Project description:The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.
Project description:BackgroundThe Healthy Communities Study (HCS) was a national study of community programs and policies that aimed to address childhood obesity; it necessitated recruitment of a large sample of children from communities throughout the United States.ObjectiveThe HCS aimed to complete visits with an average of 45 children and 12 key informants from at least 120 communities, diverse with respect to region of the country, urbanicity, socioeconomic status, race, ethnicity and intensity of community programs and policies that aim to address childhood obesity.MethodsPurchased address lists were utilized to select households for recruitment during Wave 1 of the study, and recruitment of families through schools was employed for Wave 2.ResultsThe HCS successfully obtained approval from 149 school districts and 478 schools in 130 communities, recruited 5138 families, and interviewed 1421 key informants to allow for characterization of overall intensity of obesity prevention/treatment efforts in each community.ConclusionsLessons learned are presented. Future studies should plan for inclusion of the following in development of recruitment strategies: literature review, formative research, pilot testing, and ongoing monitoring and adjustment.
Project description:BACKGROUND:Historical changes in the nature of sedentary activities have been observed in other countries, but it is not clear if similar trends exist in Canada. It is also unclear how changes in the measurement of sedentary behaviour affects national estimates. Our objective is to document all sources and measures of sedentary behaviour from Canadian, nationally representative surveys, and report on selected estimates of time spent in sedentary activities. Lessons learned can benefit the wider international surveillance community. METHODS:We describe and document all data sources of sedentary behaviour at the national level in Canada, and report on selected prevalence data from repeated cross-sectional surveys. We summarize amounts of total device-assessed sedentary time and self-reported sedentary activities (e.g., passive travel, leisure television, computer, video games, screen, and reading) by age group over time. RESULTS:Nineteen national surveys were identified. Changes in questions and/or response categories precluded direct assessment of trends over time for some measures; however, certain trends were observed. Accelerometer-measured sedentary time, leisure reading (among those < 50 years) and television/video viewing in younger age groups have remained relatively stable (with a possible slight decline in television/video viewing). Time spent in passive travel and leisure computer and electronic device use appears to have increased. Television and video viewing appears to have increased in older adults while their leisure reading appears to have fallen. CONCLUSIONS:Changes in measurement of sedentary behaviour can affect estimates and reduce comparability over time. Total leisure screen use appears to have increased over time, reflecting the ways in which Canadians spend their free time and technological advances. The main public health message is the need for continued efforts to reduce leisure screen use, especially among youth and older adults.
Project description:Registered nurses are an essential workforce group across the globe. They use their expertise and skill sets every day in clinical practice to protect, promote, and advocate on behalf of patients and families under their care. In this article we discuss the physical, emotional, and moral stresses that nurses are experiencing in their day-to-day practice settings created by the novel coronavirus. We consider the demands placed on nurses by unexpected patient surges within hospital environments and inadequate personal protective equipment and other critical resources, challenging nurses’ ability to meet their professional and ethical obligations. We also share our thoughts on supporting nurses and others now, and ideas for needed healing for both individuals and organizations as we move forward. Finally, we argue for the need for substantive reform of institutional processes and systems that can deliver quality care in the future when faced with another devastating humanitarian and public health crises. “Nursing is not just evaluating patient symptoms, dressing wounds, lab work, and value-based care—nursing impacts the soul in each of us. In our weakest places, in our most vulnerable areas of life, nursing has literally opened the door to the most painful, but most rewarding moments in the lives of others. The dying, the hurt, the raw, emotional places of life: nurses have the privilege to walk in these spaces and provide a comforting hand, a compassionate touch, and a life-changing presence.”—Love et al., 2021, 87
Project description:An important aim of clinical prediction models is to positively impact clinical decision making and subsequent patient outcomes. The impact on clinical decision making and patient outcome can be quantified in prospective comparative-ideally cluster-randomized-studies, known as 'impact studies'. However, such impact studies often require a lot of time and resources, especially when they are (cluster-)randomized studies. Before envisioning such large-scale randomized impact study, it is important to ensure a reasonable chance that the use of the prediction model by the targeted healthcare professionals and patients will indeed have a positive effect on both decision making and subsequent outcomes. We recently performed two differently designed, prospective impact studies on a clinical prediction model to be used in surgical patients. Both studies taught us new valuable lessons on several aspects of prediction model impact studies, and which considerations may guide researchers in their decision to conduct a prospective comparative impact study. We provide considerations on how to prepare a prediction model for implementation in practice, how to present the model predictions, and how to choose the proper design for a prediction model impact study.
