Remote Delivery in Reproductive Health Care: Operation of Direct-to-Patient Telehealth Medication Abortion Services in Diverse Settings.

PURPOSE: Established models of reproductive health service delivery were disrupted by the coronavirus disease 2019 (COVID-19) pandemic. This study examines rapid innovation of remote abortion service operations across health care settings and describes the use of telehealth consultations with medications delivered directly to patients. METHODS: We conducted semi-structured interviews with 21 clinical staff from 4 practice settings: family planning clinics, online medical services, and primary care practices-independent or within multispecialty health systems. Clinicians and administrators described their telehealth abortion services. Interviews were recorded, transcribed, and analyzed. Staff roles, policies, and procedures were compared across practice settings. RESULTS: Across all practice settings, telehealth abortion services consisted of 5 operational steps: patient engagement, care consultations, payment, medication dispensing, and follow-up communication. Online services and independent primary care practices used asynchronous methods to determine eligibility and complete consultations, resulting in more efficient services (2-5 minutes), while family planning and health system clinics used synchronous video encounters requiring 10-30 minutes of clinician time. Family planning and health system primary care clinics mailed medications from clinic stock or internal pharmacies, while independent primary care practices and online services often used mail-order pharmacies. Online services offered patients asynchronous follow-up; other practice settings scheduled synchronous appointments. CONCLUSIONS: Rapid innovations implemented in response to disrupted in-person reproductive health care included remote medication abortion services with telehealth assessment/follow-up and mailed medications. Though consistent operational steps were identified across health care settings, variation allowed for adaptation of services to individual sites. Understanding remote abortion service operations may facilitate dissemination of a range of patient-centered reproductive health services.Annals "Online First" article.

Comparison of Paper Diaries, Text Messages and Smartphone App to Track Bleeding and Other Symptoms for Contraceptive Studies.

OBJECTIVES: Most researchers who study the effects of hormonal contraception on menstrual bleeding rely on self-reported data via paper diaries, for which completeness and timeliness have been shown to be poor. The purpose of this exploratory study was to compare the completeness and timeliness of bleeding data collected via paper diaries, text messages or smartphone application (a.k.a "app"). METHODS: This was a sub-study of a double-blinded, placebo-controlled randomized trial comparing the effects of a non-steroidal anti-inflammatory drug, naproxen, with placebo when using a copper IUD. Participants tracked bleeding and symptoms over 112 days. Participants tracked bleeding daily using a paper diary as well as with either text messages or a smartphone app. Participants who used paper and the app were also able to record non-bleeding symptoms. RESULTS: Twenty-five participants submitted diaries. Of these participants, 10 completed both paper and app diaries, 7 completed both paper and text messages, 4 completed the paper diary only, 4 completed the app only. Text messages had the most complete data (108 days), followed by the app (96 days) and paper diaries (84 days). The lag time between a bleeding event and the date recording that event was 0.10 days for text, 1.0 days for app, and 4.73 days for paper diaries. Participants using the app reported a median of 33 other symptoms over the study period compared to 7 for the paper diaries. DISCUSSION: Our findings suggest texts demonstrated more complete and timely bleeding data than either paper diaries, or the app. Compared to paper diaries, the app delivered more complete, timely data, and also collected a large set of symptoms.

Tumor treating fields increases blood-brain barrier permeability and relative cerebral blood volume in patients with glioblastoma.

BACKGROUND AND OBJECTIVE: 200 kHz tumor treating fields (TTFields) is clinically approved for newly-diagnosed glioblastoma (nGBM). Because its effects on conventional surveillance MRI brain scans are equivocal, we investigated its effects on perfusion MRI (pMRI) brain scans. METHODS: Each patient underwent institutional standard pMRI: dynamic contrast-enhanced (DCE) and dynamic susceptibility contrast (DSC) pMRI at three time points: baseline, 2-, and 6-months on-adjuvant therapy. At each timepoint, the difference between T1 pre- versus post-contrast tumor volume (ΔT1) and these pMRI metrics were evaluated: normalized and standardized relative cerebral blood volume (nRCBV, sRCBV); fractional plasma volume (Vp), volume of extravascular extracellular space (EES) per volume of tissue (Ve), blood-brain barrier (BBB) permeability (Ktrans), and time constant for gadolinium reflux from EES back into the vascular system (Kep). Between-group comparisons were performed using rank-sum analysis, and bootstrapping evaluated likely reproducibility of the results. RESULTS: Among 13 pMRI datasets (11 nGBM, 2 recurrent GBM), therapies included temozolomide-only (n = 9) and temozolomide + TTFields (n = 4). No significant differences were found in patient or tumor characteristics. Compared to temozolomide-only, temozolomide + TTFields did not significantly affect the percent-change in pMRI metrics from baseline to 2 months. But during the 2- to 6-month period, temozolomide + TTFields significantly increased the percent-change in nRCBV (+26.9% [interquartile range 55.1%] vs -39.1% [37.0%], p = 0.049), sRCBV (+9.5% [39.7%] vs -30.5% [39.4%], p = 0.049), Ktrans (+54.6% [1768.4%] vs -26.9% [61.2%], p = 0.024), Ve (+111.0% [518.1%] vs -13.0% [22.5%], p = 0.048), and Vp (+98.8% [2172.4%] vs -24.6% [53.3%], p = 0.024) compared to temozolomide-only. CONCLUSION: Using pMRI, we provide initial in-human validation of pre-clinical studies regarding the effects of TTFields on tumor blood volume and BBB permeability in GBM.

Factors associated with successful implementation of telehealth abortion in 4 United States clinical practice settings.

OBJECTIVE: To overcome obstacles to delivering medication abortion services during the COVID-19 pandemic, clinics and providers implemented new medication abortion service models not requiring in-person care. This study identifies organizational factors that promoted successful implementation of telehealth and adoption of "no test" medication abortion protocols. STUDY DESIGN: We conducted 21 semi-structured, in-depth interviews with health care providers and clinic administrators implementing clinician-supported telehealth abortion during the COVID pandemic. We selected 15 clinical sites to represent 4 different practice settings: independent primary care practices, online medical services, specialty family planning clinics, and primary care clinics within multispecialty health systems. The Consolidated Framework for Implementation Research guided our thematic analysis. RESULTS: Successful implementation of telehealth abortion included access to formal and informal inter-organizational networks, including professional organizations and informal mentorship relationships with innovators in the field; organizational readiness for implementation, such as having clinic resources available for telehealth services like functional electronic health records and options for easy-to-use virtual patient-provider interactions; and motivated and effective clinic champions. CONCLUSIONS: In response to the need to offer remote clinical services, 4 different practice settings types leveraged key operational factors to facilitate successful implementation of telehealth abortion. Information from this study can inform implementation strategies to support the dissemination and adoption of this model. IMPLICATIONS: Examples of successfully implemented telehealth medication abortion services provide a framework that can be used to inform and implement similar patient-centered telehealth models in diverse practice settings.