contact tracing (CICT). This case study evaluates the implementation and use of a digital information system through the experiences of CICT workers in the City and County of San Francisco (CCSF). We conducted semi-structured, 90-min interviews with a sample of the CCSF CICT workforce (n = 37). Participants also completed standardized assessments of the digital system using the System Usability Scale (SUS). Qualitative analyses highlighted (1) the importance of digital tools to ensure rapid onboarding and effective data capture in a public health emergency; (2) the use of digital systems to support culturally sensitive care; and (3) the role of digitals tools in building supportive work environments. The mean SUS score was 70/100 (SD = 17), indicating relative ease of use. In summary, the analysis highlights the importance of digital tools to support manual CICT in the COVID-19 response.

Chain Peer Referral Approach for HIV Testing Among Adolescents in Kisumu County, Kenya.

New HIV infections among adolescents continues to be a large public health burden in sub-Saharan Africa, with few adolescents accessing HIV testing and counseling (HTC) services. We evaluated the effect of a peer referral program among adolescents in Kisumu county, Kenya in accessing HTC. Female adolescents aged 15 to 19 years were recruited from three health clinics in Kisumu County. They, in turn, recruited their peers for HTC by handing out referral cards. Referrals would then recruit their peers and this peer-referral repeated for approximately 5 months. The 252 female index seeds showed a relatively higher-risk profile for HIV compared to the 792 referral participants. The referral system yielded an increased proportion of first-time adolescent testers from 13.1% among index seeds to 42.7% among the second wave of referrals. However, the peer referral system ultimately did not increase the absolute number of adolescents Queryaccessing HTC. Future strategies should consider these findings to better target those with undiagnosed HIV infection.

Perspectives of women participating in a cervical cancer screening campaign with community-based HPV self-sampling in rural western Kenya: a qualitative study.

BACKGROUND: Despite cervical cancer being preventable with effective screening programs, it is the most common cancer and the leading cause of cancer-related death among women in many countries in Africa. Screening involving pelvic examination may not be feasible or acceptable in limited-resource settings. We sought to evaluate women's perspectives on human papillomavirus (HPV) self-sampling as part of a larger trial on cervical cancer prevention implementation strategies in rural western Kenya. METHODS: We invited 120 women participating in a cluster randomized trial of cervical cancer screening implementation strategies in Migori County, Kenya for in-depth interviews. We explored reasons for testing, experience with and ability to complete HPV self-sampling, importance of clinician involvement during screening, factors and people contributing to screening decision-making, and ways to encourage other women to come for screening. We used validated theoretical frameworks to analyze the qualitative data. RESULTS: Women reported having positive experiences with the HPV self-sampling strategy. The factors facilitating uptake included knowledge and beliefs such as prior awareness of HPV, personal perception of cervical cancer risk, desire for improved health outcomes, and peer and partner encouragement. Logistical and screening facilitators included confidence in the ability to complete HPV self-sampling strategy, proximity to screening sites and feelings of privacy and comfort conducting the HPV self- sampling. The barriers to screening included fear of need for a pelvic exam, fear of disease and death associated with cervical cancer. We classified these findings as capabilities, opportunities and motivations for health behavior using the COM-B framework. CONCLUSIONS: Overall, HPV self-sampling was an acceptable cervical cancer screening strategy that seemed to meet the needs of the women in this community. These findings will further inform aspects of implementation, including outreach messaging, health education, screening sites and emphasis on availability and effectiveness of preventative treatment for women who screen positive.

Women's Preferences Regarding the Processes and Outcomes of Trial of Labor After Cesarean and Elective Repeat Cesarean Delivery.

