scholarly journals An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine

2021 ◽  
Vol 19 (1) ◽  
pp. 16-23
Author(s):  
Elizabeth H. Golembiewski ◽  
Arch G. Mainous ◽  
Kiarash P. Rahmanian ◽  
Babette Brumback ◽  
Benjamin J. Rooks ◽  
...  
Author(s):  
Mariana Schutzer Ragghianti Zangrando ◽  
Ricardo Rabelo Eustachio ◽  
Maria Lúcia Rubo Rezende ◽  
Adriana Campos Passanezi Sant'ana ◽  
Carla Andreotti Damante ◽  
...  

2021 ◽  
Vol 14 (3) ◽  
Author(s):  
John A. Spertus ◽  
Mary C. Birmingham ◽  
Javed Butler ◽  
Ildiko Lingvay ◽  
David E. Lanfear ◽  
...  

Background: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms. Methods: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire. Results: The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic. Conclusions: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04252287.


2011 ◽  
Vol 82 (9) ◽  
pp. 1256-1266 ◽  
Author(s):  
Fernanda V. Ribeiro ◽  
Renato C.V. Casarin ◽  
Maria A.G. Palma ◽  
Francisco H.N. Júnior ◽  
Enilson A. Sallum ◽  
...  

2021 ◽  
Vol 10 (16) ◽  
pp. 3477
Author(s):  
Javier Montero ◽  
Abraham Dib ◽  
Yasmina Guadilla ◽  
Javier Flores ◽  
Beatriz Pardal-Peláez ◽  
...  

This study aims to assess the treatment outcomes (functional and subjective) of mandibular overdentures retained on two implants with or without an immediate loading protocol. In this randomized clinical trial, twenty fully edentulous patients were treated with a mandibular two-implant-retained overdenture and a complete new maxillary denture. In half of the sample, the implants were loaded immediately by means of VulkanLoc® abutments after emplacement of the implant, but in the counterparts, these VulkanLoc® abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at two, six, and twelve months after surgery. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after five, ten, and fifteen chewing strokes, by the occlusal force recorded by pressure-sensitive sheets, and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20). The findings of the present study show that new complete dentures resulted in significant improvements in chewing ability, patient satisfaction, and oral health-related quality of life and that subsequent implant-retained overdentures produced further and faster significant improvements. The loading protocol may influence those positive self-reported outcomes rather than the objective functional evaluations.


2021 ◽  
Vol 10 (19) ◽  
pp. 4589
Author(s):  
Javier Montero ◽  
Yasmina Guadilla ◽  
Javier Flores ◽  
Beatriz Pardal-Peláez ◽  
Norberto Quispe-López ◽  
...  

This study aims to assess the treatment outcomes (functional and subjective) of full-arch fixed hybrid rehabilitations made of PEEK (poly-ether-ether-ketone) with milled crowns of nano-filled composite (NFC) supported on four to six implants. In this randomized clinical trial, 34 edentate patients in the upper and/or the lower jaws were treated with the fixed hybrid dentures. In 16 patients (47.1% of the sample), the implants were loaded immediately (IL) by means of a provisional fixed rehabilitation made of PMMA (polymethylmethacrylate) screwed on Multi-Unit (MU) abutments connected after emplacement of the implant; however, in the counterparts (n = 18) these MU abutments were covered by healing caps and were left unloaded during two months (conventional loading protocol—CL), when all patients received a fixed hybrid PEEK-NFC rehabilitation on the upper and/or the lower jaw. Treatment outcomes were assessed 12 months after prostheses delivery. Functional outcomes were calculated according to masticatory performance, estimated by mixing ability tests of two colored chewing gums after ten chewing strokes, by the occlusal force/area recorded by pressure-sensitive sheets, and by electromyography of masseters and temporal muscles at maximum biteforce. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analog scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20). The findings of the present study showed that treatment with fixed PEEK-NFC hybrid prostheses significantly improved the masticatory performance, bite force, occlusal pattern, quality of life, and satisfaction, with the IL group being those with significantly higher occlusal bite forces and greater satisfaction in comparison with CL group. It should be concluded that PEEK-NFC hybrid prostheses can improve several patient-centered outcomes and that loading protocol significantly affects the patient’s self-rated satisfaction.


2014 ◽  
Vol 85 (8) ◽  
pp. e277-e286 ◽  
Author(s):  
Maria F. Kolbe ◽  
Fernanda V. Ribeiro ◽  
Vanessa H. Luchesi ◽  
Renato C. Casarin ◽  
Enilson A. Sallum ◽  
...  

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