scholarly journals The training game SALIENCE for the therapy of alcohol use disorder

2019 ◽  
Vol 26 (1) ◽  
pp. 499-512 ◽  
Author(s):  
Sabine Vollstädt-Klein ◽  
Philip Mildner ◽  
Jan Malte Bumb ◽  
Damian Karl ◽  
Christoph Ueberle ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Feasibility Study ◽  
Game Design ◽  
Alcohol Use Disorder ◽  
Standard Treatment ◽  
Real Life ◽  
Daily Basis ◽  
Web Based ◽  
Group 2 ◽  
Group 1

The feasibility study was aimed to develop a web-based gaming tool for the therapy of alcohol use disorder to offer patients a cue-exposure-based extinction and decision training, enhanced with virtual reality. To increase the training effect, patients playfully experience situations that resemble critical real-life situations. For implementing the game, a combination of HTML5 and JavaScript was used. The application comes with an administrator interface, to allow editing the game content. Initially, we included 21 patients (Group 1), 18 suffering from alcohol use disorder and 3 using cannabis (18/3 male/female, mean age 39 ± 13 years). Considering the iterative process of a feasibility study, we developed the game design as suggested by participants of Group 1 and additionally included 11 novel participants (Group 2) (11 suffering from an alcohol use disorder, 7/4 male/female, mean age 46 ± 14 years). Basically, the game was very well received. Usability ratings were generally high, even in patients with little computer experience. Both groups rated the application as realistic, and would generally be willing to play it on a daily basis. Given that SALIENCE is inexpensive, easily available, and engaging, it might be a reasonable add-on intervention to the standard treatment of alcohol use disorder.

scholarly journals Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022233 ◽  
Author(s):  
Amanda Jane Blatch-Jones ◽  
Wei Pek ◽  
Emma Kirkpatrick ◽  
Martin Ashton-Key
Keyword(s):  
Feasibility Study ◽  
Randomised Controlled Trials ◽  
Feasibility Studies ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Group 2 ◽  
Randomised Controlled ◽  
Pilot Feasibility Study ◽  
Group 1

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

scholarly journals Feasibility, acceptability, and impact of a web-based gratitude exercise among individuals in outpatient treatment for alcohol use disorder

2015 ◽  
Vol 10 (6) ◽  
pp. 477-488 ◽  
Author(s):  
Amy R. Krentzman ◽  
Kristin A. Mannella ◽  
Afton L. Hassett ◽  
Nancy P. Barnett ◽  
James A. Cranford ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Outpatient Treatment ◽  
Alcohol Use Disorder ◽  
Web Based

scholarly journals Field Implementation of a Monthly Multi-Modal Prophylactic Strategy (Dinotefuran-Permethrin-Pyriproxyfen and Milbemycine Oxime-Praziquantel) Against Canine Vector-Borne Diseases in Corsica

2020 ◽  
Author(s):  
Younes Laidoudi ◽  
Hacène Medkour ◽  
Djamel Tahir ◽  
Handy Dahmana ◽  
Jean-Lou Marié ◽  
...  
Keyword(s):  
Real Life ◽  
Immunofluorescence Assay ◽  
Concurrent Administration ◽  
Risk Area ◽  
High Risk Area ◽  
Milbemycin Oxime ◽  
Vector Borne Diseases ◽  
Vector Borne ◽  
Group 2 ◽  
Group 1

