Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT).

INTRODUCTION: This prospective, longitudinal, community-based study, EpidemiologiCal POpulatioN STudy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Lake CounTy, Illinois (CONTACT), investigated coronavirus disease 2019 (COVID-19) immunity, occupational risks related to SARS-CoV-2 exposure, and long-term immunoglobulin G (IgG) seroconversion kinetics. METHODS: At baseline and follow up (3, 6, and 9 months), non-hospitalized adult participants provided nasal and blood serum specimens for molecular [reverse transcription polymerase chain reaction (RT-PCR)] and serological (IgG) testing (4 November 2020-30 October 2021). RESULTS: At baseline, 6.4% (65/1008) had evidence of current/prior SARS-CoV-2 infection. At 3, 6, and 9 months, positive PCR tests were obtained from 0.4% (3/781), 0.4% (3/733), and 0% (0/673) of participants, respectively. Positive IgG occurred at baseline and 3, 6, and 9 months in 4.5% (45/1008), 6.0% (48/799), 5.4% (39/733), and 2.8% (19/673) of participants, respectively. Of participants positive for IgG at baseline, 28 had a negative IgG test at a follow-up visit; of those 28, 21 had their first negative IgG test within 6 months. Participants were more likely to retain positive IgG if they were 18-29 years of age, were male, or had medium-high/high-risk occupations. A high vaccination rate (70% received ≥ 1 dose by 9 months) was observed. Influence of occupational status or characteristics on transmission and IgG, and COVID-19 vaccination trends, are shown. CONCLUSIONS: This study expands on prior studies assessing COVID-19 immunity and IgG seroconversion by including both RT-PCR and serologic testing and longitudinal follow-up of study participants. We observed decreased infection rates over the 9 month follow-up period as well as a decline in IgG persistency after 6 months. The findings from this community-based study regarding vaccinate rates, infection rates by PCR, and IgG persistency over time can help improve our understanding of COVID-19 immunity, occupational risks related to SARS-CoV-2 exposure, and the kinetics of long-term IgG seroconversion, which is important to help guide local and national mitigation strategies. CLINICAL TRIAL REGISTRATION: NCT04611230.

On Reference-based Imputation for Analysis of Incomplete Repeated Binary Endpoints.

Reference-based imputation (RBI) is a popular method for missing data. The methodology is well established for continuous end points but less well developed for repeated binary end points due to the lack of natural multivariate conditional distributions for such end points. In this paper, we propose RBI methods for repeated binary end points based on a multivariate probit model and a logistic model, including jump-to-reference (J2R), copy-reference (CR) and copy-increment-in-reference (CIR). We explore the distribution of the missing binary end points under RBI and propose efficient algorithms to implement the proposed RBI methods. We evaluate the proposed methods by simulations and a data set from a clinical trial.

Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry.

Cluster randomized controlled trials (cluster RCTs), also known as parallel-arm group-randomized trials, are trials in which the randomized units are groups of participants, as opposed to individual participants. These trials have largely been implemented to address broad public health issues, but with the growing interest in use of real-world data in the regulatory setting, this design may be increasingly considered for industry trials. The key difference between cluster RCTs and traditional RCTs is the intraclass correlation coefficient (ICC) that needs to be considered in cluster RCTs. In this article, we discuss some key practical considerations that are related to ICC in the design, conduct, analysis, and report stages of a cluster RCT. These key considerations related to ICC can lead to improvement in how we translate research findings from cluster RCTs into practices in the biopharmaceutical industry.

EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study.

