Bruzzese 2011.

Methods	Randomized controlled trial
Participants	The study location was 5 high schools in New York City, New York, USA 175 participants were randomized to the intervention group and 170 participants were randomized to the control group The inclusion criteria were 9th or 10th graders with diagnosed moderate to severe persistent asthma (defined by NHLBI guidelines) and taking prescribed asthma medication in the past 12 months
Interventions	Intervention: ASTHMA SELF MANAGEMENT FOR ADOLESCENTS (ASMA) Students in the ASMA group receive an 8‐week intensive program. The intervention consists of 3 45‐ to 60‐minute group sessions, and individual tailored coaching sessions held at least once per week for 5 weeks. Sessions were delivered by trained health educators during the school day. In addition to teaching asthma management skills and ways to cope with asthma, the health educators encouraged students to see their medical provider for a clinical evaluation and treatment. The individual sessions reinforced the educational messages taught in the group, helped students identify and overcome barriers to managing their asthma, and coached students regarding their medical visits. The health educator offered to accompany the student to the medical visit to provide moral support, coaching, or advocacy when coaching failed. Medical providers received a presentation by experts in person or by telephone about a recommended change in therapy. The medical providers were first mailed a packet containing: a letter informing them that one of their patients was in the study and would be referred to him/her for a clinical evaluation; a blank asthma checklist the students complete throughout the intervention and bring to the visit with the provider; and a blank asthma action plan the provider is asked to complete. Within 2 weeks, a pediatric pulmonologist or adolescent medicine specialist called the students' medical providers to discuss the concepts presented in the program and to answer any questions regarding NHLBI Institute criteria for treating asthma Control: WAIT LIST CONTROL The control group were kept on wait list until the completion of 12‐month interviews and then received the ASMA intervention
Outcomes	The measures of adherence were use of asthma controller medication at 6 and 12 months measured by trained staff The patient outcomes were self reported quality of life, asthma symptom days in prior 2 weeks, night awakening in prior 2 weeks, days with activity restriction in the prior 2 weeks, school absences in prior 2 weeks and urgent healthcare usage. All the outcomes were self reported except for school absences where data were obtained from the school board. Outcome evaluations were done at 6 and 12 months by blinded interviewers
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(pg 1000) "On completion of baseline surveys, students were randomized to ASMA or a wait‐list control group. Within each school, we stratified students by asthma severity (moderate vs. severe persistent asthma). Within each stratum, we randomized students to control or intervention using computerized randomization lists generated in advance by the data manager who concealed them until randomization."
Allocation concealment (selection bias)	Unclear risk	Allocation is unclear. (pg 1000) "...we randomized students to control or intervention using computerized randomization lists generated in advance by the data manager who concealed them until randomization. Interviewers were blind to group assignment."
Selective reporting (reporting bias)	Unclear risk	None detected, protocol unavailable
Other bias	Unclear risk	Author's note: possibility of contamination of sample; control students from same schools. (pg 1004) "The study has several limitations. We relied primarily on self reported data and did not corroborate self report data with objective data. Therefore, the potential self report bias found in our school attendance data may also be present in our other outcome data. Similarly, our case detection was by self report and thus has the potential for misclassification bias. Because we targeted those with moderate and severe persistent asthma, the chance of enrolling a student who did not have asthma was low. However, we may have had false‐negatives, missing students in need. Although recruitment of eligible students exceeded that in other asthma trials with urban adolescents (15), just less than 40% of eligible youth were not enrolled; this limits the extrapolation of study results to a larger population of urban, minority high school students with moderate to severe persistent asthma. We are also unable to extrapolate study results to other populations of high school students with asthma (e.g., white suburban adolescents with mild asthma) because we limited enrollment to minority youth with moderate to severe persistent asthma. The control group was a wait‐list control group who received no attention. Although unlikely, it is possible that treatment benefits of ASMA were due to "nonspecific therapeutic factors", including the effects of attention and positive regard received by those in the intervention condition. At the same time, treatment differences may have been mitigated (1) if the consent process and/or surveys fostered attention to treating asthma in the control students; (2) if participants received interim treatments from other sources, which we did not assess; and/or (3) if there was contamination of control subjects by the treated adolescents. However, we had sufficient power to control for contamination, and our informal interviews with control subjects regarding their contact with other students in the program suggest that such contamination did not occur. Although cigarette use is prevalent among adolescents, and smoke is an asthma trigger, we did not assess the impact of smoking behavior nor exposure to second hand smoke."
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) USE OF CONTROLLER MEDICATION ‐ (pg 1000) "Interviewers were blind to group assignment."
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM DAYS ‐ (pg 1000) "Interviewers were blind to group assignment."
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) QUALITY OF LIFE ‐ (pg 1000) "Interviewers were blind to group assignment."
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) USE OF CONTROLLER MEDICATION ‐ Patients highly likely to know group allocation because of the nature of the intervention
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) SYMPTOM DAYS ‐ Patients likely to be non‐blinded due to the nature of intervention; subjective outcome
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) QUALITY OF LIFE ‐ Patients likely to be non‐blinded due to the nature of intervention; subjective outcome
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) USE OF CONTROLLER MEDICATION ‐ Author's comment: some key personnel were blind. The project director was not. However, the PI and statistician were blind, as were the senior advisors
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM DAYS ‐ interviewers blinded. Author's note: other study staff were also blind
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) QUALITY OF LIFE ‐ interviewers blinded. Author's note: other study staff were also blind
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) USE OF CONTROLLER MEDICATION ‐ (pg 1001) "Attrition, which was primarily attributable to truancy or no longer being enrolled in the school, did not differ by group assignment at any follow‐up time point (P = 0.26–0.99); 12‐month retention was 81% (Figure 1)."
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) QUALITY OF LIFE ‐ (pg 1001) "Attrition, which was primarily attributable to truancy or no longer being enrolled in the school, did not differ by group assignment at any follow‐up time point (P = 0.26–0.99); 12‐month retention was 81%."
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) SYMPTOM DAYS ‐ (pg 1001) "Attrition, which was primarily attributable to truancy or no longer being enrolled in the school, did not differ by group assignment at any follow‐up time point (P = 0.26–0.99); 12‐month retention was 81%."