A digital self-management intervention for adults with type 2 diabetes: Combining theory, data and participatory design to develop HeLP-Diabetes.

BACKGROUND: Digital health interventions have potential to contribute to better health outcomes, better healthcare and lower costs. However, evidence for their effectiveness is variable. The development and content of digital health interventions are often not described in enough detail to enable others to replicate the research or improve on previous interventions. This has led to a call for transparent reporting of intervention content and development. PURPOSE: To describe the development process and content of a digital self-management intervention for people with type 2 diabetes (HeLP-Diabetes) that has been found to achieve its target clinical outcome, the reduction of HbA1c, a measure of glycaemic control. METHOD: We synthesised theory, data from existing research evidence and international guidelines, and new qualitative data from target users to identify the determinants of self-management and the content to be included in HeLP-Diabetes. Using an ongoing iterative participatory design approach the content of the intervention was written, produced, reviewed and changed. CONCLUSION: It is possible to develop and transparently report self-management programmes for long-term conditions, which reflect current best evidence, theoretical underpinning and user involvement. We intend that reporting the development process and content will inform future digital intervention development

Altered Host Immunity, Human T Lymphotropic Virus Type I Replication, and Risk of Adult T-Cell Leukemia/Lymphoma: A Prospective Analysis from the ATL Cohort Consortium

Background: Adult T-cell leukemia/lymphoma (ATL) is a rare and often fatal outcome of infection with human T-lymphotropic virus type I (HTLV-I). Altered host immunity in HTLV-I carriers has been postulated as a risk factor for ATL, but is not well understood. Methods: We prospectively examined well-validated serologic markers of HTLV-I pathogenesis and host immunity in 53 incident ATL cases and 150 carefully matched asymptomatic HTLV-I carriers from eight population-based studies in Japan, Jamaica, the United States and Brazil. We used multivariable conditional logistic regression, conditioned on the matching factors (cohort/race, age, sex, and sample collection year), to evaluate the biomarkers’ associations with ATL in all subjects and by years (≤5, >5) from blood draw to ATL diagnosis. Results: In the pooled population, above-median soluble interleukin-2-receptor-alpha levels (sIL2R, v. ≤ median; odds ratio (OR), 95% confidence interval (CI)=4.08, 1.47-11.29) and anti-Tax seropositivity (anti-Tax; OR, 95% CI=2.97, 1.15-7.67), which indicate T cell activation and HTLV-I replication, respectively, were independently associated with an increased ATL risk. Above-median total immunoglobulin E levels (v. ≤ median; OR, 95% CI=0.45, 0.19-1.06), which indicate type 2 (B cell) activation, predicted a lower ATL risk. The sIL2R and anti-Tax associations with ATL were stronger in samples collected ≤5 years pre-diagnosis. Conclusions: The biomarker profile predictive of ATL risk suggests a role for heightened T cell activation and HTLV-I replication and diminished type 2 immunity in the etiology of ATL in HTLV-I carriers. Translation of these findings to clinical risk prediction or early ATL detection requires further investigation. Acknowledgements: This abstract is presented on behalf of the ATL Cohort Consortium