Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes.

INTRODUCTION: BT-001 (AspyreRx™) prescription digital therapy, a form of personalized cognitive behavioral therapy, has demonstrated clinically meaningful and durable hemoglobin A1c reductions in patients with type 2 diabetes (T2D). The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer perspective. METHODS: We modeled the T2D pathway using an individual patient-level simulation; clinical data were sourced from the intention-to-treat subset of the BT-001 randomized clinical trial (RCT). SoC across both arms included the composition of oral and injectable treatments for T2D. Events were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model 2 risk equation. A 3-month model cycle length was used in the first year, then annual model cycles were used in line with the original risk engine specifications. Patient characteristics informed event equations and Monte Carlo random sampling was used to assess the occurrence of events within each model cycle. Incidence of hypoglycemic events, drug discontinuation, costs, and health utilities and disutility values were sourced from the literature. RESULTS: From a payer perspective, BT-001 plus SoC versus SoC alone was dominant with a gain in quality-adjusted life years (QALYs) of 0.101 and cost savings of $7343 per patient over the lifetime horizon (i.e., more effective and less costly). BT-001 plus SoC was cost-effective at a willingness-to-pay of $100,000 per QALY (incremental net monetary benefit was $17,443). Savings with BT-001 were primarily driven by a reduction in drug acquisition costs. The reduction in hemoglobin A1c with BT-001 was associated with fewer T2D complications. CONCLUSIONS: BT-001 plus SoC was estimated to dominate SoC alone over the lifetime horizon from a payer perspective, suggesting that using BT-001 can empower patients to better manage their diabetes with the potential for lifelong advantages.

Nursing Students' Self-Efficacy in Immigrant Health.

BACKGROUND: The United States has the largest, most diverse immigrant population. Nurses will care for immigrant clients in all areas of nursing practice. PURPOSE: The purpose of this study was to determine nursing students' self-efficacy in working with immigrant clients following a service-learning experience. METHODS: A pre-/posttest descriptive study was used to measure students' self-efficacy in cultural aspects of screening, providing health education, and assisting with health care access prior to and after a voluntary service-learning experience at a resettlement agency. RESULTS: Statistical significance was found in overall scale score and in all 19 individual items except 2 related to working with (P = .21) and communicating with (P = .49) the health care team. Overall, pretest and posttest results revealed that students' self-efficacy working with immigrant clients was improved. CONCLUSION: Collaborating with an immigrant resettlement program to provide a structured immigrant health learning experience for prelicensure nursing students can improve self-efficacy in working with immigrant clients.

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes.

OBJECTIVE: To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes and an HbA1c of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA1c change from baseline to 90 days. RESULTS: Among 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m2, 54% were female, 28% Black, and 16% Latino. Baseline HbA1c was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA1c was -0.28% (95% CI -0.41, -0.15) in the BT-001 group and +0.11% (95% CI -0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA1c reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported. CONCLUSIONS: Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial.

BACKGROUND: The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles. HYPOTHESIS: To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D. METHODS: This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT-001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real-world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person-to-person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT-001-allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at-home visits for physical measures and blood sample collection. CONCLUSIONS: This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

Investigating the determinants of health-related quality of life among childhood cancer survivors.

AIM: This paper is a report of a study to survey early childhood cancer survivors' perceived health-related quality of life and its determinants and to estimate the reliability of known psychometric scales used in the measurement of these determinants. BACKGROUND: Young adult survivors of childhood cancer are considered to be a high-risk, vulnerable population for experiencing medical and psychosocial sequelae from their treatment that can adversely affect their health-related quality of life. Achieving an adequate level of health-related quality of life among childhood cancer survivors has been identified as a significant outcome in measuring the success of cancer treatment for these survivors throughout the world. METHOD: An on-line survey approach was used, and data were collected from December 2005 to May 2006 in the United States of America. Specific determinants measured were physical health status, perceived sense of hopefulness, self-esteem, social support and affect. The internal consistency of the instruments to measure these constructs among early survivors of childhood cancer was evaluated. FINDINGS: Early survivors of childhood cancer had a lower level of health-related quality of life, perceived self-esteem, physical health status and social support when compared with previously reported findings among samples of adolescents in active treatment for cancer, healthy same-age peers and other samples of childhood cancer survivors. CONCLUSION: Investigations using web-based approaches to measure determinants of health-related quality of life among young adult survivors of childhood cancer have the potential to include international samples of childhood cancer survivors.