With a mild Mediterranean-type climate, Corsica is endemic for canine vector-borne diseases (CVBDs) such as dirofilariosis (a mosquitoes borne-diseases: MBDs), leishmaniosis and ehrlichiosis. The aim of this present study was to evaluate a monthly multi-modal prophylactic strategy (MMP) against CVBDs occurring in Corsica. The study was conducted as a comparative field trial in which eighty dogs allocated into two groups were included: (i) Group 1 consisted of 25 dogs under the MMP [per-os administration of 1.5 tablet of milbemycine oxime-praziquantel and a topical line-on application of a 3.6 mL solution of dinotefuran-permethrin-pyriproxyfen] and (ii) Group 2 under various real-life prophylactic treatment (RLP) based on the use of ectoparasiticide products [different formulations: deltamethrin, fluralaner, fipronil] and/or macrocyclic lactones based-products [milbemycin oxime/praziquantel, milbemycin oxime, moxidectin] during the period ranging from June to October 2017. All animals were followed for one year and had blood drawn at day 0, followed by follow-up at 6 and 12 months. Samples were screened for filariosis using molecular tools as well as for leishmaniosis and ehrlichiosis using indirect immunofluorescence assay (IFA). At the end of the study, no new cases of CVBDs were recorded within Group 1. In Group 2, the cumulative incidence of CVBDs was 20.0% (n= 11; p= 0.015) including dirofilarioses due to Dirofilaria immitis and/or D. repens, with 16.4% (n= 9; p=0.027). Ehrlichiosis was 5.5% (n= 3; p=0.241). No new cases of leishmaniosis were detected in Group 2. The data illustrated that, unlike the RLP treatment which failed to protect at least 20% of dogs, the MMP based on the concurrent administration of milbemycine oxime-praziquantel and dinotefuran-permethrin-pyriproxyfen is efficient to protect dogs against CVBDs in a high-risk area.

scholarly journals Tolerance and Effectiveness of Targeted Therapies in Aged Patients with Metastatic Melanoma

2021 ◽  
Author(s):  
Ondine Becquart ◽  
Bastien Oriano ◽  
Stéphane Dalle ◽  
Laurent Mortier ◽  
Marie Thérèse Leccia ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Elderly People ◽  
Targeted Therapies ◽  
Objective Response ◽  
Real Life ◽  
Standard Regimen ◽  
Aged Patients ◽  
Group 2 ◽  
Group 1

Purpose: Melanoma’s incidence is increasing, and elderly people could be significantly impacted since the majority occurs in people over 65 years of age. Combined targeted therapies (TT) are current standard regimen for BRAF mutated metastatic melanoma (MM). Except for subgroups of pivotal trials, little data are available for TT in this population. Materials and Methods: Outcomes were explored in real life patients from MelBase, a French multicentric biobank dedicated to the prospective follow-up of unresectable stage III or IV melanoma. Patients treated by BRAF TT and/or MEK TT combined or not, were included from 2013 to 2017 in 2 groups: group 1 <65-year-old (yo), group 2 >65 yo, analyzed for tolerance and efficacy. Results: 353 patients were included: 231 in group 1, 122 in group 2. Median follow-up was 12 months (M). Median time of treatment was 6.9 M. A total of 80% had at least one Adverse Effect (AE). Most frequent AE (all grades) were mainly skin and subcutaneous, general, and gastrointestinal disorders. A total of 31% of AE were grade 3–4: 28% in group 1 and 39% in group 2 (p = 0.05). No differences were observed in all AE grades proportion, dose modifications, interruptions, and discontinuations. For each group, median overall survival was 20.3 M (CI 95%: 15.5–27.9) and 16.3 M (CI: 14.5–26.9), respectively (p = 0.8). Median progression free survival was 7.8 M (6.4–9.9) and 7.7 M (CI: 5.8–11.3) (p = 0.4). Objective response rate was 59% and 50% (p = 0.6). Conclusion: This study on a large multicentric cohort is the first to assess that TT is well tolerated in elderly BRAF-mutated patients such as in patients younger than 65. Efficacy was similar between groups with outcomes reaching those from pivotal studies. There is thus no argument against using TT in elderly people, although an onco-geriatric opinion is welcome for the most vulnerable.

scholarly journals Real Life Study on Allogeneic Hematopoietic Cell Transplantation Practice According to International Guidelines and Its Impact on Survival in Acute Myeloid Leukemia French Population

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4133-4133
Author(s):  
Loic Abed ◽  
Morgane Mounier ◽  
Marie Robin ◽  
Stephanie Nguyen Quoc ◽  
Nicole Raus ◽  
...  
Keyword(s):  
Myeloid Leukemia ◽  
Research Funding ◽  
Therapeutic Strategy ◽  
Hematopoietic Cell Transplantation ◽  
Real Life ◽  
Cancer Registries ◽  
Response To Treatment ◽  
Group 2 ◽  
Acute Myeloid ◽  
Group 1

