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Record W2068181643 · doi:10.1310/hct0805-311

An Estimate of the Proportion of Symptoms Reported in Self-Administered Questionnaires That Are Captured as Adverse Drug Events in an Observational Database

2007· article· en· W2068181643 on OpenAlexafffundabout
Janet Raboud, Maia Lesosky, Sherine Sterling, Elizabeth Phillips, Sharon Walmsley, Ahmed M. Bayoumi

Bibliographic record

VenueHIV Clinical Trials · 2007
Typearticle
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmacovigilance and Adverse Drug Reactions
Canadian institutionsSt. Michael's HospitalLunenfeld-Tanenbaum Research InstituteUniversity of TorontoUniversity Health Network
FundersOntario HIV Treatment Network
KeywordsMedicineInterquartile rangeDiarrheaNauseaAdverse effectCohortObservational studyCohort studyPediatricsInternal medicine

Abstract

fetched live from OpenAlex

PURPOSE: This study was conducted to determine how frequently self-reported symptoms are captured as adverse drug events (ADEs) during chart abstraction. METHOD: We studied Ontario Cohort Study (OCS) participants attending the Toronto Hospital Immunodeficiency Clinic and compared OCS data on ADEs collected semi-annually through chart review and a self-administered questionnaire, completed on up to three occasions, which asked about the frequency, severity, and chronicity of symptoms including diarrhea, nausea, fatigue, and changes in body shape. Among 64 participants who completed the questionnaires, the median age was 42 years, the median time since HIV diagnosis was 9 years, 84% were male, 58% were men who had sex with men, 70% had viral load levels below 50 copies/mL, and the median CD4 was 422 cells/mm3. All patients were taking antiretroviral therapy. RESULTS: The median (interquartile range) number of symptoms per participant reported on the questionnaire at the first visit was 3 (1-5). The most common symptoms reported by patients were diarrhea (58%), headache (59%), difficulty sleeping (52%), dry skin (53%), and changes in body shape (52%). The median number of ADEs during the study period per participant in OCS was 1 (0-2). Of 345 symptoms identified on the questionnaire, 16% were reported as ADEs in the OCS. CONCLUSION: Although some symptoms were correctly not classified as ADEs as they were not related to antiretroviral medication, others may have been missed due to incomplete reporting to the physician, incomplete physician recording, or errors in chart extraction.

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)0.025
metaresearch head score (Gemma)0.080
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.975
Threshold uncertainty score0.132

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0250.080
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0040.004
Science and technology studies0.0000.000
Scholarly communication0.0010.002
Open science0.0010.001
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0010.000

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 head0.566
GPT teacher head0.617
Teacher spread0.051 · 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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designObservational
DomainReporting
GenreEmpirical

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

Citations8
Published2007
Admission routes3
Has abstractyes

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