Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care.

BACKGROUND: Tobacco addiction is the leading cause of preventable morbidity and mortality worldwide, but only 1 in 20 cessation attempts is supervised by a health professional. The potential advantages of mobile health (mHealth) can circumvent this problem and facilitate tobacco cessation interventions for public health systems. Given its easy scalability to large populations and great potential, chatbots are a potentially useful complement to usual treatment. OBJECTIVE: This study aims to assess the effectiveness of an evidence-based intervention to quit smoking via a chatbot in smartphones compared with usual clinical practice in primary care. METHODS: This is a pragmatic, multicenter, controlled, and randomized clinical trial involving 34 primary health care centers within the Madrid Health Service (Spain). Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). The interventions in both arms were based on the 5A's (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of patients, although participants were unblinded to group assignment. An intention-to-treat analysis, using the baseline-observation-carried-forward approach for missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS: The trial was conducted between October 1, 2018, and March 31, 2019. The sample included 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 (SD 10.82) years and gender ratio of 59.3% (304/513) women and 40.7% (209/513) men. Of them, 232 patients (45.2%) completed the follow-up, 104/242 (42.9%) in the IG and 128/271 (47.2%) in the CG. In the intention-to-treat analysis, the biochemically validated abstinence rate at 6 months was higher in the IG (63/242, 26%) compared with that in the CG (51/271, 18.8%; odds ratio 1.52, 95% CI 1.00-2.31; P=.05). After adjusting for basal CO-oximetry and bupropion intake, no substantial changes were observed (odds ratio 1.52, 95% CI 0.99-2.33; P=.05; pseudo-R2=0.045). In the IG, 61.2% (148/242) of users accessed the chatbot, average chatbot-patient interaction time was 121 (95% CI 121.1-140.0) minutes, and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS: A treatment including a chatbot for helping with tobacco cessation was more effective than usual clinical practice in primary care. However, this outcome was at the limit of statistical significance, and therefore these promising results must be interpreted with caution. TRIAL REGISTRATION: Clinicaltrials.gov NCT03445507; https://tinyurl.com/mrnfcmtd. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12911-019-0972-z.

A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results.

This is a randomized phase-2 trial aimed to compare consolidation vs. maintenance in untreated patients with follicular lymphoma (FL) responding to induction. 146 patients were enrolled from 25 Spanish institutions (ZAR2007; ClinicalTrials.gov #NCT00662948). Patients in PR or CR/CR[u] after R-CHOP were randomized 1:1 to 90Y-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m2 every 8 weeks for 2 years (arm B). After a median follow-up of 10.55 years, 53 patients eventually progressed with a 10-year PFS of 50% vs. 56% for patients in arm A and B, respectively (HR = 1.42; p > 0.1). No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39, p > .1). Patients receiving 90Y-ibritumomab-tiuxetan showed higher incidence of second neoplasms than those in arm B (10-year cumulative incidence 18.5 vs. 2%, respectively; p = .038). In conclusion, in FL patients responding to R-CHOP, no significant differences were found between consolidation and maintenance, although with higher late toxicity for consolidation.

La inteligencia artificial y sus aplicaciones en medicina II: importancia actual y aplicaciones prácticas / Artificial intelligence and its applications in medicine II: Current importance and practical applications

La tecnología y la medicina siguen un camino paralelo durante las últimas décadas. Los avances tecnológicos van modificando el concepto de salud y las necesidades sanitarias están influyendo en el desarrollo de la tecnología. La inteligencia artificial (IA) está formada por una serie de algoritmos lógicos suficientemente entrenados a partir de los cuales las máquinas son capaces de tomar decisiones para casos concretos a partir de normas generales. Esta tecnología tiene aplicaciones en el diagnóstico y seguimiento de pacientes con una evaluación pronóstica individualizada de los mismos. Además, si combinamos esta tecnología con la robótica, podemos crear máquinas inteligentes que hagan propuestas diagnósticas o que sean mucho más eficientes en su trabajo. Por lo tanto la IA va a ser una tecnología presente en nuestro trabajo cotidiano a través de máquinas o programas informáticos, que de manera más o menos transparente para el usuario, van a ir siendo una realidad cotidiana en los procesos sanitarios. Los profesionales sanitarios tenemos que conocer esta tecnología, sus ventajas y sus inconvenientes, porque va a ser una parte integral de nuestro trabajo. En estos dos artículos pretendemos dar una visión básica de esta tecnología adaptada a los médicos con un repaso de su historia y evolución, de sus aplicaciones reales en el momento actual y una visión de un futuro en el que la IA y el Big Data van a conformar la medicina personalizada que caracterizará al siglo XXI

