Use of PROMIS Global-10 to measure changes in health-related quality of life among contraceptive initiators: A feasibility study.

OBJECTIVES

This study aimed to assess the feasibility of recruiting initiators of combined oral contraceptives (COC) or the levonorgestrel intrauterine device (LNG-IUD) and using Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 to compare the change in health-related quality of life (HRQOL) between baseline and 6 months.

STUDY

DESIGN

We recruited patients aged 18 to 45 years initiating COC or LNG-IUD at a single academic medical center. We also enrolled patients using a coitally dependent or no contraceptive method (hormonal contraception nonusers) for comparison. Participants completed PROMIS Global-10 at baseline and 6 months. PROMIS Global-10 measures physical and mental health quality of life, with higher scores indicating better health. We calculated the change in t scores from baseline to 6 months using appropriate nonparametric tests.

RESULTS

We enrolled 150 participants (50 per group) over a 12-month period. Of these, 39 (78%) COC, 44 (88%) LNG-IUD, and 43 (86%) hormonal contraception nonusers completed 6 months of follow-up. We did not observe a significant change in t-scores in paired-sample analyses (physical: median 0.0, interquartile range: -3.1, 3.8, p = 0.35; mental: median 0.1, interquartile range: -4.3, 4.7, p = 0.78) between baseline and 6 months for COC or LNG-IUD users. T scores were similar between the three groups at baseline (physical: p = 0.32; mental: p = 0.20) and 6 months (physical: p = 0.20; mental: p = 0.12).

CONCLUSIONS

In our setting, recruitment of COC or LNG-IUD initiators was slower than anticipated. We did not observe a difference in physical and mental HRQOL among patients initiating COC and LNG-IUD at 6 months compared to baseline, nor compared to patients not initiating hormonal contraception, using the PROMIS Global-10.

IMPLICATIONS: Using PROMIS Global-10 to measure HRQOL, we did not observe significant changes in HRQOL in the 6 months after starting LNG-IUDs or COC compared to baseline and to people not using hormonal contraception.