INTRODUCTION: EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT) is an observational, epidemiological study with a 9-month longitudinal follow-up of nonhospitalized persons aged 18 years or older currently living or employed in Lake County, IL. We describe the study design and report baseline characteristics of the study participants, including the proportion of participants with acute or previous SARS-CoV-2 infection at enrollment. METHODS: At enrollment and subsequent timepoints, participants recruited through digital and paper-based advertising campaigns reported their occupational and school-based exposure, risk factors, and behaviors, and provided nasal and serum specimens. Stratified enrichment was used to enhance enrollment into medium- and higher-risk groups within four occupational risk groups for SARS-CoV-2 infection. RT-PCR and serologic (IgG) testing were conducted to detect acute or previous SARS-CoV-2 infection in participants, respectively. RESULTS: Between November 2020 and January 2021, 1008 participants (female 70.7%, mean age ± SD 51 ± 13.8 years) completed the questionnaire and diagnostic testing. Among participants, 41.8% (n = 421) were considered low risk, 24.6% (n = 248) were medium-to-low risk, 22.3% (n = 225) were medium-to-high risk, and 11.3% (n = 114) were high risk. Of 56 (5.6%) participants with evidence of acute or previous SARS-CoV-2 infection at baseline, 11 (19.6%) were RT-PCR-positive, 36 (64.3%) were IgG-seropositive, and 9 (16.1%) were positive by both assays. Participants who were adherent vs nonadherent to social distancing measures (odds ratio [95% CI] 0.8 [0.4-1.8]) were less likely, while those in higher vs lower occupational risk groups (2.0 [1.0-4.4]) were more likely to have evidence for acute or previous SARS-CoV-2 infection. CONCLUSION: In fall/winter 2020/21, 5.6% of adults in a Lake County convenience sample had evidence for acute or previous SARS-CoV-2 infection at baseline. Nonadherence to social distancing measures and high-risk professions were associated with SARS-CoV-2 infection. The study is ongoing and future analyses will assess infection status over time. CLINICAL TRIAL REGISTRATION: NCT04611230.

Value of variation of end-tidal carbon dioxide for predicting fluid responsiveness during the passive leg raising test in patients with mechanical ventilation: a systematic review and meta-analysis.

BACKGROUND: The ability of end-tidal carbon dioxide (ΔEtCO2) for predicting fluid responsiveness has been extensively studied with conflicting results. This meta-analysis aimed to explore the value of ΔEtCO2 for predicting fluid responsiveness during the passive leg raising (PLR) test in patients with mechanical ventilation. METHODS: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched up to November 2021. The diagnostic odds ratio (DOR), sensitivity, and specificity were calculated. The summary receiver operating characteristic curve was estimated, and the area under the curve (AUROC) was calculated. Q test and I2 statistics were used for study heterogeneity and publication bias was assessed by Deeks' funnel plot asymmetry test. We performed meta-regression analysis for heterogeneity exploration and sensitivity analysis for the publication bias. RESULTS: Overall, six studies including 298 patients were included in this review, of whom 149 (50%) were fluid responsive. The cutoff values of ΔEtCO2 in four studies was 5%, one was 5.8% and the other one was an absolute increase 2 mmHg. Heterogeneity between studies was assessed with an overall Q = 4.098, I2 = 51%, and P = 0.064. The pooled sensitivity and specificity for the overall population were 0.79 (95% CI 0.72-0.85) and 0.90 (95% CI 0.77-0.96), respectively. The DOR was 35 (95% CI 12-107). The pooled AUROC was 0.81 (95% CI 0.77-0.84). On meta-regression analysis, the number of patients was sources of heterogeneity. The sensitivity analysis showed that the pooled DOR ranged from 21 to 140 and the pooled AUC ranged from 0.92 to 0.96 when one study was omitted. CONCLUSIONS: Though the limited number of studies included and study heterogeneity, our meta-analysis confirmed that the ΔEtCO2 performed moderately in predicting fluid responsiveness during the PLR test in patients with mechanical ventilation.

Sequential modeling for a class of reference-based imputation methods in clinical trials with quantitative or binary outcomes.

