Effectiveness of a conversational chatbot in the smartphone to cease smoking in the adult population: pragmatic, controlled, randomized clinical trial in primary care (Dejal@). (Preprint)

BACKGROUND The magnitude and severity of smoking, the benefits of quitting, and the existence of effective and efficient interventions make it a priority problem. Health professionals intervene less than they should, and the most effective interventions are more expensive, require specific training and more time, which is a disadvantage for the service provider and for the accessibility of the services. Information and communication technologies avoid these problems thanks to their accessibility, privacy, customization possibilities, access to social support, and scalability. OBJECTIVE To assess the effectiveness of an evidence-based intervention to cease smoking via a chatbot in the smartphone compared to usual clinical practice in primary care. METHODS Pragmatic randomized clinical trial in 34 primary healthcare centers within the Madrid Health Service (Spain). Smokers over 18 years of age 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 by 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 subjects although participants were unblinded to group assignment. An intention-to-treat analysis, entering the basal observation carried forward in cases of missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS The trial was conducted between October 1st of 2018 and March 31st of 2019. The sample comprised 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 years (SD 10.82) and gender ratio of 59.3% women and 40.7% men. Of them, 232 patients (45.2%) completed the follow-up, 104 (42.9%) in the IG and 128 (47.2%) in the CG. Main outcome: In the intention-to-treat analysis, the biochemically-validated abstinence rate at 6 months was higher in the IG with 26.03% (63/242) versus 18.82% (51/271) in the CG (odds ratio (OR)=1.52, 95% CI: 1.00–2.31, P=.05). After adjusting for basal CO-oxymetry and bupropion intake, no substantial changes were observed (OR=1.52, 95% CI 0.99–2.33 P= .053; pseudo R2=0.045). In the IG, 61.16% (148/242) of users accessed the chatbot, average bot-patient interaction time was 121 minutes (CI 95% 121.1–140.0), and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS A treatment including a chatbot for helping in tobacco cessation was more effective than usual clinical practice in primary care. CLINICALTRIAL ClinicalTrials.gov, reference number NCT 03445507.

The Fracture Liaison Service of the Virgen Macarena University Hospital Reduces the Gap in the Management of Osteoporosis, Particularly in Men. It Meets the International Osteoporosis Foundation Quality Standards

Objectives: To describe the Fracture Liaison Service (FLS), to know the characteristics of the patients attended with emphasis on sex differences, and to know the compliance of International Osteoporosis Foundation (IOF) quality standards. Methods: Observational, prospective research. All the consecutive patients that attended in usual clinical practice from May 2018 to October 2019, were over 50 years, and with a fragility fracture (FF), were included. Results: Our FLS is a type A multidisciplinary unit. We included 410 patients, 80% women. FF recorded in 328 women were: Hip (132, 40%), Clinical Vertebral (81, 25%) and No hip No vertebral (115, 35%). Those in 82 men were: Hip (53, 66%), Clinical Vertebral (20, 24%) and No hip No vertebral (9, 10%), p = 0.0001. Men had more secondary osteoporosis (OP). The most remarkable result was the low percentage of patients with OP receiving treatment and the differences between sex. Forty-nine (16%) women versus nine (7%) men had received it at some point in their lives, p = 0.04. The probability of a man not receiving prior treatment was 2.5 (95%CI 1.01–6.51); p = 0.04, and after the FF was 0.64 (0.38–1.09). Treatment adherence in the first year after the FLS was 96% in both sexes. The completion of IOF quality standards was bad for patient identification and reference time. It was poor for initial OP screening standard and good for the remaining ten indicators. Conclusions: the FLS narrowed the gap in diagnosis, treatment, and follow-up of fragility fracture patients, especially men. The FLS meets the IOF quality standards.

Recurrent Auricular Pseudocyst: Successful Treatment Using a Dental Silicon Cast

Auricular pseudocysts (APs) are benign intercartilaginous cysts at the auricle. Various therapeutic options have been used to treat APs, but they frequently recur in usual clinical practice. Here, we report a case of AP successfully treated using a silicon cast. A 65-year-old male presented with a cyst on his right auricle. Although a local injection of steroid was administered, the cyst had recurred. A dental silicon cast was applied after removal of the contents of the cyst by suction. There was no recurrence of the cyst 6 years after that treatment. Dental silicon casts are a novel technique for an appropriate fixation over auricles in the treatment of APs and had an effective therapeutic result in our case.

