Excessive weight gain and elevated blood pressure are significant risk factors for adverse pregnancy outcomes such as gestational diabetes, premature birth, and preeclampsia. More effective strategies to facilitate adherence to gestational weight gain goals and monitor blood pressure may have a positive health benefit for pregnant women and their babies. The impact of utilizing a remote patient monitoring system to monitor blood pressure and weight gain as a component of prenatal care has not been previously assessed. The objective of this study is to determine the feasibility of monitoring patients remotely in prenatal care using a mobile phone app and connected digital devices. In this prospective observational study, 8 women with low risk pregnancy in the first trimester were recruited at an urban academic medical center. Participants received a mobile phone app with a connected digital weight scale and blood pressure cuff for at-home data collection for the duration of pregnancy. At-home data was assessed for abnormal values of blood pressure or weight to generate clinical alerts to the patient and provider. As measures of the feasibility of the system, participants were studied for engagement with the app, accuracy of remote data, efficacy of alert system, and patient satisfaction. Patient engagement with the mobile app averaged 5.5 times per week over the 6-month study period. Weight data collection and blood pressure data collection averaged 1.5 times and 1.1 times per week, respectively. At-home measurements of weight and blood pressure were highly accurate compared to in-office measurements. Automatic clinical alerts identified two episodes of abnormal weight gain with no false triggers. Patients demonstrated high satisfaction with the system. In this pilot study, we demonstrated that a system using a mobile phone app coupled to remote monitoring devices is feasible for prenatal care.
Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Risk appropriate prenatal care has been asserted as a way for cost effective delivery of prenatal care. A virtual care model for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight monitoring between visits. Previous studies have demonstrated safe reduction of frequency of in person prenatal care visits in low risk patients, but have noted a reduction of patient satisfaction. Objective: The primary objective of this study is to test the effectiveness of a mobile prenatal care app to facilitate a reduced in-person visit schedule, for low risk pregnancies, while maintaining patient and provider satisfaction. Methods: This controlled trial compared a control group receiving usual care to an experimental group receiving usual prenatal care plus a mobile prenatal care app. The experimental group had a planned reduction in the frequency of in-person office visits while the control group had the usual number of visits. The trial was conducted at two diverse outpatient obstetric practices that are part of a single academic center in Washington, DC, USA. Women were eligible for enrollment if they presented to care in the first trimester, were between the ages of 18 and 40, had a confirmed desired pregnancy, were not considered “high-risk,” and had an iOS or Android smartphone that they used regularly. We measured the effectiveness of a virtual care platform for prenatal care via the following measured outcomes: (1) the number of in-person Obstetric (OB) visits during pregnancy; (2) patient satisfaction with prenatal care; (3) and provider satisfaction. Results: 88 patients were enrolled in the study, 47 in the experimental group and 41 in the control group. For patients in the experimental group, the average number of in-person OB visits during pregnancy was 7.8 and the average number in the control group was 10.2 (P=0.01204). There was no statistical difference in patient satisfaction or provider satisfaction in either group. Conclusions: The use of a mobile prenatal care app was associated with reduced in-person visits and without a reduction in patient or provider satisfaction. Clinical Trial: ClinicalTrials.gov: NCT02914301
Importance Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage. Objective To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients. Design, Setting, and Participants We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase). Participants were followed for 90 days. The first phase was conducted at a single US emergency department; the second phase was conducted at 6 US emergency departments. Adult patients were eligible to participate if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as demonstrated on computed tomography. Interventions Participants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days. Main Outcomes and Measures The primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones. Results The mean age of 512 participants randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite. The mean (SD) diameter of the urinary stones was 3.8 (1.4) mm. Four hundred ninety-seven patients were evaluated for the primary outcome. Stone passage rates were 50% in the tamsulosin group and 47% in the placebo group (relative risk, 1.05; 95.8% CI, 0.87-1.27;P = .60), a nonsignificant difference. None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome. Conclusions and Relevance Tamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm. Guidelines for medical expulsive therapy for urinary stones may need to be revised. Trial Registration ClinicalTrials.gov Identifier:NCT00382265
1 August 2014 in The American Journal of Emergency Medicine