Background: The decrease in trial of labor after cesarean (TOLAC) at institutions that offer this option suggests that patient preference could be a factor in the declining TOLAC rate. However, data regarding how women value the potential processes and outcomes of TOLAC and elective repeat cesarean delivery (ERCD) are limited. We sought to determine how women view the processes and outcomes of TOLAC and ERCD and identify sociodemographic and clinical factors associated with these preferences. Materials and Methods: This is a multicenter cross-sectional study of mode of delivery preferences among TOLAC-eligible women at 26-34 weeks gestation. The time tradeoff metric was used to obtain utilities for the processes and outcomes of TOLAC and ERCD. Multivariable regression analysis was utilized to identify independent predictors of utilities. Results: The 299 study participants constituted a geographically and racially/ethnically diverse group. Although uncomplicated TOLAC resulting in vaginal birth after cesarean and uncomplicated ERCD resulted in high utility values, any alteration in either the process or outcome resulted in substantial utility decrements. In multivariable regression analysis, race/ethnicity, insurance status, and order of scenario presentation emerged as statistically significant predictors. Conclusions: Information regarding both maternal and infant implications is important to women in discussions about approach to delivery. Both the way in which information regarding labor interventions and potential complications is presented and the characteristics of the women contemplating this information affect its impact. These findings underscore the need for evidence-based decision support to help create realistic expectations and incorporate informed patient preferences into decision-making to optimize both clinical outcomes and individual patient experience for women with a prior cesarean delivery.

Retention and viral suppression of newly diagnosed and known HIV positive pregnant women on Option B+ in Western Kenya.

Kenya introduced universal antiretroviral treatment (ART) for pregnant and breastfeeding women living with HIV (Option B+) in 2014. A retrospective study was conducted to review consecutive records for HIV positive pregnant women presenting for antenatal care (ANC) at five clinics in western Kenya. Known positive women (KP :HIV diagnosis prior to current pregnancy) were compared to newly positive (NP) women regarding virologic suppression and retention in care. Among 165 women included, 71 (43%) NP and 94 (57%) KP, NP were younger (24.5 years (SD 4.6) vs. 28.1 years (SD 5.6) compared to KP (p < .001). Almost all NP (97%) were initiated on Option B+ while over half of KP (59%) started ART for clinical/immunological criteria (p < .0001). KPs were more likely than NPs to have a VL performed following Kenyan guidelines (64% vs. 31%; p < .001). Among those tested, virologic suppression was high in both groups (92% KP vs. 100% NP; p = .31). More KPs (82%) vs. NPs (66%) remained active in care at 15-18 months of follow-up (p = .02). Women newly diagnosed with HIV during pregnancy show poorer uptake of VL testing and worse retention in care than those diagnosed prior to pregnancy.

Effect of professional society recommendations on women's desire for a routine pelvic examination.

BACKGROUND: The American College of Physicians strongly recommends against performing pelvic examinations in asymptomatic, nonpregnant women, citing evidence of harm (false-positive testing, unnecessary surgery) and no evidence of benefit. In contrast, the American Congress of Obstetricians and Gynecologists recommends pelvic examinations in asymptomatic women beginning at age 21 years, citing expert opinion. OBJECTIVE: We sought to evaluate if providing women with professional societies' conflicting statements about pelvic examinations (recommendations and rationales) would influence their desire for a routine examination. STUDY DESIGN: We recruited 452 women ages 21-65 years from 2 women's clinics to participate in a 50-minute face-to-face interview about cervical cancer screening that included a 2-phase study related to pelvic examinations. In the first phase, 262 women were asked about their desire for the examination without being provided information about professional societies' recommendations. In the second phase, 190 women were randomized to review summaries of the American College of Physicians or American Congress of Obstetricians and Gynecologists statement followed by an interview. RESULTS: First-phase participants served as the referent: 79% (208/262) indicated they would want a routine examination if given a choice. In the second phase, a similar percentage of women randomized to the American Congress of Obstetricians and Gynecologists summary had this desire (82%: 80/97; adjusted odds ratio, 1.37; 95% confidence interval, 0.69-2.70). Women randomized to the American College of Physicians summary, however, were less likely to indicate they would opt for an examination (39%: 36/93; adjusted odds ratio, 0.12; 95% confidence interval, 0.06-0.21). Overall, 94% (179/190) believed the potential benefits and harms should be discussed prior to the examination. CONCLUSION: Providing women with a professional society's recommendation advising against routine pelvic examinations substantially reduced their desire to have one. Educational materials are needed to ensure women's informed preferences and values are reflected in decisions about pelvic examinations.