Technology and medicine follow a parallel path during the last decades. Technological advances are changing the concept of health and health needs are influencing the development of technology. Artificial intelligence (AI) is made up of a series of sufficiently trained logical algorithms from which machines are capable of making decisions for specific cases based on general rules. This technology has applications in the diagnosis and follow-up of patients with an individualized prognostic evaluation of them. Furthermore, if we combine this technology with robotics, we can create intelligent machines that make more efficient diagnostic proposals in their work. Therefore, AI is going to be a technology present in our daily work through machines or computer programs, which in a more or less transparent way for the user, will become a daily reality in health processes. Health professionals have to know this technology, its advantages and disadvantages, because it will be an integral part of our work. In these two articles we intend to give a basic vision of this technology adapted to doctors with a review of its history and evolution, its real applications at the present time and a vision of a future in which AI and Big Data will shape the personalized medicine that will characterize the 21st century

[Artificial intelligence and its applications in medicine II: Current importance and practical applications]. / La inteligencia artificial y sus aplicaciones en medicina II: importancia actual y aplicaciones prácticas.

Technology and medicine follow a parallel path during the last decades. Technological advances are changing the concept of health and health needs are influencing the development of technology. Artificial intelligence (AI) is made up of a series of sufficiently trained logical algorithms from which machines are capable of making decisions for specific cases based on general rules. This technology has applications in the diagnosis and follow-up of patients with an individualized prognostic evaluation of them. Furthermore, if we combine this technology with robotics, we can create intelligent machines that make more efficient diagnostic proposals in their work. Therefore, AI is going to be a technology present in our daily work through machines or computer programs, which in a more or less transparent way for the user, will become a daily reality in health processes. Health professionals have to know this technology, its advantages and disadvantages, because it will be an integral part of our work. In these two articles we intend to give a basic vision of this technology adapted to doctors with a review of its history and evolution, its real applications at the present time and a vision of a future in which AI and Big Data will shape the personalized medicine that will characterize the 21st century.

Competencias digitales clave de los profesionales sanitarios / Key digital skills for healthcare professionals

La evolución de Internet y de la tecnología digital en la sociedad y en los sectores productivos ha planteado en los sistemas sanitarios la necesidad de una transformación digital que aporte mejoras en calidad y eficiencia. A pesar de los avances tecnológicos y de la creciente demanda social para incorporarlos en la práctica clínica diaria, el grado de implementación de la innovación digital en el sector sanitario es todavía escaso y lento, en parte debido a la brecha digital. Por ello, resulta imprescindible que todos los agentes de salud incorporen ciertos conocimientos y habilidades específicas relacionadas con el entorno digital y la transformación que conlleva. Se presentan una serie de nuevas competencias que pueden facilitar esta transición a los profesionales de la salud y ayudarles a mejorar su desempeño profesional con la ayuda de Internet y las tecnologías asociadas. Como profesionales de la información y del conocimiento, los sanitarios no debemos vivir ajenos a esta transformación, ya que la salud digital supone una oportunidad para la mejora continua en áreas tan transversales e importantes como la gestión de la información, la comunicación, la investigación, la innovación, la docencia y la publicación científica

The evolution of the Internet and digital technology in society and in all productive sectors has led to health systems establishing the need for changing to digital/computerised systems that can provide improvements in quality and efficiency. Despite technological advances and growth of social demand to incorporate them into daily clinical practice, the level of implementation of digital innovation in the healthcare sector is still limited and slow, partly due to the digital divide. This is why it is essential that accurate knowledge and skills related to the digital environment are acquired by all health workers, as well as patients. This article presents a series of digital skills for different health workers in order to facilitate this transition and improve their professional performance with the help of the Internet and associated technologies. We must not remain outside this transformation, since digital healthcare is a great opportunity for continuous improvement in such wide and important areas as information management, communication, research, innovation, teaching and scientific publication

Comparing Three Methods for Reducing Psychotropic Use in Older Demented Spanish Care Home Residents.

