Pinnock 2007.
Methods | Phase IV Implementation study (as per Medical Research Council 2008) | |
Participants | Patients: One large English general practice on 3 sites was involved in this trial. During the 12‐month study patients with asthma were offered a review service according to the allocation of the group with which they were registered. | |
Interventions | Intervention: The patients who were allocated to the intervention group were given a telephone option for their asthma review service. They were identified from the practice computer database and sent 3 invitations over the study period. They could book either a telephone or face‐to‐face review both at a pre‐arranged time. Patients who did not respond to the 3 invitations were phoned and reviewed opportunistically. Control: The control group were recalled to face‐to‐face only asthma reviews using invitations by post or as memos with repeat prescriptions. There was no option of telephone reviews and no systematic attempt was made to phone non‐ attenders opportunistically. There was a second control arm of usual care who had an established asthma clinic with no systematic recall. Invitations would only be issued in response to clinical need. |
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Outcomes | Outcomes: 1. Proportion reviewed: proportion of patients with active asthma who had received a dedicated asthma review within the previous 15 months 2. Asthma morbidity and enablement, as assessed by the following postal questionnaires: mini asthma quality of life questionnaire, Asthma Control Questionnaire, Modified Patient enablement Instrument and Asthma Bother Profile. 3. Adverse events, both clinical, e.g. asthma deaths and near‐fatal asthma attacks and organisational, e.g. complaints 4. Time, cost and mode of review were all documented |
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Notes | The population was not fixed in this implementation study as in a trial, therefore new diagnoses, changes in disease status, moves into and away from the practice were all included in the allocated service provision of the group with which they were registered | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation was decided by the toss of a coin |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding (performance bias and detection bias) All outcomes | High risk | The nurses were aware of allocation, however there were quality control checks blinded to allocation which confirmed accuracy of data transfer |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Real‐world implementation study, therefore the uptake rate by patients is part of the study, routine asthma review was provided for 66.3% of patients in the telephone only group and 53.8% in the face‐to‐face only group |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | High risk | Randomisation only took place in 2 of the 3 practices due to various considerations |