Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease.

BACKGROUND & AIMS: Ustekinumab is an effective treatment of Crohn's disease (CD). Of interest to patients is knowing how soon symptoms may improve. We analyzed ustekinumab response dynamics from the ustekinumab CD trials. METHODS: Patients with CD received intravenous induction with ustekinumab ∼6 mg/kg (n = 458) or placebo (n = 457). Week 8 ustekinumab responders received subcutaneous ustekinumab 90 mg as the first maintenance dose or as an extended induction dose for nonresponders. Patient-reported symptom changes (stool frequency, abdominal pain, general well-being) within the first 14 days and clinical outcomes through week 44 were evaluated using the CD Activity Index. RESULTS: After ustekinumab infusion, stool frequency improvement was significantly (P < .05) greater than placebo on day 1 and for all patient-reported symptoms by day 10. In patients with no history of biologic failure or intolerance, cumulative clinical remission rates increased from 23.0% at week 3 to 55.5% at week 16 after the subcutaneous dose at week 8. Corresponding cumulative rates for patients with a history of biologic failure or intolerance increased from 12.9% to 24.1%. Neither change from baseline in CD Activity Index score nor week 8 ustekinumab pharmacokinetics were associated with week 16 response. Among all patients who received subcutaneous ustekinumab 90 mg q8w, up to 66.7% were in clinical response at week 44. CONCLUSIONS: Ustekinumab induction provided symptom relief by day 1 post-infusion. Following ustekinumab infusion and a subcutaneous 90 mg injection, clinical outcomes continued to increase through week 16 and up to week 44. Regardless of week 8 clinical status or ustekinumab pharmacokinetics, patients should receive additional treatment at week 8. CLINICALTRIALS: gov numbers, NCT01369329, NCT01369342, and NCT01369355.

Experiences of peer counsellors in supporting exclusive breastfeeding in southern India: An exploratory qualitative study.

OBJECTIVE: Peer counsellors are effective in addressing a variety of health challenges, including exclusive breastfeeding (EBF). Providing education and support from a person of similar background and experience has been an important adjunct to the practice of health workers for the past 50 years. DESIGN: It is an exploratory qualitative study. POPULATION OR SAMPLE: Twenty-two peer counsellors. SETTING: In-depth Interview in the community. METHODS: To better understand the experiences of these important health workers, we conducted qualitative interviews with 22 peer counsellors who participated in a research study in Belagavi District, Karnataka, India. Transcripts of the interviews were organised and assigned codes by the research team. MAIN OUTCOME MEASURES: Experience of Peer counsellor's role in the community to improve breastfeeding practices. RESULTS: Peer counsellors had a good understanding of the larger study and of their role. Analysis of the transcripts identified three themes: personal satisfaction; the effect on the larger circle of family and community; and ideas for future programming. The positive experiences and the ability of peers to be trained in counselling women around EBF support their use in breastfeeding support and other areas of health education. CONCLUSIONS: The women from the community who served as peer counsellors were enthusiastic and satisfied about their work, which provided them with opportunities to do meaningful community work outside of their household routines. Use of the peer counsellor model to deliver a specific objective like improvement in EBF rates, immunisation or mental health in integration with healthcare providers can help in achieving desired goals.

Nurse Child Care Health Consultants, Professional Development, and Accreditation Improve Medication Safety in Child Care Programs.

Medication administration is a critical safety issue in hospitals and the community. Children are especially at risk because of their dependence on adults to safely administer medications. The purpose of this study was to examine non-compliance with state child care medication administration regulations and factors associated with improved compliance. The data included routine, unannounced inspections of child care programs by state licensing specialists collected in two time periods over 10 years. Factors potentially associated with regulatory compliance were included in this secondary analysis. Most child care center medication administration regulations showed decreased non-compliance between the two time periods. However, regulations pertaining to prescriber orders and parent permission revealed a significant increase in non-compliance (58.4%). Factors positively associated with medication administration regulatory compliance included: compliance with annual professional development (p < 0.0001 in both periods), achievement of accreditation (p = 0.0115 in Time 1), and among centers with children under 3 years of age, compliance with a weekly mandatory visit by a nurse consultant (p = 0.0004 in Time 2). Though family child care homes had a lower frequency of medication administration non-compliance, only 19% were administering medications in Time 1. High quality, safe, and affordable child-care is essential for all children including those with special health care needs. This study highlights the importance of medication safety practices in child care programs, national child care health and safety standards, federal and state policies regarding medication administration regulations, and the critical role of nurse child care health consultants in promoting safe medication administration in child care programs.

