| Methods |
Patients were randomized consecutively into intervention and control groups using equal blocks of 4 generated using the Clinstat program. This was done by the 2 nurses at their respective hospitals, by first producing 2 patient lists, by date order of receipt of their consent forms i) completed when attending or ii) returned by post. 108 patients were randomly allocated into the control group, and 103 patients were randomly allocated into the intervention group. Study nurses were not blinded to allocation after randomization occurred |
| Participants |
211 patients over 18 years old attending the emergency room department for asthma were included. Exclusion criteria were not specified, except that patients with a previously recorded diagnosis of chronic obstructive pulmonary disease were excluded |
| Interventions |
The intervention group was invited to attend a 1‐hour consultation with one of the nurses beginning 2 weeks after entry to the study, followed by 2 or more lasting half an hour, at 6‐weekly intervals. The second and third could be substituted by a telephone call. Patients were phoned, by the nurse before each appointment in order to improve attendance rates. Patient's asthma control and management were assessed followed by education on recognition and self treatment of episodes of asthma. The patients were taught to step‐up medication when they recognized uncontrolled asthma using peak expiratory flow (PEF) or symptoms. The advice was in accordance with national guideline. Prescriptions were obtained from one of the doctors in the clinic or by providing the patient with a letter to their general practitioner. Patients presenting with severe asthma (severe symptoms of PEF below 60% of their best/normal) were referred immediately to the consultant. Patients in the control group continued with their usual medical treatment and were not offered any intervention during the study period |
| Outcomes |
Measurement of compliance: the primary outcome was the patients' reported, appropriate adherence to self management of mild attacks within the previous 2 weeks or severe attacks in the previous 6 weeks
Measurement for clinical health outcomes: home peak flow and symptom diaries. Patients recorded the best of 3 PEF readings in the morning and evening, and also recorded symptom scores daily for 7 days. Quality of life was also assessed using the St. George's Respiratory Questionnaire (SGRQ), and patients use of medical services was assessed |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomization schedule. (pg 901) "Patients were randomized consecutively into intervention and control groups using equal blocks of four generated using the Clinstat program developed by Martin Bland (http://www.sghms.ac.uk/depts/phs/sta?/ jmb). This was done by the two nurses at their respective hospitals, by first producing two patient lists, by date order of receipt of their consent forms (i) completed when attending or (ii) returned by post. Patients who had a previously recorded diagnosis of chronic obstructive pulmonary disease were excluded." |
| Allocation concealment (selection bias) |
Unclear risk |
The authors state (pg 901) that "The nurses had no idea which group the patients would be randomized into". However, the technique used is not stated. Also randomization was not central ‐ was done at the 2 study centres by nurses |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
The authors note the following: (pg 907) "We could be criticized that our sample is not representative of the population at large". No other bias noted |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Outcome assessors were blinded ‐ (pg 901) "An interviewer (MR), blinded to the patients randomization status, conducted four structured telephone interviews using the St George's Respiratory Questionnaire (SGRQ) (6) and an assessment questionnaire, described below. The first, third and fourth interviews included the SGRQ and the complete assessment questionnaire and the second only included the self management sections of the assessment questionnaire. Interviews took place at about 2 weeks after randomization (baseline), 6 weeks, 3 and 6 months after randomization". |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) SYMPTOM DIARY CARD ‐ Outcome assessors were blinded ‐ (pg 901) "An interviewer (MR), blinded to the patients randomization status, conducted four structured telephone interviews using the St George's Respiratory Questionnaire (SGRQ) (6) and an assessment questionnaire, described below. The first, third and fourth interviews included the SGRQ and the complete assessment questionnaire and the second only included the self management sections of the assessment questionnaire. Interviews took place at about 2 weeks after randomization (baseline), 6 weeks, 3 and 6 months after randomization" |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of patient blinding; subjective outcome |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) SYMPTOM DIARY CARD ‐ No mention of patient blinding; subjective outcome |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Nurses were not blind to groups: "The nurses had no idea which group the patients would be randomized into, however, once randomized they became aware in order to proceed and invite intervention group patients to attend." |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) SYMPTOM DIARY CARD ‐ Nurses were unblinded but were likely not involved in outcome measurement |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Reasons for dropouts unclear |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) SYMPTOM DIARY CARD ‐ There was some loss of subjects returning diary cards during the study, but the loss was similar in the 2 groups (Table 3). We considered that selective dropout of patients during the study may explain the significant results at 6 months, however Table 7 shows data at 3 months for those subjects having data at 6 months only. The differences are very similar to those for the whole group at 3 months, and not like those at 6 months. Thus we cannot ascribe the differences between treatment and control subjects at 6 months to selective dropout (pg 904) |
