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. 2017 Nov 1;2017(11):CD008077. doi: 10.1002/14651858.CD008077.pub5
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
Interventions Slow injection (30 seconds) vs fast injection of heparin (10 seconds)
Time between 2 injections was 24 hr.
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.