Preoperative Imaging in Patients with Deep Infiltrating Endometriosis: An Important Aid in Predicting Depth of Infiltration in Rectosigmoid Disease.

STUDY OBJECTIVE: To determine the diagnostic accuracy of specialist-performed transvaginal ultrasound (TVUS) and pelvic magnetic resonance imaging (MRI) modalities in predicting depth of deep infiltrating endometriosis (DIE) of the rectosigmoid by comparison with histologic specimens obtained at surgery. DESIGN: A retrospective analysis, which met the Standards for Reporting of Diagnostic Accuracy Studies (2015) guidelines for a diagnostic accuracy study. SETTING: Tertiary teaching hospital. PATIENTS: A total of 194 cases who underwent preoperative discussion at the gynecologic endosurgery unit multidisciplinary meeting between January 2012 and December 2019 were eligible for inclusion. INTERVENTIONS: Retrospective assessment of the accuracy of TVUS and MRI in predicting histologic depth of rectosigmoid DIE after operative management. MEASUREMENTS AND MAIN RESULTS: Al total of 135 surgeries were performed for DIE; 20 underwent a rectal shave, 14 had a disc/wedge resection, 38 an anterior/segmental resection, and 63 had no rectosigmoid surgery. Of the 52 patients with full-thickness rectal wall excision, all patients had at least one imaging modality available for review; 42 (81%) had both. At least one imaging modality was in agreement with histologic depth in 48 cases (92%) (sensitivity, 94%; specificity, 50%; positive predictive value [PPV], 97.9%; negative predictive value [NPV], 25.0%; area under the receiver operating curve, 0.720; 95% confidence interval, 0.229-1.000). When TVUS was assessed in isolation, the test remained sensitive for any rectal wall involvement (sensitivity, 93.6%; specificity, 50.0%; PPV, 97.8%; NPV, 25.0%; area under the receiver operating curve, 0.718; 95% confidence interval, 0.227-1.000). When only MRI was assessed, the test demonstrated both high sensitivity and specificity for rectal wall disease (sensitivity, 86.4%; specificity, 100%; PPV, 100%; NPV, 14.2). CONCLUSION: Specialist-performed TVUS and MRI are accurate in predicting depth of disease in rectosigmoid endometriosis. These modalities were similar in their diagnostic performance at assessing depth of rectal wall involvement, and their use is justified in the preoperative planning of these gynecologic surgeries.

A Scoping Review of Computer-Based and Telecommunication Technology Interventions to Address Drug and Alcohol Misuse and Smoking in Women.

BACKGROUND: Computer-based and telecommunication technology has become increasingly common to address addiction among women. This review assessed the effect of technology-based interventions on substance misuse, alcohol use, and smoking outcomes among women. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews (PRISMA-ScR) guideline was used to conduct the scoping review. Four databases (PubMed, Web of Science, PsycINFO, and Scopus) were used to search for peer-reviewed articles published in English on computer-based and telecommunication technology use to address substance misuse, alcohol use, and smoking among women. RESULTS: A total of 30 articles were selected after the final full-text review from the U.S., England, Japan, and the Netherlands. The types of technology used in the interventions included computer software (standalone or web-based), mobile applications, video calling, phone, and text messaging. Intervention outcomes included alcohol and other substance misuse reduction as polysubstance misuse (n = 5), smoking cessation (n = 10), substance misuse reduction only (n = 6), and alcohol use reduction only (n = 9). The populations reached included women who were pregnant (n = 13), postpartum (n = 4), or non-pregnant (n = 14) ranging from adolescent to adulthood. Interventions that targeted polysubstance misuse showed statistically significant reductions (p < .05). CONCLUSION: Although effective in reducing alcohol and other substance misuse, mixed findings were identified for other outcomes targeting a single substance. Technology-based interventions might maximize their effects by targeting polysubstance misuse and addressing associated contextual issues in the form of a computer-delivered module(s).

