Correction to: Physical activity intensity, bout-duration, and cardiometabolic risk markers in children and adolescents.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

The development of an end-to-end service solution to support lupus patients and improve their experience in clinical trials.

OBJECTIVE: To develop an end-to-end clinical trial service to improve patient experience during trials, reduce the burden of participating in a trial, and increase trial retention. METHODS: A literature search and stakeholder interviews were used to identify current challenges and unmet needs of systemic lupus erythematosus patients and other systemic lupus erythematosus clinical trial stakeholders. The results from the literature search and interviews were used to create a five-phase map describing the current clinical trial experience of all stakeholders. A set of proposed solutions were developed to address the identified unmet needs and challenges. These solutions were presented to trial-experienced patients and study site personnel; any feedback obtained was used to further refine the solutions. RESULTS: Four site personnel and seven patients from three different systemic lupus erythematosus clinical trial sites were interviewed between September 2015 and December 2015. Key unmet needs and challenges were identified at each stage of the clinical trials. At the screening stage, some patients incorrectly thought they were successfully enrolled into the clinical trial. During enrollment, some patients found it difficult to keep fully informed about the trial and were unable to explain the trial process to loved ones. During the trial, patients struggled to prepare for study visits, felt overwhelmed by the trial process, and wanted someone to talk to for support. Clinical trial site personnel reported current key challenges as: delivering trial information clearly and consistently to patients, setting patient expectations, retaining enrolled patients, and providing non-clinical patient support. To address the needs of patients and site personnel, an end-to-end support service was designed, consisting of nine solutions: My Best Choice, My Eligibility, My Lupus Trial Kit, My Lupus Trial Coach, My Appointment Guide, My Clinic Compass, Our Gratitude, Building a Different Network, and My Next Chapter. CONCLUSION: The solutions proposed in this qualitative study may help improve the systemic lupus erythematosus clinical trial experience for patients, potentially helping to increase trial recruitment and retention. The solutions proposed here would also promote positive patient-trial personnel relationships, which may help site personnel identify patients at risk of early withdrawal, while ensuring that the time and resources of site personnel are used efficiently.

Physical activity intensity, bout-duration, and cardiometabolic risk markers in children and adolescents.

OBJECTIVES: To determine the role of physical activity intensity and bout-duration in modulating associations between physical activity and cardiometabolic risk markers. METHODS: A cross-sectional study using the International Children's Accelerometry Database (ICAD) including 38,306 observations (in 29,734 individuals aged 4-18 years). Accelerometry data was summarized as time accumulated in 16 combinations of intensity thresholds (≥500 to ≥3000 counts/min) and bout-durations (≥1 to ≥10 min). Outcomes were body mass index (BMI, kg/m2), waist circumference, biochemical markers, blood pressure, and a composite score of these metabolic markers. A second composite score excluded the adiposity component. Linear mixed models were applied to elucidate the associations and expressed per 10 min difference in daily activity above the intensity/bout-duration combination. Estimates (and variance) from each of the 16 combinations of intensity and bout-duration examined in the linear mixed models were analyzed in meta-regression to investigate trends in the association. RESULTS: Each 10 min positive difference in physical activity was significantly and inversely associated with the risk factors irrespective of the combination of intensity and bout-duration. In meta-regression, each 1000 counts/min increase in intensity threshold was associated with a -0.027 (95% CI: -0.039 to -0.014) standard deviations lower composite risk score, and a -0.064 (95% CI: -0.09 to -0.038) kg/m2 lower BMI. Conversely, meta-regression suggested bout-duration was not significantly associated with effect-sizes (per 1 min increase in bout-duration: -0.002 (95% CI: -0.005 to 0.0005) standard deviations for the composite risk score, and -0.005 (95% CI: -0.012 to 0.002) kg/m2 for BMI). CONCLUSIONS: Time spent at higher intensity physical activity was the main determinant of variation in cardiometabolic risk factors, not bout-duration. Greater magnitude of associations was consistently observed with higher intensities. These results suggest that, in children and adolescents, physical activity, preferably at higher intensities, of any bout-duration should be promoted.