Final published version
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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Methodological Challenges in Web-Based Trials
T2 - Update and Insights From the Relatives Education and Coping Toolkit Trial
AU - Robinson, Heather
AU - Appelbe, Duncan
AU - Dodd, Susanna
AU - Flowers, Susan
AU - Johnson, Sonia
AU - Jones, Steven
AU - Mateus, Ceu
AU - Mezes, Barbara
AU - Murray, Elizabeth
AU - Rainford, Naomi
AU - Rosala-Hallas, Anna
AU - Walker, Andrew
AU - Williamson, Paula
AU - Lobban, Fiona
PY - 2020/7/17
Y1 - 2020/7/17
N2 - There has been a growth in the number of web-based trials of web-based interventions, adding to an increasing evidence base for their feasibility and effectiveness. However, there are challenges associated with such trials, which researchers must address. This discussion paper follows the structure of the Down Your Drink trial methodology paper, providing an update from the literature for each key trial parameter (recruitment, registration eligibility checks, consent and participant withdrawal, randomization, engagement with a web-based intervention, retention, data quality and analysis, spamming, cybersquatting, patient and public involvement, and risk management and adverse events), along with our own recommendations based on designing the Relatives Education and Coping Toolkit randomized controlled trial for relatives of people with psychosis or bipolar disorder. The key recommendations outlined here are relevant for future web-based and hybrid trials and studies using iterative development and test models such as the Accelerated Creation-to-Sustainment model, both within general health research and specifically within mental health research for relatives. Researchers should continue to share lessons learned from conducting web-based trials of web-based interventions to benefit future studies.
AB - There has been a growth in the number of web-based trials of web-based interventions, adding to an increasing evidence base for their feasibility and effectiveness. However, there are challenges associated with such trials, which researchers must address. This discussion paper follows the structure of the Down Your Drink trial methodology paper, providing an update from the literature for each key trial parameter (recruitment, registration eligibility checks, consent and participant withdrawal, randomization, engagement with a web-based intervention, retention, data quality and analysis, spamming, cybersquatting, patient and public involvement, and risk management and adverse events), along with our own recommendations based on designing the Relatives Education and Coping Toolkit randomized controlled trial for relatives of people with psychosis or bipolar disorder. The key recommendations outlined here are relevant for future web-based and hybrid trials and studies using iterative development and test models such as the Accelerated Creation-to-Sustainment model, both within general health research and specifically within mental health research for relatives. Researchers should continue to share lessons learned from conducting web-based trials of web-based interventions to benefit future studies.
KW - randomized controlled trial
KW - research design
KW - methods
KW - internet
KW - web
KW - mental health
KW - relatives
KW - carers
U2 - 10.2196/15878
DO - 10.2196/15878
M3 - Journal article
VL - 7
JO - JMIR Mental Health
JF - JMIR Mental Health
SN - 2368-7959
IS - 7
M1 - e15878
ER -