Quinn 2004.
Study characteristics | ||
Methods | RCT. The effectiveness of brief telephone 'Motivational Interviewing' intervention in improving adherence to nebulised antibiotics in adults with CF has been evaluated (compared to treatment as usual). |
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Participants | Population of interest, N = 102 (patients prescribed nebulised colistimethate). Patients who met eligibility, n = 47 (patients invited to the study). Number of invited patients who declined, n = 8. Prior to randomisation all participants were given a Prodose nebuliser and used it for a 3‐month period to become accustomed to it and to generate baseline data on adherence. Number of dropouts, n = 4. Number of patients who received intended treatment, n = 35. Inclusion criteria: ‐ participants were diagnosed with CF prior to the study (by 2 positive sweat tests or recognised CF genotypes); ‐ age > 18 years; ‐ attending regional CF clinic; ‐ prescribed Colistimethate sodium delivered via a ProdoseTM Adaptive Aerosol Delivery system nebuliser. Exclusion criteria: ‐ lung function FVC < 30%; ‐ being involved in other trials; ‐ being pregnant. |
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Interventions | 1. Treatment as usual plus brief 'Motivational Interviewing' intervention (n = 16). Delivered via telephone by the principal investigator of the study. Was delivered over a 3‐month period with up to 6 MI sessions (fortnightly). Audiotapes of intervention were supervised and checked to ensure treatment fidelity. 2. Treatment as usual alone (n = 19). |
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Outcomes |
Primary outcome Difference in adherence (to aerosolised antibiotics) pre‐ and post‐intervention measured electronically monitored using Prodose. (Calculated for the previous 3 months in terms of the number of times the devise was used over the number of times its use was prescribed; 0‐100+%). Lung function measured as FEV1 and FVC. Secondary outcomes Were measured with questionnaires for anxiety (STAI‐Short Form; HADS‐A), depression (HADS‐D), and quality of life (CFQOL). Physiotherapists who administered questionnaires pre‐randomisation and immediately post‐intervention were blind to study allocation. |
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Notes | Tratement fidelity: the authors reported that audiotapes of the consultations were used in supervision, and were checked by GL to ensure treatment fidelity. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The authors provided the information that the participants were randomised using a computer generated pseudo‐random number generator. |
Allocation concealment (selection bias) | Unclear risk | Participants were randomised using a computer generated pseudo‐random number generator. But the authors did not provide information about adequate concealment of allocation. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and personnel providing the MI telephone intervention could not be blinded to intervention as usual for psychological interventions. Physiotherapists who administered questionnaires were blind to study allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors provided the information that of the 39 participants randomised 4 dropped out during the study for the following reasons: possible side effects of the medication, preferring the previous nebuliser, receiving a lung transplant. Four participants were repeatedly unavailable, but were included in the intention to treat analysis. |
Selective reporting (reporting bias) | Unclear risk | The information is insufficient to judge whether 'low' or 'high' risk. |