| Methods |
Participants were recruited using flyers posted throughout the health science center campus, within the university student health center, and in health departments within the county. In an effort to approximate the ethnicity of the surrounding county, which is 19% African American, the principal investigator also recruited participants personally in an African American church. There were 46 participants at the beginning of the study. A computerized randomization protocol was used to assign participants to one of 4 treatment groups |
| Participants |
There were 46 participants at the beginning of the study. English‐speaking adults aged 18 to 65, whose reported use of preventive medication for asthma during the 3 months prior to the study indicated that they had mild persistent to moderate persistent asthma according to the US NAEPP (2002) guidelines. Individuals were excluded if they reported daily oral steroid use, diagnosis of chronic obstructive pulmonary disorder (COPD), or symptomatic cardiac disease |
| Interventions |
4 treatment groups: (a) standard provider education (control) (n = 13); (b) audiotape alone (n = 10); (c) National Heart Lung and Blood Institute (NHLBI) booklet alone (n = 12); and (d) audiotape plus NHLBI booklet (n = 11) |
| Outcomes |
Compliance measurements: self reported and pharmacy‐verified adherence to preventive medication
Measurement of clinical health outcomes: asthma control measured with the Asthma Control Questionnaire (ACQ), asthma quality of life measured with the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), and asthma self efficacy assessed using the Perceived Control of Asthma Questionnaire (PCAQ). Asthma knowledge was measured with the Asthma Knowledge Scale, developed for this study |
| Notes |
The ACQ is a 7‐item Likert‐type scale designed to measure asthma treatment adequacy as measured by minimization of symptoms, bronchoconstriction, and short‐acting beta‐agonist use |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computerized randomization method. "A research assistant then consulted a computerized randomization protocol and provided participants with the audiotape and headphones, educational brochure, or both." (pg 79) |
| 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 |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "The researcher remained blind to group assignment until the data collection was completed." (pg 79) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) ACQ, AQLQ, PCAQ AND ASTHMA KNOWLEDGE SCALE ‐ There is an explicit statement regarding blinding the researcher who collected the data and conducted the spirometry. "The researcher remained blind to group assignment until the data collection was completed." (pg 79) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) ACQ, AQLQ, PCAQ AND ASTHMA KNOWLEDGE SCALE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) ACQ, AQLQ, PCAQ AND ASTHMA KNOWLEDGE SCALE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Not enough detail given on the dropouts to judge |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) ACQ, AQLQ, PCAQ AND ASTHMA KNOWLEDGE SCALE ‐ Detail not given on the dropouts |