BACKGROUND/OBJECTIVE: In nursing homes across the world, and particularly in Spain, there are concerns that psychotropic medications are being overused. For older Spanish nursing home residents who had dementia, we sought to evaluate the association between applying interventions designed to reduce inappropriate psychotropic medication use and subsequent psychotropic use. DESIGN: Retrospective, propensity score-matched, controlled, patient-level observational analysis. SETTING: A total of 45 nursing homes in Spain. PARTICIPANTS: A total of 1653 nursing home residents, aged 70 to 99 years, who had dementia and were prescribed an antipsychotic, anxiolytic, or antidepressant medication, 606 of whom received an intervention; the remainder served as propensity score-matched controls. INTERVENTION: Team Rounds, Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert Doctors to Right Treatment (START) criteria, or a Patient Decision Aid. MEASUREMENTS: At 2 and 4 weeks following intervention: change from baseline drug class-specific milligram-equivalent daily dose (MEDD); at 2 weeks: patient falls and restraint use. RESULTS: Within each intervention/drug-class cohort, intervention patients and matched controls had similar baseline demographic characteristics, Charlson scores, lengths of admission, and drug class-specific MEDDs. Compared to controls, patients exposed to Team Rounds experienced a 23.3% (95% confidence interval [CI] = 13.9%-32.8%) reduction in antipsychotic and a 23.1% (95% CI = 18.3%-28.0%) reduction in anxiolytic MEDDs; those exposed to Patient Decision Aids had a 24.8% (95% CI = 15.6%-33.9%) reduction in antipsychotic and a 31.8% (95% CI = 25.5%-38.2%) reduction in anxiolytic MEDDs; and those exposed to STOPP/START application had a 27.7% (95% CI = 22.4%-33.0%) reduction in antipsychotic and a 39.5% (95% CI = 35.5%-43.5%) reduction in anxiolytic MEDDs. Intervention-associated antidepressant MEDD reductions were statistically significant but less dramatic. Interventions were associated with higher rates of medication discontinuation, but not higher rates of deaths, patient falls, or physical restraints. CONCLUSION: We found strong evidence that the interventions we studied were associated with reduced psychotropic use without commensurate harms, suggesting that such interventions should be incorporated into Spanish nursing home care models. Public reporting of psychotropic medication use in Spanish care homes may encourage care homes to regularly monitor psychotropic medication use and implement such instruments. J Am Geriatr Soc, 2019.

Trombosis de la vena yugular interna en paciente portadora de marcapasos / Internal jugular vein thrombosis in a patient with internal pacemaker

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Long-Term Follow-Up of a Phase II Trial of Six Cycles of Dose-Dense R-CHOP-14 for First-Line Treatment of Diffuse Large B-Cell Lymphoma in Young and Elderly Patients.

BACKGROUND/AIMS: Rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) every 14 days seems to achieve better outcomes than R-CHOP every 21 days in diffuse large B-cell lymphoma (DLBCL) patients. Currently, the standard regimen is R-CHOP every 21 days. METHODS: This is a phase II clinical trial of treatment with 6 cycles of R-CHOP-14 with pegfilgrastim support in 2 populations of previously untreated DLBCL patients aged ≥65 years (n = 73) or <65 years (n = 51) with low-risk International Prognostic Index scores (0-2). RESULTS: With a median follow-up of 63.7 months, the 5-year event-free survival rate was 53.8% in patients aged ≥65 years and 71.0% in patients aged <65 years. The 5-year overall survival rate was 71.4 and 89.8%, respectively. The complete remission rate was 69.9% for older and 80.4% for younger patients. The median relative dose intensity of cytotoxic drugs was 143.2% in the elderly and 149.1% in the young patients. Febrile neutropenia was the most common grade 3-4 adverse event, being higher in elderly patients (21.3 vs. 9.3%). Eight deaths (7 in elderly patients) were considered treatment related. CONCLUSION: In conclusion, the R-CHOP-14 regimen is feasible and very active, though it is more toxic in elderly patients mainly due to an increased incidence of infections. New strategies, such as new monoclonal antibodies or new targeted therapies, are needed to improve the outcomes of DLBCL patients.

First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial.

