Читать книгу Randomised Clinical Trials - David Machin - Страница 25

Meyer, Warnke, Bender and Mülhauser (2003) conducted a trial involving 942 residents from 49 nursing homes. In this cluster trial design, the nursing homes contain ‘clusters’ of residents and the homes (not the individual residents) were randomised, with 25 homes, comprising a total of 459 residents, assigned to the intervention group and 24, with 483 residents, to the usual care (control) group. The intervention comprised a single education session for nursing staff, who then educated residents, and the provision of three hip protectors per resident. The control clusters administered usual care optimised by brief information to nursing staff about hip protectors and the provision of two hip protectors per cluster for demonstration purposes. The main outcome measure was the incidence of hip fractures. There were 21 hip fractures in 21 (4.6%) residents in the intervention group and 42 in 39 (8.1%) residents in the control group – a difference of 3.5% (95% CI 0.3–7.3%, p‐value = 0.072). The authors concluded:

The introduction of a structured education programme and the provision of free hip protectors in nursing homes may reduce the number of hip fractures.

Key features include the following:

 Design: Multicluster, randomised,

 Size: 49 nursing homes comprising 942 residents with high risk of falling,

 Endpoint: Hip fractures,

 Analysis: Chi‐squared test adjusted for cluster randomisation,

 Conclusion: A structured education programme and the provision of hip protectors may reduce the number of hip fractures.