El Miedany 2011.
Methods | Randomized controlled trial | |
Participants | The study location was not available 55 participants were randomized to the intervention group and 56 participants were randomized to the control group The inclusion criteria were to have early inflammatory arthritis according to the new ACR/EULAR criteria |
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Interventions | Intervention: VISUAL FEEDBACK
The active group consisted of a visual feedback facility (visualization of computer charts showing the disease progression) that was added to their management protocol. Visual feedback is a relatively new tool that enables the patient to visualize as well as monitor a real‐time change of their disease activity parameters as well as the patient's reported outcome measures. Integrating electronic data recording in the standard rheumatology clinical practice facilitated the introduction of visual feedback into the standard rheumatology practice. During their visit, the patients were given the chance to view the progression of their disease on the computer, discuss the changes in their disease activity parameters, comorbidity risks, functional disability, and quality of life. The patients were assessed at 3‐month intervals for another 6 months (unless they sustained a flare up of their condition, at which time they would be reviewed earlier). Before every assessment in the clinic, every patient completed the multidimensional patient reported outcome measures questionnaire Control: ROUTINE MANAGEMENT Control group patients continued their routine standard management and assessment every 3 months. All the patient's disease activity parameters, patient‐reported outcome measures (PROMs), medications, scores of falls, and cardiovascular risks were recorded and discussed verbally with the patient. Each patient was allowed to view his former completed forms and compare between his/her current scores in comparison to the earlier records |
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Outcomes | The measures of adherence were measured using the Electronic Recording of Outcome Measures for Inflammatory arthritis and Ankylosing spondylitis ‐ EROMIA. Using this system, medication intake could be recorded and downloaded when needed. Adherence to drug therapy was monitored every month for a 6‐month period and then every 3 months for another 6 months. The patient outcomes were disease activity score (DAS‐28) and PROMS domains: pain score, patient global assessment, functional disability, and quality of life |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information given in article. This was a double‐blind, randomized controlled study, which included 111 patients diagnosed to have early inflammatory arthritis according to the new ACR/EULAR criteria |
Allocation concealment (selection bias) | Unclear risk | No information given in article. This was a double‐blind, randomized controlled study, which included 111 patients diagnosed to have early inflammatory arthritis according to the new ACR/EULAR criteria |
Selective reporting (reporting bias) | High risk | No protocol available |
Other bias | Unclear risk | Did not report any limitations in the manuscript, but there is a lot of missing information in the study, such as percentage of participants who were retained in the study, the randomization details etc., so more information is needed |
Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) EROMIA ‐ This was a double‐blinded study (pg 3061) |
Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) DISEASE ACTIVITY SCORE (DAS‐28) AND PROMS DOMAINS ‐ Double‐blind, randomized controlled study (pg 3061) |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) EROMIA ‐ This was a double‐blinded study (pg 3061) |
Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) DISEASE ACTIVITY SCORE (DAS‐28) AND PROMS DOMAINS ‐ Not enough information in article to judge |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) EROMIA ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk' |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) DISEASE ACTIVITY SCORE (DAS‐28) AND PROMS DOMAINS ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) EROMIA ‐ Refer to Table 1: total number of participants who stopped the medication in active group is 4 and in control group is 17. Reasons for stopping are intolerance and side effects. Based on the data in Table 1, it seems that there is a large imbalance between control and active groups, but it is not clear whether there are more missing data due to other reasons |
Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) DISEASE ACTIVITY SCORE (DAS‐28) AND PROMS DOMAINS ‐ Refer to Table 1: total number of participants who stopped the medication in the active group is 4 and in the control group is 17. Reasons for stopping are intolerance and side effects. Based on the data in Table 1, it seems that there is a large imbalance between the control and active groups, but it is not clear whether there are more missing data due to other reasons |