The CryoPop study: Screening for high-grade cervical dysplasia in Karnataka, India.

OBJECTIVE: To describe our experience of screening with visual inspection with acetic acid (VIA) and colposcopy to identify women with high-grade precancerous cervical lesions who were candidates for cryotherapy. Women were screened to determine eligibility for a clinical trial testing the safety and efficacy of a new, simple and inexpensive cryotherapy device (CryoPop®) targeted for use in low and middle-income countries (LMICs). DESIGN: Prospective cohort study. SETTING: Primary and urban health centres in Belagavi, Hubballi and Vijayapur, India. POPULATION: Women in the age-group 30-49 years, premenopausal, with no prior hysterectomy and no known HIV infection were eligible for screening. METHODS: Visual inspection with acetic acid was performed on eligible women following informed consent. VIA-positive women were referred for colposcopy and biopsy. Biopsies were read by two pathologists independently, with a third pathologist acting as tie-breaker if needed. MAIN OUTCOME MEASURES: The primary outcome measures were the number/proportion of women screening positive by VIA and the number/proportion of those women screening VIA-positive found to have high-grade cervical lesions on biopsy (cervical intraepithelial neoplasia 2/3 [CIN 2/3]). Demographic variables were compared between women who screened VIA-positive and those who screened VIA-negative; a separate comparison of demographic and limited reproductive variables was performed between women who had CIN 2/3 on biopsy and those without CIN 2/3 on biopsy. Chi-square or Fisher's exact tests for categorical data and t-tests or analysis of variance for numeric data were used with all tests two-sided and performed at an alpha 0.05 level of statistical significance. RESULTS: A total of 9130 women were screened with VIA between 4 July 2020 and 31 March 2021. The mean age of all women screened was 37 years (standard deviation = 5.6 years) with 6073 of the women (66.5%) in the 30-39 year range. Only 1% of women reported prior cervical cancer screening. A total of 501 women (5.5%) were VIA-positive; of these, 401 women underwent colposcopy. Of those who had colposcopy, 17 (4.2%) had high-grade lesions on biopsy, an additional 164 (40.9%) had low-grade cervical lesions on biopsy or endocervical curettage and one woman (0.2%) was found to have invasive cancer. VIA-positive women were younger and had higher levels of education and income; however, women who were VIA-positive and found to have CIN 2/3 were older, were more likely to be housewives and had higher household income than those without CIN 2/3. CONCLUSION: Despite the COVID-19 pandemic, over 9100 women were screened with VIA for precancerous lesions. However, only 17 (4.2%) were found to have biopsy-proven high-grade cervical lesions, underscoring the subjective performance of VIA as a screening method. Given that this is significantly lower than rates reported in the literature, it is possible that the prevalence of high-grade lesions in this population was impacted by screening a younger and more rural population. This study demonstrates that screening is feasible in an organised fashion and can be scaled up rapidly. However, while inexpensive and allowing for same-day treatment, VIA may be too subjective and have insufficient accuracy clearly to identify lesions requiring treatment, particularly in low-prevalence and low-risk populations, calling into question its overall cost-effectiveness.

Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program.

BACKGROUND: Disparities in hypertension outcomes persist among Black and Hispanic adults and persons living in poverty in the United States. The "LINKED-BP Program" is a multi-level intervention linking home blood pressure (BP) monitoring with a mobile health application, support from community health workers (CHWs), and BP measurement training at primary care practices to improve BP. This study is part of the American Heart Association RESTORE (AddREssing Social Determinants TO pRevent hypErtension) Network. This study aims to examine the effect of the LINKED-BP Program on BP reduction and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the intervention. METHODS: Using a hybrid type I effectiveness-implementation design, 600 adults who have elevated BP or untreated stage 1 hypertension without diabetes, chronic kidney disease, history of cardiovascular disease (stroke or coronary heart disease) and age < 65 years will be recruited from 20 primary care practices including community health centers in the Maryland area. The practices are randomly assigned to the intervention or the enhanced usual care arms. Patients in the LINKED-BP Program receive training on home BP monitoring, BP telemonitoring through the Sphygmo app, and CHW telehealth visits for education and counseling on lifestyle modification over 12 months. The primary clinical outcome is change from baseline in systolic BP at 6 and 12 months. DISCUSSIONS: The LINKED-BP Program tests a sustainable, scalable approach to prevent hypertension and advance health equity. The findings will inform implementation strategies that address social determinants of health and barriers to hypertension prevention in underserved populations. CLINICALTRIALS.GOV IDENTIFIER: NCT05180045.

