Within this section, an overview of recently published studies across the multi-disciplinary health care arena, relating to the theme of supporting patients following invasive cardiovascular surgical procedures will be presented. Even though specific emphasis will be on highlighting evidence from randomized controlled trials, findings from studies using innovative designs will also be presented.
1.) Mostafa, S. A., Coleman, R. L., Agbaje, O. F., Gray, A. M., Holman, R. R., & Bethel, M. A. (2018). Modelling incremental benefits on complications rates when targeting lower HbA1c levels in people with Type 2 diabetes and cardiovascular disease. Diabetic Medicine, 35(1), 72-77.
This study presents the following:
1. Randomized controlled trials of glucose lowering in Type 2 diabetes mellitus have demonstrated benefits on reducing micro‐ and macrovascular complication rates. Few data, however, exist to quantify the degree of benefit that might be gained from targeting different HbA1c reductions.
2. Simulated complication rates using a validated clinical prediction model to estimate the benefits of targeting progressively lower HbA1clevels, starting from a baseline of 10.0%.
3. These simulated results demonstrate the independent contribution that HbA1c exerts on microvascular and macrovascular complications, and estimate the degree of benefit that might be gained by targeting specific HbA1c reductions.
2.) Chamuleau, S. A., van der Naald, M., Climent, A. M., Kraaijeveld, A. O., Wever, K. E., Duncker, D. J., ... & Bolli, R. (2018). Translational Research in Cardiovascular RepairTake-Home Messages: A Call for a Paradigm Shift. Circulation research, 122(2), 310-318.
This study introduces well defined stages for preclinical research, and put forth proposals that should promote more rigorous preclinical work, in an effort to improve its quality and translatability. To augment the utility of preclinical research and its translation, it is necessary to (1) improve the quality of preclinical research, (2) promote collaborative efforts, and (3) enhance the sharing of knowledge and protocols. In particular, confirmatory (stage III) preclinical studies should be considered as a preamble to clinical studies and therefore must adhere to their standards of quality (including internal validity, standardization of protocols, and multicenter design). To increase transparency and minimize bias, these studies should be prospectively registered in an independent, open database
3.) Noah, B., Keller, M. S., Mosadeghi, S., Stein, L., Johl, S., Delshad, S., ... & Spiegel, B. M. (2018). Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials. npj Digital Medicine, 1(1), 2.
The aim of this study was to evaluate randomized controlled trials (RCTs) that assess the effects of using wearable biosensors (e.g. activity trackers) for remote patient monitoring on clinical outcomes. Articles from January 2000 to October 2016 were searched in PubMed, reviewed 4,348 titles, selected 777 for abstract review, and 64 for full text review. A total of 27 RCTs from 13 different countries focused on a range of clinical outcomes and were retained for final analysis; of these, we identified 16 high-quality studies. We estimated a difference-in-differences random effects meta-analysis on select outcomes. We weighted the studies by sample size and used 95% confidence intervals (CI) around point estimates. Difference-in-difference point estimation revealed no statistically significant impact of remote patient monitoring on any of six reported clinical outcomes, including body mass index (−0.96; 95% CI: −2.30, 0.37), weight (−1.29; −3.06, 0.48), waist circumference (−2.41; −5.16, 0.34), body fat percentage (0.19; −1.2, 1.57), systolic blood pressure (−2.62; −5.31, 0.06), and diastolic blood pressure (−0.74; −2.34, 0.86). Studies were highly heterogeneous in their design, device type, and outcomes. Interventions based on health behavior models and personalized coaching were most successful. We found substantial gaps in the evidence base that should be considered before implementation of remote patient monitoring in the clinical setting.
4.) Chen, L., Eloranta, S., Martling, A., Glimelius, I., Neovius, M., Glimelius, B., & Smedby, K. E. (2018). Short-and long-term risks of cardiovascular disease following radiotherapy in rectal cancer in four randomized controlled trials and a population-based register. Radiotherapy and Oncology.
A population-based cohort and four randomized trials enriched with long-term register data were used to clarify if radiotherapy in combination with rectal cancer surgery is associated with increased risks of cardiovascular disease(CVD).
No association between preoperative radiotherapy and overall CVD risk in the register (Incidence Rate Ratio, IRR = 0.99, 95% confidence interval (CI) 0.92–1.06) or in the pooled trials (IRR = 1.07, 95% CI 0.93–1.24). We noted an increased risk of venous thromboembolism among irradiated patients in both cohorts (IRRregister = 1.41, 95% CI 1.15–2.72; IRRtrials = 1.41, 95% CI 0.97–2.04), that remained during the first 6 months following surgery among patients treated 2006–2009, after the introduction of antithrombotic treatment (IRR6 months = 2.30, 95% CI 1.01–5.21). However, the absolute rate difference of venous thromboembolism attributed to RT was low (10 cases per 1000 patients and year).