Katharine O’Connell White

Influence of depressed mood and psychological stress symptoms on perceived oral contraceptive side effects and discontinuation in young minority women

BACKGROUND We examined the influence of depressed mood and psychological stress on oral contraceptive (OC) side effects and discontinuation. STUDY DESIGN We administered standard psychological instruments to 354 young women (13-24 years old) beginning a 6-month OC continuation intervention trial and questions on OC side effects and use at 6 months. Logisitic regression determined the relationships between psychological conditions, perceived OC side effects and continuation rates. RESULTS Baseline depressed mood (21%) and stress (19%) and 6-month mood (25%) and weight changes (57%) were relatively common. Only 38% continued OCs at 6 months. Depressed mood [odds ratio (OR) 2.27, confidence interval (CI) 1.25-4.15, p=.007] and stress (OR 2.07, CI 1.12-3.82, p=.02) were associated with perceived OC-related moodiness; depressed mood was associated with perceived weight loss (OR 1.89, CI 1.01-3.55, p=.05). Depressed mood (OR 0.54, CI 0.29-0.99, p=.04), stress (OR 0.48, CI 0.25-0.91, p=.03) and perceived weight change (OR 0.60, CI 0.38-0.94, p=.03) all reduced the likelihood of OC continuation. CONCLUSION Young women with adverse psychological symptoms are at risk for perceived OC side effects and discontinuation.

Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate

OBJECTIVES To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (sc) depot medroxyprogesterone acetate (DMPA). STUDY DESIGN Women presenting to a family planning clinic to initiate, restart or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self- or clinician administered sc DMPA 104 mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months. RESULTS Two hundred fifty women were invited to participate, and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer sc DMPA. Eighty-seven percent completed follow-up. DMPA use at 1 year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at 1 year (p=0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants. CONCLUSIONS Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of sc DMPA is feasible and may be an attractive alternative for many women. IMPLICATIONS Self-administration of sc DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA.

IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial.

BackgroundPublicly reported performance on quality measures is intended to enable patients to make more informed choices. Despite the growing availability of these reports, patients’ use remains limited and disparities exist. Low health literacy and numeracy are two barriers that may contribute to these disparities. Patient navigators have helped patients overcome barriers such as these in other areas, such as cancer care and may prove useful for overcoming barriers to using publicly reported quality data.Methods/DesignThe goals of this study are: to determine the efficacy of a patient navigator intervention to assist low-income pregnant women in the use of publicly available information about quality of care when choosing a pediatrician; to evaluate the relative importance of factors influencing women’s choice of pediatric practices; to evaluate the effect of the intervention on patient engagement in management of their own and their child’s health care; and to assess variation in efficacy of the intervention for sub-groups based on parity, age, and race/ethnicity. English speaking women ages 16 to 50 attending a prenatal clinic at a large urban medical center will be randomized to receive an in-person navigator intervention or an informational pamphlet control between 20 to 34 weeks of gestation. The intervention will include in-person guided use of the Massachusetts Health Quality Partners website, which reports pediatric practices’ performance on quality measures and patient experience. The primary study outcomes will be the mean scores on a) clinical quality and b) patient experience measures.DiscussionSuccessful completion of the study aims will yield important new knowledge about the value of guided website navigation as a strategy to increase the impact of publicly reported quality data and to reduce disparities in use of these data.Trial registrationClinicalTrials.gov #NCT01784575

First trimester medication abortion practice in the United States and Canada

We conducted a cross-sectional survey of abortion facilities from professional networks in the United States (US, n = 703) and Canada (n = 94) to estimate the prevalence of medication abortion practices in these settings and to look at regional differences. Administrators responded to questions on gestational limits, while up to five clinicians per facility reported on 2012 medication abortion practice. At the time of fielding, mifepristone was not approved in Canada. 383 (54.5%) US and 78 (83.0%) Canadian facilities participated. In the US, 95.3% offered first trimester medication abortion compared to 25.6% in Canada. While 100% of providers were physicians in Canada, just under half (49.4%) were advanced practice clinicians in the US, which was more common in Eastern and Western states. All Canadian providers used misoprostol; 85.3% with methotrexate. 91.4% of US providers used 200 mg of mifepristone and 800 mcg of misoprostol, with 96.7% reporting home misoprostol administration. More than three-quarters of providers in both countries required an in-person follow-up visit, generally with ultrasound. 87.7% of US providers routinely prescribed antibiotics compared to 26.2% in Canada. Nonsteroidal anti-inflammatory drugs were the most commonly reported analgesic, with regional variation in opioid narcotic prescription. In conclusion, medication abortion practice follows evidence-based guidelines in the US and Canada. Efforts to update practice based on the latest evidence for reducing in-person visits and increasing provision by advanced practice clinicians could strengthen these services and reduce barriers to access. Research is needed on optimal antibiotic and analgesic use.

