Juanes 2018.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | 118 participants randomised (59 to medication review and 59 to control) Patients 65 years or older, with a length of stay in ED longer than 12 hours, decompensation of HF and/or COPD and polypharmacy (4 or more drugs) were included from a tertiary referral hospital from Catalonia, Spain Mean age: 80 years 50% male Mean number of medications taken regularly at home: intervention 10.5 (3.5), control 10.0 (3.3) |
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Interventions | The intervention consisted of a pharmaceutical care programme focusing on the resolution of potential drug‐related problems, from admission to ED until discharge. The pharmaceutical care programme comprised the following steps:
Patients in the control group received standard pharmaceutical care, initiated at admission to the ward and consisting of medication review and prescriptions' validation, analogous to step 3 in the intervention group. The study compares the effects of an extended medication review and a basic medication review. |
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Outcomes |
Primary outcome: drug‐related negative outcomes (DNO) defined as health problems that patients experience owing to drug use or non‐use Secondary outcomes: patients readmitted within 180 days to the same ED and/or to the hospital ward: patients readmitted owing to decompensation of HF and/or exacerbation of COPD within 180 days after inclusion in the study |
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by the hospital’s pharmacology department using SPSS V.18 (SPSS, Chicago, Illinois, USA) to create a dedicated application to randomise patients to one of the of 2 study groups (distribution 1:1). The application used a seed obtained by rolling two dice to select the row and column from a random‐number table; therefore, while replicable but unpredictable, the series was perfectly balanced between groups in 10‐case blocks. |
Allocation concealment (selection bias) | High risk | Trial authors were contacted for clarification. They replied that the pharmacology department created the randomisation scheme. The pharmacist had access to the entire randomisation. After assessing the suitability of the patient through compliance of the inclusion criteria, the pharmacist assigned each individual a group according to the randomisation scheme, chronologically (in function of the onset of the episode in the ED) and correlative according to with the randomisation scheme. We assessed the risk of bias as high, because the pharmacist had access to the randomisation form (which was made in advance by rolling dice) and thus the allocation was not hidden (e.g. if 2 patients arrived at the same time). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither patients nor healthcare professionals were blinded to the treatment group. |
Blinding of outcome assessment (detection bias) Mortality (all‐cause) | Low risk | A single pharmacist was responsible for the implementation of the programme and the assessment of results, which might have led to observer bias. However, it is unlikely that it would affect mortality. |
Blinding of outcome assessment (detection bias) Hospital readmissions (all‐cause) | Low risk | A single pharmacist was responsible for the implementation of the programme and the assessment of results, which might have led to observer bias. However, it is unlikely that it would affect hospital readmissions. |
Blinding of outcome assessment (detection bias) Hospital emergency department contacts (all‐cause) | Low risk | A single pharmacist was responsible for the implementation of the programme and the assessment of results, which might have led to observer bias. However, it is unlikely that it would affect hospital emergency department contacts. |
Incomplete outcome data (attrition bias) Mortality (all‐cause) | Low risk | States none lost to follow‐up. |
Incomplete outcome data (attrition bias) Hospital readmissions (all‐cause) | Low risk | States none lost to follow‐up. |
Incomplete outcome data (attrition bias) Hospital emergency department contacts (all‐cause) | Low risk | States none lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Average cost of hospital stay is an outcome according to the clinical trial registration, but not reported or mentioned in the publication. However, as reported results are negative and cost‐effectiveness analyses are often published as secondary publication we therefore assessed the risk of selective reporting bias as low. |
Contamination bias | High risk | No cluster‐randomisation. |
Other bias | Low risk | No evidence of other types of bias. |