Verret 2012.
Methods | Randomised trial | |
Participants | 114 participants (intervention 58: control 56) Specialised anticoagulation clinic of the Montreal Heart Institute Montreal, Canada Year of study: November 2009 to May 2010. |
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Interventions | Self‐management of anticoagulation control versus standard care as control Instruction on self‐management Patients randomised to the self‐management group immediately received training on the use of an automated device and the self‐management algorithm developed by the investigators. This included instructions on the frequency of International Normalised Ratio (INR) monitoring, specific recommendations on what to do in the case of high or low INR, how and when to communicate with the pharmacists in the self‐management programme, how to use the device, and the patient’s responsibility in the programme. The session concluded with clinical scenarios, during which patients had to apply their knowledge. They returned 1 week later to validate their use of the device and the algorithm. Patients who had difficulty using the device or algorithm at the second visit were invited to an additional second or third visit. If difficulties persisted, the patient was not allowed to undergo self‐management. On a weekly basis, patients in the self‐management group monitored their INR and adjusted their dose of warfarin according to the algorithm. Through a voicemail message, patients were required to communicate their INR result and any adjustment performed. The patient was contacted if no telephone call was received on the expected day, or if an error in management occurred. If the INR was outside the algorithm limits, the dose was adjusted by the pharmacist. Number of Interventions: 2 ‐ 3 visits over 2 ‐ 3 weeks, then weekly telephone communication Duration: 4 months |
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Outcomes | Adverse events, Quality of Life (QoL) ‐ general treatment satisfaction | |
Notes | Funding source: Dr. de Denus was supported by the Fonds de la Recherche en Sante du Quebec and the Universite de Montreal Beaulieu‐Saucier Chair in Pharmacogenomics. The Coaguchek XS devices and CoaguChek XS PT test strips were provided by Roche Diagnostics Canada. Conflict of interest: Dr. de Denus was supported by the Fonds de la Recherche en Sante du Quebec and the Universite de Montre al Beaulieu‐Saucier Chair in Pharmacogenomics. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation list was generated by using permuted random blocks of sizes 4 and 6. This list was generated by the Montreal Heart Institute Co‐ordinating Center Biostatistics Department using statistical software. |
Allocation concealment (selection bias) | Low risk | Patients were then randomised to continue their management at the anticoagulation clinic (control group) or to switch to self‐management (self‐management group). Patients randomised to the control group received no further training. |
Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Low risk | Intervention group received training on use of a device that the control group did not receive. |
Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | High risk | No objective outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | Low risk | None |