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. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3

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).
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.
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).
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.
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.