Otsuki 2009.
| Methods | Randomized controlled trial | |
| Participants | The study location was the pediatric emergency department, Johns Hopkins, Baltimore, MD, USA 84 in Asthma Basic Care and 83 in Adherence Monitoring with Feedback. 84 participants were randomized to the intervention group and 83 participants were randomized to the control group The inclusion criteria were children between 2 and 12 years of age who had physician‐diagnosed asthma, 2 ED visits or 1 hospitalization for asthma in the preceding year, resided in Baltimore city, and were prescribed an asthma controller medication |
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| Interventions | Intervention: ASTHMA BASIC CARE (ABC)
ABC intervention received 5 30‐ to 45‐minute home visits by trained asthma educators (AEs) 1, 2, 3, 4, and 8 weeks after randomization. The ABC intervention is a home‐based asthma education program with 5 core components: (1) review of the prescribed asthma regimen and training in medication, spacer, and peak flow technique; (2) development of an asthma action plan; (3) identification of barriers to accessing health care and problem‐solving to reduce barriers; (4) discussion of beliefs and concerns about asthma and medications; and (5) provision of written asthma education materials Intervention: ADHERENCE MONITORED FEEDBACK (AMF) The intervention included ABC + AMF. AMF stands for adherence monitoring with feedback and ABC stands for asthma basic care. These patients received 1. Objective feedback of medication adherence: electronic medication feedback. The AEs were trained to provide non‐threatening, supportive feedback on adherence to encourage a partnership with the family; 2. Goal‐setting: families were encouraged to set asthma control goals (e.g. no coughing at night) and weekly adherence goals. The AEs assisted families in setting age‐appropriate expectations regarding the child's ability to self manage asthma; 3. Reinforcement for attaining adherence goals: the importance of positive reinforcement. When the child attained the adherence goal, the AE provided a small reward (e.g. crayons). When it was not achieved, the AE worked with the family to identify barriers and taught problem‐solving skills. 4. Strategies for self monitoring medication use: families were taught to monitor adherence and asthma symptoms by using behavioral charts and symptom diaries. When possible, the AE highlighted the relationship between improvements in adherence and asthma outcomes Control: USUAL CARE Patients received an asthma education booklet and resource guide that provided information about low‐cost asthma care providers, social services, legal services, and other resources. Participants were encouraged to receive care from their primary care provider |
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| Outcomes | Adherence was measured by means of self reported adherence and pharmacy refill data. Trained research assistants who were blinded to study assignments conducted surveys by telephone. Pharmacy refill data were requested at baseline and 12 months from all pharmacies identified by the caregiver. Self reported adherence was collected from caregivers. Caregivers reported how the child administered the medication (e.g. 2 puffs twice a day), then estimated how often the child missed doses in the previous 7 days. Percentage self reported adherence was calculated as use/prescribed use x 100%. For pharmacy‐based adherence, by using a protocol described by Butz et al, the number of inhaled corticosteroid (ICS) refills per quarter was abstracted from pharmacy records for the year before and after randomization. The number of canisters dispensed was converted to therapeutically equivalent values so that 1 canister represented a 1‐month supply of ICS. The quarterly ICS refill rates were defined as the number of ICS canisters dispensed quarterly. These analyses included the quarter before enrollment (the baseline value) through the 4th quarter after randomization. An ICS refill rate of 3.0 is equivalent to 100% adherence for the quarter. Self reported adherence data were collected at baseline, 6, 12, and 18 months, while pharmacy records were requested at baseline and 12 months and data for baseline, 3, 6, 9, and 12 months obtained The clinical outcomes were caregiver reports of asthma symptoms (cough, wheeze, shortness of breath, or chest tightness/discomfort), night‐time awakenings, ED visits, hospitalizations, and courses of oral corticosteroids in the previous 6 months. Total numbers of days and nights (combining day and night symptoms) were calculated for each child with a range of 0 to 60 for day or night symptom counts reported during the previous 30 days for an asthma symptom frequency variable. The data were collected by blinded research staff at 1, 6, 12, and 18‐month intervals |
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| Notes | Self reported adherence was not included in the analysis. (pg 1516) "Because of lack of change over time, we were unable to model self‐reported ICS adherence." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Source of random sequence is not explicitly stated. "To mask staff to group assignment during recruitment, the statistician created block randomization schema and placed the randomization assignments into sealed envelopes, which were opened after families completed baseline surveys." (pg 1514) |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes were used. "To mask staff to group assignment during recruitment, the statistician created block randomization schema and placed the randomization assignments into sealed envelopes, which were opened after families completed baseline surveys." (pg 1514) |
| Selective reporting (reporting bias) | Unclear risk | No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias | Unclear risk | The author notes, "...we did not use Bonferroni correction for interpreting the outcomes; as a result, we may risk committing type I error." (pg 1520) |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) PHARMACY REFILL RECORD ‐ The author notes that research assistants requesting the pharmacy data and data managers and coders were not aware of study group |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) ASTHMA MORBIDITY MEASURES ‐ Trained research assistants who were blinded to study assignments conducted surveys by telephone (pg 1514) |
| Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) PHARMACY REFILL RECORD ‐ Patients not blinded but loss of blinding not likely to bias the result |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) ASTHMA MORBIDITY MEASURES ‐ This is a subjective measure; there is no information on blinding. Since participants are children under the age of 12, data are reported by their caregiver |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY REFILL RECORD ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) ASTHMA MORBIDITY MEASURES ‐ The author notes that research assistant and data managers involved with data entry and management were not aware of group assignment |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) PHARMACY REFILL RECORD ‐ There is above 80% completion of all surveys in all groups, missing numbers are fairly even but it is likely that the reason fro missing could be related to the outcome ‐ they may not have been adherent. ITT analysis was used |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) ASTHMA MORBIDITY MEASURES ‐ An ITT analysis was performed. The author also notes that missing data for all groups were primarily due to failure to reach the family at either their primary or secondary phone number or by letter |