van Bragt 2015.

Methods	Study design: parallel, cluster‐randomised, single‐blind RCT Acronym: PELICAN Length of observation: 9 months Setting: 5 outpatient clinics in Holland
Participants	Population: 33 children were randomised within the 5 clusters to the intervention group (15) or the control group (18) Baseline characteristics 66.7% of the intervention group and 57.1% of the control group were male. Mean age was 8.4 years (SD 1.7) in the intervention group and 8.7 years (SD 1.7) in the control group. 93.3% of the intervention group and 100% of the control group were white. In the intervention group, mean FEV1 was 111%; 80% were on ICS; mean PAQLQ was 6.35 (1.17); and ACQ 0.5 (0.6). In the control group, mean FEV1 was 101%; 57% were on ICS; mean PAQLQ was 6.02 (0.89); and ACQ 0.8 (1.4). Inclusion criteria: Children had physician‐diagnosed asthma, were 6 to 12 years of age, and used asthma medication (i.e. bronchodilators and/or inhaled corticosteroids) for at least 6 weeks during the previous year. Exclusion criteria: comorbid conditions that significantly influence health‐related quality of life, not able to attend a regular school class (as an indicator of normal intelligence), and insufficient skills in speaking and/or reading the Dutch language
Interventions	Intervention: shared decision‐making online tool Nurse‐led patient‐centred care via an online tool. First, children completed the PAQLQ and selected 1 to 3 personal asthma problems, which were forwarded to the nurse. Then at the consultation, the nurse discussed with the child and parent which problem to prioritise, discussed details of the problem and chose a treatment goal through shared decision‐making, formulated a SMART goal (specific, measurable, acceptable, realistic, and time‐bound), brainstormed solutions together and documented an action plan, discussed results at the next visit, and repeated if necessary. Nurses were trained in the process during a 2‐hour meeting before the study. Control: enhanced usual care Besides usual care, the intervention group also received recommendations based on the Pelican outcome by a practice nurse. Described as enhanced usual care as seen more regularly than would be the case in practice.
Outcomes	Primary: quality of life (PAQLQ). Secondary: asthma control (ACQ), symptoms and medication via a diary, cost‐effectiveness, caregiver quality of life (PACQLQ), process outcomes
Notes	Trial registration: NCT01109745 Funding: Dutch Lung Foundation (previously Dutch Asthma Foundation), NutsOhra foundation, and a grant from the Nijmegen Centre of Evidence‐Based Practice (RadboudUMC grant)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"assigned children…in a 1:1 ratio using minimization software (Minim) that forced a balance between study arms for age (6–8 vs. 9–11 years old) and asthma control (ACQ score <1 vs greater than or equal to 1)"
Allocation concealment (selection bias)	Unclear risk	Not described but states that individual practices managed allocation to groups, which may not have adequately controlled for selection biases
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Children, parents, and nurses were aware of treatment allocation."
Blinding of outcome assessment (detection bias) All outcomes	High risk	"This was a single‐blinded study. The analyses presented in this manuscript were based on blinded data. The study code was broken after the analyses were concluded." Study does not specify who was blinded. Outcome assessment and several outcomes were patient‐rated, which would introduce high risk of detection bias.
Incomplete outcome data (attrition bias) All outcomes	High risk	Protocol states: "The primary analysis is an intention‐to‐treat analysis, however both explanatory and intention‐to‐treat analyses will be performed." "A total of 33 children started with the study, 15 in the intervention group and 18 in the usual care group. One child was lost to follow‐up during the study and three children had too many missing data of the primary outcome, leaving 29 children for the analysis." All dropouts were from the usual care group.
Selective reporting (reporting bias)	Low risk	Outcomes relative to the review that were defined in the trial registration were reported but could not be included in meta‐analyses owing to non‐parametric methods.
Other bias	High risk	The 33 children recruited were significantly fewer than the 170 planned, which (1) meant the study was underpowered and (2) may reflect the feasibility of the intervention. "112 general practices was invited to participate of which 28 practices did not respond and 73 other practices refused participation for reasons such as lack of time, participation in other research projects, too few pediatric asthma patients or no affinity. Of the 11 practices that decided on participation, two practices were withdrawn due to lack of sufficient participants."