Sisk 2006.
Methods | Randomised controlled trial | |
Participants | 406 people with documented left ventricular systolic dysfunction | |
Interventions | Group 1: Usual care: Participants received information about how to manage their heart failure Group 2: Intervention group: The first visit with the heart failure nurse consisted of education about heart failure, self management strategies, lifestyle modifications, and medication adherence. All participants received printed information about heart failure. Nurses organised initiation and titration of medications. Subsequent visits were comprised of telephone follow‐up every 3 months for 12 months |
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Outcomes | Primary endpoint: all‐cause hospitalisation Secondary endpoints: emergency department presentations, heart failure hospitalisations, and medications prescribed |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer‐generated, random number sequence without blocking or stratification to centrally determine randomisation assignments" |
Allocation concealment (selection bias) | Unclear risk | Quote: "...concealed treatment group assignments in sealed, opaque envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Participants and nurses were aware of group allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...interviewers who were blinded to treatment assignments asked patients about hospitalisations at nonparticipating hospitals" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "...we conducted tests for missing data bias suggested by Hogan and colleagues and these tests gave little evidence of informative missingness. We also used linear mixed models, which are robust to data missing at random, to estimate treatment effectiveness" |
Selective reporting (reporting bias) | High risk | Comment: All outcomes except adverse events associated with the intervention were reported |