Wang 2017.
| Study characteristics | ||
| Methods | RCT, multi‐centre (n = 2); follow‐up: 12 months, control group: usual care | |
| Participants | Eligible: 162 Randomised: 130, I: 62, C: 68 Completed: 120, I: 55, C: 65 Mean age: I: 69 years, C: 72 years Sex (% male) I: 38, C: 55 Inclusion criteria: medically confirmed diagnosis of COPD based on Chinese Medical Association diagnostic criteria, including percentage forced expiratory volume for 1 second (FEV₁%) ≤ 80% and forced expiratory volume for 1 second divided by forced vital capacity (FEV₁/FVC) ≤ 70%; ability to speak Mandarin to communicate; discharged to a home where Internet and computer have been installed; ability to be reached by telephone post discharge Major exclusions: comorbidities (i.e. allergic rhinitis, myocardial infarction, severe heart failure, and malignant tumour); no access to a computer or Internet at home |
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| Interventions | Web‐based coaching programme using EHRs, accessible for patients and medical staff Intervention components ‐ Web‐based HER system to allow for input of demographic information, record of admission, discharge, and community information ‐ Ability for patient to manage and control own record and enter health information ‐ Visual presentation of trajectory of disease to medical staff and patient ‐ Access to patient on information about the disease and health education content entered by administrator (medical staff). Health education included information about COPD and pulmonary rehabilitation instructions. Information related to COPD consisted of cause of disease, development, acute exacerbation, prognosis, medication information (name, route, dosage, and adverse reactions), oxygen therapy, diet, importance of smoking cessation ‐ Direct email‐like communication with community administrator ‐ Messaging function between medical team and patient (2‐way) ‐ Telephone call from research team every 2 weeks Duration intervention: 12 months Disciplines involved: community nurse, medical practitioner, clinical nurse |
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| Outcomes | FEV₁ %, FVC%, FEV₁/FVC, peak expiratory flow and maximum mid‐expiratory flow, SGRQ, mMRC, 6MWD | |
| Notes | Dominant component: telemonitoring | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “the patients who consented to participate were assigned to the intervention or control group using a computer‐generated randomised table” |
| Allocation concealment (selection bias) | Unclear risk | Comment: n o details on concealment of allocation provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “participants were not blinded to group assignment” Not explicitly mentioned whether medical staff was blinded. However, given nature of intervention, unlikely |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: in supplementary material – CONSORT eHEALTH checklist mentioned that all data were collected face‐to‐face by research assistant, who was blinded to allocation outcome. Researchers were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: loss to follow‐up unbalance d between groups: 7/62 in intervention lost to‐follow‐up with reason ‘could not contact’; 3/68 lost to follow‐up in control group. Analysis performed with only complete measurements |
| Selective reporting (reporting bias) | Unclear risk | Comment: protocol not published nor trial registered in trial registry. All outcomes mentioned in protocol are reported, except FEV₁/FVC. No distinction between primary and secondary outcomes |