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

Abstract

Objective: To assess the feasibility of recruiting initiators of combined oral contraceptives (COC) or the levonorgestrel intrauterine device (LNG-IUD) and using PROMIS Global-10 to compare the change in health-related quality of life (HRQOL) between baseline and six months.

Study design: We recruited patients aged 18-45 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 [HC] non-users) for comparison. Participants completed PROMIS Global-10 at baseline and six 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 six months using appropriate non-parametric 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%) HC non-users completed six months of follow-up. We did not observe a significant change in t-scores in paired-sample analyses (physical: median 0.0, IQR: -3.1, 3.8, p=0.35; mental: median 0.1, IQR: -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 six months (physical: p=0.20; mental: p=0.12).

Conclusion: 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 six 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 health-related quality of life in the six months after starting LNG-IUDs or COC compared to baseline and to people not using hormonal contraception.