Chan 2007.
Methods | Randomized controlled trial | |
Participants | The study location was the island of Oahu, Hawaii, USA 60 participants were randomized to the intervention group and 60 participants were randomized to the control group The inclusion criteria were children 6 to 17 years of age with persistent asthma, dependents of US military personnel, not moving from Oahu for 12 months, ability to receive cable modem connections in the home, willing to learn to record and to send inhaler technique and peak flow data 2 times per week, willing to attend asthma education follow‐up visits either in person or electronically (virtually) at 2‐week, 6‐week, 3‐month, and 6‐month intervals after initiation into the study, willing to complete satisfaction and education surveys at the end of the study period, and willing to sign informed written consent forms |
|
Interventions | Intervention: INTERNET‐BASED HOME MONITORING AND EDUCATION
Both groups had 6 visits scheduled at 0, 2, 6, 12, 26, and 52 weeks, with the study pediatrician and 1 of the 4 assigned nurse case managers or the pediatric clinical pharmacist case manager. The intervention group received 3 in‐person visits, at 0, 26, and 52 weeks, and the rest as virtual visits. Virtual visits included asthma education, a video recording of peak flow meter and inhaler use forwarded to the Web site, daily asthma diaries, and communication with the case manager electronically via the Web site. Patients were provided a home computer system, camera, and Internet access. On‐site in‐home instruction was provided by technical experts on equipment use and Web site capabilities and use. Each patient received the same models of computer and computer equipment, as well as broadband Internet access. Patients and their parents were taught how to use the equipment and how to record and to submit videos by using a computer‐mounted digital video camera, to capture the patient's peak flow meter and inhaler technique. A detailed asthma symptom diary and quality of life survey were included on the website. Patients and families were instructed regarding the submission of daily symptom diary entries. Videos were recorded and loaded on the site for the case manager, who scored them with standardized checklists and provided instruction through e‐mail back to the patient/family. Videos were sent 2 times per week for 6 weeks and then once‐weekly thereafter. Moreover, patients received the following same service as the control group: they were contacted (by e‐mail) by the case manager 2 times per week for 6 weeks and once per week thereafter, to review the asthma action and home management plans, to assess the symptom diary, to remind the patient to perform and to record peak flow measurements daily in the diary, to remind the patient to complete symptom diary information every day, to answer questions, and to intervene if needed. All patients were able to contact the case manager 24 hours per day, 7 days per week Control: OFFICE‐BASED VISITS Patients were treated with an ambulatory asthma clinical pathway, with 6 visits scheduled 0, 2, 6, 12, 26, and 52 weeks after enrollment. At each visit, patients and their parents received in‐depth asthma education from the case manager, with specific subjects being determined by an asthma educational pathway. Office‐based group patients received all of their information in person at the pediatric clinic. Patients were able to contact their case manager by telephone |
|
Outcomes | The measures of adherence were total number of inhalers refilled (assessed by pharmacy refill data fro the entire study duration of 52 weeks), controller inhaler use (assessed by metered dose inhalers) and inhaler videos (to be submitted twice weekly for 6 weeks and once weekly thereafter until 52 weeks). Controller inhaler use was calculated as inhalers per patient ‐ month, inhaler videos were also converted to number per patient‐months The patient outcomes were 1) lung function tests (spirometry performed at intake and study exit at 1 year) 2) peak flow (percentage of personal best), 3) patient and caregiver pediatric asthma quality of life questionnaires (analyzed at intake and study exit at 1 year), 4) utilization of services (emergency department visits, hospitalizations, and unscheduled acute visits because of asthma, from centralized medical chart database and case manager records), 5) rescue therapy use (beta‐receptor agonist use and refills and use of oral prednisone rescue therapy, from computerized pharmacy records), 6) symptom control (diary symptom score) |
|
Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Explicitly refers to table of random numbers. (pg 570) "Patients underwent block randomization with a table of random numbers and were enrolled in either the "virtual" group (60 subjects) or the office‐based group (60 subjects)." |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment in the article |
Selective reporting (reporting bias) | Unclear risk | Insufficient information. Many outcomes are reported, but only broad categories are specified in the methods (pg 570) "to improved outcomes, including therapeutic and diagnostic adherence and disease control (quality of life, lung function, utilization of services, rescue therapy, symptom control, patient education, and patient satisfaction)" |
Other bias | Unclear risk | The different number of dropouts between intervention and comparison may lead to bias, but insufficient evidence to judge it. (pg 573) Table 1: 13 dropouts in the virtual group versus 5 in the office‐based group |
Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) CONTROLLER REFILL ‐ Objective measure |
Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) LUNG FUNCTION TEST ‐ staff and personnel were not blinded to allocation group and assessment of lung function could have been biased |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) CONTROLLER REFILL ‐ Patients are not blinded to the information, but it is unlikely that this may bias pharmacy refill |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) LUNG FUNCTION TEST ‐ Patient not blinded, but unlikely bias of the assessment of lung function |
Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) CONTROLLER REFILL ‐ Objective measure |
Blinding of personnel (performance bias) Patient outcome | High risk | (PRIMARY) LUNG FUNCTION TEST ‐ staff and personnel were not blinded to allocation group and assessment of lung function could have been biased |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) CONTROLLER REFILL ‐ Number of lost data imbalanced across groups; not clear how this would have impacted results |
Incomplete outcome data (attrition bias) Patient outcome | High risk | (PRIMARY) LUNG FUNCTION TEST ‐ Differential dropout may be associated with prognosis in lung functions |