Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study

Background: People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag #WeAreNotWaiting, a wealth of knowledge and real-world data have been generated by users of these systems but have been left largely untapped by research; opportunities for such multimodal studies remain open. Objective: We aimed to evaluate the feasibility of several aspects of open-source automated insulin delivery systems including challenges related to data management and security across multiple disparate web-based platforms and challenges related to implementing follow-up studies. Methods: We developed a mixed methods study to collect questionnaire responses and anonymized diabetes data donated by participants-which included adults and children with diabetes and their partners or caregivers recruited through multiple diabetes online communities. We managed both front-end participant interactions and back-end data management with our web portal (called the Gateway). Participant questionnaire data from electronic data capture (REDCap) and personal device data aggregation (Open Humans) platforms were pseudonymously and securely linked and stored within a custom-built database that used both open-source and commercial software. Participants were later given the option to include their health care providers in the study to validate their questionnaire responses; the database architecture was designed specifically with this kind of extensibility in mind. Results: Of 1052 visitors to the study landing page, 930 participated and completed at least one questionnaire. After the implementation of health care professional validation of self-reported clinical outcomes to the study, an additional 164 individuals visited the landing page, with 142 completing at least one questionnaire. Of the optional study elements, 7 participant-health care professional dyads participated in the survey, and 97 participants who completed the survey donated their anonymized medical device data. Conclusions: The platform was accessible to participants while maintaining compliance with data regulations. The Gateway formalized a system of automated data matching between multiple data sets, which was a major benefit to researchers. Scalability of the platform was demonstrated with the later addition of self-reported data validation. This study demonstrated the feasibility of custom software solutions in addressing complex study designs. The Gateway portal code has been made available open-source and can be leveraged by other research groups

Emotional and Physical Health Impact in Children and Adolescents and Their Caregivers Using Open-source Automated Insulin Delivery: Qualitative Analysis of Lived Experiences

Background: Given the limitations in the access and license status of commercially developed automated insulin delivery (AID) systems, open-source AID systems are becoming increasingly popular among people with diabetes, including children and adolescents. Objective: This study aimed to investigate the lived experiences and physical and emotional health implications of children and their caregivers following the initiation of open-source AID, their perceived challenges, and sources of support, which have not been explored in the existing literature. Methods: Data were collected through 2 sets of open-ended questions from a web-based multinational survey of 60 families from 16 countries. The narratives were thematically analyzed, and a coding framework was identified through iterative alignment. Results: A range of emotions and improvements in quality of life and physical health were reported, as open-source AID enabled families to shift their focus away from diabetes therapy. Caregivers were less worried about hypoglycemia at night and outside their family homes, leading to increased autonomy for the child. Simultaneously, the glycemic outcomes and sleep quality of both the children and caregivers improved. Nonetheless, the acquisition of suitable hardware and technical setup could be challenging. The #WeAreNotWaiting community was the primary source of practical and emotional support. Conclusions: Our findings show the benefits and transformative impact of open-source AID and peer support on children with diabetes and their caregivers and families, where commercial AID systems are not available or suitable. Further efforts are required to improve the effectiveness and usability and facilitate access for children with diabetes, worldwide, to benefit from this innovative treatment

Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1 International cross-sectional web-based survey

Aims: To investigate self-reported out-of-pocket expenses (OoPE) associated with insulin and diabetes supplies for people living with type 1 diabetes (T1D) worldwide. Methods: A web-based, cross-sectional survey was conducted from August to December 2020. The analysis included comparisons between responses from countries with no, partial, and full healthcare coverage. Results: 1,066 participants from 64 countries took part in the study. ~25% of respondents reported having underused insulin at least once within the last year due to perceived cost. A significant correlation was observed between OoPEs and reported household income for respondents with partial healthcare coverage. 63.2% of participants reported disruption of insulin supplies and 25.3% reported an increase of prices related to the COVID-19 pandemic. Conclusions: This study confirms previous reports of ~25% of people in the United States with T1D using less insulin and/or fewer supplies at least once in the last year due to cost, a trend associated with the extent of healthcare coverage. Similar trends were observed in some middle/low income countries. Moreover, patients reported an increase in insulin prices and disruption of supplies during the COVID-19 pandemic. This study highlights the importance of self-reported OoPEs and its association with underuse/rationing of insulin.Arnold VenturesCenter for Translational Science and Trainin

Recommendations for empowering early career researchers to improve research culture and practice

