Bieber 2006.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: not clear |
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Participants |
Care setting: specialized care and ambulatory care (Rheumatologic Outpatient Clinic of the University of Heidelberg); Germany
Health professionals: 10; internal medicine; fully trained Patients: 149; fibromyalgia syndrome; male and female |
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Interventions |
Multifaceted intervention: educational meeting with physician (18 hours); patient‐mediated intervention (computer‐based visualized information tool). The computer‐based tool provided information on fibromyalgia syndrome, combining textual information with diagrams and short video sequences. The educational meeting involved training physicians to improve patient‐centered communication and interaction skills. Single intervention (control): patient‐mediated intervention (computer‐based visualized information tool) The tool was the same as the multifaceted intervention. |
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Outcomes | Doctor‐patient interaction, from the patient perspective, using the QQPPI (Questionnaire on the Quality of Physician‐Patient Interaction) (continuous); joint process between healthcare professionals and patients to make decisions. | |
Notes |
Additional information Number of approached patients (eligible): not reported Number of patients per physician: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: patients were randomized but the method was unspecified. |
Allocation concealment (selection bias) | Unclear risk | Comment: not specified in the paper. |
Blinding (performance bias and detection bias) Participant‐reported outcome | Low risk | Quote: "Patients were informed on the intervention but they were blinded to the fact in which group they were being treated." Page 359 |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Unclear risk | Comment: 64/149 (43%) patients were excluded after randomization (did not meet inclusion criteria, refused to complete questionnaire); Information about missing data in our primary outcome were lacking. |
Selective reporting (reporting bias) | Unclear risk | Comment: no evidence that outcomes were selectively reported, but no protocol. |
Other bias | Low risk | Comment: no evidence of other risk of biases. |
Baseline measurement? Participant‐reported outcome | Unclear risk | Comment: baseline measurements for the FAPI are not reported, nor were they measured. |
Protection against contamination? | High risk | Comment: it was the patients who were randomized in an university outpatient setting. |
Baseline characteristics patients | Low risk | Quote: "All three patient group were comparable as to socio‐economic (see Table 1) and health related variables (see Table 3)." page 359 |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no report of characteristics. |