Herborg 2001.
| Methods | C‐NRCT, unit of allocation: pharmacy (n = 31), patient recruitment: patients or clients of primary care clinic or pharmacy Setting: Community pharmacies throughout Denmark |
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| Participants |
Control patients: n = 236 (204 at 12 month f/u), women: 54.7%, mean age: 42.4, moderate‐severe asthma (according to study), FEV1: not reported, ICS use: not reported Intervention patients: n = 264 (209 at 12 month f/u), women: 57.6%, mean age: 38.8, moderate‐severe asthma (according to study), FEV1: not reported, ICS use: not reported |
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| Interventions |
Name and duration of programme: therapeutic outcomes monitoring (TOM) programme, during 12 months Intervention group components Organisational ‐ patients: structured follow‐up; process and outcome measurement at the patient's level (PEFR, symptoms); identify and analyse drug therapy problems Organisational ‐ healthcare professionals or system: teamwork and collaborative processes between providers (patient, physician, pharmacist partnership); pharmacist training; routine reporting; meetings to discuss changes Patient education: one on one education on asthma and management of the disease Self‐management support: regular checks of inhalation technique Frequency: monthly visit to pharmacy Healthcare professionals involved: GP; pharmacist Control group components Usual care Number of components and dominant component: 9, organisational ‐ patients |
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| Outcomes |
Organisational level Organisation of care: GP, physician and patient participation rates Process outcomes: number of oral corticosteroid courses per patient; drug consumption (mean defined daily dose (DDD) per user per day) for short‐acting beta‐agonists, long‐acting beta‐agonists, total beta‐agonists, inhaled adrenergic agonists, ICS, inhaled anticholinergics, inhaled anti‐allergics, oral beta‐agonists and theophylline; drug therapy problems Healthcare utilisation: number of GP visits; number of GP phone contacts; number of specialist visits; number of physician on call visits; number of ED visits; number of hospital admissions; number of asthma clinic visits Patient level Patient satisfaction: DCPP score Quality of life: LWAQ score; NHP score Asthma symptoms and activity level: asthma morbidity index; number of days of sickness per patient Self‐management: asthma knowledge score; number of inhalation errors per patient Pulmonary function: mean PEF Time of outcome measurement: at 12 months |
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| Notes | Unit of analysis error (pharmacies randomised, patients analysed) taken into account in analyses DCPP: Danish College of Pharmacy Practice; LWAQ: Living with Asthma Questionnaire; NHP: Notthingham Health Profile |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Not randomised |
| Allocation concealment (selection bias) | High risk | Not randomised |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 20.8% dropped out in intervention group and 13.6% in control group, but no reasons were provided |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Other bias | Low risk | Hierarchical structure of data taken into account in analyses |
| Outcomes at baseline similar? | Unclear risk | Differences at baseline, but no statistical test provided |
| Characteristics at baseline similar? | Low risk | Characteristics appear well balanced (age, sex) |
| Adequate protection against contamination? | Low risk | Intervention pharmacies worked solely with intervention patients |