Development and Refinement of a Persuasive Health Communication Intervention to Persuade Adult Emergency Department Patients to be Screened for HIV and Hepatitis C

Screening for HIV and hepatitis C (HCV) in emergency departments (EDs) allows patients to benefit from life-saving treatment; however, some patients at risk for these infections decline to be tested. Interventions that overcome patient reluctance to be screened are needed so that infected patients can be linked with care. In this project, we developed a very brief, theory-based, persuasive health communication intervention (PHCI) drawn from our previous research that can be integrated into usual clinical practice. The intervention was revised with the assistance of stakeholders who would likely either deliver the intervention (ED medical staff or HIV/HCV counselors) and those who would receive it (adult ED patients). The final version of the intervention was rated as both persuasive and respectful of ED patients who initially declined HIV/HCV testing.

Thoughtful selection and use of scientific terms in clinical research: the case of ‘pragmatic’ trials

Clinical research is a discipline prone to the use of technical terms that may be particularly at risk for misunderstanding given the complex interpretation that is required. In this century, what is happening with the word ‘pragmatic’ when describing a randomized controlled trial (RCT) with medicines deserves a public reflection. Explanatory trials are conducted in ideal conditions to assess the comparative efficacy of interventions and are useful to explain whether interventions work. Pragmatic trials are those conducted in a way that resembles usual clinical practice conditions to assess the comparative effectiveness of interventions in a manner directly applicable for decision-makers. This, however, did not prevent 36% of authors of placebo-controlled, or prelicensing trials to identify their medicines RCTs as pragmatic in the title of their articles. The current situation is such that scientific literature has accepted that ‘pragmatic’ can convey the original meaning—that obtained in trials mimicking usual clinical practice—and a distorted one—that is focused on streamlining any trial procedure. Those involved in clinical trials should emphasize the importance of precision in the use of terms when describing RCTs through standardized solutions when possible. Unless clinical trial stakeholders agree when it would be correct to label an RCT as pragmatic, in a short period of time the term will be in danger of becoming meaningless. It is suggested that the Enhancing the Quality and Transparency of Health Research (EQUATOR) network, the Consolidated Standards of Reporting Trials (CONSORT) group and the International Committee of Medical Journal Editors (ICMJE) could address this topic and provide a consensus way forward.

Uses and applications of docosahexanoic acid (dha) in pediatric gastroenterology: current evidence and new perspective.

: In this paper we will review the dietary allowances of these fatty acids in the paediatric population, and also the indications in different pathologies within the field of pediatric gastroenterology. Finally, we will try to explain the reasons that may justify the difficulty in translating the good results in experimental studies to the usual clinical practice. This "good results" may be too little to be detected or there are other causes but misinterpreted as effects of dha.

Anti-drug antibodies anti-trastuzumab in the treatment of breast cancer

Introduction Trastuzumab is a monoclonal antibody which could induce the activation of a humoral immune response generating anti-drug antibodies (ADAs). Such response depends of the protein nature and the route of administration (intravenous or subcutaneous). The formation of these antibodies could block the action of trastuzumab (ADA-Tras) and forming immune complexes which decrease its efficacy, so it would be interesting to determine the presence of ADA-Tras in patients treated with trastuzumab. Material and methods The blood samples were centrifuged to separate the plasma. The presence of ADA-Tras in plasma was determined using an ELISA-type automated immunoassay. Results Fifty-one women with non-metastatic HER2-positive breast cancer treated with trastuzumab were included. Two groups were studied: patients treated intravenously and subcutaneously. In neither case was there any presence of ADA-Tras. Discussion This study may be the first ever conducted under usual clinical practice conditions to detect the presence of ADA-Tras in patients with non-metastatic HER2-positive breast cancer. We have wanted to show the antibodies anti-trastuzumab determination as a possible tool that would enable comparison of potential differences in immunogenic behavior between trastuzumab and its biosimilars.