We consider treatment effect estimation in a randomized clinical trial with longitudinally measured quantitative or categorical outcomes. To handle missing data, we usually assume missing at random and then conduct sensitivity analysis for missing not at random. In the literature, several reference-based imputation methods, including "jump to reference" (J2R) and "copy reference" (CR), have been commonly used for conducting sensitivity analysis. J2R assumes the mean effect profile of patients who discontinue the investigative treatment jumps to that of the patients in the reference group after discontinuation, while CR assumes the conditional mean effect profile given the status prior to the time of discontinuation copies that of the patients in the reference group after discontinuation. In this article, we propose a novel, wide class of reference-based imputation methods for conducting sensitivity analysis, which includes J2R and CR as two extreme ends. The framework is motivated by the thought that the investigative treatment may have no, partially, or fully carried-over effect after deviation from the assigned treatment (eg, discontinue the assigned treatment or change to a different treatment). Further, we show that the proposed reference-based imputation methods can be implemented through sequential modeling. This property ensures that the methods can be applied to clinical trials with either quantitative or categorical outcomes. We use both causal-inference arguments and numerical examples to demonstrate the performance of the proposed methods.

The effect of early vasopressin use on patients with septic shock: A systematic review and meta-analysis.

BACKGROUND: The effect of early vasopressin initiation on clinical outcomes in patients with septic shock is uncertain. A systematic review and meta-analysis was performed to evaluate the impact of early start of vasopressin support within 6 h after the diagnosis on clinical outcomes in septic shock patients. METHODS: We searched the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs) and cohort studies from inception to the 1st of February 2021. We included studies involving adult patients (> 16 years)with septic shock. All authors reported our primary outcome of short-term mortality and in the experimental group patients in the studies receiving vasopressin infusion within 6 h after diagnosis of septic shock and in the control group patients in the studies receiving no vasopressin infusion or vasopressin infusion 6 h after diagnosis of septic shock, clearly comparing with clinically relevant secondary outcomes(use of renal replacement therapy(RRT),new onset arrhythmias, ICU length of stay and length of hospitalization). Results were expressed as odds ratio (OR) and mean difference (MD) with accompanying 95% confidence interval (CI). RESULTS: Five studies including 788 patients were included. The primary outcome of this meta-analysis showed that short-term mortality between the two groups was no difference (odds ratio [OR] = 1.09; 95% CI, 0.8 to 1.48; P = 0.6; χ2 = 0.83; I2 = 0%). Secondary outcomes demonstrated that the use of RRT was less in the experimental group than that of the control group (OR = 0.63; 95% CI, 0.44 to 0.88; P = 0.007; χ2 = 3.15; I2 = 36%).The new onset arrhythmias between the two groups was no statistically significant difference (OR = 0.59; 95% CI, 0.31 to 1.1; P = 0.10; χ2 = 4.7; I2 = 36%). There was no statistically significant difference in the ICU length of stay(mean difference = 0.16; 95% CI, - 0.91 to 1.22; P = 0.77; χ2 = 6.08; I2 = 34%) and length of hospitalization (mean difference = -2.41; 95% CI, -6.61 to 1.78; P = 0.26; χ2 = 8.57; I2 = 53%) between the two groups. CONCLUSIONS: Early initiation of vasopressin in patients within 6 h of septic shock onset was not associated with decreased short-term mortality, new onset arrhythmias, shorter ICU length of stay and length of hospitalization, but can reduce the use of RRT. Further large-scale RCTs are still needed to evaluate the benefit of starting vasopressin in the early phase of septic shock.

Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial.

[Figure: see text].

Sample Size Calculation When Planning Clinical Trials with Intercurrent Events.

BACKGROUND: Missing data are not intercurrent events; missing data are consequences of intercurrent events. When planning clinical trials with potential missing data, a conventional approach is two stage: (1) to calculate a required sample size N without considering missing data; (2) to adjust the sample size using [Formula: see text], where r is the expected missing data rate. However, this approach is not estimand oriented. METHODS: Clinical trial design should be aligned with estimand. Sample size calculation is a key step in clinical trial design, so methods for sample size calculation should be aligned with estimand. RESULTS: ICH E9(R1) summarizes five strategies for dealing with intercurrent events. We consider five basic approaches for sample size calculation when planning clinical trials with intercurrent events, with each approach aligned with one of these five strategies. We extend the approaches to scenarios where some combination of multiple strategies is applied to deal with intercurrent events. CONCLUSION: Being aligned with estimands and strategies for dealing with intercurrent events, these methods can be used for sample size calculations when planning clinical trials with intercurrent events.