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian.Instituto de Patología VegetalFil: Kent, Brianne A. Simon Fraser University. Department of Psychology; CanadáFil: Holman, Constance. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; AlemaniaFil: Amoako, Emmanuella. Cape Coast Teaching Hospital. Department of Paediatrics and Child Health; GhanaFil: Amoako, Emmanuella. University of Cape Coast. School of Medicine. Department of Paediatrics and Child Health; GhanaFil: Antonietti, Alberto. Politecnico di Milano. Department of Electronics, Information and Bioengineering; ItaliaFil: Azam, James M. Stellenbosch University. DSI-NRF Center of Excellence in Epidemiological Modelling and Analysis. Department of Mathematics; SudáfricaFil: Ballhausen, Hanne. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; AlemaniaFil: Fil: Ballhausen, Hanne. Universitätsmedizin Berlin. Department of Paediatric Endocrinology and Diabetes, Charité; AlemaniaFil: Bediako, Yaw . University of Ghana. West African Centre for Cell Biology of Infectious Pathogens; GhanaFil: Belasen, Anat M. Cornell University. Society for Conservation Biology. Department of Ecology and Evolutionary Biology; Estados UnidosFil: Carneiro, Clarissa F. D. Federal University of Rio de Janeiro. Institute of Medical Biochemistry Leopoldo de Meis; BrasilFil: Chung Chen, Yen. New York University. Department of Biology; Estados UnidosFil: Debat, Humberto Julio. Instituto Nacional de Tecnología Agropecuaria (INTA). Instituto de Patología Vegetal; ArgentinaFil: Debat, Humberto Julio. Consejo Nacional de Investigaciones Científicas y Técnicas. Unidad de Fitopatología y Modelización Agrícola (UFyMA); ArgentinaFil: Weissgerber, Tracey L. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; Alemani

Evaluation of a numerical simulation for cryoablation – comparison with bench data, clinical kidney and lung cases

Purpose The accuracy of a numerical simulation of cryoablation ice balls was evaluated in gel phantom data as well as clinical kidney and lung cases. Materials and methods To evaluate the accuracy, 64 experimental single-needle cryoablations and 12 multi-needle cryoablations in gel phantoms were re-simulated with the corresponding freeze-thaw-freeze cycles. The simulated temperatures were compared over time with the measurements of thermocouples. For single needles, temperature values were compared at each thermocouple location. For multiple needles, Euclidean distances between simulated and measured isotherms (10 °C, 0 °C, −20 °C, −40 °C) were computed. Furthermore, surface and volume of simulated 0 °C isotherms were compared to cryoablation-induced ice balls in 14 kidney and 13 lung patients. For this purpose, needle positions and relevant anatomical structures defining material parameters (kidney/lung, tumor) were reconstructed from pre-ablation CT images and fused with postablation CT images (from which ice balls were extracted by manual delineation). Results The single-needle gel phantom cases showed less than 5 °C prediction error on average. Over all multiple needle experiments in gel, the mean and maximum isotherm distance were less than 2.3 mm and 4.1 mm, respectively. Average Dice coefficients of 0.82/0.63 (kidney/lung) and mean surface distances of 2.59/3.12 mm quantify the prediction performance of the numerical simulation. However, maximum surface distances of 10.57/10.8 mm indicate that locally larger errors have to be expected. Conclusion A very good agreement of the numerical simulations for gel experiments was measured and a satisfactory agreement of the numerical simulations with measured ice balls in patient data was shown

Ablation zone geometry after CT-guided hepatic microwave ablation: evaluation of a semi-automatic software and comparison of two different ablation systems

Purpose The aims of this study were to evaluate a semi-automatic segmentation software for assessment of ablation zone geometry in computed tomography (CT)-guided microwave ablation (MWA) of liver tumors and to compare two different MWA systems. Material and Methods 27 patients with 40 hepatic tumors (primary liver tumor n = 20, metastases n = 20) referred for CT-guided MWA were included in this retrospective IRB-approved study. MWA was performed using two systems (system 1: 915 MHz; n = 20; system 2: 2.45 GHz; n = 20). Ablation zone segmentation and ellipticity index calculations were performed using SAFIR (Software Assistant for Interventional Radiology). To validate semi-automatic software calculations, results (2 perpendicular diameters, ellipticity index, volume) were compared with those of manual analysis (intraclass correlation, Pearson’s correlation, Mann–Whitney U test; p < 0.05 deemed significant. Results Manual measurements of mean maximum ablation zone diameters were 43 mm (system 1) and 34 mm (system 2), respectively. Correlations between manual and semi-automatic measurements were r = 0.72 and r = 0.66 (both p < 0.0001) for perpendicular diameters, and r = 0.98 (p < 0.001) for volume. Manual analysis demonstrated that ablation zones created with system 2 had a significantly lower ellipticity index compared to system 1 (mean 1.17 vs. 1.86, p < 0.0001). Results correlated significantly with semi-automatic software measurements (r = 0.71, p < 0.0001). Conclusion Semi-automatic assessment of ablation zone geometry using SAFIR is feasible. Software-assisted evaluation of ablation zones may prove beneficial with complex ablation procedures, especially for less experienced operators. The 2.45 GHz MWA system generated a significantly more spherical ablation zone compared to the 915 MHz system. The choice of a specific MWA system significantly influences ablation zone geometry

Recommendations for empowering early career researchers to improve research culture and practice

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian

Recommendations for empowering early career researchers to improve research culture and practice

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian