Treatment Effect Estimates From Pilot Trials Are Unreliable.

Context: The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate different approaches to data collection or outcome measurement. However, pilot trials are unreliable for assessing treatment efficacy due to the statistical phenomenon called sampling variability.

Advancing workforce diversity by leveraging the Clinical and Translational Science Awards (CTSA) program.

Clinical trials continue to disproportionately underrepresent people of color. Increasing representation of diverse backgrounds among clinical research personnel has the potential to yield greater representation in clinical trials and more efficacious medical interventions by addressing medical mistrust. In 2019, North Carolina Central University (NCCU), a Historically Black College and University with a more than 80% underrepresented student population, established the Clinical Research Sciences Program with support from the Clinical and Translational Science Awards (CTSA) program at neighboring Duke University.

A Visual Tool to Help Develop a Statistical Analysis Plan for Randomized Trials in Palliative Care.

Collaboration with a statistician about the design of a statistical analysis plan can be enhanced by illustrating how statisticians conceptualize their task. This conceptualization can be represented by a directed acyclic graph (DAG), which illustrates the statistician's approach and also provides an actionable tool to assist in the development of the plan.

Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE): A randomized trial to improve post myocardial infarction management.

Objective: We evaluated the impact of a low intensity web-based and intensive nurse-administered intervention to reduce systolic blood pressure (SBP) among patients with prior MI.

Methods: Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE) was a three-arm trial. Patients were randomized to 1) post-MI education-only; 2) nurse-administered telephone program; or 3) web-based interactive tool.

Impact of lifestyle Intervention on branched-chain amino acid catabolism and insulin sensitivity in adolescents with obesity.

Unlabelled: Insulin resistance in adolescents with obesity associates with a sex-dependent metabolic 'signature' comprising branched-chain amino acids (BCAAs), glutamate and C3/C5 acylcarnitines (C3/C5), implicating altered flux through BCAA catabolic pathways. Here, we investigated the effects of lifestyle intervention on BCAA catabolism and insulin sensitivity. We hypothesized (1) weight reduction and improved insulin sensitivity associate with enhanced BCAA catabolism; (2) baseline BCAAs and their metabolic by-products predict changes in weight and insulin sensitivity during lifestyle intervention.

Methods for training collaborative biostatisticians.

The emphasis on team science in clinical and translational research increases the importance of collaborative biostatisticians (CBs) in healthcare. Adequate training and development of CBs ensure appropriate conduct of robust and meaningful research and, therefore, should be considered as a high-priority focus for biostatistics groups. Comprehensive training enhances clinical and translational research by facilitating more productive and efficient collaborations.

Epidemiologic Trends in Clostridioides difficile Infections in a Regional Community Hospital Network.

Importance: Clostridioides difficile infection (CDI) remains a leading cause of health care facility-associated infection. A greater understanding of the regional epidemiologic profile of CDI could inform targeted prevention strategies.

Objectives: To assess trends in incidence of health care facility-associated and community-acquired CDI among hospitalized patients over time and to conduct a subanalysis of trends in the NAP1 strain of CDI over time.

A multimodal international collaborative clinical research training program in China.

: There is a strong need to include training of research methods in training programs for physicians. International clinical research training programs (CRTP) that comprehensively introduce the methodology of clinical research and combined with practice should be a priority. However, few studies have reported a multimodal international CRTP that provides clinicians with an introduction to the quantitative and methodological principles of clinical research.

A New Stress Test for Knee Joint Cartilage.

Cartilage metabolism-both the synthesis and breakdown of cartilage constituents and architecture-is influenced by its mechanical loading. Therefore, physical activity is often recommended to maintain cartilage health and to treat or slow the progression of osteoarthritis, a debilitating joint disease causing cartilage degeneration. However, the appropriate exercise frequency, intensity, and duration cannot be prescribed because direct in vivo evaluation of cartilage following exercise has not yet been performed.

The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.

Background: Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.

Objective: This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.

Methods: The CITY trial tested two 24-month weight loss interventions.

Indications for and outcomes of therapeutic plasma exchange after cardiac transplantation: A single center retrospective study.

Introduction: Limited data are available describing indications for and outcomes of therapeutic plasma exchange (TPE) in cardiac transplantation.

