User Centered Design to Improve Information Exchange in Diabetes Care Through eHealth: Results from a Small Scale Exploratory Study

[EN] Heterogeneity of people with diabetes makes maintaining blood glucose control and achieving therapy adherence a challenge. It is fundamental that patients get actively involved in the management of the disease in their living environments. The objective of this paper is to evaluate the use and acceptance of a self-management system for diabetes developed with User Centered Design Principles in community settings. Persons with diabetes and health professionals were involved the design, development and evaluation of the self-management system; which comprised three iterative cycles: scenario definition, user archetype definition and system development. A comprehensive system was developed integrating modules for the management of blood glucose levels, medication, food intake habits, physical activity, diabetes education and messaging. The system was adapted for two types of principal users (personas): Type 1 Diabetes user and Type 2 Diabetes user. The system was evaluated by assessing the use, the compliance, the attractiveness and perceived usefulness in a multicenter randomized pilot study involving 20 patients and 24 treating professionals for a period of four weeks. Usage and compliance of the co-designed system was compared during the first and the last two weeks of the study, showing a significantly improved behaviour of patients towards the system for each of the modules. This resulted in a successful adoption by both type of personas. Only the medication module showed a significantly different use and compliance (p= 0.01) which can be explained by the different therapeutic course of the two types of diabetes. The involvement of patients to make their own decisions and choices form design stages was key for the adoption of a self-management system for diabetes.This study was funded by European Commission under the 7th Framework Program grant agreement number 216270.3.Fico, G.; Martinez-Millana, A.; Leuteritz, J.; Fioravanti, A.; Beltrán-Jaunsarás, ME.; Traver Salcedo, V.; Arredondo, MT. (2019). User Centered Design to Improve Information Exchange in Diabetes Care Through eHealth: Results from a Small Scale Exploratory Study. Journal of Medical Systems. 44(1):1-12. https://doi.org/10.1007/s10916-019-1472-5S112441Nolte, E, and McKee, M, Caring for People with Chronic Conditions: A Health System Perspective. UK: McGraw-Hill Education, 2008. ISBN 9780335236909.Bodenheimer, T, Lorig, K, Holman, H, and Grumbach K, PAtient self-management of chronic disease in primary care. JAMA 288(19):2469–2475, 2002. https://doi.org/10.1001/jama.288.19.2469. ISSN 0098-7484.American Diabetes Association, Standards of Medical Care in Diabetes—2008. Diabetes Care 31(Supplement 1): S12–S54, 2008. https://doi.org/10.2337/dc08-S012, http://care.diabetesjournals.org/content/31/Supplement_1/S12.Inzucchi, S E, Bergenstal, R M, Buse, J B, Diamant, M, Ferrannini, E, Nauck, M, Peters, A L, Tsapas, A, Wender, R, and Matthews, D R, Management of hyperglycemia in type 2 Diabetes, 2015: a patient-centered approach: update to a position statement of the American diabetes association and the European association for the study of diabetes. Diabetes Care 38(1):140–149, 2015. https://doi.org/10.2337/dc14-2441. ISSN 19355548.Zarkogianni, K, Litsa, E, Mitsis, K, Wu, P, Kaddi, C, Cheng, C, Wang, M, and Nikita, K, A review of emerging technologies for the management of diabetes mellitus. IEEE Trans. Bio-Med. Eng. PP(99):1, 2015. https://doi.org/10.1109/TBME.2015.2470521. http://www.ncbi.nlm.nih.gov/pubmed/26292334.Reutens, A T, Hutchinson, R, Binh, T V, Cockram, C, Deerochanawong, C, Ho, L T, Ji, L, Khalid, B A K, Kong, A P S, Lim-Abrahan, M A, Tan, C E, Tjokroprawiro, A, Yoon, K H, Zmmet, P Z, and Shaw, J E, The GIANT study, a cluster-randomised controlled trial of efficacy of education of doctors about type 2 diabetes mellitus management guidelines in primary care practice. Diabetes Res. Clin. Pract. 98(1): 38–45, 2012. https://doi.org/10.1016/j.diabres.2012.06.002. ISSN 01688227.Aslan, S., Ciocca, G., and Schettini, R.: Semantic segmentation of food images for automatic dietary monitoring. In: 2018 26th Signal Processing and Communications Applications Conference (SIU), pp. 1–4, 2018, https://doi.org/10.1109/SIU.2018.8404824.Gómez, E J, Hernando Pérez, M E, Vering, T, Cros, M R, Bott, O, García-Sáez, G, Pretschner, P, Bruguéz, E, Schnell, O, Patte, C, Bergmann, J, Dudde, R, and de Leiva, A, The INCA system: A further step towards a telemedical artificial pancreas. IEEE Trans. Inf. Technol. Biomed. 12(4): 470–479, 2008. https://doi.org/10.1109/TITB.2007.902162. ISSN 10897771.Martinez-Millana, A, Fico, G, Fernández-Llatas, C, and Traver, V, Performance assessment of a closed-loop system for diabetes management. Med. Biol. Eng. Comput. 53(12):1295–1303, 2015. https://doi.org/10.1007/s11517-015-1245-3. ISSN 1741-0444.Oreskovic, N M, Maniates, J, Weilburg, J, and Choy, G, Optimizing the use of electronic health records to identify high-risk psychosocial determinants of Health. JMIR Med. Inf. 5 (3): e25, 2017. https://doi.org/10.2196/medinform.8240. http://medinform.jmir.org/2017/3/e25/.Conte, R., Sansone, F., Grande, A., Tonacci, A., Napoli, F., Pala, A. P., Raciti, M., and Landi, P.: Development of an integrated ict system for data production, standardization and elaboration in health care. In: 2017 E-Health and Bioengineering Conference (EHB). https://doi.org/10.1109/EHB.2017.7995426, pp. 321–324, 2017.Ryu, B, Kim, N, Heo, E, Yoo, S, Lee, K, Hwang, H, Kim, J.