Women's beliefs about the purpose and value of routine pelvic examinations.

BACKGROUND: The American Congress of Obstetricians and Gynecologists recommends that a pelvic examination be offered to asymptomatic women after an informed discussion with their provider. Although the adverse health outcomes that the examination averts were not delineated, the organization stated that it helps establish open communication between patients and physicians. Recent surveys have focused on obstetrician-gynecologists' attitudes and beliefs about the examination, but the perspectives of women have not been well-characterized. OBJECTIVE: The purpose of this study was to better understand women's beliefs about the purpose and value of routine pelvic examinations. STUDY DESIGN: We completed structured interviews with 262 women who were 21-65 years old who agreed to participate in a 50-minute interview about cervical cancer screening. Recruitment took place in outpatient women's clinics at a public hospital and an academic medical center in San Francisco, CA. Women were shown an illustration of a bimanual pelvic examination and asked a series of closed-ended questions: if they knew why it was performed, if it reassured them of their health, and if they believed it helped establish open communication with their provider. Women were asked an open-ended question about their perception of the examination's purpose. Multivariable logistic regression analysis was used to identify demographic predictors of responses. RESULTS: Approximately one-half of the participants (56%) stated that they knew the examination's purpose. The most frequently cited reason was assurance of normalcy. Most of participants (82%) believed that the examination reassured them of their health. Approximately two-thirds of the participants (62%) believed that the examination helps establish open communication with their provider. In multivariate analyses, older age (≥45 years) independently predicted a higher likelihood of a belief that they knew the examination's purpose (odds ratio, 2.9; 95% confidence interval, 1.5-5.6) and a belief that it facilitates open communication (odds ratio, 2.1; 95% confidence interval, 1.1-3.9). Non-white race also was associated with a belief that the examination helps facilitate open communication between patients and providers (odds ratio, 1.9; 95% confidence interval, 1.1-3.1). CONCLUSION: Approximately one-half of the women who participated in our study reported not knowing the purpose of the pelvic examination, yet most of them believed it to be of some value, especially reassurance of health. To achieve shared, informed decision-making, clinicians will need to communicate better to their patients the examination's purpose.

The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor.

OBJECTIVE: To identify predictors of hysterotomy extension in women undergoing cesarean delivery (CD) in the second stage of labor, and whether use of nitroglycerin (NTG) during CD has a protective effect. METHODS: We conducted a retrospective cohort study of women undergoing CD in the second stage of labor from 2012 to 2015. Some women received NTG at the obstetrician's request. Logistic regression was used to examine the relationship between second stage duration and NTG administration on maternal and neonatal outcomes. RESULTS: Of the 391 women in the sample, 27% had an extension and 12% received NTG. Second stage ≥4 h was associated with a 2.14-fold higher risk of extension (95% CI 1.22-3.75), a 2.00-fold higher risk of hemorrhage (95% CI: 1.20-3.33) and 2.42-fold higher risk of blood transfusion during delivery hospitalization (95% CI: 0.99-5.91). Intravenous (IV) and sublingual-spray (SL-spray) NTG administration were not associated with an increased risk of hemorrhage or extension. SL-NTG was associated with 4.68-fold increased odds of 5-min Apgar <7 (95% CI 1.42-15.41) and 3.36-fold greater odds of NICU admission (95% CI 1.20-9.41). CONCLUSION: We found no evidence that NTG protects against extension, and SL-NTG use was associated with adverse neonatal outcomes. Clinical trials should be conducted to evaluate risk and benefits of NTG use.

Emergency Department Imaging Modality Effect on Surgical Management of Nephrolithiasis: A Multicenter, Randomized Clinical Trial.

