Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Change in Health Literacy over a Decade in a Prospective Cohort of Community-Dwelling Older Adults.

BACKGROUND: Health literacy is often viewed as a static trait in longitudinal studies, which may over or underestimate an individual's ability to manage one's health. OBJECTIVES: We sought to examine health literacy over time among older adults using three widely used measures. DESIGN: A prospective cohort study. PARTICIPANTS: Community-dwelling adults ages 55 to 74 at baseline with at least one follow-up visit (N = 656) recruited from one academic internal medicine clinic and six community health centers in Chicago, IL. MEASURES: Health literacy was measured using the Test of Functional Health Literacy in Adults (TOFHLA), Newest Vital Sign (NVS), and Rapid Estimate of Adult Literacy in Medicine (REALM) at baseline and up to three follow-up time points. RESULTS: In unadjusted analyses, significant changes since baseline were found beginning at the second follow-up (mean (M) = 6.0 years, SD = 0.6) for the TOFHLA (M = - 0.9, SD = 0.95, p = 0.049) and the REALM (M = 0.3, SD = 2.5, p = 0.004) and at the last follow-up (M = 8.6 years, SD = 0.5) for the NVS (M = - 0.2, SD = 1.4, p = 0.02). There were non-linear effects of baseline age on TOFHLA and NVS scores over time (piecewise cubic spline p = 0.01 and p < 0.001, respectively) and no effect on REALM scores (B = 0.02, 95% CI - 0.01 to 0.04, p = 0.17) using multivariable mixed-effects linear regression models, controlling for race, education, income, and comorbidity. CONCLUSION: We found a negative relationship between age and health literacy over time as measured by the TOFHLA and NVS. Health literacy barriers appear to be more prevalent among individuals in later life, when self-care demands are similarly increasing. Clinicians might consider strategies to assess and respond to limited health literacy, particularly among patients 70 and older. REALM performance remained stable over 10 years of follow-up. This questions whether health literacy tools measure the same attribute. Prospective health literacy studies should carefully consider what measures to use, depending on their objective.

Do gender and racial differences exist in letters of recommendation for obstetrics and gynecology residency applicants?

BACKGROUND: Studies in several fields demonstrate gender and racial differences in descriptions of applicants in letters of recommendation. However, gender and racial biases in obstetrics and gynecology residency letters of recommendation are understudied. OBJECTIVE: This study aimed to determine whether there are differences in the letters of recommendation written for medical students applying for obstetrics and gynecology residency based on applicant gender and underrepresented in medicine status. STUDY DESIGN: We analyzed all letters of recommendation submitted to a single obstetrics and gynecology residency program during the 2019-2020 application cycle using a computerized text analysis software to evaluate the presence of 25 word categories. Multivariable regression was used to compare differences in the frequency of word categories by gender and underrepresented in medicine status. Concurrently, we performed a qualitative content analysis of letters from a random sample of applicants balanced for gender and underrepresented in medicine status and explored emerging themes until thematic saturation was reached. RESULTS: We analyzed 3060 letters written for 834 applicants, 721 (87%) of whom were women and 198 (24%) of whom were underrepresented in medicine. Men authored 1605 letters (53%). There was no difference in word categories used in letters written for men and women applicants on multivariable analysis. Similarly, there was no word category difference between letters written for applicants who were underrepresented in medicine compared with White and Asian applicants. However, women letter writers used more communal (relationship-oriented) words compared with men letter writers (P<.001). Moreover, on the qualitative analysis of letters from a random sample of 30 applicants, comments about personality traits were frequent in all letters. Comments on surgical skills, work ethic, and leadership were found more in letters for White and Asian applicants, and phrases that were doubt raisers were found more in letters written for underrepresented medicine applicants. CONCLUSION: On linguistic analysis, letters of recommendation written for obstetrics and gynecology residency applicants were similar overall compared with applicant race and gender.

