Bailey 1999.
| Methods | Patients (n = 236) were stratified by asthma severity (moderate or severe) and randomly assigned to the 3 groups using the closed‐envelope technique: University of Alabama at Birmingham (UAB) Asthma Self Management group (n = 78), UAB Core‐Elements group (n = 76) and usual care group (n = 78). As well, standard computer procedures were employed to create a stratified, blocked randomization schedule, which consisted of block sizes of 6 to ensure 2 out of every 6 patients in each stratum were assigned to each group. Immediately following randomization, staff collected baseline data and implemented the designated educational treatment | |
| Participants | All subjects were patients in the clinics of the UAB Division of Pulmonary and Critical Care Medicine with a primary diagnosis of asthma who met the following diagnostic criteria: (1) recurrent episodes of dyspnea or wheezing, (2) objective evidence of significantly increased resistance to airflow during episodes, (3) objective evidence of improvement in airflow when symptom‐free, and (4) moderate to severe (rather than mild) asthma as assessed by their asthma care physician. New and current patients were included in the study; although patients who had participated in the earlier self management study were excluded | |
| Interventions | UAB Asthma Self Management Program (n = 78): the core component of the UAB Asthma Self Management Program (ASMP) was a skill‐oriented self help workbook, which patients were counseled about in a one‐on‐one session and during 2 asthma support group meetings. The workbook included information on physiology of asthma, asthma medications, identification and avoidance of triggers, detection of and response to asthma attacks, and asthma care services. The 1‐hour counseling session included reviewing the workbook content and skills, identifying personal expectations, asthma triggers, and barriers to adherence, and practicing inhaler use until patients were able to do so correctly. Patients were also given peak flow meters and trained to use them for early detection of impending asthma attacks. Asthma support groups, facilitated by a health educator, consisted of 4 to 6 patients with asthma and, if possible, asthma control partners (spouses or close friends). Support group meetings were held once each month many patients came every month. Patients were encouraged to share asthma concerns, discuss adherence problems, and exchange patient‐initiated solutions. Patients received 2 telephone calls and a follow‐up letter at 1, 2, and 4 weeks, after the counseling session. The first telephone call allowed the discussion of problems and to collect baseline peak flow readings and to help determine their expected peak flow rates. The letter reinforced actions to take at different levels of peak flow readings. The second telephone call provided closure for the intervention. Overall, the intervention spanned about 6 to 8 weeks for patients. UAB Core‐Elements Program (n = 76): this program consisted of a revised, shortened workbook that was given to patients. It was reviewed in a brief (15 to 20 minutes) one‐to‐one counseling session. Patients were trained to use inhalers and peak flow meters and rehearsed until these devices were used correctly. A follow‐up telephone counseling session was conducted approximately one week later to review the patient's medication regimen and inhaler and peak flow meter skills. 2 weeks later, a follow‐up letter was sent to patients, stressing the importance of adhering to the prescribed regimen and responding immediately to a drop in peak flow rate or other early signs of an attack Usual‐care control group (n = 78): patients received the education that was the standard practice of their physician. They also received a standardized set of pamphlets that contained information about asthma. No steps were taken to ensure that patients read the pamphlets, and no special counseling, support groups, or telephone calls were provided |
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| Outcomes | Compliance was measured using 2 4‐item self reports, which were based on the prototype self report scale described by Morisky et al but were modified to be more applicable to asthma. The psychometric characteristics of the asthma therapy adherence scales were good to excellent. Adherence was analyzed in terms of the percentage of subjects with the highest possible scores on these scales. 4 clinical outcome measures addressed asthma status, specifically, the impact of asthma on respiratory symptoms and illnesses, functional status, and use of healthcare services. 2 scales addressed the severity of asthma symptoms in the past 7 days and the number of respiratory illnesses in the past 3 months. The functional impairment scale assessed the extent to which asthma had a negative impact on daily activities in the past 3 months. The scale for measurement of use of healthcare services classified patients as users if they had visited an emergency department for asthma and/or been hospitalized for asthma in the past 6 months. Other patients were classifies as nonusers. These measures also analyzed the percentage of subjects who obtained the highest possible score as users | |
| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified randomization using computer‐generated numbers, closed envelopes (pg 2424) |
| Allocation concealment (selection bias) | Low risk | Central randomization using computer‐generated numbers, closed envelopes |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information; no protocol available |
| Other bias | Low risk | No other obvious biases noted |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ INTERVIEW (ASTHMA THERAPY ADHERENCE SCALE) ‐ Author note: data collectors were blind |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) ASTHMA STATUS QUESTIONNAIRES ‐ Author note: data collectors were blind |
| Blinding of participants (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ INTERVIEW (ASTHMA THERAPY ADHERENCE SCALE) ‐ Patients were blind to allocation, but it is possible that they became aware of their group later on during one‐to‐one sessions. If the patients came to know about their group they might exaggerate responses during the telephone interview. The authors have not mentioned about any measure taken to ensure that patients remained blinded throughout the study. Author's note: the only effect was not to discuss which intervention was being used |
| Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) ASTHMA STATUS QUESTIONNAIRES ‐ Patients were blind to allocation, but it is possible that they became aware of their group later on during one‐to‐one sessions. If the patients came to know about their group they might exaggerate responses during the telephone interview. Authors have not mentioned about any measure taken to ensure that patients remained blinded throughout the study. Author's note: the only effect was not to discuss which intervention was used |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ INTERVIEW (ASTHMA THERAPY ADHERENCE SCALE) ‐ Author's note: study staff were blind |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) ASTHMA STATUS QUESTIONNAIRES ‐ Author's note: study staff were blind |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ INTERVIEW (ASTHMA THERAPY ADHERENCE SCALE) ‐ Unclear whether the missed data could have changed the outcome, hence marked unclear. However, attrition is fairly low, possibly low bias |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) ASTHMA STATUS QUESTIONNAIRES ‐ Unclear whether the missed data could have changed the outcome, hence marked unclear. However, attrition is fairly low, possibly low bias |