-W., Kim, Y, Lee, J, and Jung, S Y, Impact of an electronic health record-integrated personal health record on patient participation in health care: development and randomized controlled trial of MyHealthKeeper. J. Med. Int. Res. 19(12):e401, 2017. https://doi.org/10.2196/jmir.8867. http://www.jmir.org/2017/12/e401/.Chavez, S, Fedele, D, Guo, Y, Bernier, A, Smith, M, Warnick, J, and Modave, F, Mobile Apps for the management of diabetes. Diabetes Care 40(10):e145–e146, 2017. https://doi.org/10.2337/dc17-0853. http://care.diabetesjournals.org/lookup/doi/10.2337/dc17-0853.Irace, C, Schweitzer, M A, Tripolino, C, Scavelli, F B, and Gnasso, A, Diabetes data management system to improve glycemic control in people with type 1 Diabetes: Prospective cohort study. JMIR mHealth uHealth 5(11):e170, 2017. https://doi.org/10.2196/mhealth.8532. http://mhealth.jmir.org/2017/11/e170/.Helal, A, Cook, D J, and Schmalz, M, Smart home-based health platform for behavioral monitoring and alteration of diabetes patients. J. Diabetes Sci. Technol. 3(1):141–148, 2009. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769843/.Synnott, J, Chen, L, Nugent, C D, and Moore, G: Flexible and customizable visualization of data generated within intelligent environments. In: 2012 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. https://doi.org/10.1109/EMBC.2012.6347317, pp. 5819–5822, 2012.Shahar, Y, Goren-Bar, D, Boaz, D, and Tahan, G, Distributed, intelligent, interactive visualization and exploration of time-oriented clinical data and their abstractions. Artif. Intell. Med. 38(2):115–135, 2006. https://doi.org/10.1016/j.artmed.2005.03.001.Fico, G., Fioravanti, A., Teresa Arredondo, M., Gorman, J., Diazzi, C., Arcuri, G., Conti, C., and Pirini, G., Integration of personalized healthcare pathways in an ict platform for diabetes managements: a small-scale exploratory study. IEEE J. Biomed. Health Inf. 20(1):29–38, 2016. https://doi.org/10.1109/JBHI.2014.2367863. ISSN 2168-2194.Salzburg Global Seminar, Salzburg statement on shared decision making. BMJ 342:d1745, 2011. https://doi.org/10.1136/bmj.d1745, http://www.bmj.com/content/342/bmj.d1745.Stacey, D, Bennett, C L, Barry, M J, Col, N F, Eden, K B, Holmes-Rovner, M, Llewellyn-Thomas, H, Lyddiatt, A, Légaré, F, and Thomson, R, Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst. Rev. 10:CD001431, 2011. https://doi.org/10.1002/14651858.CD001431.pub3. ISSN 1469-493X.Gabert, R, Thomson, B, Gakidou, E, and Roth, G, Identifying high-risk neighborhoods using electronic medical records: a population-based approach for targeting diabetes prevention and treatment interventions. PloS one 11(7):e0159227, 2016. https://doi.org/10.1371/journal.pone.0159227. ISSN 19326203.Barry, M J, and Edgman-Levitan S, Shared decision making — the pinnacle of patient-centered care. England J. Med. 366(9):780–781, 2012. https://doi.org/10.1056/NEJMp1109283. ISSN 0028-4793.Fico, G, Cancela, J, Arredondo, M T, Dagliati, A, Sacchi, L, Segagni, D, Millana, A M, Fernandez-Llatas, C, Traver, V, Sambo, F, et al: User requirements for incorporating diabetes modeling techniques in disease management tools. In: 6th European Conference of the International Federation for Medical and Biological Engineering, pp. 992–995. Springer, 2015.Draznin, B, Gilden, J, Golden, S H, and Inzucchi, S E, Pathways to quality inpatient management of hyperglycemia and diabetes: A call to action. Diabetes Care 36(7):1807–1814, 2013. https://doi.org/10.2337/dc12-2508. ISSN 01495992.Nielsen, J, and Molich, R: Heuristic evaluation of user interfaces. In: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems, CHI ’90, pp. 249–256. ACM, New York, 1990.. http://doi.acm.org/10.1145/97243.97281Flores, A E, Ph, D, and Vergara, V M: Functionalities of open electronic health records system. Biomed. Eng. (Bmei), 602–607. http://ieeexplore.ieee.org/xpls/abs_all.jsp?arnumber=6747011, 2013Guillén, A, Colás, J, Fico, G, and Guillén, S: Metabo: a new paradigm towards diabetes disease management. An innovative business model. In: 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC, pp. 3554–3557. IEEE, 2011.Hassenzahl, M, Burmester, M, and Koller, F: Attrakdiff: Ein fragebogen zur messung wahrgenommener hedonischer und pragmatischer qualität. In: Mensch & Computer 2003, pp. 187–196. Springer, 2003.Davis, F D: Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quart., 319–340, 1989Fioravanti, A, Fico, G, Salvi, D, García-Betances, R I, and Arredondo, M T, Automatic messaging for improving patient’s engagement in diabetes management: an exploratory study. Med. Biol. Eng. Comput. 53(12): 1285–1294, 2015. https://doi.org/10.1007/s11517-014-1237-8. ISSN 0140-0118.Haas, L, Maryniuk, M, Beck, J, Cox, C E, Duker, P, Edwards, L, Fisher, E B, Hanson, L, Kent, D, Kolb, L, McLaughlin, S, Orzeck, E, Piette, J D, Rhinehart, A S, Rothman, R, Sklaroff, S, Tomky, D, and Youssef, G., National standards for diabetes self-management education and support. Diabetes Care 35(11):2393–2401, 2012. https://doi.org/10.2337/dc12-1707. ISSN 01495992.Quinn, C C, Sareh, P L, Shardell, M L, Terrin, M L, Barr, E A, and Gruber-Baldini, A L, Mobile diabetes intervention for glycemic control. J. Diabetes Sci. Technol. 8(2):362–370, 2014. http://journals.sagepub.com/doi/10.1177/1932296813514503

