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Technical procedures and REDCap tools for internet-based clinical trials.

ABSTRACT: In March of 2020 our team of researchers developed and opened three clinical trials to investigate hydroxychloroquine as prophylaxis or treatment for the coronavirus disease 2019 (COVID-19). We simultaneously built corresponding Research Electronic Data Capture (REDCap) projects for these low-touch, remote trials that relied on participant-reported data. REDCap has built-in features that support pragmatic, internet-based studies, and REDCap is flexible enough to allow creative solutions for specific trials. We describe challenges, choices, and suggestions based on our experience with REDCap for our COVID-19 trials.

SUBMITTER: Bangdiwala AS

PROVIDER: S-EPMC8786406 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Technical procedures and REDCap tools for internet-based clinical trials.

Bangdiwala Ananta S AS Boulware David R DR

Contemporary clinical trials 20220125

In March of 2020 our team of researchers developed and opened three clinical trials to investigate hydroxychloroquine as prophylaxis or treatment for the coronavirus disease 2019 (COVID-19). We simultaneously built corresponding Research Electronic Data Capture (REDCap) projects for these low-touch, remote trials that relied on participant-reported data. REDCap has built-in features that support pragmatic, internet-based studies, and REDCap is flexible enough to allow creative solutions for spec ...[more]

PMID: 35085832

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Project description:BackgroundVarious digital learning objects (DLOs) are available via the World Wide Web, showing the flow of clinical procedures. It is unclear to what extent these freely accessible Internet DLOs facilitate or hamper students' acquisition of clinical competence.ObjectiveThis study aimed to understand the experience of undergraduate students across clinical disciplines-medicine, dentistry, and nursing-in using openly accessible Internet DLOs, and to investigate the role of Internet DLOs in facilitating their clinical learning.MethodsMid-year and final-year groups were selected from each undergraduate clinical degree program of the University of Hong Kong-Bachelor of Medicine and Bachelor of Surgery (MBBS), Bachelor of Dental Surgery (BDS), and Bachelor of Nursing (BNurs). All students were invited to complete a questionnaire on their personal and educational backgrounds, and their experiences and views on using Internet DLOs in learning clinical procedures. The questionnaire design was informed by the findings of six focus groups.ResultsAmong 439 respondents, 97.5% (428/439) learned a variety of clinical procedures through Internet DLOs. Most nursing students (107/122, 87.7%) learned preventive measures through Internet DLOs, with a lower percentage of medical students (99/215, 46.0%) and dental students (43/96, 45%) having learned them this way (both P<.001). Three-quarters (341/439, 77.7%) of students accessed DLOs through public search engines, whereas 93.2% (409/439) accessed them by watching YouTube videos. Students often shared DLOs with classmates (277/435, 63.7%), but rarely discussed them with teachers (54/436, 12.4%). The accuracy, usefulness, and importance of Internet DLOs were rated as 6.85 (SD 1.48), 7.27 (SD 1.53), and 7.13 (SD 1.72), respectively, out of a high score of 10.ConclusionsSelf-exploration of DLOs in the unrestricted Internet environment is extremely common among current e-generation learners and was regarded by students across clinical faculties as an important supplement to their formal learning in the planned curriculum. This trend calls for a transformation of the educator's role from dispensing knowledge to guidance and support.

Project description:ImportanceTogether with the forehead reconstruction, feminization of the nose is one of the most common procedures in facial feminization surgery. Rhinoplasty surgical techniques, which provide correct support and stability in the midterm to long term, are essential for obtaining a predictable result.ObjectiveTo report on the technical and clinical considerations of rhinoplasty and related procedures to feminize the nose, harmonize the nose in relation to the other modified structures (mainly the forehead and maxillomandibular complex), and achieve an aesthetic result beyond gender differences.Design, setting, and participantsCase series study of feminization rhinoplasties, in combination with lip-lift techniques, forehead reconstruction, and other procedures, were performed at a private practice between January 11, 2010, and May 29, 2015, in 200 consecutive male-to-female transgender patients. The mean (SD) medical follow-up for patients was 32 (18.84) months (range, 12-77 months). Frontonasal angles were objectively measured. Postoperative and long-term patient satisfaction were assessed.Main outcomes and measuresClinical analysis and evaluation using the 5-point Nose Feminization Scale, with 1 indicating very masculine or nose is worse and 5 indicating very feminine or exceptional result.ResultsIn these 200 patients, the mean (SD) age was 40.2 (12.2) years (range, 18-70 years). The mean (SE) frontonasal angle changed from 133.64° (0.63°) to 149.08° (0.57°) (difference in means, -15.44; 95% CI, -17.12 to -13.76; P < .001). Most patients considered their nose to appear more feminine after the surgery, and the degree of satisfaction after the rhinoplasty was 4 (much better) of 5 points on the Nose Feminization Scale. During the evaluation of feminization rhinoplasties, special attention was given to how the nose relates to other features essential to the identification of facial gender: the forehead and maxillomandibular complex. Emphasis was placed on the midterm to long-term stability of the results by reinforcing the internal structure.Conclusions and relevanceIn this case series of feminization rhinoplasties in combination with lip-lift techniques and forehead reconstruction, frontonasal angles were changed, and patient satisfaction with outcomes was high. The main goal of rhinoplasty in facial feminization surgery is to obtain feminine nasal features and the harmonization of the nose with the rest of the face. Lip-lifts and frontonasal recontouring can complement rhinoplasties associated with facial feminization surgery.Level of evidence4.

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Technical procedures and REDCap tools for internet-based clinical trials.

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Technical procedures and REDCap tools for internet-based clinical trials.

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