BACKGROUND: No standard first-line systemic treatment for mucosa-associated lymphoid tissue (MALT) lymphoma is available. In a phase 2 study we aimed to assess the safety and activity of a response-adapted combination of bendamustine plus rituximab as upfront treatment for this type of lymphoma. METHODS: In a multicentre, single-arm, non-randomised, phase 2 trial, we enrolled patients with MALT lymphoma at any site and stage and treated them with bendamustine (90 mg/m(2) on days 1 and 2) plus rituximab (375 mg/m(2) on day 1), every 4 weeks. Inclusion criteria were measurable or evaluable disease, age 18-85 years, and unequivocal active lymphoma; we also enrolled patients with MALT lymphoma arising in the stomach after failure of Helicobacter pylori eradication and primary cutaneous cases after failure of local therapies. Exclusion criteria included evidence of histological transformation, CNS involvement, and active hepatitis B or C virus or HIV infection. After three cycles, patients achieving complete response received one additional cycle (total four cycles) and those achieving partial response received three additional cycles (total six cycles). The primary endpoint was 2-year event-free survival. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01015248. FINDINGS: 60 patients from 19 centres in Spain were enrolled between May 27, 2009, and May 23, 2011, and received treatment; 57 patients were evaluable for the primary endpoint. Only 14 (25%) patients needed more than four cycles of treatment. After a median follow-up of 43 months (IQR 37-51), median event-free survival was not reached. Event-free survival at 2 years was 93% (95% CI 84-97) and at 4 years was 88% (95% CI 74-95). The most frequently observed grade 3-4 adverse events were haematological: lymphopenia in 20 (33%) patients, neutropenia in 12 (20%) patients, and leucopenia in three (5%) patients. Grade 3-4 febrile neutropenia or infections were reported in three (5%) and four (7%) patients, respectively. INTERPRETATION: This response-adapted schedule of bendamustine plus rituximab appears to be an active and well tolerated first-line treatment for patients with MALT lymphoma. FUNDING: Grupo Español de Linfomas/Trasplante de Médula Ósea (GELTAMO), Mundipharma Spain, and Roche Pharma Spain.

Stage IV and age over 45 years are the only prognostic factors of the International Prognostic Score for the outcome of advanced Hodgkin lymphoma in the Spanish Hodgkin Lymphoma Study Group series.

The International Prognostic Score (IPS) is the most widely used system to date for identifying risk groups for the outcome of patients with advanced Hodgkin lymphoma, although important limitations have been recognized. We analyzed the value of the IPS in a series of 311 patients with advanced classical Hodgkin lymphoma (cHL) (Ann Arbor stage III, IV or stage II with B symptoms and/or bulky masses) treated with first-line chemotherapy including adriamycin (adriamycin, bleomycin, vinblastine, dacarbazine [ABVD] or equivalent variants). In univariate and multivariate analyses, stage IV disease and age ≥ 45 years were the only factors with independent predictive significance for overall survival (OS) (p = 0.002 and p < 0.001, respectively). Stage IV was still significant for freedom from progression (FFP) (p = 0.001) and age ≥ 45 years was borderline significant (p = 0.058). IPS separates prognostic groups, as in the original publication, but this is mainly due to the high statistical significance of stage IV and age ≥ 45 years. Moreover, the combination of these two factors enables a simpler system to be constructed that separates groups with different FFP and OS. In conclusion, in our series, stage IV and age ≥ 45 years are the key prognostic factors for the outcome of advanced cHL.

Frontline treatment of follicular lymphoma with fludarabine, cyclophosphamide, and rituximab followed by rituximab maintenance: toxicities overcome its high antilymphoma effect. Results from a Spanish Cooperative Trial (LNHF-03).

We assessed the efficacy of fludarabine, cyclophosphamide, and rituximab in combination (FCR) as frontline treatment in patients with follicular lymphoma (FL) followed by rituximab maintenance. Seventy-five untreated patients with FL received FCR followed by maintenance with rituximab 375 mg/m(2) weekly during 4 weeks and every 6 months for 2 years. The overall response rate was 100%, with 89% complete remission (CR) and 11% partial remission (PR). Molecular remission was observed in all but one patient. Only eight patients completed all therapy planned. With a median follow-up of 47 months, the 5-year overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) were 77%, 93%, and 72%, respectively. Age below 60 and low Follicular Lymphoma International Prognostic Index (FLIPI) correlated with a better EFS. Ten patients died due to toxic complications. The FCR regimen is highly effective in untreated patients with FL, with 89% CR, including molecular responses, and a low progression rate. However, the high incidence of treatment-related mortality makes this regimen unsafe and it cannot be recommended as an upfront therapy in FL.