Assessment of the level III of Inoue by preoperative endoscopic ultrasound and elastography: a novel approach to predict a periarterial divestment technique in borderline resectable (BR) or locally advanced (LA) pancreatic adenocarcinoma—How I do it

Pancreatic cancer; Periarterial divestment; Triangle operationCáncer de páncreas; Desinversión periarterial; Operación triangularCàncer de pàncrees; Desinversió periarterial; Operació triangularBackground Periarterial divestment is a surgical technique to approach borderline resectable (BR) or locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC) with arterial involvement. There are no reports in the literature regarding the role of endoscopic ultrasound and elastography (EUS-EG) in exploring the integrity of Inoue’s level III and its correlation with the periarterial divestment technique feasibility. Our research is aimed at exploring the role of EUS-EG in this scenario. Methods We describe our approach to Inoue’s level II by EUS-EG in patients with BR and LA pancreatic cancer patients after neoadjuvant chemotherapy. Results Between June 2019 and December 2020, four patients out of 25 were eligible to perform a preoperative EUS-EG. In all cases, Inoue’s level III integrity was corroborated by EUS-EG and confirmed posteriorly in the surgical scenario where a periarterial divestment technique was feasible. Vein resections were necessary in all cases, with no need for arterial resection. An R0 (> 1 mm) margin was achieved in all patients, and the histopathological assessment showed the presence of neurovascular tissue at the peripheral arterial margin. Conclusion Preoperatively, EUS-EG is a novel approach to explore the integrity of Inoue’s level III and could be helpful to preclude a periarterial divestment technique in borderline resectable or locally advanced pancreatic adenocarcinoma with arterial involvement.Open Access Funding provided by Universitat Autonoma de Barcelona

