Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya.

Introduction: Globally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies. Methods: Healthy women ages 18-34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition. Results: Among 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36-90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and -27.1% to -20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively). Conclusion: TFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. Clinical Trial Registration: NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382].

"It Soothes Your Heart": A Multimethod Study Exploring Acceptability of Point-of-Care Viral Load Testing among Ugandan Pregnant and Postpartum Women Living with HIV.

BACKGROUND: High adherence to antiretroviral therapy (ART) is critical for achieving viral suppression and preventing onward HIV transmission. ART continuation can be challenging for pregnant women living with HIV (PWLHIV), which has critical implications for risk of vertical HIV transmission. Point-of-care viral load (POC VL) testing has been associated with improved treatment and retention outcomes. We sought to explore acceptability of POC VL testing among Ugandan PWLHIV during pregnancy and postpartum. METHODS: This multimethod analysis drew on quantitative and qualitative data collected between February and December 2021. Quantitatively, we used an intent-to-treat analysis to assess whether randomization to clinic-based POC VL testing during pregnancy and infant testing at delivery was associated with improved viral suppression (≤50 copies/mL) by 3 months postpartum compared to standard-of-care (SOC) VL testing through a central laboratory, adjusting for factorial randomization for the male partner testing strategy. Additionally, a subset of 22 PWLHIV in the POC VL arm participated in in-depth qualitative interviews. We inductively analyzed transcripts to develop categories representing concepts that characterized women's perceptions of POC VL testing during pregnancy and at delivery and ways that POC VL testing may have impacted their ART adherence and viral suppression. Key themes around women's perceptions of POC VL testing were then organized into main categories. RESULTS: Overall, 151 PWLHIV were enrolled into the study, 77 (51%) of whom were randomized to receive POC VL testing during pregnancy and at delivery. Women reported in qualitative interviews that POC VL testing had (1) motivated their ART adherence during pregnancy and postpartum and that they felt this testing method had (2) helped them protect their infants from acquiring HIV and (3) improved their emotional wellbeing. CONCLUSIONS: POC VL testing was highly acceptable among Ugandan PWLHIV and was viewed as an important tool that women believed improved their ART adherence, gave them information necessary to protect their infants from vertical HIV acquisition, and improved their emotional wellbeing. These findings support the global scale-up of POC VL testing in settings with high HIV burden, especially for PWLHIV who may be at risk of treatment disruptions or loss to follow-up.

Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya.

In a phase-IIa trial, we investigated the influence of 90 days continuous-delivery tenofovir (TFV) intravaginal rings (IVRs) with/without levonorgestrel (LNG) on the genital microbiota of Kenyan women. Eligible women (n = 27; 18-34 years; negative for HIV, sexually transmitted infections, and Amsel-bacterial vaginosis) were randomized 2:2:1 to use of IVRs containing TFV, TFV/LNG, or placebo. Using vaginal wall and IVR swabs at IVR insertion and removal, the genital microbial composition was determined using 16S rRNA gene sequencing. The presence of Candida spp. was determined using qPCR. The vaginal total bacterial burden appeared to decrease with TFV and TFV/LNG IVR use (log100.57 and log100.27 decrease respectively; p > 0.05). The TFV/LNG IVR was more 'stabilizing': 50% of the participants' microbiota community state types remained unchanged and 50% shifted towards higher Lactobacillus abundance. Specifically, TFV/LNG IVR use was accompanied by increased abundances of Lactobacillus gasseri/hominis/johnsonii/taiwanensis (16.3-fold) and L. fermentum/reuteri/vaginalis (7.0-fold; all p < 0.01). A significant shift in the overall microbial α-diversity or ß-diversity was not observed for either IVR, and IVR use did not influence Candida spp. prevalence. TFV/LNG and TFV IVRs did not adversely affect the genital microbiota and are safe to use. Our findings support further studies assessing their efficacy in preventing HIV/HSV-2 and unintended pregnancies.

Patient-to-Patient Interactions During the Pain Management Programme: The Role of Humor and Venting in Building a Socially Supportive Community.

Objectives: Social support is most positively perceived when there is an optimal match between a patient's need for communication and the purpose of their interaction. Maladaptive communication patterns may inhibit social bonding or mutual support, negatively impacting clinical outcomes. This study aimed to identify how people with chronic pain naturalistically converse together about their pain in the context of a Pain Management Programme (PMP). Methods: Seven participants (4 females; 3 males) with ongoing chronic pain who were attending a PMP in a regional hospital in the United Kingdom were audio/video recorded during breaks in their PMP. Interactions were transcribed using Jeffersonian Transcription and analyzed using Conversation Analysis. Results: Two conversational mechanisms were identified: (1) Conversational humor; and (2) A venting cycle. Participants used their pain-related experiences construct a motive for a joke, then proceeded to deliver the joke, which initiated a joke return from observers. The sequence was completed by a collaborative punchline. In the venting cycle, an initial complaint was escalated by the sharing of comparable experiences, after which the vent was concluded through a joke punchline, acting as a pivot to move the conversation forwards, terminating the venting. Conclusions: Humorous interpersonal interactions about chronic pain provided a forum for social support-building within the PMP. Humor was affiliative and built social collaboration, helping individuals to together make sense of their pain in a prosocial atmosphere, approaching pain-related experiences with levity. Patient-to-patient interactions within the PMP were strongly prosocial and inclusive, potentially facilitating enhanced PMP clinical outcomes through collaboration.

A one-stop shop model for improved efficiency of pre-exposure prophylaxis delivery in public clinics in western Kenya: a mixed methods implementation science study.

INTRODUCTION: In public clinics in Kenya, separate, sequential delivery of the component services of pre-exposure prophylaxis (PrEP) (e.g. HIV testing, counselling, and dispensing) creates long wait times that hinder clients' ability and desire to access and continue PrEP. We conducted a mixed methods study in four public clinics in western Kenya to identify strategies for operationalizing a one-stop shop (OSS) model and evaluate whether this model could improve client wait time and care acceptability among clients and providers without negatively impacting uptake or continuation. METHODS: From January 2020 through November 2020, we collected and analysed 47 time-and-motion observations using Mann-Whitney U tests, 29 provider and client interviews, 68 technical assistance reports, and clinic flow maps from intervention clinics. We used controlled interrupted time series (cITS) to compare trends in PrEP initiation and on-time returns from a 12-month pre-intervention period (January-December 2019) to an 8-month post-period (January-November 2020, excluding a 3-month COVID-19 wash-out period) at intervention and control clinics. RESULTS: From the pre- to post-period, median client wait time at intervention clinics dropped significantly from 31 to 6 minutes (p = 0.02), while median provider contact time remained around 23 minutes (p = 0.4). Intervention clinics achieved efficiency gains by moving PrEP delivery to lower volume departments, moving steps closer together (e.g. relocating supplies; cross-training and task-shifting), and differentiating clients based on the subset of services needed. Clients and providers found the OSS model highly acceptable and additionally identified increased privacy, reduced stigma, and higher quality client-provider interactions as benefits of the model. From the pre- to post-period, average monthly initiations at intervention and control clinics increased by 6 and 2.3, respectively, and percent of expected follow-up visits occurring on time decreased by 18% and 26%, respectively; cITS analysis of PrEP initiations (n = 1227) and follow-up visits (n = 2696) revealed no significant difference between intervention and control clinics in terms of trends in PrEP initiation and on-time returns (all p>0.05). CONCLUSIONS: An OSS model significantly improved client wait time and care acceptability without negatively impacting initiations or continuations, thus highlighting opportunities to improve the efficiency of PrEP delivery efficiency and client-centredness.

Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial.

BACKGROUND: Successful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya. METHODS: As part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010. FINDINGS: After the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation. INTERPRETATION: We observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible. FUNDING: National Institute of Mental Health and Bill & Melinda Gates Foundation.

Pathologists' agreement on treatment suggestions for melanocytic skin lesions.

BACKGROUND: Although treatment guidelines exist for melanoma in situ and invasive melanoma, guidelines for other melanocytic skin lesions do not exist. OBJECTIVE: To examine pathologists' treatment suggestions for a broad spectrum of melanocytic skin lesions and compare them with existing guidelines. METHODS: Pathologists (N = 187) completed a survey and then provided diagnoses and treatment suggestions for 240 melanocytic skin lesions. Physician characteristics associated with treatment suggestions were evaluated with multivariable modeling. RESULTS: Treatment suggestions were concordant with National Comprehensive Cancer Network guidelines for the majority of cases interpreted as melanoma in situ (73%) and invasive melanoma (86%). Greater variability of treatment suggestions was seen for other lesion types without existing treatment guidelines. Characteristics associated with provision of treatment suggestions discordant with National Comprehensive Cancer Network guidelines were low caseloads (invasive melanoma), lack of fellowship training or board certification (melanoma in situ), and more than 10 years of experience (invasive melanoma and melanoma in situ). LIMITATIONS: Pathologists could not perform immunohistochemical staining or other diagnostic tests; only 1 glass side was provided per biopsy case. CONCLUSIONS: Pathologists' treatment suggestions vary significantly for melanocytic lesions, with lower variability for lesion types with national guidelines. Results suggest the need for standardization of treatment guidelines for all melanocytic lesion types.

