Silver 2017.
| Study characteristics | ||
| Methods | RCT; follow‐up:6 months, control group: usual care | |
| Participants | Eligible: 574 Randomised: 428, I: 214, C: 214 Completed: 423, I: 211, C: 212 Mean age: I: 50 years, C: 57 years Sex (% male): I: 44, C: 50 Inclusion criteria: between 18 and 65 years of age; diagnosis of COPD based on FEV₁/FVC < 0.7 or FEV₁ < 80% predicted (performed before bronchodilator administration); at high risk for repeat hospitalisations or emergency department visits as predicted by hospital admission or emergency department visit in previous 12 months for a COPD exacerbation; long‐term home use of oxygen or treatment with a course of systemic corticosteroids in preceding 12 months Major exclusions: not expected to survive the hospitalisation; metastatic cancer, bed‐bound; non‐English‐speaking; inability to provide informed consent |
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| Interventions | Respiratory therapist disease management transition team Intervention components ‐ 1‐hour educational in‐service by trained respiratory therapist case manager. Education included general information about COPD, direct observation of inhaler techniques, review and adjustment of outpatient COPD medications, smoking cessation counselling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, instruction in hand hygiene ‐ Discussion with case manager and treating physician on need for pharmacotherapy ‐ Verification of COPD diagnosis with bedside spirometry if necessary ‐ Individualised written action plan ‐ Scheduled follow‐up telephone calls with case manager to address specific patient needs, concerns, and questions Duration intervention: 6 months Disciplines involved: respiratory therapist (case manager), treating physician |
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| Outcomes | Combined number of non‐hospitalised ED visits and hospital admissions for a COPD exacerbation (primary outcome); ED visits for COPD exacerbations; hospital admissions for COPD exacerbations; ED visits for other causes; hospital admissions for other causes; ICU days; hospital days; all‐cause mortality | |
| Notes | Dominant component: s tructured follow‐up with c ase manager (investigator 's judgement) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “study subjects were randomly assigned to treatment groups in a 1:1 ratio using blocked randomisation (n = 4/block) |
| 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: “we cannot exclude some form of bias in terms of the outcome assessment because this was not a blinded study” Comment: outcomes less subjective; however knowledge of allocation may have influenced participants' behaviour with regard to ED visit and other outcomes |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: study not blinded; however primary outcomes extracted from automated medical records and bi‐monthly telephone calls by study co‐ordinator to determine if participants had recent hospital or ED visits and medical indications for admission/ED visit. Outcome less subjective and based mostly on EHR, so unlikely to have biased results |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: quantity of missing data minimum (3/214 intervention and 2/214 control) and balanced between groups |
| Selective reporting (reporting bias) | Low risk | Comment: all pre‐defined outcomes reported on. Reported on more than specified in trial register. For all outcomes, also reported on (1) number of participants with ≥ 1 COPD ED visit/non‐COPD ED visit/hospital admission; (2) median (IQR) per subject COPD ED visit/non‐COPD ED visit/hospital admission; (3) number of participants with ≥ 1 COPD ED visit/non‐COPD ED visit/hospital admission |