Kalter‐Leibovici 2018.
| Study characteristics | ||
| Methods | RCT; follow‐up: 24 months; control group: usual care; multi‐centre | |
| Participants | Eligible: 1333 Randomised: 1202, I: 600, C: 602 Completed: 992, I: 500, C: 492 Mean age: I: 66.7 years, C: 68.3 years Sex (% male): I: 69, C: 73 Inclusion criteria: aged 40 years or older; COPD patients with GOLD Stage III or IV (see table‐1), or patients with GOLD Stage II COPD, with past or current history of cigarette smoking, not history of childhood asthma, and with unstable disease (≥ 1 hospital admission or 2 visits to internal wing of emergency department for COPD exacerbation during past 12 months) Major exclusion criteria: permanent tracheostomy; heart failure with left ventricular ejection fraction < 40%; severe comorbidity; significant functional or cognitive impairment; communication problems; substance abuse; participating in another trial |
|
| Interventions | Disease management intervention delivered by trained COPD nurses in addition to recommended care Intervention components ‐ Face‐to‐face session with COPD nurse during visits; remote contact in between visits ‐ Symptom and adherence to treatment monitoring by COPD nurse, exacerbation management, lifestyle advice, treatment plan, and education ‐ Co‐ordination of care ‐ On‐call disease management nurse outside office hours Duration of intervention: duration of follow‐up; minimum 2 years, maximum 5 years Disicplines involved: trained COPD nurse, disease management nurse, programme director |
|
| Outcomes | Total number hospitalisation days (all‐cause and COPD‐related), number of patients with ≥ 1 hospitalisation (all‐cause and COPD‐related), hospitalisation rate, 6MWD, mMRC, SF‐12 MCS, SF‐12 PCS, SGRQ ‐ total, FEV₁% predicted | |
| Notes | Dominant component: structured follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "after completing eligibility and baseline assessment and providing signed informed consent, patients were randomly assigned either to the study intervention or to the control intervention, using a computerized randomisation program with permuted‐block design linked to the patients’ electronic medical record" |
| Allocation concealment (selection bias) | Low risk | Quote: "after completing eligibility and baseline assessment and providing signed informed consent, patients were randomly assigned either to the study intervention or to the control intervention" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the study personnel at the COPD centres were not blinded to the patients’ assigned intervention during follow‐up assessments" Comment: primary outcomes less subjective; outcomes on health‐related quality of life, SGRQ, and depression symptoms may be biased by performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "hospital admissions were classified by two independent investigators, blinded to the patients’ assigned intervention" Comment: outcomes on hospitalisation assessed blinded to allocation. However, all other outcomes assessed by unblinded personnel at COPD centre with knowledge of allocation, likely to have biased results |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all analyses were performed according to the intention‐to‐treat principle" Comment: 1 in 6 patients in both groups lost to‐follow up. Numbers and reasons for loss to‐follow‐up balanced between groups. In the control group, number of deaths (n = 91) slightly greater compared to control group (n = 72). Unlikely to have biased results |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes specified in protocol reported. Protocol published as appendix to article |