| Methods |
Patients (n = 221) were randomized to either the intervention group (n = 109) or control group (n = 112) using the minimization method. Both groups were matched as closely as possible, for the following parameters: severity of heart failure (HF) (NYHA Grade I‐ IV), renal function (serum creatinine > or = to 200 mmol l‐1 or < 200 mmol l‐1), other concomitant illness and cognitive status (CAPE survey score). No method of allocation concealment was mentioned |
| Participants |
Patients had a diagnosis of heart failure, a score of more than 6 on the Clifton Assessments Procedures for the Elderly (CAPE) survey used to assess cognitive status, and the consent of a hospital consultant for the trial. Patients were excluded from the trial if they had significant airways disease and severe mobility problems due to other causes |
| Interventions |
Patients receiving the intervention were 1) educated on heart failure (HF), their prescribed medication and the management of HF symptoms by the research pharmacist; 2) given a printed booklet developed for this type of education program, which contained information on HF, its symptoms, the aims of treatment, the types of medication used and their possible side effects, diet and lifestyle changes, advice to stick to one brand of digoxin (it having a narrow therapeutic index) and information on the action to take if doses of medication were missed; 3) instructed on a self monitoring program (signs and symptoms of HF; compliance with prescribed medication) in which they were asked to become engaged and involved a monitoring diary card (covering 1 month); 4) asked to record their weight daily in their diary card because they had been instructed to take an extra dose of their diuretic and to contact their physician immediately if their weight increased by 3 kilograms over 48 hours or if there was a marked deterioration in their HF signs/symptoms; 5) asked to perform daily exercise (walking); and 6) given rationalization of drug therapy or simplification of dosage regimens, when deemed appropriate. Control group patients received usual care, i.e. excluding counseling and education by the research pharmacist, self monitoring, pharmacist liaison with physicians, etc. |
| Outcomes |
At the 3‐monthly outpatient clinics patients were assessed as per initial baseline assessments as follows: 2‐minute walk test (including time to walk 25 and 50 meters), blood pressure, body weight, pulse, forced expiratory vital capacity (FVC), quality of life questionnaires (MLHF questionnaire and the SF‐36), questionnaire on symptoms and knowledge of, and compliance with, prescribed medication and lifestyle advice |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Minimization was used. "After recruitment, patients were randomly assigned to one of two groups: intervention group or control group. The randomization was carried out using the minimization method described by Gore [20]." (pg 185) |
| Allocation concealment (selection bias) |
Unclear risk |
Method of concealment was not described |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Unclear risk |
"The research pharmacist delivered the pharmaceutical care programme and was also involved in some aspects of data collection. The possible bias that this could have introduced to the study was minimized, in those cases where the outcome questionnaires could not be self completed by patients, by ensuring that a strict protocol for questionnaire administration was adhered to, as designated in the SF36 manual." (pg 191) |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Outcome assessors were blinded. "Baseline measurements were performed by a research pharmacist (A.S.) with the exception of the 2‐min walk test and the FVC test, which were performed by nursing staff or a pharmacy technician. They were blinded regarding the group to which individual patients had been assigned and received training on test administration." (pg 185) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) QUALITY OF LIFE QUESTIONNAIRE ‐ The outcome assessors were blinded. "Baseline measurements were performed by a research pharmacist (A.S.) with the exception of the 2‐min walk test and the FVC test, which were performed by nursing staff or a pharmacy technician. They were blinded regarding the group to which individual patients had been assigned and received training on test administration." (pg 185) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) QUALITY OF LIFE QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) QUALITY OF LIFE QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ A total of 221 HF patients (109 intervention; 112 control) were recruited into the study. 2 patients in each group died during the study; in addition, 3 patients withdrew from the intervention group and 6 from the control group during the study, meaning that a total of 104 patients in each group completed the 12‐month follow‐up study. Unlikely that the missing data would have changed the outcome, but since it is not clear, it is marked unclear |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) QUALITY OF LIFE QUESTIONNAIRE ‐ Reasons for withdrawals were not provided |