Communicating with Vulnerable Patient Populations: A Randomized Intervention to Teach Inpatients to Use the Electronic Patient Portal.

BACKGROUND: Patient portals are expanding as a means to engage patients and have evidence for benefit in the outpatient setting. However, few studies have evaluated their use in the inpatient setting, or with vulnerable patient populations. OBJECTIVE: This article assesses an intervention to teach hospitalized vulnerable patients to access their discharge summaries using electronic patient portals. METHODS: Patients at a safety net hospital were randomly assigned to portal use education or usual care. Surveys assessed perceptions of discharge paperwork and the electronic portal. RESULTS: Of the 202 prescreened eligible patients (e.g., deemed mentally competent, spoke English, and had a telephone), only 43% had working emails. Forty-four percent of participants did not remember receiving or reading discharge paperwork. Patients trained in portal use (n = 47) or receiving usual care (n = 23) preferred hospitals with online record access (85 and 83%, respectively), and felt that online access would increase their trust in doctors (85 and 87%) and satisfaction with care (91% each). Those who received training in portal use were more likely to register for the portal (48% vs. 11%; p < 0.01). CONCLUSION: Patients had positive perceptions of portals, and education increased portal use. Lack of email access is a notable barrier to electronic communication with vulnerable patients.

Perceptions of Primary Care Notes by Patients With Mental Health Diagnoses.

There are concerns regarding whether patients with mental illness should be provided with access to their electronic medical records. This study compared perceptions of patients with (n = 400) and without (n = 2,134) a mental health diagnosis regarding access to primary care clinic notes through secure online portals. Eligible participants viewed at least 1 clinic note during a 12-month period. Administrative data were used to stratify patients by mental health diagnosis. As we hypothesized, patients with and without mental health diagnoses had similar perceptions about online access to notes.

Developing successful social support: An interpretative phenomenological analysis of mechanisms and processes in a chronic pain support group.

OBJECTIVE: The experience of long-term membership of a successful chronic pain support group (CPSG) was explored to identify; (i) factors associated with social support, and; (ii) ways that health care professionals (HCPs) could help CPSGs become more effective and supportive. DESIGN: Interpretative Phenomenological Analysis enabled exploration of participants' experiences of membership and rationales for continued attendance. MAIN OUTCOME MEASURES: Twelve participants (four males, eight females), recruited from a regional CPSG, completed semi-structured interviews lasting from 45 to 120 minutes. Following verbatim transcription, idiographic then cross-case analyses were undertaken. RESULTS: Three superordinate themes emerged: (1) Investing in the new normal; (2) The nurturing environment; (3) Growth facilitation through social evolution. Increased investment and identification with membership, generated snowballing social engagement, enhancing pain management/well-being through collective humour and peer-to-peer support. Explicit guidance by HCPs in early stages of group formation/development, and subsequent implicit influences on group attitudes and actions, promoted the group's development into its current healthy, supportive state. CONCLUSION: Contrary to stereotypes, membership offered positive respite from chronic pain through collective coping. Successful CPSGs forge an independent identity, fostering strong group investment and an ability to live well with chronic pain. HCPs can provide a stabilising foundation for CPSGs to develop positively and supportively.

Patients' perceptions of their doctors' notes and after-visit summaries: A mixed methods study of patients at safety-net clinics.