Relationship between age, sex and pupillary unrest.

Pupllary unrest in ambient light (PUAL) is the chaotic fluctuation of pupil diameter about its mean value. The degree of fluctuation is typically measured using a pupillometer and quantified using an index that sums fluctuations in a frequency range of interest. Indices that measure PUAL show promise in predicting effects of sedative or opioid drugs. Because PUAL is mediated by the parasympathetic nervous system, it would be expected to decline with age-related decreases in parasympathetic tone. In this study we measured average PUAL in 16 subjects from age 3 to 72, with at least 3 repeated measurements on each subject, each taken for approximately 10 s, at approximately 30 frames per second, with illumination of the ipsilateral eye. PUAL was calculated using the algorithm of the Neurolight pupillometer. We found that average PUAL typically declines by approximately 1% per year, and that the standard deviation of repeated measurements is approximately 20%. We therefore conclude that repeated, averaged measurements of age-normed PUAL are likely to be much more clinically useful than single, uncorrected values.

Systematic review on use of health incentives in U.S. to change maternal health behavior.

Use of financial incentives contingent on health outcomes has shown effective in health behavior change. Evidence-based information on the effect of incentive use for maternal health behavior change can inform whether and how to proceed with future research as well as incorporate incentive-based interventions in the existing healthcare system. This systematic literature review was conducted among prospective studies on incentive use for maternal health behavior change in a U.S. cohort according to the PRISMA methodology. Databases subject to the search included PubMed, Web of Science, PsycINFO, and EBSCOhost. Studies published in peer-reviewed journals on or before January 7, 2019, written in English, conducted in U.S., using incentives contingent on maternal health behavior change, and prospectively designed were included. Two authors independently searched titles and abstracts. An abstraction table was constructed, and the risk of bias was assessed using the GRADE approach. The review showed that incentives such as vouchers and other financial incentives were effective in improving outcomes especially related to substance use, tobacco use, and breastfeeding. Mixed evidence was found in improving treatment adherence outcomes; however the studies with randomized trials on the outcome of treatment adherence also showed low certainty. Continued improvements need to be made in implementing an incentive-based approach in the context of comprehensive treatment and routine healthcare, exploring electronic- or mobile-based implementation of the approach, and implementing the approach for a wider variety of outcomes during both prenatal and postpartum periods.

Health and Safety in a Family Child Care Network: An Analysis of Violation Data of Routine, Full Unannounced Inspections.

OBJECTIVE: To analyze how engagement with a staffed family child network is associated with compliance on health and safety regulations among family day care (FDC) homes. METHODS: Publically available data on health and safety inspection violations on FDC homes were merged with engagement data from a staffed family child network. Descriptive analysis, logistic regression, and latent class analysis were used. RESULTS: Network FDC homes, compared to non-network FDC homes, were less likely to have health and safety violations in the areas of Child/Family/Staff Documentation (43.1% vs. 53.6%, p = 0.001) and Indoor Safety (36.0% vs. 42.6%, p = .041). Controlling for area median income and for decades since obtaining license, network FDC homes had fewer violations, fewer violation categories, and less variety of violation categories. Additionally, FDC homes which were not engaged with the staffed family child network but were in the city or town in which the network offered services, performed better compared to FDC homes in cities or towns without network resources. CONCLUSIONS FOR PRACTICE: The better compliance among network FDC homes and among FDC homes in cities and towns where the network offers services, suggests that the network is having positive effects on health and safety quality in FDC homes. A staffed child care network may be a means to improve child care quality and may be a means of improving educational and health outcomes for children.

The Role of the Mirena Intrauterine Device in the Management of Endometrial Polyps: A Pilot Study.

