Evidence map›Paper›PMID 24107478›Full record

ArticleOtolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery2013

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

David L Witsell, Kristine A Schulz, Walter T Lee, Karen Chiswell

Abstract readComparative Study
In one paragraph

Article in Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Comparing the Study Populations in Dietary Supplement and Drug Clinical Trials for Metabolic Syndrome and Related Disorders.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2019
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

David L WitsellDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, Duke University School of Medicine, Durham, North Carolina, USA.
Kristine A Schulz
Walter T Lee
Karen Chiswell
Duke University · USClinical Research Institute · US

Funding

Clinical Trials Transformation InitiativeU19FD003800 · FDA · DUKE UNIVERSITY · PI CALIFF, ROBERT · 2009 to 2013
$8.5M
NIDCD R21/R33 Phased Infrastructure Grant for Patient-Oriented ResearchR33DC008632 · NIDCD · DUKE UNIVERSITY · PI WITSELL, DAVID L · 2008 to 2012
$2.3M
FDA HHS U19 FD003800NIDCD NIH HHS R33 DC008632
6 · The paper itself

Abstract

objectiveTo describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. STUDY

designDatabase analysis.

settingTrial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010.

methodsData extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups.

resultsA total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints.

conclusionsAnalysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Indexed as

RegistriesClinical Trials as TopicData Interpretation, StatisticalEvidence-Based MedicineHumansOtolaryngologyOtorhinolaryngologic DiseasesRetrospective StudiesUnited Statesclinical trialsdatabaseevidence-based medicineotolaryngology

Identifiers

PMID24107478
PMCPMC4121965
OpenAlexW2063586534

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.