BACKGROUND: Patients are increasingly offered electronic access to their doctors' notes, and many consistently receive paper After-Visit Summaries. Specific feedback from patients about notes and summaries are lacking, particularly within safety-net settings. DESIGN: A mixed methods study SETTING AND PARTICIPANTS: Patients with poorly controlled diabetes attending two urban safety-net primary care clinics in Washington State. METHODS: Patients read their own most recent clinic note and After-Visit Summary, then completed a brief survey followed by a focus group discussion (3 groups in a large general medicine teaching clinic and 1 in an HIV/AIDS clinic) about their perceptions of the clinic note and After-Visit Summary. RESULTS: Twenty-seven patients participated; 70% were male, 41% were Black, 48% were unemployed or disabled, 56% reported fair/poor health, and 37% had accessed the electronic patient portal. A majority of patients felt their note content was useful (89%); a minority reported that their notes were not accurate (19%), had too much medical jargon (29%), or were too long (26%). Themes identified from the discussions included reliance on the provider to explain confusing content; a desire for more rather than less detail; and perceived inaccuracies, particularly in heavily templated notes. In each focus group, one or more portal users were enthusiastically willing to teach other patients. CONCLUSIONS: The majority of focus group participants at this safety-net site had not accessed the electronic patient portal, but those who had were willing to promote the portal benefits and assist others. Patients identified specific opportunities to improve clinic notes and After-Visit Summaries.

Will use of patient portals help to educate and communicate with patients with diabetes?

OBJECTIVE: Chronic disease management can require daily attention, and increased levels of patient activation and engagement. We examined whether patients with diabetes perceive a greater benefit to having electronic access to their doctors' clinic notes compared to patients without diabetes. We hypothesized that easy electronic access to these notes may help patients with self-care by improving education and communication. METHODS: Survey of patients with and without diabetes in Massachusetts and Pennsylvania about perceptions of potential benefits and risks of reading their visit notes via an electronic patient information portal. Administrative data were used to identify patients with diabetes; we compared their perceptions to those of patients without diabetes. RESULTS: The majority of patients (both with and without diabetes) perceived a positive impact of using the portal. Patients with diabetes were significantly more likely to believe that having access to and reading their notes would help them take their medication better and take better care of themselves. CONCLUSIONS: Patients with chronic diseases such as diabetes might receive an even greater benefit from access to their doctors' notes than the general patient population. PRACTICE IMPLICATIONS: Doctors should encourage their patients with diabetes (or other chronic diseases) to use patient portals.

Ductal Carcinoma in Situ: Quantitative Preoperative Breast MR Imaging Features Associated with Recurrence after Treatment.

Purpose To investigate whether specific imaging features on breast magnetic resonance (MR) images are associated with ductal carcinoma in situ (DCIS) recurrence risk after definitive treatment. Materials and Methods Patients with DCIS who underwent preoperative dynamic contrast material-enhanced (DCE) MR imaging between 2004 and 2014 with ipsilateral recurrence more than 6 months after definitive surgical treatment were retrospectively identified. For each patient, a control subject with DCIS that did not recur was identified and matched on the basis of clinical, histopathologic, and treatment features known to affect recurrence risk. On DCE MR images, lesion characteristics (longest diameter, functional tumor volume [FTV], peak percentage enhancement [PE], peak signal enhancement ratio [SER], and washout fraction) and normal tissue features (background parenchymal enhancement [BPE] volume, mean BPE) were quantitatively measured. MR imaging features were compared between patients and control subjects by using the Wilcoxon signed-rank test, with adjustment for multiple comparisons. Results Of 415 subjects with DCIS who underwent preoperative MR imaging, 14 experienced recurrence and 11 had an identifiable matching control subject (final cohort, 11 patients and 11 control subjects). Median time to recurrence was 14 months, and median follow-up for control subjects was 102 months. When compared with matched control subjects, patients with DCIS recurrence exhibited significantly greater FTV (median, 9.3 cm3 vs 1.3 cm3, P = .01), lesion peak SER (median, 1.7 vs 1.2; P = .03), and mean BPE (median, 58.3% vs 41.1%; P = .02). Conclusion Quantitative lesion and normal breast tissue characteristics at preoperative MR imaging in women with newly diagnosed DCIS show promise for association with breast cancer recurrence after treatment. © RSNA, 2017.

Patients Typing Their Own Visit Agendas Into an Electronic Medical Record: Pilot in a Safety-Net Clinic.

Collaborative visit agenda setting between patient and doctor is recommended. We assessed the feasibility, acceptability, and utility of patients attending a large primary care safety-net clinic typing their agendas into the electronic visit note before seeing their clinicians. One hundred and one patients and their 28 clinicians completed post-visit surveys. Patients and clinicians agreed that the agendas improved patient-clinician communication (patients 79%, clinician 74%), and wanted to continue having patients type agendas in the future (73%, 82%). Enabling patients to type visit agendas may enhance care by engaging patients and giving clinicians an efficient way to prioritize patients' concerns.

Variation among pathologists' treatment suggestions for melanocytic lesions: A survey of pathologists.