Abstract Introduction Allogeneic Hematopoietic Cell Transplantation (allo-HCT) has proved its efficiency in reducing Acute Myeloid Leukemia (AML) recurrence, although it was associated with high rates of complications especially in older patients. The worldwide number of allo-HCT has increased within 35 years, from 10.000 transplantations before 1985 to over a million in 2012. The decision to perform transplantation depends on the estimated risk-benefit ratio. High-risk prognostic factors include cytogenetics, age at diagnosis, presence of comorbidities and the response to treatment. By using combination of risk factors, international recommendations have been published to harmonize AML care and maximize the benefit of using allo-HCT. The principal aim of this study is to describe real life AML care management in all consecutive patients diagnosed and registered on 3 regional cancer registries in France, to analyze their outcome after different therapeutic strategies, following or not the international recommendations. Method This retrospective study included all AML patients diagnosed between January 2012 and December 2016 reported to the French population data-based of regional cancer registries specialized in hematological malignancies. Allo-HCT data were extracted from the Société Française de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) registry. Two groups of patients were defined according to the treatment received: i) group 1, patients who have received the best recommended care including allo-HCT considering HLA compatibility and best donor choice or best conventional treatment according to therapeutic guidelines based on individuals and clinical characteristics from The American Society for Blood and Marrow Transplantation guidance; ii) group 2, patients who received a treatment outside the recommendations. To study the impact of therapeutic decision on overall survival, a case-control study was performed using a one for one matching between group 1 and group 2. An exact matching on individual and disease characteristics (cytogenetic risk, Charlson score class, age group at diagnosis, subtype AML and response to treatment) allowed to pair-match patients following or not the international recommendations for therapeutic strategy. Net survival was estimated until five-year using non-parametric Pohar-Perme estimator (survival distribution compared using Grafféo test). Results A total of 1039 AML patients diagnosed from 2012 to 2016 were identified, 449 (43 %) received a curative treatment and 540 patients a non-curative treatment (hypomethylating agents, low dose of cytarabine or other palliative treatment, best supportive care combined to no effective treatment). Based on available clinical data, 430 patients were included in the study. Group 1 included 296 patients (68%), 167 males and 129 females with 54 receiving allo-HCT (32 geno-identical and 22 unrelated). Group 2 included 134 patients (31%), 72 males and 62 females with 94 receiving allo-HCT (14 geno-identical, 50 unrelated and 30 mismatched). In patients for whom allo-HCT represented the best option according to the recommendations (Figure B, n = 44), a very significant lower survival was observed in patients who did not receive allo-HCT when they were compared to patients who received allo-HCT, with a 5 year-overall survival probability of 7 % and 50 % respectively (p= 0.019). In patients for whom allo-HCT was not recommended (Figure A, n = 42), we did not observe any significant difference of survival between patients transplanted or not. Conclusion This analysis shows the importance of allo-HCT decision in AML patients, especially when following international guidelines. Although individual risks factors have been previously studied, our analysis sums up theses factors and allow to understand the importance of integrating allo-HCT in the therapeutic strategy of AML and to re-evaluate current practices and its impact on patient outcome. Figure 1 Figure 1. Disclosures Pigneux: Roche: Consultancy, Research Funding; BMS Celgene: Consultancy, Research Funding; Sunesis: Consultancy, Research Funding; Amgen: Consultancy; Novartis: Consultancy, Research Funding. Forcade: Novartis: Other: travel grant. Mohty: Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Sanofi: Honoraria, Research Funding; Adaptive Biotechnologies: Honoraria. Dulery: Novartis: Honoraria; Takeda: Consultancy; Gilead: Other: Travel support and registration fees for scientific meetings .

scholarly journals Adherence to subcutaneous immunotherapy with aeroallergens in real-life practice during the COVID-19 pandemic