STUDY OBJECTIVE: To study the hypothesis that the levonorgestrel intrauterine device (LNG-IUD) can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women. DESIGN: Canadian Task Force classification level II1 (a controlled trial that is not randomised). SETTING: Outpatient hysteroscopy. PATIENTS: Premenopausal women who had a polyp diagnosed at outpatient hysteroscopy. INTERVENTIONS: Premenopausal women who had a polyp diagnosed at outpatient hysteroscopy and had a LNG-IUD inserted were booked for general anesthesia hysteroscopy and polypectomy through the standard booking process. A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case. MEASUREMENTS AND MAIN RESULTS: The presence of a polyp at hysteroscopy under general anesthesia. A total of 39 patients were included in the study, with 19 in the intervention group and 20 in the control group. The mean age was 43.6 (standard deviation = 5.6) and 43.2 (standard deviation = 8.1) years in the 2 groups, respectively. No difference was found in the time interval between the 2 procedures in the intervention and control groups (mean = 92 vs 84 days, p = .73). However, the proportion of polyps present at the second procedure was significantly higher in the control group (80% vs 37%; relative risk = 2.17; 95% confidence interval, 1.16-4.07; p = .0062). CONCLUSION: Our case-control study found that the LNG-IUD can have a role in the treatment of polyps for women who have heavy menstrual bleeding. This is the first study to show regression of endometrial polyps after treatment with LNG-IUD by direct visualisation at hysteroscopy.

Can Narrowband Imaging Improve the Laparoscopic Identification of Superficial Endometriosis? A Prospective Cohort Trial.

STUDY OBJECTIVE: To assess the usefulness of narrowband imaging (NBI) to detect additional areas of endometriosis not identified by standard white light in patients undergoing laparoscopy for the investigation of pelvic pain. DESIGN: A prospective cohort trial (Canadian Task Force classification II). Evidence obtained from a well-designed cohort study. SETTING: A tertiary laparoscopic subspecialty unit in Melbourne, Australia. PATIENTS: Fifty-seven patients undergoing laparoscopy for the investigation of pelvic pain were recruited. Fifty-three patients were eligible for analysis. INTERVENTIONS: Patients underwent standard white-light laparoscopy of the pelvis followed by NBI survey to assess for any additional areas suspicious for endometriosis. MEASUREMENTS AND MAIN RESULTS: All identified areas of possible endometriosis were resected and sent for blinded histopathological analysis. The additional predictive value of NBI was 0% if the preceding white-light survey was negative and 86% if the preceding white-light survey was positive. CONCLUSION: The use of NBI at laparoscopy for the investigation of pelvic pain is beneficial in finding additional areas of endometriosis if endometriosis is already suspected after white-light survey in a tertiary laparoscopic unit. Further research in nonspecialized units may show additional benefit and requires further research. NBI may also be useful as a diagnostic aid for trainees.

Multicentre retrospective study to assess diagnostic accuracy of ultrasound for superficial endometriosis-Are we any closer?

BACKGROUND: To establish whether the ultrasound findings of minimal endometriosis are confirmed at laparoscopy and that a correlation can be established as to the anatomical sites in this mild form of the disease. AIMS: Patients with pain and suspicion of endometriosis had an ultrasound scan by a sonologist with expertise in endometriosis as part of their pre-operative workup. MEASUREMENTS AND MAIN RESULTS: The clinical histories of 53 patients who had laparoscopy to investigate pelvic pain were reviewed. Ultrasounds were performed between 2012 and 2015 by a single sonologist with expertise in endometriosis assessments. The ultrasound findings were divided into subgroups as follows - presence of uterosacral ligament thickness, thickened pericolic fat, ovarian mobility and focal tenderness. These were compared with operative findings of those patients with superficial endometriosis. Evidence Level 3 - observational studies with controls and health services research that includes adjustment for likely confounding factors. RESULTS: Seventy-nine percent (42/53) of the patients had laparoscopic findings consistent with their ultrasound findings (95% CI 68-90%, P < 0.0001). Of the subgroups that we reviewed, uterosacral thickening (P < 0.05) and thickened pericolic fat (P < 0.05) were the most associated with superficial endometriosis at the time of laparoscopy. CONCLUSION: Markers on ultrasound that reliably demonstrated inflammation (thickened uterosacral ligaments and thickened pericolic fat) were shown to be significantly associated with the disease.

Is outpatient hysteroscopy the new gold standard? Results from an 11 year prospective observational study.