BACKGROUND: The extent of variability in treatment suggestions for melanocytic lesions made by pathologists is unknown. OBJECTIVE: We investigated how often pathologists rendered suggestions, reasons for providing suggestions, and concordance with national guidelines. METHODS: We conducted a cross-sectional survey of pathologists. Data included physician characteristics, experience, and treatment recommendation practices. RESULTS: Of 301 pathologists, 207 (69%) from 10 states (California, Connecticut, Hawaii, Iowa, Kentucky, Louisiana, New Jersey, New Mexico, Utah, and Washington) enrolled. In all, 15% and 7% reported never and always including suggestions, respectively. Reasons for offering suggestions included improved care (79%), clarification (68%), and legal liability (39%). Reasons for not offering suggestions included referring physician preference (48%), lack of clinical information (44%), and expertise (29%). Training and caseload were associated with offering suggestions (P < .05). Physician suggestions were most consistent for mild/moderate dysplastic nevi and melanoma. For melanoma in situ, 18 (9%) and 32 (15%) pathologists made suggestions that undertreated or overtreated lesions based on National Comprehensive Cancer Network (NCCN) guidelines, respectively. For invasive melanoma, 14 (7%) pathologists made treatment suggestions that undertreated lesions based on NCCN guidelines. LIMITATIONS: Treatment suggestions were self-reported. CONCLUSIONS: Pathologists made recommendations ranging in consistency. These findings may inform efforts to reduce treatment variability and optimize patterns of care delivery for patients.

The utilization of spitz-related nomenclature in the histological interpretation of cutaneous melanocytic lesions by practicing pathologists: results from the M-Path study.

BACKGROUND: Spitz nevi, atypical Spitz tumors and spitzoid melanomas ('spitzoid lesions') represent controversial and poorly understood cutaneous melanocytic lesions that are difficult to diagnose histologically. It is unknown how these terms are used by pathologists. METHODS: We describe use of Spitz-related terminology using data from the Melanoma Pathology (M-Path) study database comprising pathologists' interpretations of biopsy slides, a nation-wide study evaluating practicing US pathologists' (N = 187) diagnoses of melanocytic lesions (8976 independent diagnostic assessments on 240 total test cases, with 1 slide per case). RESULTS: Most pathologists (90%) used the Spitz-related terminology. However, significant variation exists in which specific lesions were diagnosed as spitzoid and in the corresponding treatment recommendations. Recommendations ranged from 'no further treatment' to 'wide excision of 10 mm or greater' with no category capturing more than 50% of responses. For spitzoid melanoma diagnoses, 90% of pathologists recommended excision with ≥10 mm margin. Pathologists report less confidence in diagnosing these lesions compared with other melanocytic proliferations and are more likely to request second opinions and additional clinical information (all p < 0.05). CONCLUSIONS: Spitzoid lesions are often not classified in any standardized way, evoke uncertainty in diagnosis by pathologists, and elicit variability in treatment recommendations.

Patient portals and personal health information online: perception, access, and use by US adults.

BACKGROUND: Access to online patient portals is key to improving care, but we have limited understanding of patient perceptions of online portals and the characteristics of people who use them. METHODS: Using a national survey of 3677 respondents, we describe perceptions and utilization of online personal health information (PHI) portals. RESULTS: Most respondents (92%) considered online PHI access important, yet only 34% were offered access to online PHI by a health care provider, and just 28% accessed online PHI in the past year. While there were no differences across race or ethnicity in importance of access, black and Hispanic respondents were significantly less likely to be offered access ( P = .006 and <.001, respectively) and less likely to access their online PHI ( P = .041 and <.001, respectively) compared to white and non-Hispanic respondents. CONCLUSION: Health care providers are crucial to the adoption and use of online patient portals and should be encouraged to offer consistent access regardless of patient race and ethnicity.

Histological features associated with diagnostic agreement in atypical ductal hyperplasia of the breast: illustrative cases from the B-Path study.

