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Record W3117262421 · doi:10.1093/ofid/ofaa602

Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic

2020· review· en· W3117262421 on OpenAlexaff
Matthew F Pullen, Katelyn A Pastick, Darlisha A Williams, Alanna A Nascene, Ananta Bangdiwala, Elizabeth C Okafor, Katherine Huppler Hullsiek, Caleb P Skipper, Sarah M Lofgren, Nicole Engen, Mahsa Abassi, Emily G. McDonald, Todd C. Lee, Radha Rajasingham, David R. Boulware

Bibliographic record

VenueOpen Forum Infectious Diseases · 2020
Typereview
Languageen
FieldMedicine
TopicCOVID-19 and healthcare impacts
Canadian institutionsMcGill University
Fundersnot available
KeywordsMedicineClinical trialPandemicOutreachThe InternetRandomized controlled trialFamily medicineCoronavirus disease 2019 (COVID-19)DiseaseSurgeryPathologyInfectious disease (medical specialty)World Wide Web

Abstract

fetched live from OpenAlex

As the severe acute respiratory syndrome coronavirus 2 pandemic evolved, it was apparent that well designed and rapidly conducted randomized clinical trials were urgently needed. However, traditional clinical trial design presented several challenges. Notably, disease prevalence initially varied by time and region, and the pockets of outbreaks evolved geographically over time. Coupled with an occupational hazard from in-person study visits, timely recruitment would prove difficult in a traditional in-person clinical trial. Thus, our team opted to launch nationwide internet-based clinical trials using patient-reported outcome measures. In total, 2795 participants were recruited using traditional and social media, with screening and enrollment performed via an online data capture system. Follow-up surveys and survey reminders were similarly managed through this online system with manual participant outreach in the event of missing data. In this report, we present a narrative of our experience running internet-based clinical trials and provide recommendations for the design of future clinical trials during a world pandemic.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.533
metaresearch head score (Gemma)0.596
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: none
Teacher disagreement score0.467
Threshold uncertainty score0.576

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.5330.596
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0060.005
Bibliometrics0.0030.003
Science and technology studies0.0020.010
Scholarly communication0.0130.017
Open science0.0060.005
Research integrity0.0110.020
Insufficient payload (model declined to judge)0.0060.002

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.554
GPT teacher head0.595
Teacher spread0.041 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainMethods
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations12
Published2020
Admission routes1
Has abstractyes

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