A Phase 2A randomized, double-blind, placebo-controlled pilot trial of GM604 in patients with Amyotrophic Lateral Sclerosis (ALS Protocol GALS-001) and a single compassionate patient treatment (Protocol GALS-C).

Background Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that lacks effective treatment options. Genervon has discovered and developed GM604 (GM6) as a potential ALS therapy. GM6 has been modeled upon an insulin receptor tyrosine kinase binding motoneuronotrophic factor within the developing central nervous system. Methods This was a 2-center phase 2A, randomized, double-blind, placebo-controlled pilot trial with 12 definite ALS patients diagnosed within 2 years of disease onset. Patients received 6 doses of GM604 or placebo, administered as slow IV bolus injections (3x/week, 2 consecutive weeks). Objectives were to assess the safety and efficacy of GM604 based on ALSFRS-R, FVC and selected biomarkers (TDP-43, Tau and SOD1, pNFH). This report also includes results of compassionate treatment protocol GALS-C for an advanced ALS patient. Results Definite ALS patients were randomized to one of two treatment groups (GM604, n = 8; placebo, n = 4). 2 of 8 GM604-treated patients exhibited mild rash, but otherwise adverse event frequency was similar in treated and placebo groups. GM604 slowed functional decline (ALSFRS-R) when compared to a historical control (P = 0.005). At one study site, a statistically significant difference between treatment and control groups was found when comparing changes in respiratory function (FVC) between baseline and week 12 (P = 0.027). GM604 decreased plasma levels of key ALS biomarkers relative to the placebo group (TDP-43, P = 0.008; Tau, P = 0.037; SOD1, P = 0.009). The advanced ALS patient in compassionate treatment demonstrated improved speech, oral fluid consumption, mouth suction with GM604 treatment and biomarker improvements. Conclusions We observed favorable shifts in ALS biomarkers and improved functional measures during the Phase 2A study as well as in an advanced ALS patient. Although a larger trial is needed to confirm these findings, the present data are encouraging and support GM604 as an ALS drug candidate.

Lack of effect of aprepitant on hydrodolasetron pharmacokinetics in CYP2D6 extensive and poor metabolizers.

To prevent chemotherapy-induced nausea and vomiting, aprepitant is given with a corticosteroid and a 5-hydroxytryptamine type 3 antagonist, such as dolasetron. Dolasetron is converted to the active metabolite hydrodolasetron, which is cleared largely via CYP2D6. The authors determined whether aprepitant, a moderate CYP3A4 inhibitor, alters hydrodolasetron pharmacokinetics in CYP2D6 poor and extensive metabolizers. Six CYP2D6 poor and 6 extensive metabolizers were randomized in an open-label, crossover fashion to treatment A (dolasetron 100 mg on day 1) and treatment B (dolasetron 100 mg plus aprepitant 125 mg on day 1, aprepitant 80 mg on days 2-3). For hydrodolasetron area under the concentration-versus-time curve (AUC0-infinity) and peak plasma concentration (Cmax), geometric mean ratios (B/A) and 90% confidence intervals (CIs) fell below the predefined limit (2.0) for clinical significance (AUC0-infinity, 1.09 [90% CI, 1.01-1.18], Cmax, 1.08 [90% CI, 0.94-1.24]). Aprepitant did not affect the pharmacokinetics of hydrodolasetron, regardless of CYP2D6 metabolizer type, and was generally well tolerated when coadministered with dolasetron in volunteers.

The Philadelphia Episiotomy Intervention Study.

OBJECTIVE: To lower the episiotomy rate through physician education and documentation of indication when episiotomy was performed. STUDY DESIGN: The intervention consisted of an evidence-based lecture recommending limited usage of episiotomy and requesting documentation of any episiotomy's indication. Data 3 months prior to the intervention were compared to those of the year following. Adjusted comparisons of episiotomy rates were completed using multivariate logistic regression models. RESULTS: For all vaginal deliveries, there was a 17% decrease in the rate of episiotomy, from 46.9% to 38.8%. For spontaneous vaginal deliveries, there was a 25% decrease in the episiotomy rate, from 40.8% to 30.8%. The most common indications for episiotomy reported were routine/elective, 41.0%; vacuum, 18.6%; forceps, 16.4%; and nonreassuring fetal heart tracing, 10.9%. CONCLUSION: Episiotomy rates may be effectively reduced through physician education and documentation of procedure indication.

