After agreeing to participate (documented by signing an Institutional Review Board IRBB) approved consent form), patients originally using TPM in monotherapy were randomized to also receive NTP or placebo at a 1 1 ratio, using random number generation trough a software.
To compare socio-demographic data and organisational features of the different subgroups (participating documenting GPs, non-participating GPs, and GPs who dropped-out (Table 1)), we used exact tests (chi test, Fisher test, median test) due to the small sample sizes of the subgroups.
Comparing the descriptive data of the participating documenting (Table 1, column 3) and non-participating GPs (Table 1, column 5/6) there were no significant and visible differences regarding type of practice and estimated number of home visits.
Potential participants who meet eligibility criteria and successfully pass the pre-screening will receive a letter inviting them to participate, a document requesting authorisation to contact their physician for clearance to participate, an informed consent document (including an additional copy for their personal records), and a self-addressed stamped envelope to return these documents.
Reasons for declining to participate were documented.
The number of women who were excluded and the proportion who consented to participate was documented to determine study uptake.
The numbers consenting to participate were documented in writing, for each of the facilities involved in the implementation project.
Exclusion criteria were unwillingness to participate, chronic documented gastrointestinal disease, cognitive-developmental delay or major dissociative disorder as determined by history as the latter two are contraindications for doing guided imagery.
Participating programs document all CR outpatients using standardized data definitions.
"Given that the EU does not recognise the illegal annexation … legal persons established in the Autonomous Republic of Crimea or the city of Sevastopol are not eligible to participate," says the document.