Awareness, Attitudes, and Actions Related to COVID-19 Among Adults With Chronic Conditions at the Onset of the U.S. Outbreak: A Cross-sectional Survey.

BACKGROUND: The evolving outbreak of coronavirus disease 2019 (COVID-19) is requiring social distancing and other measures to protect public health. However, messaging has been inconsistent and unclear. OBJECTIVE: To determine COVID-19 awareness, knowledge, attitudes, and related behaviors among U.S. adults who are more vulnerable to complications of infection because of age and comorbid conditions. DESIGN: Cross-sectional survey linked to 3 active clinical trials and 1 cohort study. SETTING: 5 academic internal medicine practices and 2 federally qualified health centers. PATIENTS: 630 adults aged 23 to 88 years living with 1 or more chronic conditions. MEASUREMENTS: Self-reported knowledge, attitudes, and behaviors related to COVID-19. RESULTS: A fourth (24.6%) of participants were "very worried" about getting the coronavirus. Nearly a third could not correctly identify symptoms (28.3%) or ways to prevent infection (30.2%). One in 4 adults (24.6%) believed that they were "not at all likely" to get the virus, and 21.9% reported that COVID-19 had little or no effect on their daily routine. One in 10 respondents was very confident that the federal government could prevent a nationwide outbreak. In multivariable analyses, participants who were black, were living below the poverty level, and had low health literacy were more likely to be less worried about COVID-19, to not believe that they would become infected, and to feel less prepared for an outbreak. Those with low health literacy had greater confidence in the federal government response. LIMITATION: Cross-sectional study of adults with underlying health conditions in 1 city during the initial week of the COVID-19 U.S. outbreak. CONCLUSION: Many adults with comorbid conditions lacked critical knowledge about COVID-19 and, despite concern, were not changing routines or plans. Noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. PRIMARY FUNDING SOURCE: National Institutes of Health.

Changes in COVID-19 Knowledge, Beliefs, Behaviors, and Preparedness Among High-Risk Adults from the Onset to the Acceleration Phase of the US Outbreak.

BACKGROUND: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis. OBJECTIVE: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020). DESIGN: Longitudinal, two-wave telephone survey. PARTICIPANTS: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago. MAIN MEASURES: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness. KEY RESULTS: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.

Protection-adjusted UV dose estimated for body areas: Daily self-reported sun protection modification of wearable UV sensor dose.

BACKGROUND: During the last 20 years, 50% of adults with sun-sensitive skin have sunburned annually. Reducing the proportion of people who sunburn requires understanding the circumstances and outdoor activities during which at-risk people sunburn. METHODS: A 7-day observational study of melanoma survivors (n = 20) and young adult first-degree relatives of melanoma survivors (FDRs) (n = 20) captured daily UV exposure, sun protection, and sunburns during spring and summer in the Midwest of the United States (latitude 41.8°N). Participants wore UV and physical activity sensors and completed a daily self-reported survey of sun protection, sunburn, and physical activities. The estimated protection-adjusted UV dose was calculated for each body area by integrating self-reported sun protection with UV sensor dose. RESULTS: In 254 days, at least one body area in 9 of 20 (45%) melanoma survivors and 11 of 20 (55%) FDRs was sunburned (erythema at 24 hours). Sunburns were associated with spring and walking for transportation or leisure, especially walking the dog. Melanoma survivors used sunscreen daily on the face; however, forearms and lower legs were not protected during walking. Young adults did not use sun protection on the face, forearms or lower legs during walking for transportation and use was ineffective during sports. CONCLUSION: The sun protection patterns of daily living identified in this study may promote recognition of erythema as sunburn and inform the development of tailored sun protection mobile applications promoting self-monitoring with wearable UV sensors.

Clinically Meaningful Use of Mental Health Apps and its Effects on Depression: Mixed Methods Study.