2021 ◽  
Author(s):  
Osman Ozan Yeğit ◽  
semra demir ◽  
Derya Erdoğdu ◽  
Muge Olgac ◽  
Kadriye Terzioğlu ◽  
...  
Keyword(s):  
Public Transportation ◽  
Clinical Symptoms ◽  
Real Life ◽  
Delay Group ◽  
Subcutaneous Immunotherapy ◽  
Asthmatic Patients ◽  
Symptom Scores ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: The success of subcutaneous immunotherapy (SCIT) mostly depends on regular injections. Our aim was to investigate adherence to SCIT with aeroallergens during the COVID-19 pandemic and demonstrate clinical consequences of treatment disruptions in real-life. Methods: Visual analogue scale for quality of life (VAS-QoL), VAS for symptom scores (VAS-symptom), medication scores (MSs) and total symptom scores (TSS-6) were recorded during the pandemic in 327 adult allergic rhinitis and/or asthmatic patients receiving maintenance SCIT and these scores were compared with the pre-pandemic data. Patients were grouped according to SCIT administration intervals; no delay (Group 1), <2 months (Group 2), and ≥2 month intervals (Group 3). Results: 104 (31.8%) patients (Group 3) were considered as non-adherent which was mostly related to receiving SCIT with HDMs and using public transportation for reaching the hospital. Median MS, VAS-symptom and TSS-6 scores of Group 3 patients during the pandemic were higher than the pre-pandemic scores (p=0.005, p<0.001, p<0.001, respectively) whereas median VAS-QoL scores of Group 3 during the pandemic were lower than the pre-pandemic scores (p<0.001). Median TSS-6 and VAS-symptom scores were the highest in Group 3 compared to other groups (p<0.001 for each comparison). Median VAS-QoL scores were the lowest in Group 3 compared to Group 1 and Group 2 (p<0.001, p=0.043, respectively). Conclusion: When precautions in allergy clinics are carefully applied, adherence to SCIT can be high during a pandemic. Patients must be warned about adhering to SCIT injections since delays in SCIT administration can deteriorate clinical symptoms.

The Real-Life Effectiveness and Safety of Omalizumab Updosing in Patients With Chronic Spontaneous Urticaria

2019 ◽  
Vol 23 (5) ◽  
pp. 496-500 ◽  
Author(s):  
Andac Salman ◽  
Elif Comert
Keyword(s):  
Real Life ◽  
Complete Response ◽  
Response To Therapy ◽  
Chronic Spontaneous Urticaria ◽  
Life Effectiveness ◽  
The Mean ◽  
Group 2 ◽  
Urticaria Activity Score ◽  
Higher Doses ◽  
Group 1

Background: Omalizumab is a third-line treatment for chronic spontaneous urticaria (CSU). Studies investigating the use of higher doses of omalizumab in patients unresponsive to regular doses are limited. Objectives: This study aims to investigate the effectiveness and safety of omalizumab 450 mg in CSU. Methods: A retrospective cohort study was conducted. The response to therapy was evaluated using the Urticaria Activity Score over 7 days (UAS7) and the Urticaria Control Test (UCT). Patients showing complete response (CR) (UAS7: 0-1) to omalizumab 300 mg (Group 1) and patients receiving at least 3 doses of omalizumab 450 mg (Group 2) between 2016 and 2018 were included. Results: A total of 72 patients (Group 1: 59; Group 2: 13) were included. In Group 2, the mean UAS7 score decreased from 18.6 to 5.1 and the mean UCT score increased from 8.6 to 12 after a mean 4.3 courses of 450 mg omalizumab treatment. Of the 13 patients in Group 2, 6 had CR and 3 had good disease control (UAS7: 2-6). The rate of patients with low baseline IgE levels (< 43 IU/mL) was significantly higher in Group 2. Conclusions: Higher doses of omalizumab are effective and safe in patients with CSU that is unresponsive to omalizumab 300 mg. Lower baseline total IgE levels might be used as a predictor of nonresponse to omalizumab and the need for higher doses.

