| Methods |
Random allocation by sealed envelope technique. Blinding of patients or staff to the experimental treatment that individual patients were receiving was not performed, however, contacts/care givers of control patients were kept separate from those of the intervention group |
| Participants |
Patients meeting the following diagnostic criteria were included in the study: recurrent episodes of wheezing or dyspnea, objective evidence of significantly increased airflow resistance during episodes, objective evidence of improvement in airflow when symptom free. Patients excluded from the study were those less than 18 years of age, those who refused to participate, or those with another pulmonary or severely debilitating disease that may have confused result interpretation |
| Interventions |
Patients randomized to the control or usual care group were provided with a standardized set of asthma pamphlets, which contained comprehensive information about asthma. No special steps, however, were taken to ensure that patients actually read the pamphlets, and no special counseling, support groups, or systematic encouragement beyond routine physician encouragement were provided. While patients in the interventional self management group were also provided with the standardized asthma pamphlets, they in addition were provided with a skill‐oriented self help workbook, a one‐to‐one counseling session, and were subject to several adherence‐enhancing strategies, such as attending an asthma support group and receiving telephone calls from a health educator. Physicians emphasized these skills at regular clinic visits. A standard protocol for classifying patients in terms of level of severity and for relating their treatment regimen to their level of severity was employed |
| Outcomes |
Measurement of adherence: 3 outcome measures directly assessed adherence to recommended regimens: a 10‐item observational checklist to assess inhaler use skills, self report scales to determine adherence to medications and inhaler use, and subjective assessment on a 3‐point scale by a project staff member. Measurement of healthcare outcomes: 4 status scales were employed in assessing healthcare outcomes: the first assessed the severity of asthma symptoms during the past 7 days, the next focused on psychological/psychosomatic aspects of asthma (whether the patients were 'bothered' by asthma in the past 7 days), the next scale assessed the number of episodes of respiratory problems/diseases experienced in the last 3 months, and the final scale measured whether asthma had interfered with the patients' lives in the last 3 months (prevented them from doing something) |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Closed envelope method used. Physicians treating the patients were involved in stratification. (pg 1666) "Patients were then randomized to two groups by using the closed envelope method. Patients were then stratified by 11 UAB pulmonary physicians based on severity of asthma. Randomization envelopes were prepared in advance, using a separate schedule for each strata". |
| Allocation concealment (selection bias) |
Low risk |
(pg 1666) "Patients were then randomized to two groups by using the closed envelope method." |
| Selective reporting (reporting bias) |
Unclear risk |
All the 9 pre‐specified outcome measures reported. Protocol required for further evaluation (Table 2pg 1667). (pg 1666) "Nine outcome measures assessed at baseline and at the 12‐month" |
| Other bias |
Unclear risk |
Insufficient information to determine if other bias occurred |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) 10‐ITEM OBSERVATION CHECKLIST ‐ (pg 1666) "It proved impossible to blind either patients or project staff to the experimental treatment that individual patients were receiving. To minimize the contamination of the usual care condition with the Self management group all contacts with the usual care group were limited to a staff member who had no part in implementing the intervention program". |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) ASTHMA SEVERITY SCALE ‐ (pg 1666) "It proved impossible to blind either patients or project staff to the experimental treatment that individual patients were receiving. To minimize the contamination of the usual care condition with the Self management group all contacts with the usual care group were limited to a staff member who had no part in implementing the intervention program". |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) 10‐ITEM OBSERVATION CHECKLIST ‐ (pg 1666) "It proved impossible to blind either patients or project staff to the experimental treatment that individual patients were receiving. To minimize the contamination of the usual care condition with the Self management group all contacts with the usual care group were limited to a staff member who had no part in implementing the intervention program" |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) ASTHMA SEVERITY SCALE ‐ (pg 1666) "It proved impossible to blind either patients or project staff to the experimental treatment that individual patients were receiving." |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) 10‐ITEM OBSERVATION CHECKLIST ‐ (pg 1666) "It proved impossible to blind either patients or project staff to the experimental treatment that individual patients were receiving. To minimize the contamination of the usual care condition with the Self management group all contacts with the usual care group were limited to a staff member who had no part in implementing the intervention program". |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) ASTHMA SEVERITY SCALE ‐ (pg 1666) "It proved impossible to blind either patients or staff to the experimental treatment that individual patients were receiving. To minimize the "contamination" of the usual care condition with the Self‐Management Program, all contacts with usual care patients were limited to a Staff member who had no part in implementing the intervention program." |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) 10‐ITEM OBSERVATION CHECKLIST ‐ 34 patients from the usual care and 8 from the self management program were lost at the 12‐month follow‐up and were excluded from data analysis. Originally the groups were balanced ‐ 135 and 132 to usual care and SMP groups and were closely matched at baseline. Excluding the dropouts analysis was carried out for 101 patients from the usual care and 123 from intervention group. It is stated in the paper (pg 1666) that "Analyses of baseline data indicated that dropouts were highly similar to subjects who persisted in the study, and that there was no dropout". However, not sure whether the imbalance in numbers could have affected the results |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) ASTHMA SEVERITY SCALE ‐ 34 patients from the usual care and 8 from the self management program were lost at the 12‐month follow‐up and were excluded from data analysis. Originally the groups were balanced ‐ 135 and 132 to usual care and SMP groups and were closely matched at baseline. Excluding the dropouts analysis was carried out for 101 patients from the usual care and 123 from intervention group. It is stated in the paper (pg 1666) that " Analyses of baseline data indicated that dropouts were highly similar to subjects who persisted in the study, and that there was no dropout". However, not sure whether the imbalance in numbers could have affected the results. |