PURPOSE: In the emergency department ultrasonography is emerging as an alternative to computerized tomography for diagnosing patients with nephrolithiasis. In this multicenter randomized clinical trial we examined rates of urological referral and intervention to elucidate whether the initial diagnostic imaging modality affected the management of nephrolithiasis. MATERIALS AND METHODS: Patients 18 to 76 years old who presented to the emergency department with renal colic across 15 diverse treatment centers were randomized to receive abdominal ultrasonography by an emergency department physician or a radiologist, or abdominal computerized tomography. We analyzed the 90-day followup for patients diagnosed with nephrolithiasis to assess subsequent urological evaluation, procedure type and time to intervention. RESULTS: Of 1,666 patients diagnosed with nephrolithiasis in the emergency department 241 (14.5%) had a consultation with urology at initial presentation, 503 (30%) saw a urologist in followup and 192 (12%) underwent at least 1 urological procedure. Median time to outpatient procedure and type of procedure performed did not vary significantly among imaging groups. Most patients (78%) had computerized tomography performed before elective intervention. Patients with ultrasonography performed by an emergency department physician were 2.6 times more likely to undergo computerized tomography before intervention than those who had ultrasonography performed by a radiologist. CONCLUSIONS: Patients undergoing a urological intervention who had ultrasonography as initial imaging do not experience a significant delay to intervention or different procedure types, but the majority ultimately undergoes computerized tomography before surgery. Formal ultrasonography by a radiologist may encourage less computerized tomography preoperatively.

Predictors of CT Radiation Dose and Their Effect on Patient Care: A Comprehensive Analysis Using Automated Data.

Purpose To determine patient, vendor, and institutional factors that influence computed tomography (CT) radiation dose. Materials and Methods The relevant institutional review boards approved this HIPAA-compliant study, with waiver of informed consent. Volume CT dose index (CTDIvol) and effective dose in 274 124 head, chest, and abdominal CT examinations performed in adult patients at 12 facilities in 2013 were collected prospectively. Patient, vendor, and institutional characteristics that could be used to predict (a) median dose by using linear regression after log transformation of doses and (b) high-dose examinations (top 25% of dose within anatomic strata) by using modified Poisson regression were assessed. Results There was wide variation in dose within and across medical centers. For chest CTDIvol, overall median dose across all institutions was 11 mGy, and institutional median dose was 7-16 mGy. Models including patient, vendor, and institutional factors were good for prediction of median doses (R2 = 0.31-0.61). The specific institution where the examination was performed (reflecting the specific protocols used) accounted for a moderate to large proportion of dose variation. For chest CTDIvol, unadjusted median CTDIvol was 16.5 mGy at one institution and 6.7 mGy at another (adjusted relative median dose, 2.6 mGy [95% confidence interval: 2.5, 2.7]). Several variables were important predictors that a patient would undergo high-dose CT. These included patient size, the specific institution where CT was performed, and the use of multiphase scanning. For example, while 49% of patients (21 411 of 43 696) who underwent multiphase abdominal CT had a high-dose examination, 8% of patients (4977 of 62 212) who underwent single-phase CT had a high-dose examination (adjusted relative risk, 6.20 [95% CI: 6.17, 6.23]). If all patients had been examined with single-phase CT, 69% (18 208 of 26 388) of high-dose examinations would have been eliminated. Patient size, institutional-specific protocols, and multiphase scanning were the most important predictors of dose (change in R2 = 8%-32%), followed by manufacturer and iterative reconstruction (change in R2, 0.2%-15.0%). Conclusion CT doses vary considerably within and across facilities. The primary factors that influenced dose variation were multiphase scanning and institutional protocol choices. It is unknown if the variation in these factors influenced diagnostic accuracy. © RSNA, 2016.

The interaction between maternal race/ethnicity and chronic hypertension on preterm birth.

