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/m2 (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/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg CI −3.17, −0.67, P = 0.003), but not at 12 and 24 months.
Conclusions
Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.
A New Stress Test for Knee Joint Cartilage Paranjape, Chinmay S; Cutcliffe, Hattie C; Grambow, Steven C ...
Scientific reports,
02/2019, Letnik:
9, Številka:
1
Journal Article
Recenzirano
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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. To address this gap in knowledge, we developed a cartilage stress test to measure the in vivo strain response of healthy human subjects' tibial cartilage to walking exercise. We varied both walk duration and speed in a dose-dependent manner to quantify how these variables affect cartilage strain. We found a nonlinear relationship between walk duration and in vivo compressive strain, with compressive strain initially increasing with increasing duration, then leveling off with longer durations. This work provides innovative measurements of cartilage creep behavior (which has been well-documented in vitro but not in vivo) during walking. This study showed that compressive strain increased with increasing walking speed for the speeds tested in this study (0.9-2.0 m/s). Furthermore, our data provide novel measurements of the in vivo strain response of tibial cartilage to various doses of walking as a mechanical stimulus, with maximal strains of 5.0% observed after 60 minutes of walking. These data describe physiological benchmarks for healthy articular cartilage behavior during walking and provide a much-needed baseline for studies investigating the effect of exercise on cartilage health.
Health effects associated with particulate matter (PM) show seasonal variations. We hypothesized that these heterogeneous effects may be attributed partly to the differences in the elemental ...composition of PM. Normal human bronchial epithelial (NHBE) cells and alveolar macrophages (AMs) were exposed to equal mass of coarse PM with aerodynamic diameter of 2.5-10 μm ( PM2.5-10), fine ( PM2.5), and ultrafine (${\rm PM}_{<0.1}$) ambient PM from Chapel Hill, North Carolina, during October 2001 (fall) and January (winter), April (spring), and July (summer) 2002. Production of interleukin (IL)-8, IL-6, and reactive oxygen species (ROS) was measured. Coarse PM was more potent in inducing cytokines, but not ROSs, than was fine or ultrafine PM. In AMs, the October coarse PM was the most potent stimulator for IL-6 release, whereas the July PM consistently stimulated the highest ROS production measured by dichlorofluorescein acetate and dihydrorhodamine 123 (DHR). In NHBE cells, the January and the October PM were consistently the strongest stimulators for IL-8 and ROS, respectively. The July PM increased only ROS measured by DHR. PM had minimal effects on chemiluminescence. Principal-component analysis on elemental constituents of PM of all size fractions identified two factors, Cr/Al/Si/Ti/Fe/Cu and Zn/As/V/Ni/Pb/Se, with only the first factor correlating with IL-6/IL-8 release. Among the elements in the first factor, Fe and Si correlated with IL-6 release, whereas Cr correlated with IL-8 release. These positive correlations were confirmed in additional experiments with PM from all 12 months. These results indicate that elemental constituents of PM may in part account for the seasonal variations in PM-induced adverse health effects related to lung inflammation.
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. Patients had no prior diagnosis of CRC or inflammatory bowel disease, and had not undergone colonoscopy examinations in the previous 10 years. We compared EMR-documented, endoscopist-recommended intervals for colonoscopies with intervals recommended by the 2008 Multi-Society Task Force guidelines. Results The overall rate of non-adherence to guideline recommendations was 36% and ranged from 3% to 80% among facilities. Non-adherence was 28% for patients who underwent normal colonoscopies, but 45%−52% after colonoscopies that identified hyperplastic or adenomatous polyps. Most of all recommendations that were not followed recommended a shorter surveillance interval. In adjusted analyses, non-adherence was significantly higher for patients whose colonoscopies identified hyperplastic (odds ratio OR = 3.1; 95% CI, 1.7–5.5) or high-risk adenomatous polyps (OR = 3.0; 95% CI, 1.2−8.0), compared to patients with normal colonoscopy examinations, but not for patients with low-risk adenomatous polyps (OR = 1.8; 95% CI, 0.9–3.7). Nonadherence was also associated with bowel preparation quality, geographic region, Charlson comorbidity score, and colonoscopy indication. Conclusions In a managed care setting with salaried physicians, endoscopists recommend repeat colonoscopy sooner than guidelines for more than one third of patients. Factors associated with non-adherence to guideline recommendations were colonoscopy findings, quality of bowel preparation, and geographic region. Targeting endoscopist about non-adherence to colonoscopy guidelines could reduce overuse of colonoscopy and associated healthcare costs.
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.
In this tutorial we use computer simulation to demonstrate the influence of sampling variability on efficacy estimates from pilot trials, illustrating why pilot trial designs should not be used to evaluate whether a treatment is promising or not.
We simulate a 2-arm parallel group trial (N=20 per group) with a survival outcome as an example. Simulations are done under two scenarios: 1) the treatment is efficacious at the level of a hypothetical minimum clinically important difference (hazard ratio HR = 0.75); and 2) the treatment is not efficacious (HR=1).
