The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials

Author(s): Julia V Bailey , BSc, MBBS, MSc, PhD ¹ ^, , Menelaos Pavlou , BSc, MSc, PhD ² , Andrew Copas , MSc, PhD ³ , Ona McCarthy , BA(Hons), MSc ⁴ , Ken Carswell , BA(Hons), Mphil, DClinPsy ⁵ , Greta Rait , MB ChB, Research MD, FHEA, MRCGP ⁶ , Graham Hart , BA(Hons), FMedSci, PhD ⁷ , Irwin Nazareth , MBBS, LRCP, FRCGP, PhD ⁶ , Caroline Free , MBChB, MRCGP, PhD ⁴ , Rebecca French , MSc, PhD ⁴ , Elizabeth Murray , FRCGP, FRCP (Edin), PhD ¹

Editor(s): Gunther Eysenbach

Other contributor(s): Rebecca Ortiz (Reviewer), Jessica Willoughby (Reviewer), B.R. Simon Rosser (Reviewer), Lisa Hightow-Weidman (Reviewer)

Publication date (Electronic): 11 December 2013

Journal: Journal of Medical Internet Research

Publisher: JMIR Publications Inc.

Keywords: Internet, randomized controlled trials as topic, outcome assessment (health care), sexual health, sexually transmitted diseases, behavioral research

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Abstract

Background

Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition.

Objective

This study addresses the feasibility of several dimensions of online trial design—recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up.

Methods

Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the “Sexunzipped” online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data.

Results

The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health outcomes and 47.4% (118/249) for return of chlamydia urine samples by post.

Conclusions

It was quick and efficient to recruit young people to this online trial. Our procedures for obtaining online consent, verifying participant identity, automated randomization, and concealment of allocation worked well. The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials. Multiple methods of participant contact, requesting online data only, and higher value compensation increased trial retention at 3-month follow-up.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/ISRCTN55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).

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Most cited references 48

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A systematic review of the effect of retention methods in population-based cohort studies

Cara Booker, Seeromanie Harding, Michaela Benzeval (2011)

Background Longitudinal studies are of aetiological and public health relevance but can be undermined by attrition. The aim of this paper was to identify effective retention strategies to increase participation in population-based cohort studies. Methods Systematic review of the literature to identify prospective population-based cohort studies with health outcomes in which retention strategies had been evaluated. Results Twenty-eight studies published up to January 2011 were included. Eleven of which were randomized controlled trials of retention strategies (RCT). Fifty-seven percent of the studies were postal, 21% in-person, 14% telephone and 7% had mixed data collection methods. A total of 45 different retention strategies were used, categorised as 1) incentives, 2) reminder methods, repeat visits or repeat questionnaires, alternative modes of data collection or 3) other methods. Incentives were associated with an increase in retention rates, which improved with greater incentive value. Whether cash was the most effective incentive was not clear from studies that compared cash and gifts of similar value. The average increase in retention rate was 12% for reminder letters, 5% for reminder calls and 12% for repeat questionnaires. Ten studies used alternative data collection methods, mainly as a last resort. All postal studies offered telephone interviews to non-responders, which increased retention rates by 3%. Studies that used face-to-face interviews increased their retention rates by 24% by offering alternative locations and modes of data collection. Conclusions Incentives boosted retention rates in prospective cohort studies. Other methods appeared to have a beneficial effect but there was a general lack of a systematic approach to their evaluation.

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Interactive computer-based interventions for sexual health promotion.

Jackie A. Cassell, Greta Rait, Catherine Mercer … (2009)

