Little 2015.
Study characteristics | ||
Methods | Individuals sharing a household by mailed invitation through general practices in England were recruited. After consent, participants were randomised online by an automated computer‐generated random‐number program to receive either no access or access to a bespoke automated web‐based intervention that maximised hand‐washing intention, monitored hand‐washing behaviour, provided tailored feedback, reinforced helpful attitudes and norms, and addressed negative beliefs. Participants were enrolled into an additional cohort (randomised to receive intervention or no intervention) to assess whether the baseline questionnaire on hand‐washing would affect hand‐washing behaviour. Participants were not masked to intervention allocation, but statistical analysis commands were constructed masked to group. The primary outcome was number of episodes of RTIs in index participants in a modified intention‐to‐treat population of randomly assigned participants who completed follow‐up at 16 weeks. | |
Participants | 344 physician offices were recruited over a wide area of England, and 20,066 participants were enrolled and randomised to intervention (N = 16,086) and control (N = 10,026). Modified ITT was performed on 16,908 participants who completed the follow‐up questionnaire at 16 weeks (intervention = 8241 and control = 8667). Inclusion criteria: adult patients (aged 18 years or older) identified from computerised lists in general practitioner (GP) practices in England, for whom there was at least 1 other individual living in the household who was willing to report illness to the index person Exclusion criteria: patients with severe mental problems (e.g. major uncontrolled depression or schizophrenia, dementia, or severe mental impairment) or who were terminally ill, and those reporting a skin complaint that would restrict hand‐washing |
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Interventions | Automated web‐based intervention that maximised hand‐washing intention, monitored hand‐washing behaviour, provided tailored feedback, reinforced helpful attitudes and norms, and addressed negative beliefs. Control no access to intervention web pages. See Table 4 for details. | |
Outcomes | The primary outcome was the number of index individuals that reported 1 or more RTIs (including ILI) at 16 weeks. Secondary: duration of symptoms, transmission of respiratory infections, gastrointestinal infections, attendance at the practice, and use of health service resources Infections self‐reported by participants. RTI defined as 2 symptoms of an RTI for at least 1 day or 1 symptom for 2 consecutive days. Definition of ILI was a high temperature (feeling very hot or very cold; or measured temperature > 37.5 °C), a respiratory symptom (sore throat, cough, or runny nose), and a systemic symptom (headache, severe fatigue, severe muscle aches, or severe malaise). No safety outcomes reported. |
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Notes | Government funded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were automatically randomly assigned by the intervention software, but sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Participants were automatically randomly assigned by the intervention software. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded study |
Incomplete outcome data (attrition bias) All outcomes | High risk | High attrition that was different in the 2 groups |
Selective reporting (reporting bias) | Low risk | Specified outcomes reported. |