Shelledy 2009.
Methods | STUDY DESIGN: Parallel group trial. DURATION OF STUDY: 6 months. DESCRIPTION OF WITHDRAWALS/DROPOUTS: Provided in study report (N = 7) COMPLIANCE: Five visits were scheduled for the intervention groups. Mean home visits in treatment groups: 4.5 (SD 1.2) & 4.4 (SD 1.4). CONFOUNDERS: Oxygen saturation higher in treatment groups compared with usual care. |
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Participants | N SCREENED: 200 N ELIGIBLE: Unclear N RANDOMISED: 166 N COMPLETED: 159 M = 25/F = 124 MEAN AGE: 42.5 BASELINE CHARACTERISTICS: FEV1: 1.99L; PEFR: 5.2; SGRQ total scores: 56. INCLUSION CRITERIA: Adult patients (age 18–64 years) treated in the ED or hospitalised for an acute exacerbation of asthma at a large urban teaching hospital were invited to participate. EXCLUSION CRITERIA: Exclusion criteria included COPD, other pulmonary disorders or diagnosis of co‐morbid disease that was disabling in nature. |
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Interventions |
Education group Treatment group 1 Asthma management programme delivered by respiratory nurse, consisting of:
Treatment group 2 Asthma management programme as outlined above. Delivered by respiratory therapist. Control group Usual care. FOLLOW‐UP: 6 months. |
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Outcomes | Hospitalizations; in‐patient days; hospitalisation cost; ED visits and cost, clinic visits, pulmonary function, symptoms | |
Notes | TL emailed for data on hospitalisation from authors (9th March 2010) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | '...participants were stratified into severity blocks based on the number of ED visits and steroid use for the 12 months prior to enrolment' |
Allocation concealment (selection bias) | Low risk | 'subjects were randomised to (treatment groups) using a randomised envelope system administered by an independent research associate.' |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding of participants was not possible. 'The investigators, co‐investigators and research associates who performed the data collection and analysis were blinded as to group assignment.' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In view of the low attrition rate (4%) this is unlikely to have a significant impact on the data. 'An intent‐to‐treat approach was used that included all patients who participated in the initial enrolment data collection and consent visit'. |
Selective reporting (reporting bias) | Unclear risk | Data for hospital admission not available as dichotomous values. Reported in the Discussion section of the manuscript as: 12 hospitalisations (usual care group); 0 hospitalisations (AMP RN); and 2 hospitalisations (AMP RT). Contacted for clarification of data but no response was forthcoming. No change to primary outcome listed on record listed on ClinicalTrials.gov (healthcare utilization). Review primary outcome measured but not in a way that would enable data to be analysed in our review. |
Other bias | Low risk | No other sources of bias could be identified. |