Project description:BACKGROUND:Catheter-tissue contact force is an important factor influencing lesion size and efficacy and thereby potential for arrhythmia recurrence following accessory pathway (AP) radiofrequency ablation. We aim to evaluate adequacy and perception of catheter contact on the tricuspid and mitral annuli. METHODS:Data were collected from 42 patients undergoing catheter ablation. Operators were blinded to contact force information and reported perceived contact (poor, moderate, or good) while positioning the catheter at four tricuspid annular sites (12, 9, 6 and 4 o'clock positions; abbreviated as TA12, TA9, TA6 and TA4) and three mitral annular sites (3, 5 and 7 o'clock positions; abbreviated as MA3, MA5 and MA7) through long vascular sheaths. RESULTS:The highest and lowest mean contact forces were obtained at MA7 (13.3 ± 1.7 g) and TA12 (3.6 g ± 1.3 g) respectively. Mean contact force on tricuspid annulus (6.1 g ± 0.9 g) was lower than mitral annulus (9.8 ± 0.9 g) locations (p = 0.0036), with greater proportion of sites with <10 g contact force (81.7% vs 60.4%; p = 0.0075). Perceived contact had no impact on measured mean contact force for both mitral and tricuspid annular positions (p = 0.959 and 0.671 respectively). There was correlation of both impedance and atrial electrogram amplitude with contact force, though insufficient to be clinically applicable. CONCLUSION:A high proportion of annular catheter applications have low contact force despite being performed with long vascular sheaths in the hands of experienced operators. In addition, there was no impact of operator perceived contact force on actual measured contact force. This may carry implications for success of AP ablation.
Project description:Despite the increasing popularity of translation research, few studies have described the process and challenges involved in implementing a translation study. The main objective was to determine whether a multi-component group behavioral intervention could be successfully translated from an academic setting into the community health system of federally qualified health centers (FQHCs) funded by the Health Resources and Services Administration (HRSA) in Miami, NY, and NJ. Key challenges and "lessons learned" from the dissemination and implementation process for the SMART/EST (Stress Management And Relaxation Training/Emotional Supportive Therapy) Women's Project (SWP) III in low-resource primary care settings are described. The Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) model served as the theoretical framework for the translation of the study. This study outlines several essential factors related to Glasgow's RE-AIM model that need to be considered in order to accomplish successful translation of evidence-based interventions from traditional academia to "real-world" community health center settings.
Project description:In the past 3 years, we have witnessed the completion of four randomized phase III studies in neuroendocrine tumors and the approval of two new drugs, everolimus and sunitinib, for the treatment of patients with well-differentiated pancreatic neuroendocrine tumors. These studies demonstrate a shift from case series and single-arm studies toward prospective, randomized controlled clinical trials and evidence-based therapy in the neuroendocrine tumor field. However, the clinical development of these agents also highlights the potential challenges awaiting other new drugs in this area. Herein, we discuss the strengths and weaknesses of the most recent phase II and phase III neuroendocrine tumor studies and discuss how limitations inherent in current trial design can lead to potential pitfalls. We also discuss how trial design can be improved, with the hope of increasing the number of drugs successfully developed to treat patients with neuroendocrine tumors.
Project description:The National Institutes of Health (NIH) established the Rare Diseases Clinical Research Network to address the unique challenges of performing research on rare diseases. The Urea Cycle Disorders Consortium (UCDC) was one of the original ten consortia established. The UCDC represents a unique partnership among clinicians, patients, and the NIH with a primary goal of increasing the development of therapeutics that improve patient outcomes for persons affected with a UCD. Based in part on financial incentives associated with the Orphan Drug Act biopharmaceutical and investment entities have an intense interest in engaging with research consortia like the UCDC, which have compiled potentially valuable longitudinal data characterizing outcomes in a relatively large number of affected individuals. We describe the UCDC experience and the bases for evaluating partnerships with such private entities. We review early industry interactions, the development of policies and procedures, and describe the establishment of an Industry Relations Committee, including guiding principles. Challenges encountered, particularly in the transition when products are approved, and potential solutions are discussed. By building a framework for industry partnerships that guides us in resolving inevitable challenges, we can enthusiastically pursue novel and promising collaborations that can lead to breakthroughs in therapeutic interventions for patients.