BACKGROUND: In both the biomedical and public health literature, the risk for preterm birth has been linked to maternal racial/ethnic background, in particular African-American heritage. Despite this well-documented health disparity, the relationship of comorbid conditions, such as chronic hypertension, to maternal race/ethnicity and preterm birth has received relatively limited attention in the literature. OBJECTIVE: The objective of the study was to evaluate the interaction between chronic hypertension and maternal racial/ethnic background on preterm birth. STUDY DESIGN: This is a retrospective cohort study of singleton pregnancies among women who delivered between 2002 and 2015 at the University of California, San Francisco. The associations of chronic hypertension with both spontaneous and medically indicated preterm birth were examined by univariate and multivariate logistical regression, adjusting for confounders including for maternal age, history of preterm birth, maternal body mass index, insurance type (public vs private), smoking, substance abuse, history of pregestational diabetes mellitus, and use of assisted reproductive technologies. The interaction effect of chronic hypertension and racial/ethnicity was also evaluated. All values are reported as odds ratios, with 95% confidence intervals and significance set at P = .05. RESULTS: In this cohort of 23,425 singleton pregnancies, 8.8% had preterm deliveries (3% were medically indicated preterm birth, whereas 5.5% were spontaneous preterm births), and 3.8% of women carried the diagnosis of chronic hypertension. Chronic hypertension was significantly associated with preterm birth in general (adjusted odds ratio, 2.74, P < .001) and medically indicated preterm birth specifically (adjusted odds ratio, 5.25, P < .001). When evaluating the effect of chronic hypertension within racial/ethnic groups, there was an increased odds of a preterm birth among hypertensive, African-American women (adjusted odds ratio, 3.91, P < .001) and hypertensive, Asian-American/Pacific Islander women (adjusted odds ratio, 3.51, P < .001) when compared with their nonhypertensive counterparts within the same racial/ethnic group. These significant effects were also noted with regard to medically indicated preterm birth for hypertensive African-American women (adjusted odds ratio, 6.85, P < .001) and Asian-American/Pacific Islander women (adjusted odds ratio, 9.87, P < .001). There was no significant association of chronic hypertension with spontaneous preterm birth (adjusted odds ratio, 0.87, P = .4). CONCLUSION: The effect of chronic hypertension on overall preterm birth and medically indicated preterm birth differs by racial/ethnic group. The larger effect of chronic hypertension among African-American and Asian/Pacific Islander women on medically indicated and total preterm birth rates raises the possibility of an independent variable that is not captured in the data analysis, although data regarding the indication for medically indicated preterm delivery was limited in this data set. Further investigation into both social-structural and biological predispositions to preterm birth should accompany research focusing on the effect of chronic hypertension on birth outcomes.

Cost Analysis of the STONE Randomized Trial: Can Health Care Costs be Reduced One Test at a Time?

BACKGROUND: Decreasing the use of high-cost tests may reduce health care costs. OBJECTIVE: To compare costs of care for patients presenting to the emergency department (ED) with suspected kidney stones randomized to 1 of 3 initial imaging tests. RESEARCH DESIGN: Patients were randomized to point-of-care ultrasound (POC US, least costly), radiology ultrasound (RAD US), or computed tomography (CT, most costly). Subsequent testing and treatment were the choice of the treating physician. SUBJECTS: A total of 2759 patients at 15 EDs were randomized to POC US (n=908), RAD US, (n=893), or CT (n=958). Mean age was 40.4 years; 51.8% were male. MEASURES: All medical care documented in the trial database in the 7 days following enrollment was abstracted and coded to estimate costs using national average 2012 Medicare reimbursements. Costs for initial ED care and total 7-day costs were compared using nonparametric bootstrap to account for clustering of patients within medical centers. RESULTS: Initial ED visit costs were modestly lower for patients assigned to RAD US: $423 ($411, $434) compared with patients assigned to CT: $448 ($438, $459) (P<0.0001). Total costs were not significantly different between groups: $1014 ($912, $1129) for POC US, $970 ($878, $1078) for RAD US, and $959 ($870, $1044) for CT. Hospital admissions contributed over 50% of total costs, though only 11% of patients were admitted. Mean total costs (and admission rates) varied substantially by site from $749 to $1239. CONCLUSIONS: Assignment to a less costly test had no impact on overall health care costs for ED patients. System-level interventions addressing variation in admission rates from the ED might have greater impact on costs.

