Fullen 1973.
| Methods | Study design: A single centre study. Country: United States. Follow up was adequate. |
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| Participants | Number: 129 participants with proximal femoral fractures. Age: Average age 69 and 67 years (filter and control group respectively). Sex: Gender distribution not stated. Inclusion criteria: Proximal femoral fractures were invited to participate in the study. Exclusion criteria: Refusal to participate in the trial. |
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| Interventions | Treatment: Permanent caval filter. Control: No filter. |
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| Outcomes | Primary outcomes. 1. Mortality. 2. Pulmonary embolism. Secondary outcomes. 1. Complications from filter insertion. Outcomes assessed when clinically indicated and at discharge. |
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| Notes | Jadad score 2/5. Anticoagulation was not used in either the intervention (filter) or control arm. Not an intention to treat analysis. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | High risk | Randomisation based on odd or even hospital number. |
| Allocation concealment? | High risk | Open study design; participation in filter group based on consent. |
| Blinding? Mortality | High risk | Open study design; blinding of outcome assessors not stated. |
| Blinding? Pulmonary embolism | High risk | Open study design; blinding of outcome assessors not stated. |
| Incomplete outcome data addressed? Mortality | Low risk | Cause of death and numbers reported. Follow‐up complete as in‐hospital population. |
| Incomplete outcome data addressed? Pulmonary embolism | Low risk | Definite, probable and possible pulmonary embolism rates reported. Blinding of outcome assessors not stated. Use of chest radiography in diagnosis of PE is inaccurate. Not stated whether all patients had routine imaging, or only when clinically indicated. |
| Free of selective reporting? | Unclear risk | Protocol brief. Mortality, PE and filter complication outcomes documented. Rates of DVT not reported. |