Korajkic 2011.
Study characteristics | ||
Methods | RT Setting: ambulatory setting 9 months |
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Participants | 70 participants Ambulatory setting Attendees at a heart failure outpatient clinic, > 18 years, had New York Heart Association class II, III or IV heart failure, stable signs and symptoms of heart failure, clinically euvolaemic, daily frusemide dose up to a maximum of 320 mg, treatment with other drugs such as beta‐blockers, digoxin, vasodilators and spironolactone was permitted. Participants were excluded if they were not on frusemide; were on a daily frusemide dose above 320 mg and/or thiazide diuretic; had baseline renal impairment (serum creatinine concentration > 200 µmol/L or on dialysis); had a severe psychiatric illness or moderate‐severe dementia; life expectancy of < 3 months; severe hearing impairment or legal blindness; or had difficulty understanding and speaking English and did not have an interpreter or family member to assist. Other exclusions included scheduled cardiac surgery; heart transplant candidacy; inability to give informed consent; and no access to a telephone. |
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Interventions | Pharmacist intervention focused on participants improving self‐care, recognising symptoms of fluid retention, measuring weight daily and self‐adjusting diuretic dose using frusemide. Intervention group: participants assigned to the intervention group received usual care plus pharmacist intervention. The intervention was provided to every participant in the intervention group and consisted of a 30‐min educational session during the clinic appointment. The pharmacist intervention focused on participants improving self‐care, recognising symptoms of fluid retention, measuring weight daily and self‐adjusting diuretic dose using a flexible frusemide dose‐adjustment regimen, and improving knowledge and understanding of heart failure and heart failure medications. Usual care (control group): usual care was provided to all of the eligible participants by a cardiologist, heart failure nurse co‐ordinators and a dietitian during the clinic appointment. Usual care consisted of assessment of clinical status and medications, education on daily weight measurement, diet, fluid and sodium management, and recognition of signs and symptoms of fluid retention and dehydration. In case of a sudden increase in weight of more than 1 kg/d for 2 d, participants were encouraged to contact the heart failure nurse co‐ordinators for advice in consultation with the cardiologist to self‐adjust their frusemide dose. The heart failure nurse co‐ordinators followed up participants 48 h after a dose adjustment to assess if their weight had decreased and condition improved. The key difference between the groups was that the control group called a heart failure nurse co‐ordinator to discuss frusemide dose modification, while the intervention group adjusted the diuretic dose themselves. |
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Outcomes | Hospital readmissions due to fluid overload: measured at 1st, 2nd and 3rd months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation occurred after selection criteria had been observed. No description of the randomisation method/sequence generation was presented. |
Allocation concealment (selection bias) | Unclear risk | A significant number of heart failure participants were not good candidates for the intervention. Only 1 in 3 participants who met inclusion criteria remained eligible after application of exclusion criteria. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is unclear if participants were blinded to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments and readmissions were evaluated and confirmed by an independent doctor blinded to the randomisation using data from participants, hospital admissions records and medical records. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported as mentioned at the start of the trial. |
Protection against contamination bias | Unclear risk | It can not be determined if the intervention group interacted with the control group. |
Other bias | Unclear risk | The intervention was delivered by the same pharmacist. It precludes study of other factors, such as pharmacist attitudes or behaviours that may have promoted delivery of the intervention and limit the generalisability of the intervention. This study was conducted at a single institution, and the results may reflect local population characteristics and patterns of care. |