Patient Navigators and Parent Use of Quality Data: A Randomized Trial.

BACKGROUND: Consumers rarely use publicly reported health care quality data. Despite known barriers to use, few studies have explored the effectiveness of strategies to overcome barriers in vulnerable populations. METHODS: This randomized controlled trial tested the impact of a patient navigator intervention to increase consumer use of publicly reported quality data. Patients attending an urban prenatal clinic serving a vulnerable population enrolled between May 2013 and January 2015. The intervention consisted of 2 in-person sessions in which women learned about quality performance and viewed scores for local practices on the Massachusetts Health Quality Partners Web site. Women in both the intervention and control arms received a pamphlet about health care quality. Primary study outcomes were mean clinical quality and patient experience scores of the practices women selected (range 1–4 stars). RESULTS: Nearly all (726/746; 97.3%) women completed the study, 59.7% were Hispanic, and 65.1% had a high school education or less. In both unadjusted and adjusted models, women in the intervention group chose practices with modestly higher mean clinical quality (3.2 vs 3.0 stars; P = .001) and patient experience (3.0 vs 2.9 stars; P = .05) scores. When asked to rate what factors mattered the most in their decision, few cited quality scores. CONCLUSIONS: An intervention to reduce barriers to using publicly reported health care quality data had a modest effect on patient choice. These findings suggest that factors other than performance on common publicly reported quality metrics have a stronger influence on which pediatric practices women choose.

An exploratory analysis of associations between eating disordered symptoms, perceived weight changes, and oral contraceptive discontinuation among young minority women.

PURPOSE To explore associations between eating-disordered (ED) symptoms, perceived oral contraceptive (OC)-related weight changes, and OC discontinuation among young minority women. METHODS We conducted a prospective substudy of a randomized controlled trial evaluating the impact of a pill pack supply (3 vs. 7 months) on OC continuation among young urban women presenting to a university-affiliated community-based family planning clinic for OC management. Participants (n = 354) were adolescent (n = 173) and young adult (n = 181) women aged 13-24 years, predominantly underinsured and largely Hispanic (92%). We conducted a structured baseline interview that included an ED screening instrument. At the 6-month follow-up, we conducted a telephone interview to determine OC continuation and dimensions of perceived OC-related weight changes during the study period. RESULTS At baseline, 24% of the subjects fulfilled the moderate/severe ED symptom screen criteria (n = 60). By 6 months, 57% of the subjects (n = 200) reported weight changes and 62% (n = 218) had discontinued OC use. Unadjusted discontinuation rates were similar across age- and ED symptom groups. In multivariate analysis, both ED symptoms (odds ratio = .49, 95% confidence interval = .25-.96, p = .04) and perceived weight changes (odds ratio = .60, 95% confidence interval = .38-.94, p = .03) were negatively associated with OC continuation. CONCLUSIONS ED symptoms and perceived weight changes were associated with an increased likelihood of OC discontinuation among these young women. Reproductive health practitioners should consider psychological symptoms when managing OC.

The pharmacokinetics of 12-week continuous contraceptive patch use

OBJECTIVES We sought to assess the change in serum ethinyl estradiol (EE2) and norelgestromin (NGMN) levels over 12 weeks of continuous contraceptive patch use. STUDY DESIGN We asked participants (n=30) to apply consecutive patches to be worn continuously (without a patch-free interval) for 12 weeks. We collected blood samples at the end of each patch week and two times during weeks 4, 8, and 12 (with the additional blood draw occurring mid-week). Liquid chromatography-tandem triple quadrupole mass spectrometry (LC-MS/MS) was utilized to assess EE2 and NGMN levels. RESULTS Twenty-seven women completed the study; 26 were compliant with patch use. Ethinyl estradiol levels ranged from 0 to 193 pg/mL over the period. We observed an accumulation over the 12-week time at an estimated rate of 2.15 pg/mL per week (95% confidence interval 0.95-3.35, p<.001). The change in NGMN levels ranged from 0 to 2.52 ng/mL over the 12 weeks (95% confidence interval 0.021-0.019, p=.915). The most common side effects reported were vaginal spotting, breast tenderness and abdominal pain/cramping. There were no serious adverse events reported. CONCLUSION While the range of weekly EE2 values was quite wide, the absolute values remain low and generally within the expected range described in product labeling. Providers may consider prescribing continuous use of the patch, but given the slow accumulation of EE2 over time, 12 weeks should not be exceeded in the absence of safety data.