PMID- 23701349
OWN - NLM
STAT- MEDLINE
DCOM- 20131018
LR  - 20240502
IS  - 1553-2712 (Electronic)
IS  - 1069-6563 (Print)
IS  - 1069-6563 (Linking)
VI  - 20
IP  - 4
DP  - 2013 Apr
TI  - The use of delayed telephone informed consent for observational emergency 
      medicine research is ethical and effective.
PG  - 403-7
LID - 10.1111/acem.12117 [doi]
AB  - OBJECTIVES: The objective was to describe the rate of successful consent using an 
      altered (deferred telephone) consent process in emergency department (ED) 
      patients. METHODS: This study evaluated the consent process employed during a 
      prospective, multicenter, observational study of outcomes in anticoagulated 
      patients with blunt head trauma. The study was approved by the institutional 
      review boards (IRBs) at all participating centers. Patients were not informed of 
      the study during their enrollment at their index ED visit. Patient names, 
      clinical findings, and contact information were collected at the time of initial 
      ED visits. The patients or their legally designated surrogates were contacted by 
      telephone at least 14 days after ED discharge, given all the elements of informed 
      consent, and then consented for study participation. Study results are presented 
      with simple descriptive statistics. RESULTS: A total of 506 patients with a mean 
      (+/-SD) age of 75.8 (+/-12.2) years including 274 female subjects (54.2%; 95% 
      confidence interval [CI] = 49.7% to 58.6%) were enrolled into the study. Patients 
      or their surrogates were successfully contacted by telephone in 501 of 506 cases 
      (99.0%; 95% CI = 97.7% to 99.7%). Consent was obtained in 500 of 501 cases at 
      time of telephone follow-up (99.8%; 95% CI = 98.9% to 100.0%). Surrogates 
      provided consent in 199 cases (39.7%; 95% CI = 35.4% to 44.2%). Median time from 
      ED visit to phone contact was 21 days (interquartile range [IQR] = 17 to 27 
      days). The median number of phone attempts for successful contact was 1 (IQR = 1 
      to 2 attempts). CONCLUSIONS: The authors achieved a very high rate of successful 
      telephone follow-up in this predominantly older ED population. Obtaining consent 
      to participate in a research study using a deferred telephone contact process was 
      effective and well received by both subjects and surrogates. IRBs should consider 
      deferred telephone consent for minimal-risk studies requiring telephone 
      follow-up, as opposed to a consent process requiring written documentation at the 
      time of initial ED visit.
CI  - (c) 2013 by the Society for Academic Emergency Medicine.
FAU - Offerman, Steven R
AU  - Offerman SR
AD  - Kaiser Permanente Northern California, Oakland, CA.
FAU - Nishijima, Daniel K
AU  - Nishijima DK
FAU - Ballard, Dustin W
AU  - Ballard DW
FAU - Chetipally, Uli K
AU  - Chetipally UK
FAU - Vinson, David R
AU  - Vinson DR
FAU - Holmes, James F
AU  - Holmes JF
LA  - eng
GR  - L30 TR000286/TR/NCATS NIH HHS/United States
GR  - UL1 RR024146/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Acad Emerg Med
JT  - Academic emergency medicine : official journal of the Society for Academic 
      Emergency Medicine
JID - 9418450
RN  - 0 (Anticoagulants)
SB  - IM
CIN - Acad Emerg Med. 2013 Aug;20(8):855. PMID: 23879772
CIN - Acad Emerg Med. 2013 Aug;20(8):856. PMID: 24033629
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/therapeutic use
MH  - Emergency Medicine/*ethics/*methods
MH  - Female
MH  - Head Injuries, Closed/*therapy
MH  - Humans
MH  - Informed Consent/*ethics
MH  - Male
MH  - Patient Selection/*ethics
MH  - Prospective Studies
MH  - Telephone
MH  - Time Factors
PMC - PMC4034372
MID - NIHMS447450
EDAT- 2013/05/25 06:00
MHDA- 2013/10/19 06:00
PMCR- 2014/05/27
CRDT- 2013/05/25 06:00
PHST- 2012/11/20 00:00 [received]
PHST- 2012/12/09 00:00 [revised]
PHST- 2012/12/11 00:00 [accepted]
PHST- 2013/05/25 06:00 [entrez]
PHST- 2013/05/25 06:00 [pubmed]
PHST- 2013/10/19 06:00 [medline]
PHST- 2014/05/27 00:00 [pmc-release]
AID - 10.1111/acem.12117 [doi]
PST - ppublish
SO  - Acad Emerg Med. 2013 Apr;20(4):403-7. doi: 10.1111/acem.12117.