Pinnock 2007a.
Methods |
Study design: 12 month before‐and‐after implementation study Setting: 1 large English general practice on 3 sites |
|
Participants |
Population: 3 practices were randomised to: 1. a choice of remote phone check‐ups or face‐to‐face check‐ups (554 on list), 2. face‐to‐face only check‐ups (659 on list), or 3. a usual care control group which was not included in this systematic review (515 on list) Baseline characteristics: mean age, years (SD): remote 43 (24.8); face‐to‐face 42.3 (24.4) % male: remote 44.2; face‐to‐face 44.9 % predicted FEV1 (SD): not reported Inclusion criteria: adults and adolescents with a diagnosis of asthma and prescribed asthma medication in the previous year Exclusion criteria: children under 12 years of age, diagnosis of COPD |
|
Interventions |
Intervention: participants 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 check‐up both at a pre‐arranged time. Participants who did not respond to the 3 invitations were phoned and reviewed opportunistically Control: participants were recalled to face‐to‐face only asthma check‐ups using invitations by post or as memos with repeat prescriptions. There was no option of telephone check‐ups and no systematic attempt was made to phone non‐attenders opportunistically. Group excluded: the usual‐care control group maintained their well established asthma clinic, and existing procedures (for example, invitations are issued in response to clinical need), but no systematic recall was undertaken |
|
Outcomes | Proportion reviewed, asthma morbidity and enablement on the mini AQLQ, ACQ, modified patient enablement instrument and Asthma Bother Profile, adverse events, costs | |
Notes | Funding: Scientific Foundation Board of the Royal College of General Practitioners (SFB/2003/45) ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study decided allocation to the telephone option by the public toss of a coin. |
Allocation concealment (selection bias) | High risk | The study allocated individuals to treatment after the two clusters had been decided by the toss of a coin. |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The nurses were aware of allocation but it was unclear whether it was the nurses measuring outcomes, or if it was someone independent from the study who could remain blind to allocation. The study did not describe this. The study stated that 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 participants is part of the study, routine asthma check‐up was provided for 66.3% of participants in the telephone only group and 53.8% in the face‐to‐face only group. |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting. |
Other bias | High risk | This study was a cluster implementation study with a before‐and‐after design. It randomised 2 practices to the interventions which would not have controlled for baseline imbalances in the same way as individual randomisation, and this meant the participant population in each group was not static. The intervention was a telephone option and many in that practice opted for a usual face‐to‐face check‐up, which meant the study was not making a direct comparison of remote and face‐to‐face check‐ups. Additionally, people in the telephone option group were phoned opportunistically to increase uptake of check‐ups which did not happen in the face‐to‐face group. These factors mean we cannot be certain that mode of check‐up, and not the increased likelihood of check‐up, was the variable being measured. |