Holland 2007.
Methods | Randomized controlled trial | |
Participants | The study location was UK 149 participants were randomized to the intervention group and 144 participants were randomized to the control group The inclusion criteria were adults (aged over 18 years), admitted as an emergency in which heart failure was an important ongoing clinical condition, and prescribed 2 or more drugs (from any drug class) on discharge The exclusion criteria were living in a residential or nursing home, awaiting surgery for ischemic or valvular heart disease or heart transplantation, or had terminal malignancy |
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Interventions | Intervention: HEARTMED PHARMACIST INTERVENTION
The pharmacist arranged a home visit, within 2 weeks of hospital discharge, at a time when they could meet the patient and any carer(s). Where appropriate, pharmacists educated the patient/carer about heart failure and their drugs and gave basic exercise, dietary, and smoking cessation advice. They also encouraged completion of simple sign and symptom monitoring diary cards (including monitoring body weight), removed discontinued drugs (with the patient's consent), fed back recommendations to the general practitioner, and fed back to the local pharmacist any need for a drug adherence aid (for example, a Medidos or Dosett container). We provided all pharmacists with a detailed manual describing the expected components of their visit and asked them to deliver education in line with advice given in the British Heart Foundation's booklet Living with Heart Failure, which they left with patients after the first visit. Pharmacists completed a standardized visit form during each visit. One follow‐up visit occurred at 6 to 8 weeks after discharge to review progress and reinforce original advice. We also recorded a selection of pharmacists' visits to investigate the intervention's delivery and the pharmacists' communication skills Control: USUAL CARE The nature of the intervention meant that no clear "placebo" could be provided. Participants were told after randomization which group they were in. Those in the control group received usual care |
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Outcomes | The measures of adherence were a mailed questionnaire that measures drug adherence (medication adherence report scale or MARS) at baseline and 2 years The patient outcomes were emergency admissions and mortality (data obtained from hospital records) and quality of life (Minnesota living with heart failure questionnaire and EQ 5D). Measures were performed at baseline and at 2 years |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number. (pg 2) "We used third party telephone randomisation based on a computer generated random allocation sequence. We stratified randomisation by New York Heart Association class (class I/II—no or mild limitation, III—moderate limitation, or IV— severe limitation) and recruitment site." |
Allocation concealment (selection bias) | Low risk | Third party allocation, assumed this is concealed. (pg 2) "We used third party telephone randomisation based on a computer generated random allocation sequence. We stratified randomisation by New York Heart Association class (class I/II—no or mild limitation, III—moderate limitation, or IV— severe limitation) and recruitment site." |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Low risk | None noted |
Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Self report is subjective and no mention of blinding outcomes assessors |
Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) HOSPITAL READMISSIONS ‐ No mention of blinding and not clear how these data were collected |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patients were not blinded to treatment group. (pg 5) "However, patients could not be blinded to treatment group, which may have biased their responses to questionnaires." |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HOSPITAL READMISSIONS ‐ No mention of blinding but unlikely to affect this outcome |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk' |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) HOSPITAL READMISSIONS ‐ No mention of blinding and not clear how these data were collected |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Reasons for loss to follow‐up not explicit; loss between groups not balanced |
Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) HOSPITAL READMISSIONS ‐ Reasons for dropouts not provided; unequal loss to follow‐up across groups |