External Validation of the STONE Score, a Clinical Prediction Rule for Ureteral Stone: An Observational Multi-institutional Study.

STUDY OBJECTIVE: The STONE score is a clinical decision rule that classifies patients with suspected nephrolithiasis into low-, moderate-, and high-score groups, with corresponding probabilities of ureteral stone. We evaluate the STONE score in a multi-institutional cohort compared with physician gestalt and hypothesize that it has a sufficiently high specificity to allow clinicians to defer computed tomography (CT) scan in patients with suspected nephrolithiasis. METHODS: We assessed the STONE score with data from a randomized trial for participants with suspected nephrolithiasis who enrolled at 9 emergency departments between October 2011 and February 2013. In accordance with STONE predictors, we categorized participants into low-, moderate-, or high-score groups. We determined the performance of the STONE score and physician gestalt for ureteral stone. RESULTS: Eight hundred forty-five participants were included for analysis; 331 (39%) had a ureteral stone. The global performance of the STONE score was superior to physician gestalt (area under the receiver operating characteristic curve=0.78 [95% confidence interval {CI} 0.74 to 0.81] versus 0.68 [95% CI 0.64 to 0.71]). The prevalence of ureteral stone on CT scan ranged from 14% (95% CI 9% to 19%) to 73% (95% CI 67% to 78%) in the low-, moderate-, and high-score groups. The sensitivity and specificity of a high score were 53% (95% CI 48% to 59%) and 87% (95% CI 84% to 90%), respectively. CONCLUSION: The STONE score can successfully aggregate patients into low-, medium-, and high-risk groups and predicts ureteral stone with a higher specificity than physician gestalt. However, in its present form, the STONE score lacks sufficient accuracy to allow clinicians to defer CT scan for suspected ureteral stone.

Radiation Doses in Consecutive CT Examinations from Five University of California Medical Centers.

PURPOSE: To summarize data on computed tomographic (CT) radiation doses collected from consecutive CT examinations performed at 12 facilities that can contribute to the creation of reference levels. MATERIALS AND METHODS: The study was approved by the institutional review boards of the collaborating institutions and was compliant with HIPAA. Radiation dose metrics were prospectively and electronically collected from 199 656 consecutive CT examinations in 83 181 adults and 3871 consecutive CT examinations in 2609 children at the five University of California medical centers during 2013. The median volume CT dose index (CTDIvol), dose-length product (DLP), and effective dose, along with the interquartile range (IQR), were calculated separately for adults and children and stratified according to anatomic region. Distributions for DLP and effective dose are reported for single-phase examinations, multiphase examinations, and all examinations. RESULTS: For adults, the median CTDIvol was 50 mGy (IQR, 37-62 mGy) for the head, 12 mGy (IQR, 7-17 mGy) for the chest, and 12 mGy (IQR, 8-17 mGy) for the abdomen. The median DLPs for single-phase, multiphase, and all examinations, respectively, were as follows: head, 880 mGy · cm (IQR, 640-1120 mGy · cm), 1550 mGy · cm (IQR, 1150-2130 mGy · cm), and 960 mGy · cm (IQR, 690-1300 mGy · cm); chest, 420 mGy · cm (IQR, 260-610 mGy · cm), 880 mGy · cm (IQR, 570-1430 mGy · cm), and 550 mGy · cm (IQR 320-830 mGy · cm); and abdomen, 580 mGy · cm (IQR, 360-860 mGy · cm), 1220 mGy · cm (IQR, 850-1790 mGy · cm), and 960 mGy · cm (IQR, 600-1460 mGy · cm). Median effective doses for single-phase, multiphase, and all examinations, respectively, were as follows: head, 2 mSv (IQR, 1-3 mSv), 4 mSv (IQR, 3-8 mSv), and 2 mSv (IQR, 2-3 mSv); chest, 9 mSv (IQR, 5-13 mSv), 18 mSv (IQR, 12-29 mSv), and 11 mSv (IQR, 6-18 mSv); and abdomen, 10 mSv (IQR, 6-16 mSv), 22 mSv (IQR, 15-32 mSv), and 17 mSv (IQR, 11-26 mSv). In general, values for children were approximately 50% those for adults in the head and 25% those for adults in the chest and abdomen. CONCLUSION: These summary dose data provide a starting point for institutional evaluation of CT radiation doses.

