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Participants (N=252, average age=82) were randomly allocated to a control (patient satisfaction questionnaire) or intervention (healthy living booklet) group.
These improvements in breast cancer awareness were sustained at 12 months although were somewhat less marked (24% of the interaction plus booklet group and 12% of the booklet only group compared with 4% of the usual care group).
For example, if an interim analysis demonstrates a significant beneficial effect of rehabilitation (based on the pre-specified stopping rules), then both the non rehab groups i.e. no rehab no book, book only will be stopped and the remaining trial population will be randomised to either the rehabilitation only or rehabilitation and booklet group.
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Testing for booklet effects revealed no significant differences between the booklet groups.
Those allocated to either the booklet-only group or the rehabilitation-plus-booklet group, will get the "Your back operation" on discharge (see details below).
Interventions included an information session, program booklets, group-based financial incentives and access to a free online weight loss program.
The patients were randomised to receive either six sessions of an arthritis self management programme plus an education booklet (intervention group) or the education booklet alone (control group).
Interventions Randomisation to either six sessions of an arthritis self management programme plus an education booklet (intervention group) or the education booklet alone (standard care control group).
There could be only one booklet per group.
Lack of adherence in the booklet only group was most commonly explained by fear of its inducing dizziness symptoms.
Group 2 – advice to rest the arm; or Participants randomised to receive advice to rest the arm received a leaflet similar in length, design and appearance to the booklet for Group 1.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com