Safety and efficacy of the new CryoPop® cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls.

BACKGROUND: Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions. METHODS: This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers, and potential participants. Organized community based as well as hospital-based screening is being conducted using visual inspection with acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high-grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device. DISCUSSION: There is a need to develop an inexpensive, simple, and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment. TRIAL REGISTRATION: Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644 . Registered on November 6, 2019.

Intrahepatic cholangiocarcinoma treated with local-regional therapy: quantitative volumetric apparent diffusion coefficient maps for assessment of tumor response.

PURPOSE: To evaluate volumetric changes in apparent diffusion coefficient (ADC) and contrast material enhancement on contrast-enhanced (CE) magnetic resonance (MR) images in hepatic arterial and portal venous phases for assessing early response in cholangiocarcinoma treated with transcatheter arterial chemoembolization (TACE). MATERIALS AND METHODS: Twenty-nine patients with unresectable cholangiocarcinoma, including 11 men (mean age, 60 years; standard deviation, 16.8) and 18 women (mean age, 63 years; standard deviation, 11.5) were included in this retrospective institutional review board-approved, HIPAA-compliant study; informed consent was waived. Sixty-nine TACE procedures were performed during the observational time (range, one to five TACE sessions). No patients received another form of therapy after treatment with TACE. MR Imaging was performed before and 3-4 weeks after TACE, and images were analyzed with a semiautomatic volumetric software package. Patients were stratified as responders and nonresponders on the basis of overall survival (OS) as the primary end point. Differences between responders and nonresponders were analyzed with paired t tests, and OS was calculated with the Kaplan-Meier method. Significant differences were analyzed with the log-rank test. RESULTS: Mean volumetric ADC increased from 1.54×10(-3) mm2/sec to 1.92×10(-3) mm2/sec (P<.0001), with no significant decrease in mean volumetric enhancement in hepatic arterial (40.6% vs 37.5%, P=.546) and portal venous (79.0% vs 70.0%, P=.105) phases. Patients who demonstrated improved survival of 10 months or more had a significant increase in mean volumetric ADC and volumetric ADC above the threshold level of 1.60×10(-3) mm2/sec (P<.002). Patients with 45% or greater (n=21; log-rank test, P<.02) and 60% or greater (n=12; log-rank test, P<.009) ADC changes for the whole tumor volume demonstrated better OS compared with patients in whom these ADC changes were not achieved. CONCLUSION: Patients with percentage tumor volume increase in ADC of 45% or greater and 60% or greater above the threshold level of 1.60×10(-3) mm2/sec had favorable response to therapy and improved survival.

Prevalence of honorary coauthorship in the American Journal of Roentgenology.

OBJECTIVE: The objective of our study was to determine the prevalence of honorary authorship in articles published in the American Journal of Roentgenology (AJR) and to evaluate the factors that might influence the perception of honorary authorship. MATERIALS AND METHODS: Corresponding authors of 1333 Original Research articles published in AJR between 2003 and 2010 were invited by e-mail to complete a Web-based, self-administered survey. Univariable analysis of sample proportions was performed using the chi-square test. Multivariable logistic regression models were used to assess the independent factors that were associated with the probability of honorary authorship. RESULTS: Responses were received from authors of 490 articles (36.8% response rate). Most respondents were aware of the authorship guidelines proposed by the International Committee of Medical Journal Editors (n = 399, 81.4%) and the issue of honorary authorship (n = 353, 72.0%). Authorship was most commonly decided by the first author (n = 256, 52.2%). One hundred twenty-one authors (24.7%) perceived that one or more coauthors listed for the respective article did not make sufficient contributions. Factors most strongly associated with honorary authorship included a work environment where a senior department member was automatically listed (odds ratio [OR], 1.33), the suggestion that an honorary author should be included (OR, 5.96), and the perception that a coauthor performed only a single nonauthor task (i.e., reviewing the manuscript: OR, 1.54). CONCLUSION: A substantial proportion of articles had evidence of honorary authorship. The rate of honorary authors was higher among authors who worked in an environment where senior members were routinely added to all manuscripts submitted for publication, authors who perceived that a coauthor listed had only reviewed the manuscript, and authors who reported that someone suggested they should include an honorary author.