BACKGROUND: User engagement is key to the effectiveness of digital mental health interventions. Considerable research has examined the clinical outcomes of overall engagement with mental health apps (eg, frequency and duration of app use). However, few studies have examined how specific app use behaviors can drive change in outcomes. Understanding the clinical outcomes of more nuanced app use could inform the design of mental health apps that are more clinically effective to users. OBJECTIVE: This study aimed to classify user behaviors in a suite of mental health apps and examine how different types of app use are related to depression and anxiety outcomes. We also compare the clinical outcomes of specific types of app use with those of generic app use (ie, intensity and duration of app use) to understand what aspects of app use may drive symptom improvement. METHODS: We conducted a secondary analysis of system use data from an 8-week randomized trial of a suite of 13 mental health apps. We categorized app use behaviors through a mixed methods analysis combining qualitative content analysis and principal component analysis. Regression analyses were used to assess the association between app use and levels of depression and anxiety at the end of treatment. RESULTS: A total of 3 distinct clusters of app use behaviors were identified: learning, goal setting, and self-tracking. Each specific behavior had varied effects on outcomes. Participants who engaged in self-tracking experienced reduced depression symptoms, and those who engaged with learning and goal setting at a moderate level (ie, not too much or not too little) also had an improvement in depression. Notably, the combination of these 3 types of behaviors, what we termed "clinically meaningful use," accounted for roughly the same amount of variance as explained by the overall intensity of app use (ie, total number of app use sessions). This suggests that our categorization of app use behaviors succeeded in capturing app use associated with better outcomes. However, anxiety outcomes were neither associated with specific behaviors nor generic app use. CONCLUSIONS: This study presents the first granular examination of user interactions with mental health apps and their effects on mental health outcomes. It has important implications for the design of mobile health interventions that aim to achieve greater user engagement and improved clinical efficacy.

Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial.

BACKGROUND: IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems. OBJECTIVE: This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use. METHODS: A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics. RESULTS: The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58). CONCLUSIONS: IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877.

New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial.

PURPOSE: Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing density and biological healing within the aneurysm. While enhanced occlusion and durability has been shown for the first generation hydrogel coils, their use was limited by technical challenges. Less data is available regarding the second-generation hydrogel coils which have been designed to perform like bare platinum coils. METHODS: The new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) is a multicenter, randomized controlled trial that compares the health outcomes of the second-generation HydroCoil Embolic System with bare platinum coils in the endovascular intracranial aneurysms. The primary endpoint is aneurysm recurrence, defined as any progression on the Raymond aneurysm scale, over a 24-month follow-up period. Secondary endpoints include packing density, functional independence, procedural adverse events, mortality rate, initial complete occlusion, aneurysm retreatment, hemorrhage from treated aneurysm, and any aneurysm recurrence. RESULTS: Patient recruitment initiated in June 2011 and ended in January 2016 in 46 centers. Six hundred eligible patients diagnosed with an intracranial aneurysm, ruptured or unruptured were randomly assigned to one of the two treatment arms. CONCLUSION: The HEAT trial compares the durability, imaging, and clinical outcomes of the second-generation hydrogel versus bare platinum coils in the endovascular treatment of ruptured or unruptured intracranial aneurysms. The results of this trial may further inform current endovascular treatment guidelines based on observed long-term outcomes.

Statistical Methods Dictate the Estimated Impact of Body Mass Index on Major and Minor Complications After Total Joint Arthroplasty.