BACKGROUND: In Australia, gynaecologists continue to investigate women with abnormal bleeding and suspected intrauterine pathology with inpatient hysteroscopy despite some evidence in the literature that that there is no difference in safety and outcome when compared to an outpatient procedure. AIMS: This prospective study assessed the safety, effectiveness and acceptability of outpatient hysteroscopy over 11 years at a tertiary hospital in Australia. Resource savings were then calculated. MATERIALS AND METHODS: A prospective database was analysed from March 2003 to January 2014 (130 months, 990 women). RESULTS: Successful hysteroscopic access was obtained in 94% of cases. Twenty-six percent of patients required a second procedure, including 132 for endometrial polyps and 33 for submucosal fibroids that were not able to be treated in the outpatient setting. On questioning, 88% of women would be happy to have the procedure again. Factors affecting success were pre-procedure pain, menopausal status and previous vaginal delivery. The difference between pain experienced versus pain expected was a major factor in patient acceptability. A vasovagal episode occurred in 5% of cases. CONCLUSION: Outpatient hysteroscopy was demonstrated to be safe, effective and acceptable to women. Provision of an outpatient hysteroscopy service saves theatre time and approximately $1000 per case. Improved techniques and technology will allow progression to a 'see and treat' service, providing further savings. With budget constraints, increasing wait times for major procedures and concerns about trainee surgical experience, an outpatient hysteroscopy service should be considered the 'gold standard' investigation over hysteroscopy in theatre.

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.

BACKGROUND AND AIMS: Previously published long-term safety data reported a favourable ustekinumab safety profile for the treatment of inflammatory bowel disease [IBD]. We present the final cumulative safety data from pooled ustekinumab IBD phase 2/3 clinical studies through 5 years in Crohn's disease [CD] and 4 years in ulcerative colitis [UC]. METHODS: In phase 3 studies, patients received a single intravenous placebo or ustekinumab [130 mg or ~6 mg/kg] induction dose followed by subcutaneous maintenance doses of placebo or ustekinumab [90 mg q8w or q12w]. Analyses included all patients who received one dose of study treatment and included patients who were biologic-naïve and patients with a history of biologic failure. Safety outcomes are summarized and presented using number of events per 100 patient-years of follow-up and corresponding 95% confidence intervals. RESULTS: In this final pooled safety analysis, 2575 patients were treated with ustekinumab with 4826 patient-years of follow-up. Rates of key safety events, including major adverse cardiac events and malignancies, were similar between placebo and ustekinumab or not higher for ustekinumab. Opportunistic infections, including tuberculosis, and malignancies were reported infrequently. Rates of key safety events in the IBD group were no higher in the ustekinumab group than in the placebo group for both patients who were biologic-naïve or who had a history of biologic failure. No lymphomas or cases of posterior reversible encephalopathy syndrome [formerly known as reversible posterior leukoencephalopathy syndrome] were reported. CONCLUSION: The final cumulative ustekinumab safety data through 5 years in CD and 4 years in UC demonstrated favourable safety compared to placebo and continue to support the well-established safety profile across all approved indications. CLINICAL TRIALS.GOV NUMBERS: NCT00265122, NCT00771667, NCT01369329, NCT01369342, NCT01369355, NCT02407236.

Is the detection of endometrial nerve fibers useful in the diagnosis of endometriosis?

Laparoscopy is currently considered to be the gold standard investigation in patients suspected to have endometriosis, but this is an invasive and relatively costly procedure and there may be significant delays in diagnosis. As the eutopic endometrium is recognized to be abnormal in patients with endometriosis, it has been suggested that endometrial sampling could provide an indirect diagnostic approach. In particular, recent reports have suggested that the presence of nerve fibers within the endometrial functional layer could represent a specific and sensitive marker of concurrent peritoneal endometriosis. However, such studies have been performed in select patient groups and using novel sampling and analytic techniques that are not used routinely in clinical pathology laboratories. The present study was performed upon conventional endometrial biopsies from 68 patients who underwent laparoscopy for suspected endometriosis. The biopsies were stained immunohistochemically for the neural marker PGP 9.5 and examined in a blinded manner. Endometrial functional layer nerve fibers were identified in 15 (22%) biopsies overall including 9/47 (19%) cases with histologically confirmed peritoneal endometriosis and 6/21 (29% cases) without endometriosis. There was no correlation between the presence of functional layer nerve fibers and the presenting symptoms, endometrial histology, or current hormonal therapy. In our experience, endometrial functional layer nerve fibers assessment performed using standard immunohistochemical techniques on routine biopsy specimens proved neither sensitive nor specific for the diagnosis of endometriosis. Pathologists and gynecologists considering this diagnostic approach should carefully consider the methodological factors that may influence its reliability.

