Grover 2016.

Methods	A single‐centre randomised controlled trial aiming to develop, implement and evaluate the efficacy of a culturally contextualised asthma education program for Indian parents and children with asthma
Participants	Inclusion criteria: Indian children aged between 7 and 12 years; family spoke either English/Hindi; child diagnosed with asthma and child had at least 2 asthma‐related visits to the hospital in the 12 months prior to study Exclusion criteria: Not stated Clinical asthma: Child needed to be diagnosed with asthma, however not defined as to who made diagnosis Recruitment strategy: Eligible participants were recruited and invited by their physician or by medical record review when attending asthma outpatient clinic in a Chest Diseases Hospital in New Dehli Number approached: Not stated Number refused: Not stated Number randomised (parent‐child pairs): n = 24 (intervention group; n = 16 control group (usual care)
Interventions	Education program development: The overarching aim was to develop, implement and evaluate the efficacy of a culturally adapted asthma education program to parents and children with asthma. The asthma education program was designed based on key principles of health education and pedagogy and was split into three key components: Power point presentation (covering asthma symptoms, triggers, medication, adherence, medication‐related beliefs, inhaler techniques, written asthma action plans and setting health goals) A child workbook (covering same topics as the power point presentation but with graphics, child friendly language and space for the child to write in) Related activities interspersed at appropriate spots during power point presentation The asthma education content was underpinned by international asthma guidelines (Global initiative for Asthma ‐ GINA). Participant recruitment dates: July to December 2012 Sample size: n = 20 per arm (total n = 40) Parents and children were invited to participate in the RCT when attending asthma outpatient visit. It was not clear if the intervention was done at the time of the outpatient visit or arranged for another time convenient to families. While not reported, it was assumed that the intervention was individualised with parent‐carer pairs. Both the intervention and control group completed data collection at the baseline visit. This included asthma caregiver quality of life questionnaire, paediatric asthma control, asthma knowledge, asthma control, medication adherence, inhaler use competence and asthma action plan ownership. Intervention group: This was delivered by two allied health professionals (pharmacists) and asthma educators (researchers x 2) and included: Delivery of the asthma education intervention (1 hour) Working through power point/child workbook Collaborative goal setting All parent‐child pairs sent to physician for asthma action plan Further data collection was done at 3 months (phone call) and at 6 months (face to face follow‐up) to collect primary and secondary outcome data. Control group: After baseline data were collected (identical to intervention group), parents and children were given a standard information pack for asthma in line with GINA guidelines. They were assessed at 6 months (face‐to‐face follow‐up) to collect primary and secondary outcome data.
Outcomes	Primary outcome Paediatric asthma caregiver quality of life Secondary outcomes Asthma knowledge (customised questionnaire ‐ score ranging from 0 to 34. A high score indicated increased knowledge) Asthma control (Juniper questionnaire ‐ score is a mean of 7 items. 0 = poorly controlled, 7 = well controlled) Medication adherence (validated beliefs questionnaire ‐ 9 items. Score ranged between 0 (not hard at all) and 2 (very hard) Inhaler technique Outcomes were assessed at baseline, 3 and 6 months
Notes	It was not clear how many people were screened or if written informed consent was provided. Study reached sample size, however baseline imbalance between groups (n = 24 intervention group and n = 16 control group). Analysis of baseline characteristics was not clinically significant. Funding: Nil
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Authors describe participants were recruited from asthma outpatient clinic and through note reviews. Generated using Microsoft Excel, using number sequence generation
Allocation concealment (selection bias)	High risk	Authors acknowledge in discussions that allocation concealment was not implemented
Blinding of participants and personnel (performance bias) All outcomes	High risk	It was not clear when the intervention took place with the parent‐child at the time of outpatient visit, or arranged for another time convenient for the family. It was not possible to keep participants blinded after randomisation
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors were not blinded to treatment groups
Incomplete outcome data (attrition bias) All outcomes	Low risk	Authors report all participants remained in study until end of study at 6 months
Selective reporting (reporting bias)	Low risk	Authors report primary and secondary outcomes
Other bias	Low risk	Nil