BACKGROUND: Elevated body mass index (BMI) is considered a risk factor for complications after THA and TKA. Stakeholders have proposed BMI cutoffs for those seeking arthroplasty. The research that might substantiate BMI cutoffs is sensitive to the statistical methods used, but the impact of the statistical methods used to model BMI has not been defined. QUESTIONS/PURPOSES: (1) How does the estimated postarthroplasty risk of minor and major complications vary as a function of the statistical method used to model BMI? (2) What is the prognostic value of BMI for predicting complications with each statistical method? METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2012, we investigated the impact of BMI on major and minor complication risk for THA and TKA. Analyses were weighted with covariate-balancing propensity scores to account for the differential rate of comorbidities across the range of BMI. We specified BMI in two ways: (1) categorically by World Health Organization (WHO) BMI classes; and (2) as a smooth, continuous variable using splines. Models of risk for major complications (deep surgical site infection [SSI], pulmonary embolism, stroke, cardiac arrest, myocardial infarction, wound disruption, implant failure, unplanned intubation, > 48 hours on a ventilator, acute renal insufficiency, coma, sepsis, reoperation, or mortality) and minor complications (superficial SSI, pneumonia, urinary tract infection, deep vein thrombosis, or peripheral nerve injury) were constructed and were adjusted for confounding variables known to correlate with complications (eg, American Society of Anesthesiologists classification). Results were compared for different specifications of BMI. Receiver operating characteristic (ROC) curves were compared to determine the additive prognostic value of BMI. RESULTS: The type of BMI parameterization leads to different assessments of risk of postarthroplasty complications for BMIs > 30 kg/m and < 20 kg/m with the spline specification showing better fit in all adjusted models (Akaike Information Criteria favors spline). Modeling BMI categorically using WHO classes indicates that BMI cut points of 40 kg/m for TKA or 35 kg/m for THA are associated with higher risks of major complications. Modeling BMI continuously as a spline suggests that risk of major complications is elevated at a cut point of 44 kg/m for TKA and 35 kg/m for THA. Additionally, in these models, risk does not uniformly increase with increasing BMI. Regardless of the method of modeling, BMI is a poor prognosticator for complications with area under the ROC curves between 0.51 and 0.56, false-positive rates of 96% to 97%, and false-negative rates of 2% to 3%. CONCLUSIONS: The statistical assumptions made when modeling the effect of BMI on postarthroplasty complications dictate the results. Simple categorical handling of BMI creates arbitrary cutoff points that should not be used to inform larger policy decisions. Spline modeling of BMI avoids arbitrary cut points and provides a better model fit at extremes of BMI. Regardless of statistical management, BMI is an inadequate independent prognosticator of risk for individual patients considering total joint arthroplasty. Stakeholders should instead perform comprehensive risk assessment and avoid use of BMI as an isolated indicator of risk. LEVEL OF EVIDENCE: Level III, diagnostic study.

IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety.

BACKGROUND: Digital mental health tools have tended to use psychoeducational strategies based on treatment orientations developed and validated outside of digital health. These features do not map well to the brief but frequent ways that people use mobile phones and mobile phone apps today. To address these challenges, we developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style. IntelliCare apps prioritize interactive skills training over education and are designed for frequent but short interactions. OBJECTIVE: The overall objective of this study was to pilot a coach-assisted version of IntelliCare and evaluate its use and efficacy at reducing symptoms of depression and anxiety. METHODS: Participants, recruited through a health care system, Web-based and community advertising, and clinical research registries, were included in this single-arm trial if they had elevated symptoms of depression or anxiety. Participants had access to the 14 IntelliCare apps from Google Play and received 8 weeks of coaching on the use of IntelliCare. Coaching included an initial phone call plus 2 or more texts per week over the 8 weeks, with some participants receiving an additional brief phone call. Primary outcomes included the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) for anxiety. Participants were compensated up to US $90 for completing all assessments; compensation was not for app use or treatment engagement. RESULTS: Of the 99 participants who initiated treatment, 90.1% (90/99) completed 8 weeks. Participants showed substantial reductions in the PHQ-9 and GAD-7 (P<.001). Participants used the apps an average of 195.4 (SD 141) times over the 8 weeks. The average length of use was 1.1 (SD 2.1) minutes, and 95% of participants downloaded 5 or more of the IntelliCare apps. CONCLUSIONS: This study supports the IntelliCare framework of providing a suite of skills-focused apps that can be used frequently and briefly to reduce symptoms of depression and anxiety. The IntelliCare system is elemental, allowing individual apps to be used or not used based on their effectiveness and utility, and it is eclectic, viewing treatment strategies as elements that can be applied as needed rather than adhering to a singular, overarching, theoretical model. TRIAL REGISTRATION: Clinicaltrials.gov NCT02176226; http://clinicaltrials.gov/ct2/show/NCT02176226 (Archived by WebCite at http://www.webcitation/6mQZuBGk1).