LYR study: Influence of a web-based application on the systematic chronological and effectiveness of network-guided patient management processes in lymphological care

Phlebologie ◽  
2016 ◽  
Vol 45 (01) ◽  
pp. 7-14
Author(s):  
J. Berger ◽  
V. Rahms ◽  
H. Uhlemann ◽  
K. Waldvogel-Röcker ◽  
S. Hahn
Keyword(s):  
Quality Of Life ◽  
Feasibility Study ◽  
Patient Management ◽  
Standard Treatment ◽  
Epidemiological Data ◽  
Data Access ◽  
Web Based ◽  
Management Processes ◽  
Study Results

SummaryThe systematic acquisition of data for proving the benefit of standard treatment, demonstrating the efficiency of treatment provided by interprofessional patient management processes and providing valid epidemiological data is inadequate or even nonexistent in the treatment of lymphological disorders. The LYR study firstly uses a webbased documentation tool to examine whether treatment quality is ensured under the conditions provided by an outpatient lymph network that has been guaranteed by a systematic and guideline-compliant treatment analogy. The study evaluated the introduction and handling of a web-based documentation platform for joint case management. LYR also stands synonymously for Lymph Register, and represents a feasibility study with regard to establishing a national lymph register. A phase 1 multicentre interventional study of complex physical decongestion therapy on 61 subjects with different lymphological disorders investigated the immediate and late effects of a prespecified treatment analogy and web-based data acquisition with interdisciplinary data access in six regional lymph networks. Findings on the changes to quality of life and on the effect of the frequency of manual lymphatic drainage and the height of lymphological compression bandages on the results of decongestion were documented and data on prescribing periods and the behaviour of cost bearers were acquired. The study results show that a web-based, structured documentation system can usefully support treatment regimens and simplify mutual access to the patient management process. The epidemiological data acquired during the evaluation of the findings sheet are completely new in Germany and are seen as a feasibility study for a national lymph register that is being prepared. LYR also shows that standard treatment (CPD) has positive effects on circumferences, quality of life, and mobility. It was also shown that a high frequency of manual lymph drainage shortened the decongestion treatment period.

Idiopathic polypoidal choroidal vasculopathy in Caucasians: The POLYON real-life study in 50 naive patients

2019 ◽  
Vol 30 (5) ◽  
pp. 948-955 ◽  
Author(s):  
Hussam El Chehab ◽  
Laurent Kodjikian ◽  
Constance Lagenaite-Desmaizère ◽  
Emilie Agard ◽  
Flore De Bats ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Photodynamic Therapy ◽  
Polypoidal Choroidal Vasculopathy ◽  
Real Life ◽  
Caucasian Population ◽  
Intravitreal Injections ◽  
Final Visual Acuity ◽  
Group 2 ◽  
Choroidal Vasculopathy ◽  
Group 1

Objectives: Polypoidal choroidal vasculopathy is a common disease in Asia, but it has been less described in the Caucasian population. The aim of this real-life observational study was to describe the diagnostic and therapeutic practices as well as the prognosis in this population. Method: Fifty Caucasian patients with polypoidal choroidal vasculopathy were included in this study. All patients underwent angiography to confirm the diagnosis. Patients were divided into two treatment groups: patients of group 1 only received anti–vascular endothelial growth factor injections and those of group 2 required photodynamic therapy rescue in addition to intravitreal injections in case of suboptimal (anatomically or functionally) response. Clinical (visual acuity, fundus examination), paraclinical (retinal pigment epithelium detachment height and central retinal thickness on optical coherence tomography), and therapeutic (number of intravitreal injections) criteria were analyzed after 24 months. Results: Patient mean age was 73.9 ± 9.1 years, and half of the patients had age-related macular degeneration. In the whole cohort, the initial visual acuity was equivalent to the final visual acuity (59.9 ± 24.0 letters vs 62.5 ± 21.1 letters, p = 0.259). In group 1, the final visual acuity was significantly increased (from 56.9 ± 24.7 letters to 63.4 ± 21.6 letters, p = 0.016), while in group 2, it remained stable (from 61.7 ± 23.4 letters to 61.0 ± 21.4 letters, p = 0.249). The number of intravitreal injections was similar between both groups. Conclusion: In a Caucasian population, polypoidal choroidal vasculopathy seems to have a later onset. A non-standardized management allows stabilizing the functional prognosis. Patients requiring photodynamic therapy rescue have a poorer prognosis.

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