Opt-out as an acceptable method of obtaining consent in medical research: a short report

<p>Abstract</p> <p>Background</p> <p>A prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of <it>E. coli </it>urinary tract infection in the community. Participation of patients...

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Main Authors: Hanahoe Belinda, Cormican Martin, Vellinga Akke, Bennett Kathleen, Murphy Andrew W
Format: Article
Language:English
Published: BMC 2011-04-01
Series:BMC Medical Research Methodology
Online Access:http://www.biomedcentral.com/1471-2288/11/40
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author Hanahoe Belinda
Cormican Martin
Vellinga Akke
Bennett Kathleen
Murphy Andrew W
author_facet Hanahoe Belinda
Cormican Martin
Vellinga Akke
Bennett Kathleen
Murphy Andrew W
author_sort Hanahoe Belinda
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>A prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of <it>E. coli </it>urinary tract infection in the community. Participation of patients with urinary tract infection was obtained through an opt-out methodology. This short paper reports on the acceptability of the opt-out recruitment approach.</p> <p>Methods</p> <p>Participating practices (22) were requested to send a urine sample from all patients presenting with symptoms of urinary tract infection. Upon receipt of the sample in the laboratory, a letter explaining the study, an opt-out form and a freepost envelope were sent to all adult patients. A website with additional information and including an 'opt-out' button was set up for the study.</p> <p>Results</p> <p>A total of 1362 urine samples were submitted by the 22 participating practices representing 1178 adult patients of whom 193 actively responded to the letter: 142 opted out by letter, 15 through the website, 2 by phone and 12 sent the letter back without indication, making a total of 171 patients or 14.5% opt-out; the remaining 22 patients (1.9%) explicitly opted in. The total group consisted of 80% women and the mean age was 50.9 years (sd 20.8). No significant differences were found between patients who participated and those who opted out in terms of age, gender or whether the urine sample was positive or not.</p> <p>Conclusions</p> <p>Overall the opt-out method was well received and participation in the study reached 85.5%. The low number of complaints (2) indicates that this is a generally acceptable method of patient recruitment. The 14.5% opt-out shows that it effectively empowers patients to decline participation. The similarity between patients opting out and the rest of the patients is reassuring for extrapolation of the results of the study.</p>
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spelling doaj.art-8ed8d311a36642ae964b74a6bf57f28b2022-12-22T02:58:09ZengBMCBMC Medical Research Methodology1471-22882011-04-011114010.1186/1471-2288-11-40Opt-out as an acceptable method of obtaining consent in medical research: a short reportHanahoe BelindaCormican MartinVellinga AkkeBennett KathleenMurphy Andrew W<p>Abstract</p> <p>Background</p> <p>A prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of <it>E. coli </it>urinary tract infection in the community. Participation of patients with urinary tract infection was obtained through an opt-out methodology. This short paper reports on the acceptability of the opt-out recruitment approach.</p> <p>Methods</p> <p>Participating practices (22) were requested to send a urine sample from all patients presenting with symptoms of urinary tract infection. Upon receipt of the sample in the laboratory, a letter explaining the study, an opt-out form and a freepost envelope were sent to all adult patients. A website with additional information and including an 'opt-out' button was set up for the study.</p> <p>Results</p> <p>A total of 1362 urine samples were submitted by the 22 participating practices representing 1178 adult patients of whom 193 actively responded to the letter: 142 opted out by letter, 15 through the website, 2 by phone and 12 sent the letter back without indication, making a total of 171 patients or 14.5% opt-out; the remaining 22 patients (1.9%) explicitly opted in. The total group consisted of 80% women and the mean age was 50.9 years (sd 20.8). No significant differences were found between patients who participated and those who opted out in terms of age, gender or whether the urine sample was positive or not.</p> <p>Conclusions</p> <p>Overall the opt-out method was well received and participation in the study reached 85.5%. The low number of complaints (2) indicates that this is a generally acceptable method of patient recruitment. The 14.5% opt-out shows that it effectively empowers patients to decline participation. The similarity between patients opting out and the rest of the patients is reassuring for extrapolation of the results of the study.</p>http://www.biomedcentral.com/1471-2288/11/40
spellingShingle Hanahoe Belinda
Cormican Martin
Vellinga Akke
Bennett Kathleen
Murphy Andrew W
Opt-out as an acceptable method of obtaining consent in medical research: a short report
BMC Medical Research Methodology
title Opt-out as an acceptable method of obtaining consent in medical research: a short report
title_full Opt-out as an acceptable method of obtaining consent in medical research: a short report
title_fullStr Opt-out as an acceptable method of obtaining consent in medical research: a short report
title_full_unstemmed Opt-out as an acceptable method of obtaining consent in medical research: a short report
title_short Opt-out as an acceptable method of obtaining consent in medical research: a short report
title_sort opt out as an acceptable method of obtaining consent in medical research a short report
url http://www.biomedcentral.com/1471-2288/11/40
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AT vellingaakke optoutasanacceptablemethodofobtainingconsentinmedicalresearchashortreport
AT bennettkathleen optoutasanacceptablemethodofobtainingconsentinmedicalresearchashortreport
AT murphyandreww optoutasanacceptablemethodofobtainingconsentinmedicalresearchashortreport