Gamble 2011.
| Methods | Randomized controlled trial | |
| Participants | The study location was Northern Ireland Regional Difficult Asthma Service, Northern Ireland 9 participants were randomized to the intervention group and 11 participants were randomized to the control group The inclusion criteria were 18 years of age, attending the Difficult Asthma Service, a Juniper Asthma Control Score =317 and remained non‐adherent despite participating in Phase 1 The exclusion criteria were current tobacco smoking or significant other co‐morbidity, which contributed to persisting respiratory symptoms |
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| Interventions | Intervention: INTERVENTION
The intervention was individualized, provided psycho‐education and led by experienced registered nurse with basic level psycho therapy training for 12 months to improve adherence to medication. In addition to standard asthma care, intervention group subjects were offered up to 8 months of individual visits within a 12‐week period. Although the proposed intervention was unique in its design, to increase the internal validity of the study, the Compliance Therapy Model was used to provide the underpinning theoretical framework. This model encompassed the Transtheoretical Model of Change, Motivational Interviewing and Cognitive Behavioral Therapy principles, providing a flexible short‐term intervention using patient's individual reasons for non‐adherence as a guide to plan intervention content. The model used a non‐confrontational technique which elicited self motivation and provided a process to resolve ambivalence towards medication taking Control: STANDARD ASTHMA CARE All participants received standard asthma care at the difficult asthma service but the control group did not receive any further intervention. Subsequent follow‐up visits for the control group was conducted at 6 months and 12 months post‐recruitment |
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| Outcomes | The measures of adherence were GP refill records. All prescribed medication was obtained via prescription from a single General Practitioner (GP) and prescription refills for inhaled combination therapy (ICT) were obtained for the previous 6 months and expressed as a percentage of prescribed medication. Non‐adherence was defined as prescription filling of >= 50%. Data were collected at 6 and 12 months The patient outcomes were daily prescribed dose of inhaled corticosteroid (ICS), courses of rescue oral corticosteroids, total inhaled and nebulised beta‐agonist doses, hospital admissions, and lung function (spirometry), as well as Asthma Control Questionnaire (ACQ), Asthma Quality of Life Score (AQLQ) and Hospital Anxiety and Depression Scale/State Trait Anxiety Scale (HADS). Outcomes for follow‐up visits were obtained from the patient or medical notes, and lung function, questionnaires were obtained during the patient visit |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not enough information to judge. (pg 1309) Patients were randomly allocated to either the intervention or control group |
| Allocation concealment (selection bias) | Low risk | Author's note: patients were randomly allocated using pre‐sealed, sequentially numbered, opaque envelopes |
| Selective reporting (reporting bias) | Low risk | No protocol available |
| Other bias | Low risk | None noted |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RECORDS ‐ Appear to be low risk of bias. (pg 1309) Adherence was measured as previously described and validated, using prescription refill records. In Northern Ireland, all prescribed medication is obtained via prescription from a single General Practitioner (GP) and prescription refills for inhaled combination therapy (ICT) were obtained for the previous 6 months and expressed as a percentage of prescribed medication |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ Objective measure of outcome |
| Blinding of participants (performance bias) Adherence measure | Unclear risk | (PRIMARY) PRESCRIPTION REFILL RECORDS ‐ Appear to be low risk of bias |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ Objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RECORDS ‐ Appear to be low risk of bias |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ Objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RECORDS ‐ Only 2 withdrawals |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ Only 2 withdrawals |