van der Meer 2009.
Methods | Randomized controlled trial | |
Participants | The study location was 37 general practices (69 general practitioners) in the Leiden and The Hague area and the Outpatient Clinic of the Department of Pulmonology at the Leiden University Medical Center, Leiden, the Netherlands 101 participants were randomized to the intervention group and 99 participants were randomized to the control group The inclusion criteria were physician‐diagnosed asthma coded according to the International Classification of Primary Care in the electronic medical record, age 18 to 50 years, prescription of inhaled corticosteroids for at least 3 months in the previous year, no serious comorbid conditions that interfered with asthma treatment, access to the Internet at home, and mastery of the Dutch language The exclusion criteria were receiving maintenance oral glucocorticosteroid treatment |
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Interventions | Intervention: INTERNET‐BASED SELF MANAGEMENT
An internet based self management program consisting of a specially designed website, which allowed monitoring through the website or text messaging, use of an internet‐based treatment plan, online education and web communications with a specialized asthma nurse was administered to the intervention group. Patients monitored their asthma weekly by completing an electronic version of the Asthma Control Questionnaire on the website and instantly received feedback on the current state of their asthma control along with advice on how to adjust their treatment according to a predefined algorithm and treatment plan. Self management education consisted of both web‐based and face‐to‐face, group‐based education. Web‐based education included asthma information, news, frequently asked questions, and interactive communication with a respiratory nurse specialist. All patients were offered 2 group‐based education sessions, which lasted 45 to 60 minutes, for patients in the Internet‐based self management group within 6 weeks after entering the trial. Both sessions included exploration of a patient's interests and previous knowledge, personalized feedback, and empowerment of self management. The first educational session also included pathophysiology of asthma, information on the web‐based action plan, and information and review of inhalation technique. The second educational session gave information about the mechanisms and side effects of medication and explained trigger avoidance Control: USUAL CARE Website access for usual care patients was restricted to a diary page for patients to keep during assessments |
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Outcomes | The measure of adherence was self reported medication adherence assessed at baseline and 12 months The patient outcome was asthma‐related quality of life, as the primary outcome, measured by the 32‐item Asthma Quality of Life Questionnaire. 5 secondary clinical outcomes: asthma control, symptom‐free days, prebronchodilator FEV1, daily inhaled corticosteroid dose, and exacerbations. All outcomes except for exacerbations were assessed over 2 weeks, at 3 months, after the baseline period, and again at 12 months. During these assessments, all patients kept Internet‐based daily diaries as they had during the baseline period. Calculated daily inhaled corticosteroid dose as fluticasone equivalents. Exacerbations were defined as deterioration in asthma that required emergency treatment or hospitalization or the need for oral steroids for 3 days or more, as judged by the attending physician, and assessed them over the whole year. Participants provided the Asthma Control Questionnaires, symptom‐free days, and prebronchodilator FEV1 through the Internet. Other outcomes were collected by written questionnaire |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used computer‐generated sequences. "After the 2‐week baseline period, we randomly assigned participants to either the Internet group or the usual care group. We stratified according to care provider (primary vs. subspecialty care) and asthma control at baseline (15). We randomly assigned patients to the 2 groups (1:1 ratio) by using a computer‐generated, permuted‐block scheme." (pg 111) |
Allocation concealment (selection bias) | Low risk | The allocation was concealed. "Allocation took place by computer after collection of the baseline data, ensuring concealment of allocation." (pg 111) |
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 | Unclear risk | (pg 117) "A potential limitation of our study was that the patients and physicians were aware of the allocation group". This might have introduced biased reporting by patients and clinicians |
Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Blinding of personnel (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Blinding of personnel (performance bias) Patient outcome | High risk | (PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no blinding |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ ITT analysis done and missing values were not imputed; missing data fairly balanced |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) ASTHMA‐RELATED QUALITY OF LIFE QUESTIONNAIRE ‐ ITT analysis done and missing values were not imputed; missing data fairly balanced |