The REDCap consortium: Building an international community of software platform partners

Harris, Paul A.; Taylor, Robert J.; Minor, Brenda; Elliott, Veida; Fernández, Michelle; O'Neal, Lindsay; McLeod, Laura; Delacqua, Giovanni; Delacqua, Francesco; Kirby, Jacqueline; Duda, Stephany N.

doi:10.1016/j.jbi.2019.103208

Cited by 11,764 publications

(7,160 citation statements)

References 46 publications

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“…5 Study data were collected and managed using REDCap (Research Electronic Data Capture) hosted at University of California, San Francisco. 6,7 Interventions All participants received instruction in oral hygiene at the baseline and 4-, 8-, and 12-month study visits. Participants in the intensive group received full-mouth scaling and root planing (below the gumline deep cleaning treatment), local controlled-release antibiotic administration (minocycline hydrochloride [HCl]; Arestin microspheres [Valeant Pharmaceuticals]) in deeper gum pockets ≥ 5 mm, and recommendation for extraction of teeth that could not be saved (hopeless teeth) at the baseline study visit.…”

Section: Measures and Data Collectionmentioning

confidence: 99%

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial

et al. 2020

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Rationale & Objective Observational studies have suggested that periodontal disease may be a modifiable risk factor for chronic kidney disease (CKD). The Kidney and Periodontal Disease (KAPD) Study was designed to determine the feasibility of conducting a periodontal disease treatment trial among a high-risk (mostly poor and racial/ethnic minority) population and estimate the magnitude and variability of kidney and inflammatory biomarker levels in response to intensive periodontal treatment. Study Design Single-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups. Setting & Participants English- and Spanish-speaking individuals aged 20 to 75 years receiving primary care within the San Francisco Community Health Network with evidence of both moderate to severe periodontal disease and CKD. Intervention Immediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months. Outcomes Feasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months. Results KAPD randomly assigned 51 participants to the immediate (34 participants) or rescue (17 participants) groups. 14% dropped out of the study (4 immediate, 3 rescue) and 80% completed all 4 visits of the 12-month protocol (28 immediate, 13 rescue). Fewer than half the teeth recommended for extraction were extracted and 40% of immediate group visits were outside the protocol window. Bleeding on probing and probing depth improved more in the immediate group than in the rescue group; there was no significant separation in periodontal status. Levels of markers of vascular endothelial and systemic injury declined in both groups. Limitations No true control group. Conclusions This 12-month, pilot, randomized, controlled trial successfully recruited and retained a high-risk population but was less successful observing treatment adherence, treatment effect, and variability of biomarker levels. Although KAPD did not meet all of its goals, important lessons learned can be applied to future studies. Funding National Institute of Diabetes and Digestive and Kidney Disease (Bethesda, MD; grant number 1K23DK093710-01A1) and Harold Amos Medical Faculty Development Program of the Robert Wood Johnson Foundation, Princeton, NJ. Funders had no role in study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the report for publication. Trial Registration NCT01802216 .

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Section: Measures and Data Collectionmentioning

confidence: 99%

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial

et al. 2020

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“…A short break was provided between each session. Data were downloaded to REDCap (Harris et al, 2019; Harris et al, 2009) for storage and analysis.…”

Section: Methodsmentioning

confidence: 99%

Listening difficulties in children: Behavior and brain activation produced by dichotic listening of CV syllables

Moore

Hugdahl

Stewart

et al. 2019

Preprint

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AbstractListening difficulties (LiD), also known as auditory processing disorders, are common in children with and without hearing loss. Impaired interactions between the two ears have been proposed as an important component of LiD. Previous studies have focused on testing using multiple sequential dichotic digits that carry a substantial memory load and executive control demands. We examined the ability of 6-13 year old children with normal audiometric thresholds to identify and selectively attend to dichotically presented CV syllables using the Bergen Dichotic Listening Test (BDLT;www.dichoticlistening.com). Children were recruited as typically developing (TD; n=39) or having LiD (n=35) based primarily on composite score of the ECLiPS caregiver report. Different single syllables (ba, da, ga, pa, ta, ka) were presented simultaneously to each ear (6×36 trials). Children reported the syllable heard most clearly (non-forced, NF) or the syllable presented to the right (forced, FR) or left (FL) ear. Interaural level differences (ILDs) manipulated bottom-up perceptual salience. Dichotic listening data (correct responses, Laterality Index) were analyzed initially by group (LiD, TD), age, report method (NF, FR, FL) and ILD (0, ± 15 dB) and compared with speech-in-noise thresholds (LiSN-S) and cognitive performance (NIH Toolbox). fMRI measured brain activation produced by a receptive speech task that segregated speech, phonetic and intelligibility components. Some activated areas (planum temporale, inferior frontal gyrus and orbitofrontal cortex) were correlated with dichotic results in TD children only.Neither group, age nor report method affected the Laterality Index of right/left recall. However, a significant interaction was found between ear, group and ILD. Children with LiD were more influenced by large ILDs, especially favoring the left ear, than were TD children. Neural activity associated with Speech, Phonetic and Intelligibility sentence cues did not significantly differ between groups. Significant correlations between brain activity level and BDLT were found in several frontal and temporal locations for the TD but not for the LiD group.Children with LiD were more influenced by large ILDs, especially favoring the left ear, than were TD children and were thus less able to modulate performance through attention, and more driven by the physical properties of the acoustic stimuli.

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“…The maternal antenatal visits also include recording of maternal anthropometric data, medical history of diseases, diet, and use of medications and nutritional supplements. Study data is being collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Pontificia Universidad Católica de Chile [27].…”

Section: Data Collectionmentioning

confidence: 99%

Early origins of allergy and asthma (ARIES): study protocol for a prospective prenatal birth cohort in Chile

et al. 2020

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Background: Growing evidence shows that atopic dermatitis (AD), food allergy (FA), allergic rhinitis, and asthma are largely determined during the first 1000 days (time elapsed from conception to the 2nd birthday). The ARIES birth cohort aims to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases and asthma in the offspring. Methods: We have designed a birth cohort of 250 families with prenatal recruitment (~14 weeks). We will genotype relevant allergy/asthma-associated variants in trios and will perform immunophenotyping and evaluation of allergy biomarkers in cord blood. At 1 and 2 years of age we will assess if infants have developed allergic sensitization, AD, FA, as well as biomarkers of asthma including the asthma predictive index. We will also evaluate how maternal conditions modify immune programming through epigenetic modifications and will then depict newborn epigenetic cues of allergy/asthma risk. Next, we will assess composition/diversity of maternal gut, placenta, breastmilk and infant gut microbiome and their association with immunophenotype and biomarkers at birth, and clinical outcomes at age 1 and 2. Finally, we plan to assess how environmental exposures (perinatal outdoor and indoor pollution, allergens and endotoxin) affect the incidence of allergic sensitization, AD, FA, and risk of asthma.Discussion: The in-depth study of the ARIES birth cohort shall provide crucial information to understand the rising incidence of allergies and asthma in developing countries, and hopefully provide cues on how to prevent and treat these diseases.Trial registration: clinicaltrials.gov NCT04186949, retrospectively registered on December 5, 2019.

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The REDCap consortium: Building an international community of software platform partners

Cited by 11,764 publications

References 46 publications

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial

Listening difficulties in children: Behavior and brain activation produced by dichotic listening of CV syllables

Early origins of allergy and asthma (ARIES): study protocol for a prospective prenatal birth cohort in Chile

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