AIMS: This study examined the case-specific characteristics associated with interobserver diagnostic agreement in atypical ductal hyperplasia (ADH) of the breast. METHODS AND RESULTS: Seventy-two test set cases with a consensus diagnosis of ADH from the B-Path study were evaluated. Cases were scored for 17 histological features, which were then correlated with the participant agreement with the consensus ADH diagnosis. Participating pathologists' perceptions of case difficulty, borderline features or whether they would obtain a second opinion were also examined for associations with agreement. Of the 2070 participant interpretations of the 72 consensus ADH cases, 48% were scored by participants as difficult and 45% as borderline between two diagnoses; the presence of both of these features was significantly associated with increased agreement (P < 0.001). A second opinion would have been obtained in 80% of interpretations, and this was associated with increased agreement (P < 0.001). Diagnostic agreement ranged from 10% to 89% on a case-by-case basis. Cases with papillary lesions, cribriform architecture and obvious cytological monotony were associated with higher agreement. Lower agreement rates were associated with solid or micropapillary architecture, borderline cytological monotony, or cases without a diagnostic area that was obvious on low power. CONCLUSIONS: The results of this study suggest that pathologists frequently recognize the challenge of ADH cases, with some cases being more prone to diagnostic variability. In addition, there are specific histological features associated with diagnostic agreement on ADH cases. Multiple example images from cases in this test set are provided to serve as educational illustrations of these challenges.

Improving Breast Ultrasound Interpretation in Uganda Using a Condensed Breast Imaging Reporting and Data System.

RATIONALE AND OBJECTIVES: This study aimed to determine whether a 2-day educational course using a condensed Breast Imaging Reporting and Data System (condensed BI-RADS) improved the accuracy of Ugandan healthcare workers interpreting breast ultrasound. MATERIALS AND METHODS: The target audience of this intervention was Ugandan healthcare workers involved in performing, interpreting, or acting on the results of breast ultrasound. The educational course consisted of a pretest knowledge assessment, a series of lectures on breast imaging interpretation and standardized reporting using a condensed BI-RADS, and a posttest knowledge assessment. Participants interpreted 53 different ultrasound test cases by selecting the finding type, descriptors for masses, and recommendations. We compared the percent correct on the pretest and posttest based on occupation and training level. RESULTS: Sixty-one Ugandan healthcare workers participated in this study, including 13 radiologists, 13 other physicians, 12 technologists, and 23 midlevel providers. Most groups improved in identifying the finding type (P < 0.05). All occupations showed improved use of descriptive terms for the shape and internal echogenicity of masses (P < 0.05). Most groups showed significant improvement in recommendations for normal and benign findings with a corresponding reduction in biopsy recommendations. CONCLUSIONS: Targeted breast ultrasound education using a condensed BI-RADS improved the interpretive performance of healthcare workers and was particularly successful in reducing the frequency of unnecessary biopsies for normal and benign findings. Multimodal educational efforts to improve accuracy and management of breast ultrasound findings may augment breast cancer early detection efforts in resource-limited settings.

Are Qualitative Assessments of Background Parenchymal Enhancement, Amount of Fibroglandular Tissue on MR Images, and Mammographic Density Associated with Breast Cancer Risk?

PURPOSE: To investigate whether qualitative magnetic resonance (MR) imaging assessments of background parenchymal enhancement (BPE), amount of fibroglandular tissue (FGT), and mammographic density are associated with risk of developing breast cancer in women who are at high risk. MATERIALS AND METHODS: In this institutional review board-approved HIPAA-compliant retrospective study, all screening breast MR images obtained from January 2006 to December 2011 in women aged 18 years or older and at high risk for but without a history of breast cancer were identified. Women in whom breast cancer was diagnosed after index MR imaging comprised the cancer cohort, and one-to-one matching (age and BRCA status) of each woman with breast cancer to a control subject was performed by using MR images obtained in women who did not develop breast cancer with follow-up time maximized. Amount of BPE, BPE pattern (peripheral vs central), amount of FGT at MR imaging, and mammographic density were assessed on index images. Imaging features were compared between cancer and control cohorts by using conditional logistic regression. RESULTS: Twenty-three women at high risk (mean age, 47 years ± 10 [standard deviation]; six women had BRCA mutations) with no history of breast cancer underwent screening breast MR imaging; in these women, a diagnosis of breast cancer (invasive, n = 12; in situ, n = 11) was made during the follow-up interval. Women with mild, moderate, or marked BPE were nine times more likely to receive a diagnosis of breast cancer during the follow-up interval than were those with minimal BPE (P = .007; odds ratio = 9.0; 95% confidence interval: 1.1, 71.0). BPE pattern, MR imaging amount of FGT, and mammographic density were not significantly different between the cohorts (P = .5, P = .5, and P = .4, respectively). CONCLUSION: Greater BPE was associated with a higher probability of developing breast cancer in women at high risk for cancer and warrants further study.