| Methods |
Randomization was accomplished using a randomized block design in which block size was randomly allocated between 2 and 4 to ensure that the size of the intervention and control groups was equivalent. Randomization was not balanced on any other variables. Random group assignments were generated and were placed in sequentially numbered envelopes. Envelopes were not opened to reveal group assignments until informed consent was obtained and enrolment (baseline) interviews were completed |
| Participants |
56 subjects to be included in the study; subjects were between the ages of 2 to 18 years, had State of Louisiana Medicaid insurance, had a telephone at home, had a history of asthma, had not been intubated or mechanically ventilated for asthma, did not have other clinically significant (i.e. moderate to severe) chronic illness, presented to the ED when an investigator was available, had informed consent provided by a parent or guardian, child voluntarily assents to participation in the study if older than 12 years |
| Interventions |
Subjects in the intervention group received basic asthma education; instructions on use of a metered‐dose inhaler with holding chamber; a written asthma self management plan illustrated by zones colored green, yellow, and red; a sample age‐appropriate holding chamber; and prescriptions for medication needed to implement the plan. This medication included an inhaled corticosteroid drug for everyday use and a quick‐acting bronchodilator for use as needed. The importance of seeking urgent medical care in the red zone was emphasized. 3 brief follow‐up phone calls were placed to patients in the intervention group at 1 to 2 weeks, 4 to 6 weeks, and 3 months after enrolment |
| Outcomes |
Self reported method to measure the compliance plus pharmacy refills. Medicaid claims files used to assess frequency of medication dispensing, dates of asthma‐related hospital admissions, and dates of ED visits (identified by ICD‐9) discharge diagnosis) |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No mention of method of random number creation. (pg 108) "Randomization was accomplished using a randomized block design in which block size was randomly allocated between 2 and 4 to ensure that the size of the intervention and control groups was equivalent. Randomization was not balanced on any other variables. Random group assignments were generated and were placed in sequentially numbered opaque (manila) envelopes by someone not associated with the study. Envelopes were not opened to reveal group assignments until informed consent was obtained and enrollment (baseline) interviews were completed." |
| Allocation concealment (selection bias) |
Low risk |
(pg 108) "Randomization was accomplished using a randomized block design in which block size was randomly allocated between 2 and 4 to ensure that the size of the intervention and control groups was equivalent. Randomization was not balanced on any other variables. Random group assignments were generated and were placed in sequentially numbered opaque (manila) envelopes by someone not associated with the study. Envelopes were not opened to reveal group assignments until informed consent was obtained and enrollment (baseline) interviews were completed." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Low risk |
No important risks of bias noted in limitations; no obvious risks of bias in trial |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) MEDICATION DISPENSING EVENTS ‐ No blinding reported for outcome assessment of frequency of medication dispensing |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) FUNCTIONAL SEVERITY OF ASTHMA ‐ (pg 109) "The telephone interviewer was blinded as to study group assignment." Outcome assessor was blinded |
| Blinding of participants (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) MEDICATION DISPENSING EVENTS ‐ No blinding reported for outcome assessment of frequency |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) FUNCTIONAL SEVERITY OF ASTHMA ‐ Blinding of patient was not reported and mostly likely not feasible. This may introduce recall bias since the parents in the intervention group will have more knowledge on asthma and may likely to pay more attention to children symptoms as a result. Since the measurement is purely based on the recall of the parents, there is a high risk of bias |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) MEDICATION DISPENSING EVENTS ‐ No mention of blinding for this outcome |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) FUNCTIONAL SEVERITY OF ASTHMA ‐ No report of blinding for other key study personnel. Risk of bias cannot be determined |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) MEDICATION DISPENSING EVENTS ‐ Missing data were balanced in number across groups and missing outcomes were not enough to have a clinically relevant impact on observed effect size |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) FUNCTIONAL SEVERITY OF ASTHMA ‐ Missing data were balanced in number across groups and missing outcomes were not enough to have a clinically relevant impact on observed effect size |
