Wang 2010 b.
Methods | Randomized controlled trial | |
Participants | The study location was Pulmonary Medicine outpatient clinic, Tri‐Service General Hospital, Taipei, Taiwan 35 in the Asthma Education Program and 34 in the Asthma Education and Pharmacist Counseling Program participants were randomized to the intervention group and 35 participants were randomized to the control group The inclusion criteria were 1) outpatient aged 18 to 80 years, 2) good cognitive function, 3) able to understand Chinese, 4) confirmed diagnosis of bronchial asthma as determined by clinical features before treatment, 5) clinically stable, and 6) willing to participate The exclusion criteria were other medical conditions that could impact quality of life, including psychiatric illness or cognitive impairment |
|
Interventions | Intervention: PHARMACIST COUNSELING
Patients participated in the standard nurse administered asthma education program with additional pharmacist counseling with the pharmacist. A detailed workbook prepared by chest physicians was used for each session. The asthma education program covered 4 topics taught in sequence in 3 1‐hour sessions offered during monthly clinic visits (at months 1, 2, and 3). Topics covered were: (1) definition, etiology, diagnosis, disease progress, and complications of asthma; (2) instruction to monitor disease severity, especially skills needed to use the peak expiratory flow (PEF) meter and the format to record symptoms in a diary; (3) introduction on medications for asthma therapy, including protocol of a stepwise treatment plan, pharmacology of leading asthma drugs and correct inhaler techniques; and (4) guidelines for self management, including understanding potential environmental triggers and irritant factors, environmental control and standard procedure for coping with asthma attacks. Pharmacist counseling covered information related to the action and side effects of asthma medications, treatment plans for individualized medication, and modification of medications in response to progressive asthma Intervention: NURSE‐ADMINISTERED ASTHMA EDUCATION PROGRAM Patients participated in the standard nurse‐administered asthma education program. A detailed workbook prepared by chest physicians was used for each session. The asthma education program covered 4 topics taught in sequence in 3 1‐hour sessions offered during monthly clinic visits (at months 1, 2, and 3). Topics covered were: (1) definition, etiology, diagnosis, disease progress, and complications of asthma; (2) instruction to monitor disease severity, especially skills needed to use the peak expiratory flow (PEF) meter and the format to record symptoms in a diary; (3) introduction on medications for asthma therapy, including protocol of a stepwise treatment plan, pharmacology of leading asthma drugs and correct inhaler techniques; and (4) guidelines for self management, including understanding potential environmental triggers and irritant factors, environmental control and standard procedure for coping with asthma attacks Control: CONTROL Patients in the control group received only routine asthma care |
|
Outcomes | The measures of adherence were the Self Assessment of Medication Adherence questionnaire, which includes 4 items on specific self management behavior in use of asthma medication within the past month, and was measured at baseline, 3 and 6 months The patient outcome was one questionnaire, used to measure participants' HRQOL pre‐ and post‐intervention. Acceptable validity and reliability of the instruments had been previously determined. Asthma patients' quality of life was measured with the AQLQ, a 32‐item questionnaire with 4 subscales of activity limitations, symptoms, emotional status, and exposure to environmental triggers. The instrument's reliability has been validated after 7 years of use in clinical trials |
|
Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization was not described in detail. "The study is a random block design. The investigator randomly assigned patients to one of three groups: 35 were assigned to the nurse‐administered asthma education program (Group 1), 34 to the education program combined with pharmacist counseling (Group 2), and 35 received routine asthma care only (Control group). " (pg 724) |
Allocation concealment (selection bias) | Unclear risk | No information was provided about how allocation was handled |
Selective reporting (reporting bias) | Unclear risk | No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
Other bias | Low risk | The study seems to be free of other types of bias |
Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of outcome assessors; subjective outcome |
Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) HEALTH‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of patients; subjective outcome |
Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) HEALTH‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
Blinding of personnel (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of study staff; subjective outcome |
Blinding of personnel (performance bias) Patient outcome | High risk | (PRIMARY) HEALTH‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding. |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Fairly equal dropouts across groups; reasons for dropouts provided |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) HEALTH‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ Fairly equal dropouts across groups; reasons for dropouts provided |