Methods: In a retrospective study of patients who underwent cardiac transplantation at Duke University Medical Center from 2010 to 2014, we reviewed 3 TPE treatment patterns: a Single TPE procedure within 24 h of transplant; Multiple TPE procedures initiated within 24 h of transplant; and 1 or more TPE procedures beginning >24 h post-transplant. Primary and secondary outcomes were overall survival (OS) and TPE survival (TS), respectively.

Statistical competencies for medical research learners: What is fundamental?

Introduction: It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from 'fundamental' (necessary for all) to 'specialized' (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized.

Outcome by Gender in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere Weight Management Program.

Background: Few evaluations of the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (MOVE!) weight management program have assessed 6-month weight change or factors associated with weight change by gender.

Materials And Methods: Analysis of administrative data from a national sample of veterans in the VA MOVE!

Results: A total of 62,882 participants were included, 14.6% were women.

The Symptom Experience in Rectal Cancer Survivors.

Context: As the number of rectal cancer survivors grows, it is important to understand the symptom experience after treatment. Although data show that rectal cancer survivors experience a variety of symptoms after diagnosis, little has been done to study the way these symptoms are grouped and associated.

Objectives: To determine symptom prevalence and intensity in rectal cancer survivors and if clusters of survivors exist, who share similar symptom-defined survivor subgroups that may vary based on antecedent variables.

Mobile health devices: will patients actually use them?

Although mobile health (mHealth) devices offer a unique opportunity to capture patient health data remotely, it is unclear whether patients will consistently use multiple devices simultaneously and/or if chronic disease affects adherence. Three healthy and three chronically ill participants were recruited to provide data on 11 health indicators via four devices and a diet app. The healthy participants averaged overall weekly use of 76%, compared to 16% for those with chronic illnesses.

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

Objective: To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.

Methods: Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.

Results: The 365 randomized participants had mean baseline BMI of 35 kg/m(2) .

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

Background/aims: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible.

Impact of Smoking Cessation on Subsequent Pain Intensity Among Chronically Ill Veterans Enrolled in a Smoking Cessation Trial.

Context: Prior cross-sectional studies have reported greater pain intensity among persistent smokers compared with nonsmokers or former smokers; yet, few prospective studies have examined how smoking abstinence affects pain intensity.

Objectives: To determine the impact of smoking cessation on subsequent pain intensity in smokers with chronic illness enrolled in a smoking cessation trial.

Methods: We recruited veteran smokers with chronic illness (heart disease, cancer, chronic obstructive pulmonary disease, diabetes, or hypertension) for a randomized controlled smoking cessation trial and prospectively examined pain intensity and smoking status.

Willingness of Patients to Use Computers for Health Communication and Monitoring Following Myocardial Infarction.

We describe the computer use characteristics of 406 post-myocardial infarction (MI) patients and their willingness to engage online for health communication and monitoring. Most participants were computer users (n = 259; 63.8%) and half (n = 209; 51.

Physician Non-adherence to Colonoscopy Interval Guidelines in the Veterans Affairs Healthcare System.

Background & Aims: Colonoscopy can decrease colorectal cancer (CRC) mortality, although performing this procedure more frequently than recommended could increase costs and risks to patients. We aimed to determine rates and correlates of physician non-adherence to guidelines for repeat colonoscopy screening and polyp surveillance intervals.

Methods: We performed a multi-center, retrospective, observational study using administrative claims, physician databases, and electronic medical records (EMR) from 1455 patients (50-64 y old) who underwent colonoscopy in the Veterans Affairs healthcare system in fiscal year 2008.

Patient-provider communication, self-reported medication adherence, and race in a postmyocardial infarction population.

Objectives: Our objectives were to: 1) describe patient-reported communication with their provider and explore differences in perceptions of racially diverse adherent versus nonadherent patients; and 2) examine whether the association between unanswered questions and patient-reported medication nonadherence varied as a function of patients' race.

Methods: We conducted a cross-sectional analysis of baseline in-person survey data from a trial designed to improve postmyocardial infarction management of cardiovascular disease risk factors.

Results: Overall, 298 patients (74%) reported never leaving their doctor's office with unanswered questions.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

Background: The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults.

Association between perceived life chaos and medication adherence in a postmyocardial infarction population.

Background: The benefits of medication adherence to control cardiovascular disease (CVD) are well defined, yet multiple studies have identified poor adherence. The influence of life chaos on medication adherence is unknown. Because this is a novel application of an instrument, our preliminary objective was to understand patient factors associated with chaos.