Rasmussen 2006.
Methods | RCT, assessor blinded, venography. | |
Participants | Patients undergoing major abdominal surgery for either malignant or benign diseases. | |
Interventions | LMWH (dalteparin 5000 IU, total treatment period 28 days) or no treatment. | |
Outcomes | LMWH 165 Control 178 | |
Notes | Follow‐up period 3 months. Complete follow‐up. All patients were scheduled for bilateral venography. Adequate definitions of VTE and bleeding complications were described in the paper. Venography performed on day 28. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation list. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Open‐label study with assessor‐blinded evaluation of the venograms. Patients, healthcare providers and data‐analysts were not blinded. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Forty‐four (19.8%) patients in control group and 40 (19.5%) patients in experimental group excluded. |
Selective reporting (reporting bias) | Unclear risk | Modified intention‐to‐treat analysis of patients reaching an evaluable VTE end point (venogram or objection verification of symptomatic VTE). |
Other bias | Low risk | The study appears to be free of other sources of bias. |