Usability and acceptability testing of a Plan of Safe Care in a mobile health platform.

Purpose: Women who are pregnant or parenting while recovering from substance use disorder (SUD) are at risk for insufficient recovery support. With the federal mandate, implementation has been left to each state for the Plan of Safe Care (POSC), leading to challenges in providing comprehensive care coordination and meeting federal reporting requirements. Methods: This research tests the usability and acceptability of a POSC platform, called SAFE4BOTH, which combines a mobile health (mHealth) app for use by mothers with substance use disorder (MSUD) with a web-based case management system for use by stakeholders to reduce the issue of fragmented postnatal maternal and infant care. The platform was designed to enable access to services, improve reporting task workflow, and assist in improving interactions between mothers and service providers.After applying a user-centered design approach, the usability and acceptability of the SAFE4BOTH platform were evaluated using focus groups, interviews, and a System Usability Scale (SUS). The evaluation involved four staff members from a Medication for Addiction Treatment clinic (comprising of three case management workers and one peer counselor), four state employees of the Delaware Division of Family Services, and 20 mothers with MSUD who had delivered infants in need of a POSC.Features tested in the SAFE4BOTH platform included a secure, web-based POSC, a contingency management-based reward system, a micro-learning library, a resources locator, a chat messaging and videoconferencing system, a directory for contact management, a QR code reader, use of an appointment compliance system engaging geofencing, and an enhanced calendar. Family services and treatment center staff accessed SAFE4BOTH from their laptops or tablets, and MSUD accessed SAFE4BOTH from their phones. Results: Family services staff, treatment center staff, and MSUD participants rated SAFE4BOTH as usable and acceptable with average System Usability Scale scores of 68.1 (SD 8.5), 92.5 (SD 11.73), and 78.4 (SD 12.5) (respectively). Conclusion: The platform was judged both usable and acceptable by all three target populations (family services staff, treatment center staff, and MSUD). Further studies are planned to explore the efficacy of longitudinally supporting the mother's recovery and the infant's healthy development.

A training curriculum for an mHealth supported peer counseling program to promote exclusive breastfeeding in rural India.

BACKGROUND: Despite strong evidence about the benefits of exclusive breastfeeding, that is the baby receiving only breast milk, no other foods or liquids, rates have remained relatively unchanged over the past two decades in low- and middle-income countries. One strategy for increasing exclusive breastfeeding is through community-based programs that use peer counselors for education and support. The use of mobile health applications is also gaining increasing applicability in these countries. Minimal information is available about training peer counselors in the use of mobile technologies to support exclusive breastfeeding. The present article describes our curriculum in the state of Karnataka, India for supporting new mothers to exclusively breastfeed using a mobile health application in rural India. METHODS: Twenty-five women from the community surrounding the city of Belgavi, Karnataka, India were trained to be peer counselors and to use a mobile health application to conduct a structured curriculum to support new mothers in exclusive breastfeeding. The three-day interactive training, conducted in March 2018, was based on the WHO breastfeeding course, translated, and adapted to the local culture The curriculum, which included information collected during a formative research process, consisted of eight visits, two during the antenatal period and continuing for six months postpartum. Twelve nursing and obstetric experts validated curriculum content. Pre-post-evaluation of the training focused on breastfeeding knowledge, self-efficacy, skills, and app usability. RESULTS: We observed a significant increase in the mean scores for knowledge (P < 0.0001) and skills (P = 0.0006) from pre- to post-training. Age of the peer counselors and their own breastfeeding experience correlated significantly with the acquisition of knowledge and skills. The mobile health app showed high usability scores. CONCLUSIONS: The culturally adapted curriculum presented here, combined with an mHealth app, can be an important educational strategy for training rural women in the acquisition of exclusive breastfeeding knowledge and skills.

