3. Medication adherence in the trials.
Trial | Adherence definition | Assessment method | HR arm | Placebo arm |
DOPS 2012 | Not reported | |||
EAGAR 2006 | % study medication taken |
Pill counts | > 80% up to 30 months of treatment | > 80% up to 30 months of treatment |
EPAT 2001 | % study medication taken |
Pill counts | Level of adherence 95% (87% of participants evaluated) | Level of adherence 92% (92% of participants evaluated) |
EPHT 2006 | > 80% of prescribed treatment taken |
Number of collected/returned drugs and clinic reports |
< 40% compliant at three years (estimated from graph) | < 30% compliant at three years (estimated from graph) |
ERA 2000 | % study medication taken |
Pill counts | Level of adherence at 3.2 years: Women on single therapy (measured in 79% of participants): 74%; women on combination therapy (measured in 82% of participants): 84% |
Level of adherence at 3.2 years: (measured in 80% of participants): 86% 5 women initiated treatment outside study |
ERT II 1979 | Not reported | |||
ESPRIT 2002 | “Regular tablet use” | Self report to family doctor. Self report to study nurse at six weeks and whenever in contact with trial staff |
Number non‐adherent: 51% at 12 months 57% at 24 months |
Number non‐adherent: 31% at 12 months 37% at 24 months |
EVTET 2000 | Not reported | |||
STOP IT 2001 | Not defined | Pill counts | 65% at 36 months in those taking HRT 62% at 36 months in those taking HRT + calcitriol |
78% at 36 months |
Greenspan 2005 | ≥ 80% of the medication ≥ 80% of the study period | Not reported | 61% | 67% |
HALL 1998 | Not reported |
|||
HERS I 1998 | Taking at least 80% of study medication |
Pill counts | 82% adherent at one year; 75% adherent at three years 3% initiated treatment outside study About 50% continued to use open‐label HT during unblinded follow‐up (4.2 to 6.8 years) |
91% adherent at one year; 81% adherent at three years Under 10% used HRT during unblinded follow‐up (4.2 to 6.8 years) |
WAVE 2002 | % study medication taken |
Pill counts | At 2.8 years: Adherence 67% in the 78% of women analysed |
At 2.8 years: Adherence 70% in the 81% of women analysed |
WELL‐HART 2003 | % study medication taken |
Pill counts | Oestrogen group: 92.6% with oestrogen and 99.9% with progestin matched placebo Oestrogen‐Progestin group: 94.1% with oestrogen and 96.1% with progestin |
93.6% with oestrogen matched placebo and 98.4% with progestin matched placebo |
WEST 2001 | % study medication taken |
Self report to study nurse three‐monthly Computer chip in medication bottle records opening date and time Pill counts |
At 2.8 years: Mean adherence including drop‐outs: 70% Mean adherence excluding dropouts: 90% 35% discontinued medication by 2.8 years, of whom 1% initiated treatment outside study |
At 2.8 years: Mean adherence including dropouts: 74% over 2.8 years Mean adherence excluding dropouts: 90% 24% discontinued medication 2% initiated treatment outside study |
WHI I 2002 | Taking at least 80% of study medication Temporary discontinuation (e.g. during surgery) permitted |
Weighing medication bottles | 42% non‐adherent by 5.2 years Of these 6.2% initiated HRT outside study |
38% non‐adherent by 5.2 years Of these 10.7% initiated HRT outside study |
WHI II 2004 | Taking at least 80% of study medication Temporary discontinuation (e.g. during surgery) permitted |
Weighing medication bottles | At 6.8 years, about 53.8% of women were non‐adherent In addition 5.7% of women had initiated hormone use through their own physician |
At 6.8 years, about 53.8% of women were non‐adherent In addition 9.1% of women had initiated hormone use through their own physician |
WHISP 2006 | Not specified | Not specified | 25 out of 49 discontinued study drug (51%) | 14 out of 51 discontinued study drug (27%) |
WISDOM 2007 | Supply of study medication |
Time at risk minus temporary interruptions and time after withdrawal from treatment | 73% of time | 86% of time |
HRT: hormone replacement therapy