Remote Options for Medication Abortion: Improving Patient Care During and After the Covid-19 Crisis

The COVID-19 pandemic has shifted primary care and other practices towards remote care and telemedicine options to minimize viral exposure. Although in-person visits are sometimes indispensable, research shows that telemedicine can expand access to vital services without sacrificing patient-centered care. Medication abortion is an essential, time-sensitive service that is particularly well-suited to telemedicine provision, including in primary care settings. Decades of clinical research and practice guidelines from core medical societies affirm the safety and efficacy of providing medication abortion remotely. Neither FDA nor professional guidelines require sonography for medication abortion, and research shows that necessary clinical assessments can be achieved without ultrasound. New practice guidelines recommend against Rh testing for abortions under 8 weeks of pregnancy and rely on patient history for those provided from 8 to 11 weeks. As primary care providers, we can and should provide high-quality, low-risk abortion care for patients without point-of-care exams and labs. This discussion includes a detailed checklist for providing such remote-care medication abortion in a variety of settings. Such strategies will allow more clinicians to offer this essential care both during and after the Covid-19 crisis.https://deepblue.lib.umich.edu/bitstream/2027.42/155399/1/Stein main article.pd

33731 Use of digital resource centers for atopic dermatitis patients, caregivers, and health care professionals to improve shared decision-making and proactive management

Overview: To close gaps in atopic dermatitis (AD) care, we developed and analyzed aligned resource centers for patients/caregivers and health care professionals (HCPs). Methods: The patient resource center was designed to support patients/caregivers in being more proactive in their AD care. The HCP-targeted resource center aimed to increase their awareness of AD patient perspectives and improve communication. Surveys were completed by users of both resource centers. Results: Of the 1014 HCPs, 22% were physicians (30% specialists), 19% were nurse practitioners/physician assistants, 47% were nurses, and 12% were pharmacists. Approximately one-half of 801 patients (98% adults) reported that they only treat their AD when experiencing a flare, and only 30% were very satisfied with their care. Only 56% indicated that they make all decisions with their HCP, and only 22% of HCPs reported that they always involve their AD patients/caregivers in shared decision-making. Only 21% of patients always share preferences, goals, or concerns about AD with their HCP, and only 6% of HCPs rated their ability to ask about and understand the impact of AD on patients’ quality of life as “very good.” Actions that patients planned to take included proactive skin care, asking their HCP about additional treatment options, and telling their HCP about the impact of AD on their quality of life. Nearly 60% of 764 HCPs planned to educate AD patients/caregivers about treatment options and expectations. Conclusions: These results highlight communication gaps between AD patients/caregivers and HCPs. Insights from these data can be used to improve shared decision-making

34039 Maintenance of skin clearance in a long-term open-label study of fixed-combination halobetasol propionate and tazarotene lotion for psoriasis in participants with prior use of topical treatments

Background: Most patients with psoriasis are dissatisfied with their current treatment, primarily because of limited effectiveness. This post hoc subgroup analysis evaluated long-term efficacy and safety of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) in participants with use of topical corticosteroid (TCS; 137/550 [24.9%]) or other antipsoriatic topical medications (51/550 [9.3%]) before entry in an open-label study of HP/TAZ (NCT02462083). Methods: Participants in the open-label study received HP/TAZ once daily. At week 8, participants who achieved treatment success (investigator’s global assessment [IGA] score of 0 or 1) stopped treatment and were reevaluated monthly through 52 weeks; those who did not achieve treatment success continued HP/TAZ. Twenty-four continuous weeks of treatment were allowed if participants achieved ≥1-grade improvement in IGA from baseline at week 12, with monthly reevaluation. If at any point the condition intensified to IGA ≥2, HP/TAZ was resumed, otherwise, HP/TAZ was discontinued. Results: From weeks 8 to 52, similar treatment success rates were achieved by participants with prior use of TCS (range, 20.0%-40.0%) or other topicals (range, 21.1%-53.8%). Mean affected body surface area at baseline was 5.7% and 5.5%, respectively, and decreased to 3.8% and 2.4%, respectively, at week 52. Percentage of participants who maintained disease control for 29 to 85 days after HP/TAZ cessation was comparable. Rates of adverse events were similar between groups. Conclusions: Regardless of the type of previous topical therapy, participants with prior use of topical medications maintained skin clearance with HP/TAZ over 52 weeks

34587 Efficacy of ruxolitinib cream for the treatment of atopic dermatitis by anatomic region: Pooled analysis from two randomized phase 3 studies