Liver steatosis induces portal hypertension regardless of fibrosis in patients with NAFLD: A proof of concept case report

Esteatosi hepàtica; Hipertensió portalLiver steatosis; Portal hypertensionEsteatosis hepática; Hipertensión portalNo financial support was received for data analysis or writing assistance. JRE is a PhD student at Universitat Autònoma de Barcelona, Spain. JMP reports having received consulting fees from Boehringer Ingelheim, MSD and Novo Nordisk. He has received speaking fees from Gilead, Intercept, and Novo Nordisk, and travel expenses from Gilead, Rubió, Pfizer, Astellas, MSD, CUBICIN, and Novo Nordisk. He has received educational and research support from Madrigal, Gilead, Pfizer, Astellas, Accelerate, Novartis, Abbvie, ViiV, and MSD. Funds from European Commission/EFPIA IMI2 853966-2, IMI2 777377, H2020 847989, and ISCIII PI19/01898 (PI22/01770). JG has received consulting fees from Boehringer Ingelheim, speaking fees from Echosens and travel expenses from Gilead and Abbie. Funds from ISCIII PI18/00947 and PI21/00691. All other authors: nothing to disclose

Nanocrystalline silicon substituted hydroxyapatite effects on osteoclast differentiation and resorptive activity

In the present study, the effects of nanocrystalline hydroxyapatite (nano-HA) and nanocrystalline Si-substituted hydroxyapatite (nano-SiHA) on osteoclast differentiation and resorptive activity have been evaluated in vitro using osteoclast-like cells. The action of these materials on proinflammatory and reparative macrophage populations was also studied. Nano-SiHA disks delayed the osteoclast differentiation and decreased the resorptive activity of these cells on their surface, as compared to nano-HA samples, without affecting cell viability. Powdered nano-SiHA also induced an increase of the reparative macrophage population. These results along with the beneficial effects on osteoblasts previously observed with powdered nano-SiHA suggest the potential of this biomaterial for modulating the fundamental processes of bone formation and turnover, preventing bone resorption and enhancing bone formation at implantation sites in treatment of osteoporotic bone and in bone repair and regeneration

Hepatic Rupture as the Initial Presentation of an EGFR-Mutated Lung Adenocarcinoma: A Case Report

Metastatic hepatic rupture; Non-small cell lung carcinoma; Tyrosine kinase inhibitorRuptura hepática metastásica; Carcinoma de pulmón de células no pequeñas; Inhibidor de la tirosina quinasaRuptura hepàtica metastàtica; Carcinoma de pulmó de cèl·lules no petites; Inhibidor de la tirosina quinasaHepatic rupture is a rare complication of solid tumor malignancies, notably in lung adenocarcinomas, and carries an extremely poor overall prognosis. Epidermal growth factor receptor (EGFR) mutations in lung adenocarcinoma predict benefit with tyrosine kinase inhibitors (TKIs). This case report describes a female patient who presented with a metastatic hepatic rupture and was subsequently diagnosed with EGFR-mutated lung adenocarcinoma. The tumor had an impressive response to TKI inhibitor treatment, reversing her extremely poor, short-term prognosis. We believe this unique case sheds light on the treatment management of hepatic ruptures and supports the high response rate seen with TKIs in EGFR-mutated lung cancers, regardless of the patient’s performance status

ACE Score Identifies HBeAg-negative Inactive Carriers at a Single-point Evaluation, Regardless of HBV Genotype