Fire fatalities among children: an analysis across Philadelphia's census tracts.

OBJECTIVE: This study investigates the possible causes of high levels of residential fire deaths to children younger than 15 years of age in Philadelphia from 1989 to 2000. METHODS: The authors analyzed 246 deaths from 146 residential fires by census tract in Philadelphia using both individual level data and aggregate level data drawn from the records of the Fire Marshall's Office. Death rates by age and sex were calculated using the 1990 Census. Data on fires from official records were combined with aggregate level data by census tract from the 1990 Census and analyzed using logistic regression. Newspaper articles on the fires analyzed were used to identify residences with possible fire code violations. The authors used data from the Philadelphia Bureau of Licenses and Inspections to provide evidence of code violations. RESULTS: The statistically significant variables that resulted from the logistic regression were census tracts in the highest quartile for low income households, census tracts in the highest quartile for single-parent households with children younger than age 18, census tracts in the highest quartile for houses built before 1939, and the number of children younger than 15 years of age in a census tract. CONCLUSION: Population characteristics by census tract are useful in identifying risk factors for residential fire deaths of children. Census tracts identified as at highest risk can provide fire prevention units with opportunities to take preventative measures such as the distribution of smoke detectors, and the education of residents about the dangers of careless smoking and planning for the rescue of children in the event of a fire.

Methodological issues in online data collection.

AIM: This paper is a report of a study to evaluate the use of an online data collection method to survey early survivors of childhood cancer about their physical and psychosocial characteristics and health-related quality of life. BACKGROUND: A major advantage in conducting web-based nursing research is the ability to involve participants who are challenging to study because of their small numbers or inaccessibility because of geographic location. As paediatric oncology patients and early survivors of childhood cancer are often not easily accessible because of their small numbers at single institutions, web-based research methods have been proposed as a potentially effective approach to collect data in studies involving these clinical populations. METHOD: Guided by published literature on using the Internet for data collection, an online protocol was developed; this included construction of a website, development of a homepage and interactive HyperText Markup Language pages and the posting of the study link on various websites. Data collection occurred over a 6-month period between December 2005 and May 2006. FINDINGS: Despite using strategies in conducting online research cited in published literature, the recruitment of subjects was very prolonged and the volume of missing data among many respondents excluded them from the study and created bias within the study's results. CONCLUSION: Web-based, online data collection methods create opportunities to conduct research globally, especially among difficult to access populations. However, web-based research requires careful consideration of how the study will be advertised and how data will be collected to ensure high quality data and validity of the findings.

The effect of the neutropenic diet in the outpatient setting: a pilot study.

PURPOSE/OBJECTIVES: To determine whether use of the neutropenic diet in the outpatient setting decreases the number of febrile admissions and positive blood cultures associated with chemotherapy-induced neutropenia. DESIGN: Descriptive pilot study. SETTING: Outpatient chemotherapy unit of a medical center in a major metropolitan area. SAMPLE: Convenience sample of 28 patients aged 33-67 years beginning treatment with 1 of 13 chemotherapy regimens. METHODS: Twelve-week prospective study beginning on day 1 of chemotherapy cycle 1. Patients received instructions regarding the neutropenic diet before starting chemotherapy. Adherence assessment telephone calls were made at weeks 6 and 12. Hospital admission charts were reviewed at study completion. MAIN RESEARCH VARIABLES: Adherence with neutropenic diet, number of febrile admissions, and number of positive blood cultures. FINDINGS: Sixteen patients were compliant with the neutropenic diet, four of which were admitted for neutropenia with gram-negative rods. No significant differences were found in the rates of febrile admissions or positive blood cultures between compliant and noncompliant patients. CONCLUSIONS: Clinical significance in this pilot study is related to the time required for diet education, content of diet education regarding food restrictions, and difficulty adhering to diet requirements given the multitude of side effects (e.g., nausea, vomiting, mouth sores, diarrhea) of chemotherapy. IMPLICATIONS FOR NURSING: No clear evidence exists that the neutropenic diet makes a difference in overall rates of infection. Nursing research to compare the neutropenic diet with a less restrictive food safety education-focused diet is needed to guide clinical practice.