Vitamin D Insufficiency and Fracture Risk in Urban Children.

BACKGROUND: Investigation into the role of vitamin D in fractures in the pediatric population has been limited despite estimates that as many as 70% of American children have inadequate vitamin D levels (measured as 25-hydroxyvitamin D, 25(OH)D). The purpose of this study was to evaluate vitamin D's role in pediatric fracture risk by comparing 25(OH)D between fractured and nonfractured cohorts. METHODS: A 12-month prospective case-control study was completed in children aged 2 to 14 years in an urban, academic hospital. Sixty fractured children requiring conscious sedation or general anesthesia for management were compared with 60 nonfractured controls. All participants and their guardians were surveyed for low bone density risk factors, and total serum 25(OH)D was measured. Statistical analysis was completed using Student t tests, χ tests, analysis of variance, and logistic regression models. RESULTS: After controlling for age and daily sun exposure, lower total serum 25(OH)D was associated with higher fracture risk (odds ratio=0.94; 95% confidence interval, 0.90-0.99; P=0.023). In the fractured cohort, 6 (10%) patients were deficient (25(OH)D<20 ng/mL) and 33 (55%) were insufficient (25(OH)D, 20 to 30 ng/mL). Of the nonfractured population, 8 (13%) were deficient and 19 (32%) were insufficient. There were more insufficient patients in the fractured than in the nonfractured cohort (odds ratio=2.99; 95% confidence interval, 1.27-7.0; P=0.037). CONCLUSIONS: Higher fracture incidence is associated with serum 25(OH)D insufficiency. Hypovitaminosis D may place the pediatric population at increased risk for fracture. Consideration should be given to routine assessment of vitamin D in fractured children. LEVEL OF EVIDENCE: Prognostic level III-prospective case-control study.

Failure to Improve the Oxygenation Index Is a Useful Predictor of Therapy Failure in Acute Respiratory Distress Syndrome Clinical Trials.

OBJECTIVE: Acute respiratory distress syndrome trials powered for mortality require significant resources, limiting the number of evaluable therapies. Validation of intermediate endpoints would enhance the feasibility of testing novel acute respiratory distress syndrome therapies in pilot studies and potentially reduce the frequency of failed large clinical trials. We sought to determine whether a change in the oxygenation index over the first 7 days of acute respiratory distress syndrome could discriminate between therapies likely or unlikely to show benefit in larger clinical trials. DESIGN: A derivation cohort from three acute respiratory distress syndrome studies was used to estimate the 7-day change in oxygenation index. Receiver operating characteristic curves were used to calculate optimal thresholds and predictability of the change in oxygenation index for 28-day mortality and ventilator-free days. The thresholds were then validated in two cohorts. Then, for each individual acute respiratory distress syndrome study, the threshold 7-day oxygenation index change was tested as an outcome measure and compared with mortality and ventilator-free days as reported in the original study. SETTING: Medical ICUs. PATIENTS: Acute respiratory distress syndrome patients. INTERVENTIONS: Various. MEASUREMENTS AND MAIN RESULTS: Change in oxygenation index, 28-day mortality, and ventilator-free days. In the derivation cohort, the mean 7-day oxygenation index improved by 4.2 (± 11.7) in 28-day survivors compared with an increase of 2.4 (± 11.6) in 28-day nonsurvivors (p < 0.001). The mean 7-day oxygenation index decreased by 5.9 (± 8.4) in patients with more than 14 ventilator-free days, compared with a decrease of 1.9 (± 12.4) among those with less than 14 ventilator-free days (p = 0.001). The optimal 7-day oxygenation index threshold for predicting mortality was an increase of 1.71 and for predicting less than 14 ventilator-free days, a decrease of 2.34. When used as a surrogate endpoint, the optimal 7-day oxygenation index change closely approximated mortality and ventilator-free day outcomes in three Acute Respiratory Distress Syndrome Network studies used for the derivation cohort and a distinct study used for validation. The change in oxygenation index was a poor predictor of individual patient outcome. CONCLUSIONS: Failure to meet a threshold improvement in the oxygenation index over the first 7 days of therapy can be used to identify therapies unlikely to succeed in subsequent trials powered for mortality and ventilator-free days. By reducing trial time and costs, use of the 7-day oxygenation index change as an intermediate endpoint could increase the number of clinical trials of promising therapies for acute respiratory distress syndrome and reduce the number of large-scale trials of therapies unlikely to be of benefit.

