Bonner 2009.
Methods | Randomized controlled trial | |
Participants | The study location was not stated 56 participants were randomized to the intervention group and 63 participants were randomized to the control group The inclusion criteria were pediatric patients who had been treated for asthma in either the general pediatric practice or the pulmonary clinic of a university hospital during the previous 12 months |
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Interventions | Intervention: INDIVIDUALIZED ASTHMA MANAGEMENT INTERVENTION
Families in the intervention group received asthma education by a trained Family Co‐ordinator who also provided individualized support in helping caregivers monitor their children's asthma using diaries. The Family Co‐ordinator helped caregivers interpret the diaries and communicate the contents to their doctors. 3 group education workshops were held at 1‐month intervals that followed the asthma self regulation model. Families were trained to use the diaries and peak flow meters. Family Co‐ordinators regularly called families to discuss their diary records. The second workshop used patients' diary records as illustrations of the relative effectiveness of controller medicines over rescue/quick‐relief drugs in preventing asthma symptoms over time. Participants reviewed their own records of medicines and symptoms. The third workshop described asthma management as a 2‐pronged effort of pharmacotherapy and trigger control. Between the first and second workshops, the Family Co‐ordinator prepared families for their doctor visit. The Family Co‐ordinator accompanied families to the doctor visit where he intervened if the family failed to communicate a thorough asthma history. The children in the intervention group were tested for allergies by an attending allergist at the hospital if they had not recently been tested by their own physician. Family Co‐ordinator conducted a home environment assessment and suggested strategies for reducing asthma triggers Control: USUAL CARE Control patients (n = 63) received usual medical care at private or hospital‐affiliated community pediatric practice |
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Outcomes | The measures of adherence were family's adherence to frequency and dosage of prescribed medication and prophylactic bronchodilator use measured at 3 months in face‐to‐face at‐home interviews by the trained Family Co‐ordinator The patient outcomes were self reported symptom persistence and activity restriction as reported in a diary by the caregiver |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. (pg 169) "After the baseline interview, families were randomly assigned to control or intervention conditions." |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. (pg 169) "After the baseline interview, families were randomly assigned to control or intervention conditions." |
Selective reporting (reporting bias) | Unclear risk | None detected; protocol not available |
Other bias | Unclear risk | The authors note (pg 177) "A limitation of this study was that a single Family Coordinator delivered the intervention. This precluded any measurement of the Family Coordinator's personal characteristics that may have contributed to patients' skill development. Only 28% of the patients who were originally contacted finally consented to participate in the study, which precludes generalization to the entire population of urban clinic patients. Another limitation is that an intervention period of three months was insufficient to measure how lasting were the gains in patient behavior or how robust was relationship between patient and physician. Another limitation of the study is that reliance on self reported data without confirmation by objective measures may overestimate the impact of the intervention because of participants' response bias towards success." However, it is not clear what impact these limitations would have had on this study |
Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) FAMILY'S SELF REPORTED ADHERENCE ‐ No blinding mentioned |
Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) SELF EFFICACY FOR MANAGING ASTHMA ‐ Insufficient information regarding blinding of the research assistant |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) FAMILY'S SELF REPORTED ADHERENCE ‐ Patients likely to be aware of the intervention due to it's nature |
Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) SELF EFFICACY FOR MANAGING ASTHMA ‐ Patients likely to be aware of the intervention due to it's nature |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) FAMILY'S SELF REPORTED ADHERENCE ‐ Blinding of other personnel to study group not mentioned |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) SELF EFFICACY FOR MANAGING ASTHMA ‐ Insufficient information about blinding |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) FAMILY'S SELF REPORTED ADHERENCE ‐ (pg 174) Control: 50/63 (13 families dropped out) Intervention: 50/56 (6 families dropped out). "There were no significant differences between the dropout rates in the two groups (i.e., 13 control families and 6 intervention families). Nor was there a significant demographic difference at baseline between those who did or did not drop out of either the control group, F(3, 59) = 1.57, n.s., or the intervention group, F(3, 52) = 0.05, n.s. Finally, there was no significant difference at baseline in the health outcome measures between those who did or did not drop out of either the control group, F(10, 52) = 0.57, n.s., or the intervention group, F(10, 45) = 1.08, n.s." |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) SELF EFFICACY FOR MANAGING ASTHMA ‐ (pg 174) Control: 50/63 (13 families dropped out) Intervention: 50/56 (6 families dropped out). "There were no significant differences between the dropout rates in the two groups (i.e., 13 control families and 6 intervention families). Nor was there a significant demographic difference at baseline between those who did or did not drop out of either the control group, F(3, 59) = 1.57, n.s., or the intervention group, F(3, 52) = 0.05, n.s. Finally, there was no significant difference at baseline in the health outcome measures between those who did or did not drop out of either the control group, F(10, 52) = 0.57, n.s., or the intervention group, F(10, 45) = 1.08, n.s." |