Gallefoss 1999.
| Methods | At inclusion, patients signed a written consent and were then randomized to an intervention group or a control group. Concealment of allocation was unclear. Technical staff assessing bronchodilator spirometry were blinded to control and intervention patients. (Study reported in 2 papers) | |
| Participants | Eligible subjects were patients with bronchial asthma or chronic obstructive pulmonary disease (COPD) between 18 and 70 years of age, not suffering from any serious disease such as unstable coronary heart disease, heart failure, serious hypertension, diabetes mellitus, or kidney or liver failure. Participants with stable asthma were to have a pre‐bronchodilator FEV1 equal to or higher than 80% of predicted value "in stable phase". Furthermore, either a positive reversibility test, a documented 20% spontaneous variability (PEF or FEV1) or a positive methacholine test (provocative dose causing a 20% decrease in FEV1 (PD20) was required. A positive reversibility test required at least a 20% increase (FEV1 or PEF) after inhalation of 400 µg salbutamol. Subjects with COPD were to have a pre‐bronchodilator FEV1 equal to or higher than 40% and lower than 80% of predicted | |
| Interventions | The control group participants were followed by their GPs and the intervention group received an education program and were then also transferred to a 1‐year follow‐up by their GPs The educational intervention consisted of a specially constructed 19‐page patient booklet with essential information about asthma/COPD, medication, compliance, self care, and self management plan. Instructions in the recoding of PEF and symptoms in a diary were given to both asthmatics and patients with COPD. There were also two 2‐hour group sessions (separate groups for asthmatics and patients with COPD) of 5 to 8 people on 2 separate days. The COPD group received more information about tobacco weaning, but besides this the educational interventions were comparable The first session was given by a medical doctor, concentrating on pathophysiology, symptom awareness, prevention of attacks and factors causing exacerbations, especially smoking. The second group session was given by a pharmacist, focusing on drugs and their appropriate use. One or two 40‐minute individual sessions were then supplied by a nurse, and another one or two 40‐minute individual sessions, by a physiotherapist. With regard to anti‐obstructive medication the following was emphasized: the components of obstruction were explained together with the site of action of the actual medication. The patient's pulmonary symptoms were registered and discussed with emphasis on the early symptoms experienced at exacerbations. The individual factors causing attacks/exacerbations and concerns regarding adverse effects of medication were discussed and inhalation technique was checked. At the final teaching the patients received an individual treatment plan on the basis of the acquired personal information and 2 weeks of peak flow monitoring. The personal understanding of the treatment plan with regard to changes in PEF and symptoms was discussed and tested |
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| Outcomes | One paper reported compliance of regular medication, calculated as a % age: (dispensed Defined Daily Dosage/Prescribed Defined Daily Dosage) x 100 during the 1‐year follow‐up. Patients were defined as compliant when dispensed regular medication was greater than 75% of prescribed regular medication during the study period. Pre‐bronchodilator spirometry was performed before randomization and at 12‐month follow‐up by standard methods The other paper reported that 4 simple health‐related quality of life (HRQoL) questions were asked at baseline. HRQoL as measured by the St George's Respiratory Questionnaire (SGRQ) at 12 months plus the same 4 questions asked at baseline. FEV measured via spirometry prior to randomization and at 12 months |
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| Notes | Patients who failed to attend all group sessions or who failed to meet at individual sessions were withdrawn. There was no similar "faintness of heart" procedure for the control group. Thus, 38 of 39 control asthma patients were included in the compliance assessment but only 30 of 39 intervention group patients | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information given in article. "We performed a randomized, controlled intervention study in patients with mild to moderate asthma or COPD using a standardized education program and a self management plan." |
| Allocation concealment (selection bias) | Unclear risk | No information given in article. "We performed a randomized, controlled intervention study in patients with mild to moderate asthma or COPD using a standardized education program and a self management plan." |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Unclear risk | No other biases noted or obvious but insufficient information provided to make a judgment |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY FILL RECORD ‐ No mention of blinding of personnel. (pg 2001) "Dispensed medication was reported from all local pharmacies through monthly print‐outs from the pharmacy data registers. At the 1‐yr follow‐up all patients were asked whether they had received medication elsewhere." |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ (pg 2002) "The technical staff did not know whether the patients belonged to the control or intervention groups." |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) PHARMACY FILL RECORD ‐ Patients would have known if they received the educational intervention |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) SPIROMETRY ‐ Unlikely that lack of patient blinding would affect this outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY FILL RECORD ‐ No mention of blinding of personnel collecting data. (pg 2001) "Dispensed medication was reported from all local pharmacies through monthly print‐outs from the pharmacy data registers. At the 1‐yr follow‐up all patients were asked whether they had received medication elsewhere." |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) SPIROMETRY ‐ No mention of study personnel blinding |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) PHARMACY FILL RECORD ‐ Reasons for missing data are noted but unclear whether unequal missing data effects outcome |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) SPIROMETRY ‐ Not enough information provided |