Evaluation of benefit to educational material for photoprotection in those with cutaneous lupus erythematosus.

BACKGROUND: Photosensitivity (PS) in cutaneous lupus erythematosus (CLE) contributes to decreased quality of life (QoL). AIMS: We aimed to assess baseline knowledge about sun protection in persons with CLE and identify knowledge differences by race. Additionally, we aimed to determine the impact of a verbal educational intervention on photoprotection and CLE. METHODS: 31 adults with CLE were recruited from an academic-based dermatology clinic and completed a 17-item questionnaire about CLE and sun protection at three time points: pre- intervention (PR-I), post-intervention (PO-I), and 3-month phone follow up (3MF). An educational intervention using American Academy of Dermatology CLE and sun protection education materials was delivered between PR-I and PO-I. RESULTS: 31 subjects participated at PR-I and PO-I, and 25 subjects (81%) at 3MF. Baseline CLE-related PS and photoprotection knowledge differed significantly by race, with non-Caucasians demonstrating less knowledge (P= 0.049). Knowledge about sun exposure being linked to lupus increased from 81% to 97% (P=0.25) between PR-I and PO-I. At PR-I, 19% agreed that smoking was linked to lupus compared to 90% PO-I (P<0.001). There was increased knowledge of lupus risk for non-Caucasians, UV exposure indoors, and photo-avoidance during peak daytime (P<0.001). CONCLUSION: There is a baseline disparity in knowledge related to PS and photo protection in CLE by race. A short educational intervention successfully improved immediate lupus-related PS and sun exposure knowledge, but knowledge was not retained long-term. It appears educational materials must be improved.

Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

Perioperative Outcomes Following Unilateral Versus Bilateral Total Knee Arthroplasty.

Simultaneous bilateral total knee arthroplasty (SB-TKA) is potentially a cost saving manner of caring for patients with bilateral symptomatic knee arthritis. We performed a retrospective analysis using the 2010-2012 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) to evaluate the risk of perioperative complication following SB-TKA. Demographic characteristics, comorbidities, and 30-day complication rates were studied using a propensity score-matched analysis comparing patients undergoing unilateral TKA and SB-TKA. A total of 4489 patients met the inclusion criteria, of which 973 were SB-TKA. SB-TKA was associated with increased overall complications (P = 0.023), medical complications (P = 0.002) and reoperation (OR 2.12, P = 0.020). Further, total length of hospital stay (4.0 vs 3.4 days, P < 0.001) was significantly longer following bilateral surgery.

The Effect of BMI on 30 Day Outcomes Following Total Joint Arthroplasty.

Hip and knee arthroplasty (THA, TKA) are safe, effective procedures with reliable, reproducible outcomes. We aim to investigate obesity's effect on complications following arthroplasty surgery. Using the American College of Surgeons-National Surgical Quality Improvement Program database, 13,250 subjects were stratified into 5 groups based on BMI and matched for gender, age, surgery type and ASA class. Matched, multivariable generalized linear models adjusting for demographics and comorbidities demonstrated an association between elevated BMI and overall (P<0.001), medical (P=0.005), surgical complications (P<0.001), including superficial (P=0.019) and deep wound infection (P=0.040), return to OR (P=0.016) and time from OR to discharge (P=0.003). Elevated BMI increases risk for post-operative complications following total joint arthroplasty.