Atopic dermatitis (AD) is a highly pruritic inflammatory skin disease. Two phase 3 studies (TRuE-AD1/TRuE-AD2) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area. Patients (total N = 1249; median age, 32 years) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks of double-blind treatment, and thereafter continued in a long-term, 44-week period of the studies. In this pooled analysis, mean percentage change from baseline in Eczema Area and Severity Index (EASI) anatomic region subscores is reported up to Week 8 (n = 1208). For the head and neck region, patients applying 0.75%/1.5% ruxolitinib cream (vs vehicle) achieved mean improvements of 59.3%/55.8% (vs 13.4%), 70.4%/71.3% (vs 22.4%), and 70.0%/78.7% (vs 45.0%) at Weeks 2, 4, and 8, respectively (all P \u3c.0001). Results were similar for the upper limbs region (48.5%/54.7% [vs 13.3%], 66.6%/70.3% [vs 25.0%], and 73.5%/74.9% [vs 35.1%] all P \u3c.0001). For the trunk region, patients achieved mean improvements of 49.8%/60.0% (vs 12.1%), 67.3%/73.8% (vs 15.0%), and 72.7%/81.0% (vs 15.6%) at Weeks 2, 4, and 8, respectively (all P \u3c.0001). Similar results were observed for the lower limbs region (46.0%/48.2% [vs 16.3%], 65.9%/66.2% [vs 13.9%], and 76.3%/74.9% [vs 39.8%]; all P \u3c.0001). Ruxolitinib cream was well tolerated, with an adverse event profile similar to vehicle. In summary, ruxolitinib cream demonstrated significant improvements vs vehicle in patients with AD across anatomic regions as early as Week 2

367 Googling acne: Analyzing ingredients and price of over the counter acne products

Introduction: Given the convenience of the over-the-counter (OTC) market, many individuals trial OTC products as a means to combat their acne. Within the OTC acne market, there is great heterogeneity in ingredients and price. Herein, we analyze the distribution of ingredients and price among OTC acne products in top Google searches, which the public may encounter when performing an online search. Methods: Google searches for key terms “acne”, “acne treatment”, “top acne treatment”, and “best acne regimen” were performed. Unique acne products for the first 100 websites for each term were collected. Summary statistics for median, range, mean, and standard deviation for price per topical therapy were analyzed. A factorial ANOVA was performed assessing effect of ingredient on price. Results: A total of 272 unique products were collected out of the 400 websites analyzed. The mean price per ounce of all products was $24.79 (standard deviation of$31.84) and median[range] was $10.40 [ Conclusion: Providers play an important role in educating and helping patients to navigate the OTC market. Based on efficacy and affordability, benzoyl peroxide and adapalene should remain the active ingredient of choice when turning to the OTC market. Given the heterogeneity of the OTC market, patients should carefully evaluate OTC products and be aware that not all products will have ingredients containing a grade A strength of recommendation and know that products with the same topical therapy can vary dramatically in price

Short Term and Long-Term Efficacy of Calcipotriene/ Betamethasone Dipropionate Foam Combination

Psoriasis is a well-known chronic disease characterized by the development of erythematous, indurated, scaly, pruritic plaques on the skin with cycles of remission and symptom flare-ups. The management of patients with chronic plaque psoriasis has been more challenging since the Covid-19 pandemic as health care professionals have had to adapt to remote consultations for some patients, and patients have had to adapt to the changing health landscape. The rapid resolution of psoriasis symptoms especially those with a substantial impact on quality of life can improve patient satisfaction and adherence, making it an important factor in successful treatment. Cal/BD foam contributes to improved patient adherence and treatment outcome through its rapid action and superior efficacy versus Cal or BD monotherapy, Cal/BD ointment and gel and clobetasol cream in the short-term flare treatment of psoriasis. Moreover, the benefits of proactive long-term management of psoriasis compared to reactive management and its favourable safety profile are higher efficacy and a better health-related quality of life. Cal/BD foam should be considered an effective topical treatment for short-term flare treatment and long-term control of adult psoriatic patients

Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study.

BackgroundOnce-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.ObjectivesTo evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.MethodsIn two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose.ResultsAmong 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P<0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant.ConclusionsAssessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ≥ 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity

Motivational Interviewing with Computer Assistance as an Intervention to Empower Women to Make Contraceptive Choices while Incarcerated: Study Protocol for Randomized Controlled Trial

Background: Unplanned pregnancies and sexually transmitted infections (STIs) are important and costly public health problems in the United States resulting from unprotected sexual intercourse. Risk factors for unplanned pregnancies and STIs (poverty, low educational attainment, homelessness, substance abuse, lack of health insurance, history of an abusive environment, and practice of commercial sex work) are especially high among women with a history of incarceration. Project CARE (Contraceptive Awareness and Reproductive Education) is designed to evaluate an innovative intervention, Motivational Interviewing with Computer Assistance (MICA), aimed at enhancing contraceptive initiation and maintenance among incarcerated women who do not want a pregnancy within the next year and who are anticipated to be released back to the community. This study aims to: (1) increase the initiation of highly effective contraceptives while incarcerated; (2) increase the continuation of highly effective contraceptive use at 3, 6, 9, and 12 months after release; and (3) decrease unsafe sexual activity. Methods/Design: This randomized controlled trial will recruit 400 women from the Rhode Island Department of Corrections (RI DOC) women’s jail at risk for an unplanned pregnancy (that is, sexually active with men and not planning/wanting to become pregnant in the next year). They will be randomized to two interventions: a control group who receive two educational videos (on contraception, STIs, and pre-conception counseling) or a treatment group who receive two sessions of personalized MICA. MICA is based on the principles of the Transtheoretical Model (TTM) and on Motivational Interviewing (MI), an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. Women will be followed at 3, 6, 9, and 12 months post release and assessed for STIs, pregnancy, and reported condom use. Discussion: Results from this study are expected to enhance our understanding of the efficacy of MICA to enhance contraceptive initiation and maintenance and reduce sexual risk-taking behaviors among incarcerated women who have re-entered the community