HBV DNA; Hepatitis B virus; Inactive carrierADN del VHB; Virus de la hepatitis B; Portador inactivoADN del VHB; Virus de l'hepatitis B; Portador inactiuBackground and Aims Hepatitis B virus (HBV) biomarkers have been used for a better categorization of patients, even though the lack of simple algorithms and the impact of genotypes limit their application. Our aim was to assess the usefulness of noninvasive markers for the identification of HBV inactive carriers (ICs) in a single-point evaluation and to design a predictive model for their identification. Methods This retrospective-prospective study included 343 consecutive HBeAg-negative individuals. Clinical, analytical, and virological data were collected, and a liver biopsy was performed if needed. Subjects were classified at the end of follow-up as ICs, chronic hepatitis B and gray zone.A predictive model was constructed, and validated by 1000-bootstrap samples. Results After 39 months of follow-up, 298 subjects were ICs, 36 were chronic hepatitis B CHB, and nine were gray zone. Eighty-nine (25.9%) individuals required a liver biopsy. Baseline HBV DNA hazard ratio (HR) 6.0, p<0.001), HBV core-related antigen (HBcrAg) (HR 6.5, p<0.001), and elastography (HR 4.6, p<0.001) were independently associated with the IC stage. The ACE score (HBV DNA, HBcrAg, elastography), obtained by bootstrapping, yielded an area under the receiver operating characteristics (AUROC) of 0.925 (95% CI: 0.880–0.970, p<0.001) for identification of ICs. The AUROC for genotype D was 0.95, 0.96 for A, 0.90 for E, and 0.88 for H/F. An ACE score of <1 had a positive predictive value of 99.5%, and a score ≤12 points had a diagnostic accuracy of 93.8%. Conclusions Low baseline HBV DNA, HBcrAg, and liver stiffness were independently associated with the IC phase. A score including those variables identified ICs at a single-point evaluation, and might be applied to implement less intensive follow-up strategies.This study received partial financial support from Instituto de Salud Carlos III (PI17/02233 and PI20/01692)

Authentication of Iberian dry-cured ham: New approaches by polymorphic fingerprint and ultrahigh resolution mass spectrometry

Foods with high added value, such as Iberian dry-cured products, are susceptible to fraud. Many attempts have been made to differentiate the commercial/quality categories of Iberian dry-cured hams by analytical determinations. However, as discrimination by such means is not fully reliable, legislation to prevent fraudulent practice is based on administrative controls and certification. Here, new analytical approaches based on ultrahigh resolution mass spectrometry (UHRMS) and crystallographic techniques applied to the lipid fraction, in combination with chemometrics, are studied. The results of the triacylglycerol profile determined by UHRMS and the fingerprint provided by the thermograms obtained by differential scanning calorimetry offer the promise of analytic discrimination of Iberian dry-cured ham categories. In addition, these determinations, in combination with chemometrics, may prove extremely useful to authenticate many foods containing high to moderate amounts of lipids

A Nine-Strain Bacterial Consortium Improves Portal Hypertension and Insulin Signaling and Delays NAFLD Progression In Vivo

Bacterial consortium; Gut microbiome; Portal hypertensionConsorcio bacteriano; Microbioma intestinal; Hipertensión portalConsorci bacterià; Microbioma intestinal; Hipertensió portalThe gut microbiome has a recognized role in Non-alcoholic fatty liver disease (NAFLD) and associated comorbidities such as Type-2 diabetes and obesity. Stool transplantation has been shown to improve disease by restoring endothelial function and insulin signaling. However, more patient-friendly treatments are required. The present study aimed to test the effect of a defined bacterial consortium of nine gut commensal strains in two in vivo rodent models of Non-alcoholic steatohepatitis (NASH): a rat model of NASH and portal hypertension (PHT), and the Stelic animal (mouse) model (STAM™). In both studies the consortium was administered orally q.d. after disease induction. In the NASH rats, the consortium was administered for 2 weeks and compared to stool transplant. In the STAM™ study administration was performed for 4 weeks, and the effects compared to vehicle or Telmisartan at the stage of NASH/early fibrosis. A second group of animals was followed for another 3 weeks to assess later-stage fibrosis. In the NASH rats, an improvement in PHT and endothelial function was observed. Gut microbial compositional changes also revealed that the consortium achieved a more defined and richer replacement of the gut microbiome than stool transplantation. Moreover, liver transcriptomics suggested a beneficial modulation of pro-fibrogenic pathways. An improvement in liver fibrosis was then confirmed in the STAM™ study. In this study, the bacterial consortium improved the NAFLD activity score, consistent with a decrease in steatosis and ballooning. Serum cytokeratin-18 levels were also reduced. Therefore, administration of a specific bacterial consortium of defined composition can ameliorate NASH, PHT, and fibrosis, and delay disease progression