Small-molecule mimicry hunting strategy in the imperial cone snail, Conus imperialis.

Venomous animals hunt using bioactive peptides, but relatively little is known about venom small molecules and the resulting complex hunting behaviors. Here, we explored the specialized metabolites from the venom of the worm-hunting cone snail, Conus imperialis Using the model polychaete worm Platynereis dumerilii, we demonstrate that C. imperialis venom contains small molecules that mimic natural polychaete mating pheromones, evoking the mating phenotype in worms. The specialized metabolites from different cone snails are species-specific and structurally diverse, suggesting that the cones may adopt many different prey-hunting strategies enabled by small molecules. Predators sometimes attract prey using the prey's own pheromones, in a strategy known as aggressive mimicry. Instead, C. imperialis uses metabolically stable mimics of those pheromones, indicating that, in biological mimicry, even the molecules themselves may be disguised, providing a twist on fake news in chemical ecology.

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care.

INTRODUCTION: Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m2) or obese range (≥30 kg/m2). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months). Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans. We describe the rationale and design of a cluster-randomised controlled trial to test the efficacy of the Peer-Assisted Lifestyle (PAL) intervention compared with enhanced usual care (EUC) to improve BM loss, clinical and behavioural outcomes (aim 1); identify BM-loss predictors (aim 2); and increase PCP counselling (aim 3). METHODS AND ANALYSIS: We are recruiting 461 veterans aged 18-69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System. To deliver counselling, PAL uses in-person and telephone-based peer support, a tablet-delivered goal-setting tool and PCP training. Patients in the EUC arm receive non-tailored healthy living handouts. In-person data collection occurs at baseline, month 6 and month 12 for patients in both arms. Repeated measures modelling based on mixed models will compare mean BM loss (primary outcome) between study arms. ETHICS AND DISSEMINATION: The protocol has been approved by the Institutional Review Board and the Research and Development Committee at the VA NY Harbor Health Systems (#01607). We will disseminate the results via peer-reviewed publications, conference presentations and meetings with stakeholders. TRIAL REGISTRATION NUMBER: NCT03163264; Pre-results.

Validity and reliability of a short self-efficacy instrument for hypertension treatment adherence among adults with uncontrolled hypertension.

OBJECTIVE: To establish the reliability and validity of a self-report measure designed to assess self-efficacy for hypertension treatment adherence. METHODS: This investigation was embedded within a six-month randomized clinical trial (RCT), which demonstrated that a tailored, stage-matched intervention was more effective at improving hypertension control than usual care among individuals (n = 533) with repeated uncontrolled hypertension. The instrument used to assess self-efficacy for hypertension treatment adherence (SE-HTA) comprised three subscales that assessed diet self-efficacy (DSE), exercise self-efficacy (ESE), and medication self-efficacy (MSE). To determine SE-HTA validity and reliability, we assessed internal consistency using Cronbach's α coefficients, conducted exploratory factor analysis, and evaluated convergent and discriminant validity, as well as test-retest reliability using Spearman's ρ correlation coefficients. RESULTS: Cronbach's α (internal consistency) values for DSE, ESE, and MSE were 0.81, 0.82 and 0.74. Factor analysis and the scree plot demonstrated three distinct factors, which correspond to the three subscales contained in the SE-HTA instrument. SE-HTA possessed good convergent and discriminant validity, and moderate test-retest reliability. CONCLUSION: The SE-HTA instrument containing diet, exercise, and medication adherence subscales is valid and reliable in adults with uncontrolled hypertension. PRACTICE IMPLICATIONS: This SE-HTA instrument measures self-efficacy and could help facilitate behavior change in hypertension.

A method for sample size calculation via E-value in the planning of observational studies.

Confounding adjustment plays a key role in designing observational studies such as cross-sectional studies, case-control studies, and cohort studies. In this article, we propose a simple method for sample size calculation in observational research in the presence of confounding. The method is motivated by the notion of E-value, using some bounding factor to quantify the impact of confounders on the effect size. The method can be applied to calculate the needed sample size in observational research when the outcome variable is binary, continuous, or time-to-event. The method can be implemented straightforwardly using existing commercial software such as the PASS software. We demonstrate the performance of the proposed method through numerical examples, simulation studies, and a real application, which show that the proposed method is conservative in providing a slightly bigger sample size than what it needs to achieve a given power.

Two basic statistical strategies of conducting causal inference in real-world studies.

Randomized controlled clinical trials are the gold standard in drug development, but their costs, duration, and limited generalizability have motivated some to look for real-world studies as alternatives. On the other hand, real-world studies may be less convincing due to the presence of confounding bias. In the literature of causal inference, a variety of statistical methods have been proposed to adjust for confounding bias. However, it is challenging for the users to understand the statistical properties enjoyed by each method and then explicitly specify its underlying model assumptions. As a tutorial, in this article, we investigate two basic statistical strategies of conducting causal inference in real-world studies, which cover many commonly used methods. These two strategies are the weighting strategy and the standardization strategy. The weighting strategy defines a target estimand using a propensity-score model (treatment assignment ~ confounders), while the standardization strategy defines an estimand using an outcome-regression model (outcome variable ~ treatment assignment + confounders). Although these two strategies are different at the beginning, at the end both of them are robust for estimating the treatment effect under the same set of identifiability conditions and therefore same kind of sensitivity analysis is needed for evaluating the impact caused by the violation of these conditions.

Key considerations in the design of real-world studies.

Randomized controlled clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. However, real-world studies may be less convincing due to the lack of randomization and blinding. In this article, we discuss some key considerations in the design of real-world studies, which include experimental studies (e.g., hybrid or pragmatic clinical trials and non-randomized single-arm clinical trials with external controls) and non-experimental studies (e.g., cohort studies, cross-sectional studies, and case-control studies). Causal inference plays a critical role in the derivation of robust real-world evidence (RWE) from the analysis of real-world data (RWD). Therefore, we apply the hypothetical strategy, along with the concept of potential outcome, to lay out these key considerations, and we hope these considerations are helpful for the design, conduct, and analysis of real-world studies.

A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence.

Randomized controlled clinical trials are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. On the other hand, real-world data may be much less convincing due to the lack of randomization and the presence of confounding bias. In this article, we propose a statistical roadmap to translate real-world data (RWD) to robust real-world evidence (RWE). The Food and Drug Administration (FDA) is working on guidelines, with a target to release a draft by 2021, to harmonize RWD applications and monitor the safety and effectiveness of pharmaceutical drugs using RWE. The proposed roadmap aligns with the newly released framework for FDA's RWE Program in December 2018 and we hope this statistical roadmap is useful for statisticians who are eager to embark on their journeys in the real-world research.

Predicting adults likely to develop heart failure using readily available clinical information: An analysis of heart failure incidence using the NHEFS.

BACKGROUND: Heart failure is a heavy burden on the health care system in the United States. Once heart failure develops, the quality of life and longevity are dramatically affected. As such, its prevention is critical for the well-being of at risk patients. We evaluated the predictive ability of readily available clinical information to identify those likely to develop heart failure. METHODS: We used a classification and regression tree (CART) model to determine the top predictors for heart failure incidence using the NHANES Epidemiologic Follow-up Study (NHEFS). The identified predictors were hypertension, diabetes, obesity, and myocardial infarction (MI). We evaluated the relationship between these variables and incident heart failure by the product-limit method and Cox models. All analyses incorporated the complex sample design to provide population estimates. RESULTS: We analyzed data from 14,407 adults in the NHEFS. Participants with diabetes, MI, hypertension, or obesity had a higher incidence of heart failure than those without risk factors, with diabetes and MI being the most potent predictors. Individuals with multiple risk factors had a higher incidence of heart failure as well as a higher hazard ratio than those with just one risk factor. Combinations that included diabetes and MI had the highest incidence rates of heart failure per 1000 person years and the highest hazard ratios for incident heart failure. CONCLUSIONS: Having diabetes, MI, hypertension or obesity significantly increased the risk for incident heart failure, especially combinations including diabetes and MI. This suggests that individuals with these conditions, singly or in combination, should be prioritized in efforts to predict and prevent heart failure incidence.

Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study.

INTRODUCTION: Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC). METHOD: We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes. CONCLUSION: If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.

A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial.

BACKGROUND: Goals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA's intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC). Our secondary aim was to test the impact of GEM on weight, diet and physical activity when compared to EUC. METHODS: Veterans with a Body Mass Index ≥30 kg/m2 or 25-29.9 kg/m2 with comorbidities (n = 45) were recruited in two phases and randomized to GEM (n = 22) or EUC (n = 23). We collected process measures (e.g. number of coaching calls completed, number and types of lifestyle goals, counseling documentation) and qualitative feedback on quality of counseling and acceptability of call duration. We also measured weight and behavioral outcomes. RESULTS: GEM participants reported receiving high quality counseling from health coaches and that call duration and frequency were acceptable. They received 5.9 (SD = 3.7) of 12 coaching calls on average, and number of coaching calls completed was associated with greater weight loss at 6-months in GEM participants (Spearman Coefficient = 0.71, p < 0.001). Four participants from GEM and two from EUC attended the MOVE! program. PCPs completed clinical reminders in 12% of PCP visits with GEM participants. Trends show that GEM participants (n = 21) tended to lose more weight at 3-, 6-, and 12-months as compared to EUC, but this was not statistically significant. There were no significant differences in diet or physical activity. CONCLUSIONS: We found that a technology assisted health coaching intervention delivered within primary care using student health coaches was feasible and acceptable to Veteran patients. This pilot study helped elucidate challenges such as low provider engagement, difficulties with health coach continuity, and low patient attendance in MOVE! which we have addressed and plan to test in future studies. TRIAL REGISTRATION: NCT03006328 Retrospectively registered on December 30, 2016.

The Role of Oral Steroids in the Treatment of Phonotraumatic Vocal Fold Lesions in Women.

OBJECTIVES: (1) To determine the short-term effectiveness of oral steroids in women with benign vocal fold lesions and (2) to determine the effectiveness of adjuvant oral steroids in women undergoing voice therapy for benign vocal fold lesions. STUDY DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary voice care center. SUBJECTS AND METHODS: Thirty-six patients undergoing voice therapy for the treatment of phonotraumatic vocal fold lesions randomly received either a 4-day course of oral steroids or a placebo prior to initiating voice therapy. Voice Handicap Index-10 (VHI-10) scores, video and audioperceptual analyses, acoustic and aerodynamic analyses at baseline, and patient perception of improvement after a short course of steroids or a placebo and at the conclusion of voice therapy were collected. RESULTS: Thirty patients completed the study, of whom 27 (only female) were analyzed. The primary outcome measure, VHI-10, did not improve after the 4-day course of steroids or placebo. Secondary measures similarly showed no improvement with steroids relative to placebo. Voice therapy demonstrated a positive effect on both VHI-10 and patient-perceived improvement of voice in all subjects. CONCLUSION: A short course of oral steroids did not benefit women with phonotraumatic vocal fold lesions. In addition, steroids had little beneficial effect when used adjunctively with voice therapy in this patient cohort.