| A geospatial analysis of persons opting out of an exception from informed consent out-of-hospital clinical trial. | |
| | |
MedLine Citation:
|
PMID: 19010580 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
STUDY OBJECTIVE: For trials involving exception from informed consent, some IRBs require that community members be allowed to "opt out" prior to enrollment. We tested for geospatial clustering of opt-out requests and the associated census tract characteristics in one study region. METHODS: This was a retrospective study at a single site of a multicenter exception from informed consent resuscitation trial. We collected and geocoded mailing addresses for persons requesting opt-out bracelets over 16 months, then tested for geospatial clustering using geographic information systems (GIS) analysis. Characteristics for tracts with and without bracelet clustering were compared using univariate tests, multivariable regression, and classification and regression tree (CART) analysis. RESULTS: We received 395 phone calls requesting 718 bracelets, of which 673 were analyzable. Of 397 census tracts in the region, 208 (52%) had at least one request and 38 (10%) demonstrated clustering. In multivariable models, an increasing proportion of family households (OR .90, 95%CI .85-.93), veterans (OR .91, 95%CI .81-1.02), and renters (OR .96, 95%CI .92-.99) were associated with lower odds of requesting an opt-out bracelet, while census tracts with higher income had higher odds of opting-out (OR 1.07, 95%CI 1.02-1.11). Using CART, the proportion of family households and graduate education identified the majority of opt-out requests by census tracts (cross-validation sensitivity 92%, specificity 56%). CONCLUSIONS: Opt-out requests for an exception from informed consent trial at one study site were geographically clustered and associated with certain population demographics. These findings may help identify key target groups for community consultation in future trials. |
| | |
Authors:
|
Maria J Nelson; Craig Warden; Denise Griffiths; Dana Zive; Terri Schmidt; Jerris R Hedges; Mohamud Daya; Craig D Newgard |
Publication Detail:
|
Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S. Date: 2008-11-17 |
Journal Detail:
|
Title: Resuscitation Volume: 80 ISSN: 0300-9572 ISO Abbreviation: Resuscitation Publication Date: 2009 Jan |
Date Detail:
|
Created Date: 2008-12-23 Completed Date: 2009-03-10 Revised Date: 2010-09-23 |
Medline Journal Info:
|
Nlm Unique ID: 0332173 Medline TA: Resuscitation Country: Ireland |
Other Details:
|
Languages: eng Pagination: 89-95 Citation Subset: IM |
Affiliation:
|
Oregon Health & Science University School of Medicine, Portland, OR, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Censuses Clinical Trials as Topic / legislation & jurisprudence*, psychology*, statistics & numerical data Geography Humans Informed Consent* Oregon Patient Identification Systems / statistics & numerical data Refusal to Participate / statistics & numerical data* Regression Analysis Retrospective Studies Therapeutic Human Experimentation / legislation & jurisprudence |
| Grant Support | |
ID/Acronym/Agency:
|
5U01 HL077863/HL/NHLBI NIH HHS; HL077863/HL/NHLBI NIH HHS; HL077866/HL/NHLBI NIH HHS; HL077867/HL/NHLBI NIH HHS; HL077871/HL/NHLBI NIH HHS; HL077872/HL/NHLBI NIH HHS; HL077881/HL/NHLBI NIH HHS; HL077885/HL/NHLBI NIH HHS; HL077908/HL/NHLBI NIH HHS; U01 HL077863-03/HL/NHLBI NIH HHS; U01 HL077863-03S1/HL/NHLBI NIH HHS; U01 HL077863-04/HL/NHLBI NIH HHS; U01/HL-04-001/HL/NHLBI NIH HHS; UL1 RR024140/RR/NCRR NIH HHS |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: The impact of introducing medical emergency team system on the documentations of vital signs.
Next Document: Utility of pre-cordial thump for treatment of out of hospital cardiac arrest: a prospective study.