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. 2012 Nov 14;2012(11):CD007978. doi: 10.1002/14651858.CD007978.pub2

Bergmo 2009.

Methods Study design: Randomised controlled trial
Duration of intervention: 1 year
Recruitment: 131 parents invited to participate during outpatient consultation at the paediatric and dermatology clinic. Recruitment period lasted 15 months.
Participants Description: Parents of children who visited the Paediatric and Dermatology clinic.
Setting: Paediatric and Dermatology clinics at secondary care hospitals in Norway. No inclusion or exclusion criteria.
119 parents agreed to participate, 21 did not return consent form, 98 children randomised, 50 to intervention group and 48 to control group.
Interventions Intervention: System allowed parents of children to send photos of the eczema area and a written description of the child's condition to the specialist. Provision of software to parents enabling them to use the secure messaging system. A digital camera was loaned to parents who did not own one. Parents log in with a user name and a password over an encrypted connection. Two‐phased authentication, one‐time password sent to participant cell phone, valid for 10 min. Procedure repeated for sending messages/retrieving responses. Specialist responds with treatment advice.
Control: Received standard treatment without access to specialist care. Encouraged to seek treatment through traditional means such as GP visits and hospital care.
Co‐interventions: Both groups took part in a 30 min individual face‐to‐face educational session prior to the intervention ‐ knowledge of Atopic Dermatitis and self‐management skills were strengthened by instruction in eczema‐related skin care from a specialist nurse.
Outcomes Use of web consultations (during study period, unclear how measured).
Self management behaviour (via self‐reported questionnaire on treatments used, at 12 months).
Severity of eczema (health outcomes, assessed by physicians using the SCOring Atopic Dermatitis (SCORAD) tool at 12 months).
Resource use (healthcare visits/expenses via self‐reported questionnaire at 12 months).
Parents absence from employment (family costs via self‐reported questionnaire at 12 months).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Children were consecutively randomised into two groups, using the simple randomisation method with shuffled envelopes.
Allocation concealment (selection bias) Low risk The envelopes used were sealed.
Blinding (performance bias and detection bias) 
 All outcomes High risk The dermatologist assessing the severity of eczema in participants was aware of group allocation. For all other outcomes investigators were blinded. This was confirmed by contact with the author. Parents received a letter informing them of their group allocation.
Incomplete outcome data (attrition bias) 
 All outcomes. High risk Self management behaviour, resource use, parents absence from employment: only 74% of participants responded to the post‐intervention questionnaire and no information is given on non‐responders.
Severity of eczema: No information given on whether the SCORAD for measuring severity of eczema was completed for all participants and as the results are not presented by group it is not possible to tell.
Not possible to tell if an intention to treat analysis was carried out as the results are not presented as intervention versus control group.
Selective reporting (reporting bias) High risk The results are presented such that it is not possible to see how many were in each group (I/C) for the main outcome measures.
The results for the primary outcomes are presented by intervention and control group at baseline, but not at the end of the intervention period, where they are presented for the whole sample only. Pre intervention/post intervention figures are presented for the whole sample rather than by intervention/control group.
Author contact confirmed that authors chose to present the data in this way 'We would have presented the results separately for the two groups in more detail if we had found an interaction effect (between group differences). But we did not.'
Other bias High risk Baseline comparability: Sample differed significantly by age of parents (P = 0.02) (control parents older) and number of people living in urban areas (P = 0.006) with more people in the control group living in urban areas. Otherwise comparable.
Validation of measures: No information is given on whether the participant questionnaire is validated. SCORAD tool is validated.
Reliability of measures: Authors state that the lack of inter‐rater reliability in the estimated SCORAD is a limitation.
Selection bias: There was potential for selection bias as all study participants had Internet access, and they were recruited at outpatient clinics (authors discuss 'bias towards technology acceptance and a higher frequency of health care visits than children with AD in general').
Recall bias: questionnaires and data on resource use were self‐reported.