The impact of a nurse externship program on the transition process from graduate to registered nurse: Part 1 quantitative findings.

This article is Part I of a three-part series that reports the quantitative findings that investigated if an externship program had a long-term effect on new graduates' role socialization to the healthcare environment. Two groups were compared: a group of 26 registered nurses who had participated in the externship program and a matched cohort group of 26 nurses who had not participated in an externship program at this institution or any other clinical agency. No statistically significant differences were found between the groups on the variables of job satisfaction and sense of belonging. In contrast, the analysis did demonstrate significant differences in the mean scores for professionalism and role socialization between the two groups; however, the average score on each scale for those nurses in the cohort group was higher as compared to the average scale score of the nurses who had been nurse externs.

A predictive model of hopefulness for adolescents.

PURPOSE: To develop a predictive model of hopefulness using the variables of age, gender, and self-esteem among a sample of adolescents with cancer and a sample of healthy adolescents. METHODS: Forty-five healthy adolescents were individually matched with 45 adolescents with cancer on the basis of gender and age. Of the 90 subjects included in this study, 48 were male and 42 were female; half of the males (n = 24) and half of the females (n = 21) had cancer. Perceived level of self-esteem was measured using the Coppersmith Self-Esteem Inventory (SEI), and their degree of hopefulness was measured with the Hopefulness Scale for Adolescents (HSA). Data were analyzed using the Statistical Analysis System (SAS) Version 8. RESULTS: Adolescents' perceived level of self-esteem and hopefulness did not differ by gender or disease status. Patients with cancer had a significantly higher mean hopefulness score than healthy subjects (p = .031), and those adolescents with cancer did not have a lower perceived sense of self-esteem than healthy adolescents. The correlation coefficients between SEI and HSA were statistically significant for females with cancer, r = 0.723 (p < .001) and for healthy females, r = 0.676 (p < .001). In contrast, the correlations between SEI and HSA for males were not statistically significant. A model was constructed to predict a subject's hopefulness score that included the variables of self-esteem (p < .001), gender (p = .001), disease status (p = .005), and the interaction between self-esteem and gender (p = .002). CONCLUSIONS: The findings of this study demonstrate that hopefulness is a coping strategy used by female adolescents, both healthy and ill, that is closely related to their perceived sense of self-esteem.

Long-term outcome of patients with prostate cancer and pathologic seminal vesicle invasion (pT3b): effect of adjuvant radiotherapy.

OBJECTIVES: To evaluate the long-term outcome of patients with prostate cancer who have pathologic seminal vesicle invasion without lymph node metastasis (pT3bN0M0) and compare management strategies. METHODS: From October 1987 to August of 1997, 43 men underwent radical prostatectomy at Thomas Jefferson University Hospital, had pT3bN0M0 disease, complete preoperative and postoperative prostate-specific antigen (PSA) data, and a minimum of 2 years of follow-up. Eighteen patients with undetectable postoperative PSA levels received adjuvant radiotherapy (RT) within 6 months of surgery. Twelve patients with undetectable PSA levels postoperatively were considered for salvage treatment at biochemical progression. Thirteen patients with persistently elevated PSA levels postoperatively underwent immediate salvage RT. We evaluated the prognostic factors for freedom from biochemical failure (bNED), distant metastasis (DM), disease-specific survival, and overall survival. RESULTS: The median follow-up time was 5.9 years (range 2 to 10). Patients who received adjuvant RT had significantly greater 5-year bNED survival than patients who did not (80% versus 8%, P <0.001) and increased freedom from DM that was of borderline significance (P = 0.05). The 5-year survival estimates for DM were 0% for the adjuvant RT versus 17% for the observed patient group. In patients with undetectable postoperative PSA levels, the preoperative PSA level was an independent prognostic factor for later disease progression. Patients with a preoperative PSA level of less than 20 ng/mL showed significantly greater 5-year bNED survival than those with a preoperative PSA level of 20 ng/mL or greater (56% versus 32%, P <0.05). The survival curves for risk of DM and death from prostate cancer for those two patient groups were not significantly different statistically. CONCLUSIONS: Although pathologic seminal vesicle invasion has been associated with poor prognosis and high DM risk, adjuvant RT may result in improved bNED survival in patients with undetectable PSA levels after radical prostatectomy. The effect on clinical outcome awaits additional follow-up.