Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant''s responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help

Attainable yield and soil texture as drivers of maize response to nitrogen: a synthesis analysis for Argentina

The most widely used approach for prescribing fertilizer nitrogen (N) recommendations in maize (Zea Mays L.) in Argentina is based on the relationship between grain yield and the available N (kg N ha−1), calculated as the sum of pre-plant soil NO3--N at 0−60 cm depth (PPNT) plus fertilizer N (Nf). However, combining covariates related to crop N demand and soil N supply at a large national scale remains unexplored for this model. The aim of this work was to identify yield response patterns associated to yield environment (crop N demand driver) and soil texture (soil N supply driver). A database of 788 experiments (1980−2016) was gathered and analyzed combining quadratic-plateau regression models with bootstrapping to address expected values and variability on response parameters and derived quantities. The database was divided into three groups according to soil texture (fine, medium and coarse) and five groups based on the empirical distribution of maximum observed yields (from Very-Low = 13.1 Mg ha−1) resulting in fifteen groups. The best model included both, attainable yield environment and soil texture. The yield environment mainly modified the agronomic optimum available N (AONav), with an expected increase rate of ca. 21.4 kg N Mg attainable yield−1, regardless of the soil texture. In Very-Low yield environments, AONav was characterized by a high level of uncertainty, related to a poor fit of the N response model. To a lesser extent, soil texture modified the response curvature but not the AONav, mainly by modifying the response rate to N (Fine > Medium > Coarse), and the N use efficiencies. Considering hypothetical PPNT levels from 40 to 120 kg N ha−1, the expected agronomic efficiency (AENf) at the AONav varied from 7 to 31, and 9–29 kg yield response kg fertilizer N (Nf)−1, for Low and Very-High yield environments, respectively. Similarly, the expected partial factor productivity (PFPNf) at the AONav ranged from 62 to 158, and 55–99 kg yield kg Nf−1, for the same yield environments. These results highlight the importance of combining attainable yield environment and soil texture metadata for refining N fertilizer recommendations. Acknowledging the still low N fertilizer use in Argentina, space exists to safely increasing N fertilizer rates, steering the historical soil N mining profile to a more sustainable agro-environmental scenario in the Pampas.Fil: Correndo, Adrián A.. Kansas State University; Estados UnidosFil: Gutiérrez Boem, Flavio Hernán. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Agronomía; ArgentinaFil: García, Fernando O.. Universidad Nacional de Mar del Plata. Facultad de Ciencias Agrarias; ArgentinaFil: Alvarez, Carolina. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Álvarez, Cristian. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Angeli, Ariel. I+D CREA; ArgentinaFil: Barbieri, Pablo Andres. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Mar del Plata. Facultad de Ciencias Agrarias; Argentina. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Barraco, Mirian Raquel. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Berardo, Angel. Laboratorio de Suelo S.a.; ArgentinaFil: Boxler, Miguel. Private Consultant; ArgentinaFil: Calviño, Pablo Antonio. Private Consultant; ArgentinaFil: Capurro, Julia E.. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Carta, Héctor. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Caviglia, Octavio Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Entre Ríos. Facultad de Ciencias Agropecuarias; ArgentinaFil: Ciampitti, Ignacio Antonio. Kansas State University; Estados UnidosFil: Diaz Zorita, Martin. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de La Pampa. Facultad de Agronomía; ArgentinaFil: Díaz Valdéz, Santiago. Bayer Crop Science; ArgentinaFil: Echeverría, Hernán E.. Universidad Nacional de Mar del Plata. Facultad de Ciencias Agrarias; ArgentinaFil: Espósito, Gabriel Pablo. Universidad Nacional de Río Cuarto. Facultad de Agronomía y Veterinaria; ArgentinaFil: Ferrari, Manuel. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Ferraris, Gustavo Nestor. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Gambaudo, Sebastian Pedro. Universidad Nacional del Litoral. Facultad de Ciencias Agrarias; Argentina. Private Consultant; ArgentinaFil: Gudelj, Vicente. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Ioele, Juan P.. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Melchiori, Ricardo J. M.. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Molino, Josefina. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Orcellet, Juan Manuel. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Pagani, Agustin. Clarion Inc.; ArgentinaFil: Pautasso, Juan Manuel. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Reussi Calvo, Nahuel Ignacio. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Laboratorio de Suelo S.a.; ArgentinaFil: Redel, Matías. Private Consultant; ArgentinaFil: Rillo, Sergio. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Rimski-korsakov, Helena. Universidad de Buenos Aires. Facultad de Agronomía; ArgentinaFil: Sainz Rozas, Hernan Rene. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Mar del Plata. Facultad de Ciencias Agrarias; Argentina. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Saks, Matías. Bunge Argentina S.A; ArgentinaFil: Tellería, María Guadalupe. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Ventimiglia, Luis. Instituto Nacional de Tecnología Agropecuaria; ArgentinaFil: Zorzín, Jose L.. Private Consultant; ArgentinaFil: Zubillaga de Sanahuja, María de Las Mercedes. Universidad de Buenos Aires. Facultad de Agronomía; ArgentinaFil: Salvagiotti, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina. Instituto Nacional de Tecnología Agropecuaria. Centro Regional Santa Fe. Estación Experimental Agropecuaria Oliveros; Argentin

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

BACKGROUND: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. METHODS AND RESULTS: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. CONCLUSIONS: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.Journal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov'tinfo:eu-repo/semantics/publishe

Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial

Background: Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event. &lt;p/&gt;Methods: This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries. Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin. Patients and investigators were masked to treatment allocation. The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death). We planned a sequential statistical analysis of non-inferiority (margin 1·05) followed by analysis of superiority. Analysis was by intention to treat. The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee. This study is registered, number ISRCTN66157730. &lt;p/&gt;Findings: 9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28·3 months (SD 7·7). The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR] 1·02, 95% CI 0·94–1·12). There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints. We recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1·11, 95% CI 1·02–1·21), but no significant differences in other safety endpoints. &lt;p/&gt;Interpretation: The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary endpoint with terutroban and aspirin, without safety advantages for terutroban. In a worldwide perspective, aspirin remains the gold standard antiplatelet drug for secondary stroke prevention in view of its efficacy, tolerance, and cost

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

BACKGROUND: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. METHODS AND RESULTS: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. CONCLUSIONS: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P &lt; 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)