Long-Term Results of Fludarabine/Melphalan as a Reduced-Intensity Conditioning Regimen in Mantle Cell Lymphoma: The GELTAMO Experience.

BACKGROUND: We herein report the long-term results of an allogeneic reduced-intensity conditioning (allo-RIC) protocol used in 21 consecutive patients (16 males, median age 56 years, 71% in complete remission) diagnosed with mantle cell lymphoma (MCL). METHODS: The allo-RIC consisted of fludarabine plus melphalan and peripheral blood hematopoietic stem cells (PBSCs) from human leukocyte antigen (HLA)-identical siblings were used in all cases. Median CD34+ infused cells was 5.8 times 10(6)/kg. All patients engrafted promptly. RESULTS: Early toxicity included mild/moderate mucositis (43%), febrile neutropenia (33%) and bacterial infections (19%). With a median follow up of 48 months, four deaths were reported, all due to infections and/or graft-versus-host disease (GVHD), yielding a 3-year cumulative incidence of nonrelapse mortality of 19.5%. Grade III-IV acute GVHD occurred in 15% and chronic GVHD in 78%, being extensive in 39%. The 5-year progression-free survival (PFS) and overall survival (OS) were both 80% (95% CI: 63-97%). Age was the only possible prognostic factor for OS, which was 43% for those aged more than 60 years and 100% for those younger (p < 0.001). CONCLUSIONS: Our data confirm that allo-RIC offers a low toxicity profile and a chance for prolonged long-term disease-free survival in MCL, particularly in younger patients.

Reduced intensity conditioning HLA identical sibling donor allogeneic stem cell transplantation for patients with follicular lymphoma: long-term follow-up from two prospective multicenter trials.

BACKGROUND: Allogeneic hematopoietic stem cell transplantation is an effective treatment for patients with poor risk lymphoma, at least in part because of the graft-versus-lymphoma effect. Over the past decade, reduced intensity conditioning regimens have been shown to offer results similar to those of conventional high-dose conditioning regimens but with lower toxicity early after transplantation, especially in patients with chemosensitive disease at transplant. DESIGN AND METHODS: The aim of this study was to analyze the long-term outcome of patients with follicular lymphoma who received an HLA identical sibling allogeneic stem cell transplant with a reduced intensity conditioning regimen within prospective trials. The prospective multicenter studies considered included 37 patients with follicular lymphoma who underwent allogeneic stem cell transplantation between 1998 and 2007 with a fludarabine plus melphalan-based reduced intensity conditioning regimen. RESULTS: The median age of the patients was 50 years (range, 34-62 years) and the median follow-up was 52 months (range, 0.6 to 113 months). Most patients (77%) had stage III-IV at diagnosis, and patients had received a median of three lines of therapy before the reduced intensity conditioning allogeneic stem cell transplantation. At the time of transplantation, 14 patients were in complete remission, 16 in partial remission and 7 had refractory or progressive disease after salvage chemotherapy. The 4-year overall survival rates for patients in complete remission, partial remission, or with refractory or progressive disease were 71%, 48% and 29%, respectively (P=0.09), whereas the 4-year cumulative incidences of non-relapse mortality were 26% (95% CI, 11-61), 33% (95% CI, 16-68) and 71% (95% CI, 44-100), respectively. The incidence of relapse for the whole group was only 8% (95% CI, 2-23). CONCLUSIONS: We conclude that this strategy of reduced intensity conditioning allogeneic stem cell transplantation may be associated with significant non-relapse mortality in heavily pre-treated patients with follicular lymphoma, but a remarkably low relapse rate. Long-term survival is likely in patients without progressive or refractory disease at the time of transplantation.

Tromboembolia pulmonar masiva en una paciente portadora de una inusual combinación de factores genéticos protrombóticos / Massive pulmonary embolism in a patient with an unusual combination of prothrombotic genetic factors

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