Decongestion Models and Metrics in Acute Heart Failure: ESCAPE Data in the Age of the Implantable Cardiac Pressure Monitor.

The United States Food and Drug Administration restricts the use of implantable cardiac pressure monitors to patients with New York Heart Association (NYHA) class III heart failure (HF). We investigated whether single-pressure monitoring could predict survival in HF patients as part of a model constructed using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial. We validated survival models in 204 patients, using all-cause 180-day mortality. Two levels of model complexity were tested: 1) a simplified 1-pressure model based on pulmonary artery mean pressure ([PAM]1P) (information obtainable from an implanted intracardiac monitor alone), and 2) a pair of 5-variable risk score models based on right atrial pressure (RAP) + pulmonary capillary wedge pressure (PCWP) ([RAP+PCWP]5V) and on RAP + PAM ([RAP+PAM]5V). The more complex models used 5 dichotomous variables: a congestion index above a certain threshold value, baseline systolic blood pressure of <100 mmHg, baseline blood urea nitrogen level of ≥ 34 mg/dL, need for cardiopulmonary resuscitation or mechanical ventilation, and posttreatment NYHA class IV status. The congestion index was defined as posttreatment RAP+PCWP or posttreatment RAP+PAM, with congestion thresholds of 34 and 42 mmHg, respectively (median pulmonary catheter indwelling time, 1.9 d). The 5-variable models predicted survival with areas under the curve of 0.868 for the (RAP+PCWP)5V model and 0.827 for the (RAP+PAM)5V model, whereas the 1-pressure model predicted survival with an area under the curve of 0.718. We conclude that decongestion as determined by hemodynamic assessment predicts survival in HF patients and that it may be the final pathway for treatment benefit despite improvements in pharmacologic intervention since the ESCAPE trial.

Design, Development, and Testing of BEST4Baby, an mHealth Technology to Support Exclusive Breastfeeding in India: Pilot Study.

BACKGROUND: Exclusive breastfeeding (EBF) at 6 months of age in most low- and middle-income countries, including India, is surprisingly low. There is a relative lack of mobile health apps that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing EBF practices in low- and middle-income countries. OBJECTIVE: This study aimed to design, develop, and test the usability of Breastfeeding Education Support Tool for Baby (BEST4Baby), a mobile health app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India on optimal breastfeeding practices. METHODS: A user-centered design process with an agile development methodology was used. The approach involved stakeholders and mothers who were trained to serve as PCs to guide BEST4Baby's design and development, including the app's content and features. PCs were engaged through focus groups with interactive wireframes. During the 24-month pilot study period, we conducted a feasibility test of the BEST4Baby app with 22 PCs who supported home visits with mothers residing in rural India. The intervention protocol required PCs to provide education and follow mothers using the BEST4Baby app, with 9 scheduled home visits from the late prenatal stage to 6 months post partum. BEST4Baby's usability from the PCs' perspective was assessed using the translated System Usability Scale (SUS). RESULTS: The findings of this study align with best practices in user-centered design (ie, understanding user experience, including context with iterative design with stakeholders) to address EBF barriers. This led to the cultural tailoring and contextual alignment of an evidence-based World Health Organization breastfeeding program with an iterative design and agile development of the BEST4Baby app. A total of 22 PCs tested and rated the BEST4Baby app as highly usable, with a mean SUS score of 85.3 (SD 9.1), placing it over the 95th percentile for SUS scores. The approach translated into a highly usable BEST4Baby app for use by PCs in breastfeeding counseling, which also statistically increased EBF practices. CONCLUSIONS: The findings suggest that BEST4Baby was highly usable and accepted by mothers serving as PCs to support other mothers in their EBF practices and led to positive outcomes in the intervention group's EBF rates. The pilot study demonstrated that using the specially designed BEST4Baby app was an important support tool for mothers to serve as PCs during the 9 home visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT03533725; https://clinicaltrials.gov/ct2/show/NCT03533725.