Sexual health promotion is a major public health challenge; there is huge potential for health promotion via technology such as the Internet. To determine effects of interactive computer-based interventions (ICBI) for sexual health promotion, considering cognitive, behavioural, biological and economic outcomes. We searched more than thirty databases for randomised controlled trials (RCTs) on ICBI and sexual health, including CENTRAL, DARE, MEDLINE, EMBASE, CINAHL, British Nursing Index, and PsycINFO. We also searched reference lists of published studies and contacted authors. All databases were searched from start date to November 2007, with no language restriction. RCTs of interactive computer-based interventions for sexual health promotion, involving participants of any age, gender, sexual orientation, ethnicity or nationality. 'Interactive' was defined as packages that require contributions from users to produce tailored material and feedback that is personally relevant. Two review authors screened abstracts, applied eligibility and quality criteria and extracted data. Results of RCTs were pooled using a random-effects model with standardised mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for binary outcomes. We assessed heterogeneity using the I(2) statistic. Separate meta-analyses were conducted by type of comparator: 1) minimal intervention such as usual practice or leaflet, 2) face-to-face intervention or 3) a different design of ICBI; and by type of outcome (cognitive, behavioural, biological outcomes). We identified 15 RCTs of ICBI conducted in various settings and populations (3917 participants). Comparing ICBI to 'minimal interventions' such as usual practice, meta-analyses showed statistically significant effects as follows: moderate effect on sexual health knowledge (SMD 0.72, 95% CI 0.27 to 1.18); small effect on safer sex self-efficacy (SMD 0.17, 95% CI 0.05 to 0.29); small effect on safer-sex intentions (SMD 0.16, 95% CI 0.02 to 0.30); and also an effect on sexual behaviour (OR 1.75, 95% CI 1.18 to 2.59). Data were insufficient for meta-analysis of biological outcomes and analysis of cost-effectiveness.In comparison with face-to-face sexual health interventions, meta-analysis was only possible for sexual health knowledge, showing that ICBI were more effective (SMD 0.36, 95% CI 0.13 to 0.58). Two further trials reported no difference in knowledge between ICBI and face-to-face intervention, but data were not available for pooling. There were insufficient data to analyse other types of outcome.No studies measured potential harms (apart from reporting any deterioration in measured outcomes). ICBI are effective tools for learning about sexual health, and they also show positive effects on self-efficacy, intention and sexual behaviour. More research is needed to establish whether ICBI can impact on biological outcomes, to understand how interventions might work, and whether they are cost-effective.

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Relationship between urinary sodium excretion and pioglitazone‐induced edema

Akinobu Nakamura, Takeshi Osonoi, Yasuo Terauchi (2010)

Abstract To investigate the factors contributing to pioglitazone‐induced edema, we analyzed sodium excretion and several clinical parameters before and after administration of pioglitazone. We analyzed these parameters before and after 8 weeks of administration of pioglitazone to female subjects with type 2 diabetes. When we evaluated whether a significant correlation was found between salt excretion and blood pressure, six patients showed such correlation and 20 patients did not. After 8 weeks of pioglitazone administration, five patients had developed edema, and, surprisingly, such correlation was not found in all five subjects. Salt excretion after administration of pioglitazone was significantly lower in subjects who developed edema and those who showed the correlation, and the hematocrit was significantly lower after administration in the subjects who showed the correlation, but not in the edema group. Pioglitazone‐induced edema would be caused not only by fluid retention, but also by other factors, such as vascular permeability. (J Diabetes Invest, doi: 10.1111/ j.2040‐1124.2010.00046.x, 2010)

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Author and article information

Contributors

Julia V Bailey:

e-Health UnitResearch Department of Primary Care and Population HealthUniversity College LondonUpper 3rd Floor, Royal Free HospitalRowland Hill StreetLondon, NW3 2PFUnited Kingdom44 776661778344 2074726871julia.bailey@ucl.ac.uk

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications Inc. (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: December 2013

Publication date (Electronic): 11 December 2013

Volume: 15

Issue: 12

Electronic Location Identifier: e278

Affiliations

[1] ¹e-Health Unit Research Department of Primary Care and Population Health University College London LondonUnited Kingdom

[2] ²Department of Statistical Science University College London LondonUnited Kingdom

[3] ³Department of Infection and Population Health University College London LondonUnited Kingdom

[4] ⁴London School of Hygiene and Tropical Medicine LondonUnited Kingdom

[5] ⁵Queen Mary University of London LondonUnited Kingdom

[6] ⁶PRIMENT Clinical Trials Unit Research Department of Primary Care and Population Health University College London LondonUnited Kingdom

[7] ⁷Faculty of Population Health Sciences University College London LondonUnited Kingdom

Author notes

Corresponding Author: Julia V Bailey julia.bailey@ 123456ucl.ac.uk

Article

Publisher ID: v15i12e278

DOI: 10.2196/jmir.2668

PMC ID: 3868980

PubMed ID: 24334216

SO-VID: 8ca78a39-b671-45c3-863f-55f90573c917

Copyright © ©Julia V Bailey, Menelaos Pavlou, Andrew Copas, Ona McCarthy, Ken Carswell, Greta Rait, Graham Hart, Irwin Nazareth, Caroline Free, Rebecca French, Elizabeth Murray. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.12.2013.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 13 April 2013

Date revision requested : 15 June 2013

Date revision received : 14 August 2013

Date accepted : 06 September 2013

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