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 ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Family Medicine ◽  
Randomized Clinical Trial ◽  
Broad Consent ◽  
Patient Centered ◽  
Electronic Tool

Clinical and patient‐centered outcomes using two types of subepithelial connective tissue grafts: A split‐mouth randomized clinical trial

2020 ◽  
Author(s):  
Mariana Schutzer Ragghianti Zangrando ◽  
Ricardo Rabelo Eustachio ◽  
Maria Lúcia Rubo Rezende ◽  
Adriana Campos Passanezi Sant'ana ◽  
Carla Andreotti Damante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Connective Tissue ◽  
Randomized Clinical Trial ◽  
Patient Centered ◽  
Tissue Grafts

scholarly journals Novel Trial Design: CHIEF-HF

2021 ◽  
Vol 14 (3) ◽  
Author(s):  
John A. Spertus ◽  
Mary C. Birmingham ◽  
Javed Butler ◽  
Ildiko Lingvay ◽  
David E. Lanfear ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Randomized Clinical Trial ◽  
Kansas City ◽  
Mobile Technologies ◽  
Patient Centered ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Diabetes Status ◽  
Patient Reported

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.

Health Within Reach—a Patient-Centered Intervention to Increase Hepatitis B Screening Among Asian Americans: a Randomized Clinical Trial

2022 ◽  
Author(s):  
Mandana Khalili ◽  
Nicole J. Kim ◽  
Janice Y. Tsoh ◽  
Judith M. E. Walsh ◽  
L. Elizabeth Goldman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hepatitis B ◽  
Randomized Clinical Trial ◽  
Asian Americans ◽  
Patient Centered ◽  
Hepatitis B Screening

Clinical and Patient-Centered Outcomes After Minimally Invasive Non-Surgical or Surgical Approaches for the Treatment of Intrabony Defects: A Randomized Clinical Trial

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 ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Minimally Invasive ◽  
Randomized Clinical Trial ◽  
Surgical Approaches ◽  
Intrabony Defects ◽  
Patient Centered

scholarly journals Functional and Patient-Centered Treatment Outcomes with Mandibular Overdentures Retained by Two Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial

2021 ◽  
Vol 10 (16) ◽  
pp. 3477
Author(s):  
Javier Montero ◽  
Abraham Dib ◽  
Yasmina Guadilla ◽  
Javier Flores ◽  
Beatriz Pardal-Peláez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oral Health ◽  
Treatment Outcomes ◽  
Randomized Clinical Trial ◽  
Muscular Activity ◽  
Health Impact ◽  
Patient Centered ◽  
Satisfaction Scale ◽  
Chewing Ability ◽  
Edentulous Patients

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.

Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial

2020 ◽  
Vol 75 (11) ◽  
pp. 651-653
Author(s):  
Miriam Kuppermann ◽  
Anjali J. Kaimal ◽  
Cinthia Blat ◽  
Juan Gonzalez ◽  
Mari-Paule Thiet ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Randomized Clinical Trial ◽  
Cesarean Delivery ◽  
Decision Support Tool ◽  
Patient Centered ◽  
Support Tool ◽  
Trial Of Labor ◽  
Previous Cesarean

scholarly journals Patient-Centered Treatment Outcomes with Full-Arch PEEK Rehabilitation Supported on Four Immediate or Conventionally Loaded Implants. A Randomized Clinical Trial

2021 ◽  
Vol 10 (19) ◽  
pp. 4589
Author(s):  
Javier Montero ◽  
Yasmina Guadilla ◽  
Javier Flores ◽  
Beatriz Pardal-Peláez ◽  
Norberto Quispe-López ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Outcomes ◽  
Randomized Clinical Trial ◽  
Health Impact ◽  
Masticatory Performance ◽  
Patient Centered ◽  
Satisfaction Scale ◽  
Chewing Gums ◽  
Ability Tests ◽  
Mixing Ability

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.

Photodynamic Therapy During Supportive Periodontal Care: Clinical, Microbiologic, Immunoinflammatory, and Patient-Centered Performance in a Split-Mouth Randomized Clinical Trial

2014 ◽  
Vol 85 (8) ◽  
pp. e277-e286 ◽  
Author(s):  
Maria F. Kolbe ◽  
Fernanda V. Ribeiro ◽  
Vanessa H. Luchesi ◽  
Renato C. Casarin ◽  
Enilson A. Sallum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Photodynamic Therapy ◽  
Randomized Clinical Trial ◽  
Patient Centered
Sign in / Sign up

Export Citation Format

Share Document