Christianne Joy Lane

Insufficient recruitment of participants remains a critical roadblock to successful clinical research, particularly clinical trials. Social media provide new ways for connecting potential participants with research opportunities. Researchers suggest that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. This pilot study aimed to examine the feasibility and impact of using Twitter monitoring data (ie, user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in Los Angeles County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. We will conduct a mixed-methods interrupted time series study design with a before-and-after social media recruitment intervention. On the basis of a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across 6 disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the University of Southern California (USC) Norris Comprehensive Cancer Center. We will monitor messages about these 6 cancer conditions posted by Twitter users in Los Angeles County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes-feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials-will be assessed using qualitative interviews and the 4-point Likert scale and by calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of enrollees in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. This study has been funded by the National Center for Advancing Translational Science through a Clinical and Translational Science Award. Study approval was obtained from the clinical investigations committee at USC Norris and the institutional review board at USC. Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants across 6 cancer disease types. We will shed light on the acceptance of the social media intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations. ClinicalTrials.gov NCT03408561; https://clinicaltrials.gov/ct2/show/NCT03408561 (Archived by WebCite at http://www.webcitation.org/72LihauzW). RR1-10.2196/9762.

BACKGROUND Insufficient recruitment of participants remains a critical roadblock to successful clinical research, in particular clinical trials. Social media (SM) provides new ways for connecting potential participants with research opportunities. Researchers suggested that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. OBJECTIVE The objective of this pilot study is to examine the feasibility and impact of using Twitter monitoring data (i.e., user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in LA County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. METHODS We will conduct a mixed-methods interrupted time series study design with a before and after SM recruitment intervention. Based on a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across six disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the USC Norris Comprehensive Cancer Center (USC Norris). We will monitor messages about the six cancer conditions posted by Twitter users in LA County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes include, first, feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials, which will be assessed using qualitative interviews and 4-point Likert scale, and calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of people who enrolled in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. RESULTS This study has been funded by the National Center for Advancing Translational Science (NCATS) through a Clinical and Translational Science Award (CTSA) award. Study approval was obtained from the Clinical Investigations Committee (CIC) at USC Norris and the Institutional Review Board (IRB) at USC. Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. CONCLUSIONS This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants center across six cancer disease types. We will shed light on the acceptance of the SM intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite, randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations.

US states have offered billions of dollars in film industry incentives, but despite the popularity of these incentives, the effects of these investments are unclear. This study adopts an ecological framework and tests the hypothesis that film incentives are effective when they produce changes in the composition of organizational communities. The results of longitudinal linear mixed-effects models, centred around incentive introduction in each state, show that above the impact of their dollar value, the simple presence of economic incentives, organizational diversity and the presence of dominant organizational populations are associated with increases in filming, employment and new establishments. Theoretical and policy implications are discussed.

Objectives: Surgical reconstruction of the anterior cruciate ligament (ACL) is essential for those who wish to resume athletic activity following ACL rupture. However, the trauma of surgical repair and post-operative immobility can exacerbate muscle loss and strength. This study investigated the effect of perioperative testosterone administration on lean mass recovery following ACL reconstruction in men. The effects of testosterone on leg strength and clinical outcome scores were also investigated. We hypothesized that testosterone would increase lean mass and leg strength, and improve clinical outcome scores 6 and 12 weeks after surgery to a greater degree than placebo. Methods: This was a randomized, controlled, double blinded clinical trial comparing testosterone and placebo for recovery from ACL repair. Thirteen male subjects scheduled for ACL reconstruction were randomized into two groups, testosterone (n=6) and placebo (n=7). Participants in the testosterone group received 200 mg of testosterone administration weekly for 8 weeks starting 2 weeks prior to surgery. Participants in the control group received a saline placebo intramuscularly following the same schedule. Both intervention groups underwent standard physical rehabilitation. The primary outcome was change in total lean body mass at 6 and 12 weeks, measured by whole-body dual-energy x-ray absorptiometry. Secondary outcomes were extensor muscle strength measured using a Cybex Dynamometer, and the Tegner Activity Score (TAS) and Knee Injury and Osteoarthritis Outcome Score (KOOS). Results: Total testosterone levels in the blood increased from baseline to an average of 860 ± 254 ng/dL by 1 day prior to surgery and 746 ± 173 ng/dL at 6 weeks post-surgery for the testosterone group. The differences in serum testosterone levels between the placebo and testosterone groups at 1 day prior to surgery and 6 weeks post-surgery were both statistically significant (p<0.001). We found that testosterone increased lean mass by 2.8 ± 1.7 kg from baseline at 6 weeks following surgery, while the placebo group had a decrease in lean muscle mass of 0.1 ± 1.5 kg (p=0.01) (Figure 1). Extensor strength of the non-injured leg had a greater increase from baseline in the testosterone group (20.8 ± 25.6 Nm) than the placebo group (-21.4 ± 36.7 Nm) at 12 weeks (p=0.02). There were no significant differences in injured leg strength or clinical outcome scores throughout the study period. Conclusion: Despite a catabolic environment, acute testosterone supplementation increased lean mass 6 weeks after ACL reconstruction, and strength of the non-injured leg 12 weeks after surgery, to a greater degree than placebo. These results suggest that testosterone may be a novel, useful adjunct to physical therapy for knee surgery rehabilitation by offsetting perioperative muscle loss from surgery and immobility. Larger studies are now necessary to elucidate the effects of perioperative testosterone administration on injured leg strength and clinical outcomes following surgery.

Objectives: To assess whether a telephone-based breastfeeding intervention delivered by lactation educators influenced exclusive breastfeeding rates among low-income Hispanic women in the USA. Design: Randomised two-group design. Setting: Pregnant low-income Hispanic women (298) were recruited from community health clinics in Los Angeles County (USA) and randomly assigned to either a control or an intervention group. Methods: Data relating to the factors associated with breastfeeding were collected during the third trimester. Breastfeeding outcome data were collected at 72 hours, 1 month, 3 months and 6 months postpartum. Results: There were no differences between the groups in rates of breastfeeding initiation. There was a significant difference in the duration of exclusive breastfeeding among participants during the infant’s first week of life. While not significant, after controlling for covariates and intent to breastfeed at third trimester, the duration of exclusive breastfeeding among all participants was, on average, longer for intervention group mothers than control group mothers. Additionally, the intervention group mothers were more likely to report exclusive and only breastfeeding at all data points compared to the control group and less likely to discontinue breastfeeding. Conclusion: Findings from this study suggest that telephone-based breastfeeding interventions delivered by a lactation educator show promise as a cost-effective strategy for improving both the quantity and the duration of breastfeeding among low-income Hispanic women in the USA. Intervention group mothers not only sustained breastfeeding for a longer durations but also provided their infants with greater amounts of breast milk over these longer durations.

There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance.

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.