Patient managed clinical trial

Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

“…A pilot showed that doing a trial on HT in Finland was unlikely to succeed due to women's and physicians' strong preferences to HT [ 5 ], and it was decided to carry out the trial (EPHT trial) in Estonia. Originally we had planned to do our trial in close co-operation with WISDOM.…”

“…Previous studies of the process of preventive trials have mainly concentrated on the recruitment process [ 1 , 3 - 5 ], failures in recruitment [ 6 ], the non-medical intervention effect on compliance [ 7 , 8 ], and randomization [ 9 ]. Oakley et al [ 1 , 2 ] have reported a trial process on social support in motherhood and on peer-led sex education.…”

“…In a trial on the delivery of very low birth weight infants, Lumley et al [ 9 ] failed to achieve randomization because of a critical shift in obstetric practice. In Finland the pilot for a non-blind, patient-managed trial on hormone therapy (HT) revealed several obstacles to the main trial, including the difficulty to discontinue HT and a negative attitude among Finnish physicians towards the trial [ 5 ].…”

Factors associated with the difference in score between women's and doctors' decisional conflict about hormone therapy: a multilevel regression analysis

“…Women expect that HT will improve their sense of general well‐being and their capacity to fulfil their social roles 11,12 . In contrast, even with the existence of conflicting evidences about HT long‐term benefits, doctors are more likely to believe in its benefits 13,14 and to find that women use HT for a shorter period of time than they recommend 15 . It is in this context that menopausal women are said to be dissatisfied with the medical profession 16 …”