Koufopoulos 2016.
Methods |
Design: open‐label, parallel‐group, proof‐of‐concept randomised controlled trial Duration: 9 weeks Setting: recruited through emails sent to 40 largest universities in the UK requesting that those with individuals managing their asthma with an ICS preventer should consider enrolling Trial registration: ISRCTN29399269 |
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Participants |
Population: 216 adults with asthma randomised to an online community intervention ("AsthmaVillage") (n = 99) or no online community intervention ("AsthmaDiary") (n = 117) Age: mean (SD) in the intervention group 27.2 (9.2) years and in the control group 28.8 (10.1) years Baseline asthma severity: not reported Inclusion criteria: individuals managing their asthma with an ICS preventer Exclusion criteria: failed to complete the eligibility questionnaire (n = 256) or baseline measures (n = 228), did not have asthma (n = 105), were not prescribed an ICS preventer inhaler for a weekly regimen of at least 1 dose per week (n = 87), failed to complete informed consent (n = 35), had previously participated in the pilot study (n = 9) Percentage withdrawn: 60.6% from the intervention group and 45.3% from the usual care group ('withdrawn' defined as insufficiently engaging in the intended intervention) Other allowed medication: not reported |
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Interventions |
Intervention summary: an online community in which participants could report their preventer use and write posts, comments or questions. Questions and comments needed to be answered by community members themselves because no experimenter intervention was provided once the trial had begun. The only feedback participants could receive during the trial was that received from other participants because this intervention was optimised for implementation at scale and at low cost. This trial attempted to determine the value of an online community, implemented without the added support of a community manager to engage members Control summary: Control condition comprised an online diary, AsthmaDiary. This online diary was created with the use of Google Forms. A single‐item survey was created: “How many times did you take your preventer?” Participants randomised to the control condition could report the number of puffs and, after entering their unique PIN, hit “submit”. Because participants did not need to log in with a username to fill out the form, participants used a PIN that allowed their posts to be identified by the researcher. Participants in the control condition could not see the posts of other participants and could not otherwise know whether other participants were posting on their condition Complex intervention: no |
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Outcomes |
Outcomes measured: medication adherence (SMAQ), website activity/'adherence' Adherence calculation: SMAQ was recalculated with dichotomous scoring of all variables (more than 2 missed uses was treated as non‐adherent) and reverse scoring of item 4 of the SMAQ (“Thinking about the last week, how often have you not taken your asthma preventer medicine as prescribed?”) |
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Notes |
Type of publication: single peer‐reviewed journal article Funding: funded by a pilot grant from the University of Leeds School of Psychology. A Fulbright Scholarship from the US‐UK Fulbright Commission supported the first study author |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization occurred through a random number generator, yielding two unequal groups" |
Allocation concealment (selection bias) | Unclear risk | "The experimenters then manually separated the two lists and emailed both groups log‐in instructions" It seems unlikely that allocation was not concealed given the nature of the study design (i.e. the participant is 'remote'), but this is not a standard description of an allocation procedure, so we cannot be sure exactly what the process entailed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to group allocation and knowledge of group allocation, and adherence monitoring may have affected their self‐reported adherence (e.g. those in the intervention arm systematically over‐estimating adherence) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The participant is the outcome assessor for the main outcome ‐ self‐reported adherence ‐ and as participants were aware of group allocation, we consider this outcome to be at high risk of bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Very high and unbalanced drop‐out (60% in intervention arm and 45% in control arm). Although an ITT analysis was performed for the primary outcome ‐ self‐reported adherence ‐ it is unclear how this high level of drop‐out may have impacted the results |
Selective reporting (reporting bias) | High risk | Trial retrospectively registered (ISRCTN 29399269), but not all outcomes reported in trial report, including AQLQ |
Other bias | Low risk | None noted |