The estimates also assumed that secretarial and administrative staff costs for the novel and standard service models were approximately equal, with the support for additional clinics in the novel service being offset by that for obtaining family history forms from all patients and the higher nonattendance rate in the standard service.
Testing can be done directly from self-collected vaginal specimens, thus removing the need for an additional clinic visit to obtain a specimen for cytology or p16 testing, which requires well-preserved cells.
Participants returned annually for nine additional clinic visits and were also contacted by telephone every 6 months.
Costs incurred either in the process of switching or as a consequence of switching are thus likely to include those for administration, additional clinic visits, extra laboratory tests and possibly hospitalization due to the patient's condition not being adequately controlled by the substituted drug (e.g. for cardiovascular events associated with suboptimal blood pressure control [ 17]).
Of the 60 patients not known to be certified, 57 were invited for an additional clinic or screening appointment to determine their certification eligibility and status due to prior failed attendance (n = 19), unavailability of notes (n = 25), awaiting intervention (n = 3) e.g. cataract surgery, or due to being initially identified as certifiable but not certified (n = 10).
However if the patient's follow-up visit does not coincide with the day that specimens are collected, this necessitates an additional clinic visit for the patient.
Other ethical issues include contraception for all women of childbearing age during the course of the trial and additional clinic visits required for baseline assessments and dose titration (limited to only 40 and 80 mg arms).
No treatment algorithm was provided for study purposes, nor were any additional clinic visits or laboratory/diagnostic tests conducted.
For commercial trials, considerable extra costs were incurred by additional clinic visits and imaging investigations.
Additional clinic information is found in Table 2. Costs for performing vasectomies varied greatly from country to country and at different clinics within one country.