Ultrasonography versus computed tomography for suspected nephrolithiasis.

BACKGROUND: There is a lack of consensus about whether the initial imaging method for patients with suspected nephrolithiasis should be computed tomography (CT) or ultrasonography. METHODS: In this multicenter, pragmatic, comparative effectiveness trial, we randomly assigned patients 18 to 76 years of age who presented to the emergency department with suspected nephrolithiasis to undergo initial diagnostic ultrasonography performed by an emergency physician (point-of-care ultrasonography), ultrasonography performed by a radiologist (radiology ultrasonography), or abdominal CT. Subsequent management, including additional imaging, was at the discretion of the physician. We compared the three groups with respect to the 30-day incidence of high-risk diagnoses with complications that could be related to missed or delayed diagnosis and the 6-month cumulative radiation exposure. Secondary outcomes were serious adverse events, related serious adverse events (deemed attributable to study participation), pain (assessed on an 11-point visual-analogue scale, with higher scores indicating more severe pain), return emergency department visits, hospitalizations, and diagnostic accuracy. RESULTS: A total of 2759 patients underwent randomization: 908 to point-of-care ultrasonography, 893 to radiology ultrasonography, and 958 to CT. The incidence of high-risk diagnoses with complications in the first 30 days was low (0.4%) and did not vary according to imaging method. The mean 6-month cumulative radiation exposure was significantly lower in the ultrasonography groups than in the CT group (P<0.001). Serious adverse events occurred in 12.4% of the patients assigned to point-of-care ultrasonography, 10.8% of those assigned to radiology ultrasonography, and 11.2% of those assigned to CT (P=0.50). Related adverse events were infrequent (incidence, 0.4%) and similar across groups. By 7 days, the average pain score was 2.0 in each group (P=0.84). Return emergency department visits, hospitalizations, and diagnostic accuracy did not differ significantly among the groups. CONCLUSIONS: Initial ultrasonography was associated with lower cumulative radiation exposure than initial CT, without significant differences in high-risk diagnoses with complications, serious adverse events, pain scores, return emergency department visits, or hospitalizations. (Funded by the Agency for Healthcare Research and Quality.).

Study of Tomography Of Nephrolithiasis Evaluation (STONE): methodology, approach and rationale.

BACKGROUND: Urolithiasis (kidney stones) is a common reason for Emergency Department (ED) visits, accounting for nearly 1% of all visits in the United States. Computed tomography (CT) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound. This paper describes the rationale and methods of STONE (Study of Tomography Of Nephrolithiasis Evaluation), a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis. METHODS: STONE is a multi-center, non-blinded pragmatic randomized comparative effectiveness trial of patients between ages 18 and 75 with suspected nephrolithiasis seen in an ED setting. Patients were randomized to one of three initial imaging examinations: point-of-care ultrasound, ultrasound performed by a radiologist or CT. Participants then received diagnosis and treatment per usual care. The primary aim is to compare the rate of severe SAEs (Serious Adverse Events) between the three arms. In addition, a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone, email and mail questionnaires. RESULTS: Excluding 17 patients who withdrew after randomization, a total of 2759 patients were randomized and completed a baseline questionnaire (n=908, 893 and 958 in the point-of-care ultrasound, radiology ultrasound and radiology CT arms, respectively). Follow-up is complete, and full or partial outcomes were assessed on over 90% of participants. CONCLUSIONS: The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting.