As expected, in both simulated scenarios the range of observed results is distributed around the true treatment effect, HR=0.75 or HR=1. Importantly, ∼20% of trials simulated under scenario 1 incorrectly suggest the treatment may be harmful (HR > 1). Under scenario 2, half of the simulated studies incorrectly suggest the treatment is beneficial.
Treatment effect estimates from pilot trials should not be used to make future development decisions regarding a novel therapy because of the high risk of misleading conclusions.
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.
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. The study was conducted 2009–2013.
Participants (n = 415) had a mean age of 61 years (standard deviation SD, 11). Relative to the education-only group, the 12-month differential improvement in SBP was − 3.97 and − 3.27 mmHg for nurse-administered telephone and web-based groups, respectively. Neither were statistically significant. Post hoc exploratory subgroup analyses found participants who received a higher dose (>12 encounters) in the nurse-administered telephone intervention (n = 60; 46%) had an 8.8 mmHg (95% CI, 0.69, 16.89; p = 0.03) differential SBP improvement versus low dose (<11 encounters; n = 71; 54%). For the web-based intervention, those who had higher dose (n = 73; 53%; >1 web encounter) experienced a 2.3 mmHg (95% CI, −10.74, 6.14; p = 0.59) differential SBP improvement versus low dose (n = 65; 47%).
The main effects were not statistically significant.
Completing the full dose of the intervention may be essential to experience the intervention effect.
The unique identifier is NCT00901277 (http://www.clinicaltrials.gov/ct2/show/NCT00901277?term=NCT00901277&rank=1).
•Patients who experience myocardial infarction (MI) have elevated risk for second MI or stroke.•We evaluated web-based vs. intensive nurse-administered approach to reduce SBP.•Highly engaged participants in nurse-delivered intervention experienced a greater SBP reduction.
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. Device adherence declined across all participants during the study. Patients with chronic illnesses, with arguably the most to benefit from advanced (or increased) monitoring, may be less likely to adopt and use these devices compared to healthy individuals. Results suggest device fatigue may be a significant problem. Use of mobile technologies may have the potential to transform care delivery across populations and within individuals over time. However, devices may need to be tailored to meet the specific patient needs.
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. This program was designed to increase exposure of students from diverse educational, racial, and ethnic backgrounds to the field of clinical research, with a special focus on health equity education. In the first year, the program graduated 11 students from the two-semester certificate program, eight of whom now hold positions as clinical research professionals. This article describes how leveraging the CTSA program helped NCCU build a framework for producing a highly trained, competent, and diverse workforce in clinical research responsive to the call for increased diversity in clinical trial participation.
Abstract 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. Participants ( n = 380) were asked to rate their pain in the past week from 0 to 10 at baseline and the five-month follow-up. The primary outcome measure was self-reported pain intensity at the five-month follow-up survey. Self-reported smoking status was categorized as an abstainer if patients reported no cigarettes in the seven days before the follow-up survey. Results In unadjusted analyses, abstainers reported significantly lower pain levels at the five-month follow-up compared with patients who continued to smoke (parameter estimate = −1.07; 95% CI = −1.77, −0.36). In multivariable modeling, abstaining from cigarettes was not associated with subsequent pain intensity at five-month follow-up (parameter estimate = −0.27; 95% CI = −0.79, 0.25). Conclusion Participants who were classified as abstainers did not report significantly different levels of pain intensity than patients who continued to smoke. Future studies should expand on our findings and monitor pain intensity in smoking cessation trials. Trial Registration ClinicalTrials.gov NCT00448344.
The Symptom Experience in Rectal Cancer Survivors Gosselin, Tracy K., RN, PhD, AOCN; Beck, Susan, APRN, PhD, AOCN, FAAN; Abbott, David H., MS, MCS ...
Journal of pain and symptom management,
11/2016, Letnik:
52, Številka:
5
Journal Article
Recenzirano
Odprti dostop
Abstract Context As the number of rectal cancer survivors grows, it's important to understand the symptom experience posttreatment. While data show that rectal cancer survivors experience a variety ...of symptoms post 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 upon antecedent variables. Methods A secondary analysis of the Cancer Care and Outcomes Research and Surveillance (CanCORS) database was undertaken. Cluster analysis was performed on 15 month post diagnosis data to form posttreatment survivor subgroups, these were examined for differences in demographic and clinical characteristics. Data were analyzed using cluster analysis, Chi-Square, and analysis of variance. Results A total of 275 rectal cancer survivors were included who had undergone chemotherapy, radiation therapy and surgery. Most frequently reported symptoms included feeling “worn out” (87%), feeling “tired” (85%), and “trouble sleeping” (66%). Four symptom defined survivor subgroups (minimally symptomatic n = 40, tired & trouble sleeping n = 138, moderate symptoms n = 42, and highly symptomatic n = 55) were identified with symptom differences existing amongst each subgroup. Age and being married/partnered were the only two antecedents found to differ across subgroups. Conclusion This study documents differences in the symptom experience posttreatment. The identification of survivor subgroups allows researchers to further investigate tailored, supportive care strategies to minimize ongoing symptoms in those with the greatest symptom burden.
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