Limitations of this pilot feasibility study include the enrolment of patients via convenience sampling, and differences in the logistics of the chart review process between the two sites.
Persistent GWs were defined as GWs present in the same anatomical site for at least two consecutive visits, which could include the enrolment visit.
Limitations of this pilot study include the enrolment of patients via convenience sampling, the fact that patient outcomes were not monitored beyond hospital discharge and that a risk/benefit analysis was not included in the study design.
Recurrent BV (RBV) was defined as incident BV (as described above) following a positive BV result obtained at a previous visit (including the enrolment visit).
Recent investigations from the National Coffee Information Organization showed that in the period 1982 2009, which includes the enrolment period of the NOWAC Study, 90% of Norwegians aged over 40 years had an average coffee consumption of 4 5 cups/day [ 21].
At each follow-up visit, study staff assess participants in an objective manner according to a clinical record form and assessment for adverse events is conducted in a prospective, systematic fashion during all visits, including the enrolment visit (eg, vomiting post-AL).
The present analysis involved trial participants who, during follow-up (including the enrolment visit), had at least one BV episode, followed by: an "effective BV treatment" and at least one subsequent visit at which a Nugent test was performed or; a visit at which a negative BV result was obtained.
In view of the recent publication of the open label Vertos II trial, 17 we extended our analysis to include the specific enrolment criteria, pain of recent onset (≤6 weeks) and pain score of 5 or more, from that trial, and again were unable to show a treatment benefit for vertebroplasty (data not shown).
The methodology of the MDP feasibility study, including the structured enrolment interviews, has been detailed previously [ 27], as has the methodology for the coital diary study [ 22].
In this situation, the research midwife (RM) will ensure that all base line data including the mandatory enrolment data is collected whilst visiting the participant.
Specific measures to boost girls' enrolment include the prohibition of school fees of all kinds, the integration of education policies into national plans for poverty reduction, the inclusion of girls' education as an essential component of development efforts and increased international funding for education.