Epithelial cells in nipple aspirate fluid and subsequent breast cancer risk: a historic prospective study.

BACKGROUND: Past studies have shown that women with abnormal cytology or epithelial cells in nipple aspirate fluid (NAF) have an increased relative risk (RR) of breast cancer when compared to women from whom NAF was attempted but not obtained (non-yielders). This study analyzed NAF results from a group of women seen in a breast clinic between 1970-1991 (N = 2480). Our analysis presented here is an aggregate of two sub-groups: women with questionnaire data (n = 712) and those with NAF visits beginning in 1988 (n = 238), the year in which cancer case information was uniformly collected in California. METHODS: Cytological classification was determined for a group of 946 women using the most abnormal epithelial cytology observed in fluid specimens. Breast cancer incidence and mortality status was determined through June 2006 using data from the California Cancer Registry, California Vital Statistics and self-report. We estimated odd ratios (ORs) for breast cancer using logistic regression analysis, adjusting for age. We analyzed breast cancer risk related to abnormality of NAF cytology using non-yielders as the referent group and breast cancer risk related to the presence or absence of epithelial cells in NAF, using non-yielders/fluid without epithelial cells as the referent group. RESULTS: Overall, 10% (93) of the 946 women developed breast cancer during the follow-up period. Age-adjusted ORs and 95% confidence intervals (C.I.) compared to non-yielders were 1.4 (0.3 to 6.4), 1.7 (0.9 to 3.5), and 2.0 (1.1 to 3.6) for women with fluid without epithelial cells, normal epithelial cells and hyperplasia/atypia, respectively. Comparing the presence or absence of epithelial cells in NAF, women with epithelial cells present in NAF were more likely to develop breast cancer than non-yielders or women with fluid without epithelial cells (RR = 1.9, 1.2 to 3.1). CONCLUSION: These results support previous findings that 1) women with abnormal epithelial cells in NAF have an increased risk of breast cancer when compared to non-yielders or women with normal epithelial cells in NAF and 2) women with epithelial cells present in NAF have an increased risk of breast cancer when compared to non-yielders or women who had NAF without epithelial cells present.

Allergy-related polymorphisms influence glioma status and serum IgE levels.

Previous studies have shown that glioma patients report allergies less frequently than controls, harbor lower atopy-associated IgE levels, and harbor different frequencies of polymorphisms in the IL13 and IL4 pathways than controls. We sought to confirm this latter result and extend the analysis to IgE levels. Glioma patients (n = 456) and controls (n = 541) were genotyped for genetic variants in IL4, IL4R, and IL13 and tested for total IgE levels (n = 248 controls and 289 cases). Among Whites, IL4 and IL4R polymorphisms and haplotypes were neither significantly associated with IgE levels in controls nor associated with glioma status. IL13 R110G and C-1112T were associated with increased IgE levels in controls (P < 0.001 and P = 0.04, respectively), and IL13 C-1112T was inversely associated with case-control status (P = 0.05, test for trend in dose model). An IL4R haplotype was borderline associated with increased risk in case-control analysis [odds ratio (OR), 1.5; 95% confidence interval (95% CI), 1.0-2.3]. In addition, a rare haplotype for IL4 was associated with decreased risk (OR, 0.23; 95% CI, 0.07-0.83), and a common haplotype in IL13 was associated with decreased risk (OR, 0.73; 95% CI, 0.53-1.00). Our data provide evidence for a role of IL13 polymorphisms on IgE levels and a role for IL4, IL4R, and IL13 haplotypes on case-control status. We did not find any evidence that the interleukin (IL) polymorphisms exerted their effect on glioma risk via their effects on IgE levels. Further exploration of immune susceptibility factors, including genetics, in glioma etiology is advisable.