| Methods | Design: randomised and self‐controlled trial | |
| Participants | Baseline: 150 participants ‐ 102 female and 48 male; mean age of participants was 74.8 (SD 12.37) years Setting: patients who were hospitalised in the 2 orthopaedic units of a teaching hospital in northern Italy Country: Italy Injection site: left or right side of lower abdomen Injection protocol: needle gauge 27.5, 5/8 inch, syringe volume 0.4 mL, enoxaparin 4000 IU Inclusion criteria: received SC injection of LMWH, were monitored for at least 3 days after first injection Exclusion criteria: already received SC heparin injection; had haematological, cardiologic, or liver disease; were pregnant; were taking oral anticoagulant or antiaggregate drugs; had altered integrity of abdominal skin |
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| Interventions | Slow injection (30 seconds) vs fast injection of heparin (10 seconds) Time between 2 injections was 24 hr. |
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| Outcomes | Extent of injection site bruising was evaluated at 48 hr after each injection with a plastic ruler to measure maximum horizontal diameter of bruise recorded as mm | |
| Notes | Funding sources: not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was reported but how sequence was generated was not described. Quote: "the order of the treatment (A or B) was randomly selected." The CIS contacted trial authors to ask for information about randomisation method; trial authors stated that random sequence was generated by computer. |
| Allocation concealment (selection bias) | Unclear risk | Method not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel blinding was impossible in this trial. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The decision (treatment A, 10 seconds left hypochondrium; treatment B, 30 seconds right hypochondrium) was written in a paper and placed in an envelope and kept in a locked safe." Quote: "Nurses evaluating the bruising did not know which treatment had been performed on the left and right side of the abdomen. The data analysis was also performed in a blinded fashion. The envelope containing this information was opened after analysis was complete." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Trial authors reported no losses to follow‐up. |
| Selective reporting (reporting bias) | Low risk | All stated outcomes were reported. |
| Other bias | Low risk | No potential other bias was identified. |