Can the American College of Surgeons Risk Calculator Predict 30-Day Complications After Knee and Hip Arthroplasty?

Accurate risk stratification of patients undergoing total hip (THA) and knee (TKA) arthroplasty is essential in the highly scrutinized world of pay-for-performance, value-driven healthcare. We assessed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) surgical risk calculator's ability to predict 30-day complications using 1066 publicly-reported Medicare patients undergoing primary THA or TKA. Risk estimates were significantly associated with complications in the categories of any complication (P = .005), cardiac complication (P < .001), pneumonia (P < .001) and discharge to skilled nursing facility (P < .001). However, predictability of complication occurrence was poor for all complications assessed. To facilitate the equitable provision and reimbursement of patient care, further research is needed to develop accurate risk stratification tools in TKA and THA surgery.

Pancreatic enzyme replacement therapy dosing and nutritional outcomes in children with cystic fibrosis.

OBJECTIVES: To utilize the Cystic Fibrosis Foundation Patient Registry to evaluate whether pancreatic enzyme dose is associated with better nutritional status as measured by average body mass index (BMI) percentile. STUDY DESIGN: A retrospective analysis of the Cystic Fibrosis Foundation Patient Registry from 2005-2008 was performed. The final analysis included 42 561 patient visits from 14 482 patients 2-20 years of age taking pancreatic enzyme replacement therapy from 179 programs. Cystic fibrosis care programs were assigned to quartiles based on adjusted mean patient BMI percentiles. Differences in median lipase dose between programs in the highest and lowest BMI quartiles were examined using a mixed effects model that adjusted for individual patient BMI, age, race, ethnicity, forced expiratory volume in 1 second percent, acid-blocker use, presence of Pseudomonas aeruginosa, nutritional supplement use, growth hormone use, and diagnosis of cystic fibrosis-related diabetes. RESULTS: A significant difference in median enzyme dose existed between the highest and lowest BMI quartiles. Multivariable analysis demonstrated the effect persisted after adjustment for covariates. Highest quartile programs had a median enzyme dose of 1755 lipase units/kg/meal compared with 1628 lipase units/kg/meal for lowest quartile programs. CONCLUSION: Patients attending US cystic fibrosis programs achieving highest nutritional outcomes, measured by mean BMI percentile, have higher enzyme dosing than those attending programs at lower performance levels. Further randomized clinical trials are necessary to determine the role of enzyme dose in improving nutritional outcomes.

Comorbid anxiety as a differential treatment predictor for telephone versus face-to-face administered cognitive behavioral therapy for depression.

BACKGROUND: The present study examines the role of comorbid anxiety on depression outcomes for those receiving cognitive behavioral therapy (CBT) for depression by telephone (T-CBT) or face-to-face (FtF-CBT). METHODS: Three hundred twenty-five participants were randomized to T-CBT or FtF-CBT. Comorbid anxiety was measured using the Mini International Neuropsychiatric Interview and Generalized Anxiety Disorder 7. Depression was measured using the Hamilton Rating Scale for Depression and Patient Health Questionnaire 9. RESULTS: A hierarchical model including the two-way interaction of treatment assignment and anxiety status indicated a significant effect for all outcome variables (Ps < .05). Post hoc t tests indicated T-CBT participants with comorbid anxiety disorders had significantly higher symptom severity over time compared to their T-CBT counterparts without anxiety (Ps < .001) and FtF-CBT counterparts with comorbid anxiety (Ps < .003). There were no significant differences in outcomes between those with and without comorbid anxiety disorders receiving FtF-CBT, or between T-CBT and FtF-CBT among those without comorbid anxiety disorders. CONCLUSIONS: The findings indicate that the presence of baseline anxiety impacts the overall effect of T-CBT for the treatment of depression.