Continuous adaptation of conversation aids for uterine fibroids treatment options in a four-year multi-center implementation project.

BACKGROUND: Fibroids are non-cancerous uterine growths that can cause symptoms impacting quality of life. The breadth of treatment options allows for patient-centered preference. While conversation aids are known to facilitate shared decision making, the implementation of these aids for uterine fibroids treatments is limited. We aimed to develop two end-user-acceptable uterine fibroids conversation aids for an implementation project. Our second aim was to outline the adaptations that were made to the conversation aids as implementation occurred. METHODS: We used a multi-phase user-centered participatory approach to develop a text-based and picture-enhanced conversation aid for uterine fibroids. We conducted a focus group with project stakeholders and user-testing interviews with eligible individuals with symptomatic uterine fibroids. We analyzed the results of the user-testing interviews using Morville's Honeycomb framework. Spanish translations of the conversation aids occurred in parallel with the English iterations. We documented the continuous adaptations of the conversation aids that occurred during the project using an expanded framework for reporting adaptations and modifications to evidence-based interventions (FRAME). RESULTS: The first iteration of the conversation aids was developed in December 2018. Focus group participants (n = 6) appreciated the brevity of the tools and suggested changes to the bar graphs and illustrations used in the picture-enhanced version. User-testing with interview participants (n = 9) found that both conversation aids were satisfactory, with minor changes suggested. However, during implementation, significant changes were suggested by patients, other stakeholders, and participating clinicians when they reviewed the content. The most significant changes required the addition or deletion of information about treatment options as newer research was published or as novel interventions were introduced into clinical practice. CONCLUSIONS: This multi-year project revealed the necessity of continuously adapting the uterine fibroids conversation aids so they remain acceptable in an implementation and sustainability context. Therefore, it is important to seek regular user feedback and plan for the need to undertake updates and revisions to conversation aids if they are going to be acceptable for clinical use.

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol.

BACKGROUND: Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS: We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION: This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION: Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.

Risk-based screening for Chlamydia trachomatis and Neisseria gonorrhoeae prior to intrauterine device insertion.

OBJECTIVE: The objective was to compare three strategies for Chlamydia trachomatis and Neisseria gonorrhoeae screening prior to intrauterine device (IUD) insertion. STUDY DESIGN: This was a secondary analysis of the Contraceptive CHOICE Project. We measured the prevalence of C. trachomatis and/or N. gonorrhoeae at the time of IUD insertion. We then compared sensitivity, specificity, negative and positive predictive values, and likelihood ratios for three screening strategies for C. trachomatis and N. gonorrhoeae prior to IUD insertion: (a) "age-based" ­ age ≤25 years alone; (b) "age/partner-based" ­ age ≤25 and/or multiple sexual partners; and (c) "risk-based" ­ age ≤25, multiple sexual partners, inconsistent condom use and/or history of prior sexually transmitted infection (STI). RESULTS: Among 5087 IUD users, 140 (2.8%) tested positive for C. trachomatis, 16 (0.3%) tested positive for N. gonorrhoeae, and 6 (0.1%) were positive for both at the time of IUD insertion. The "risk-based" screening strategy had the highest sensitivity (99.3%) compared to "age-based" and "age/partner-based" screening (80.7% and 84.7%, respectively.) Only one (0.7%) woman with a chlamydia or gonorrhea infection would not have been screened using "risk-based" screening. CONCLUSION: A risk-based strategy to screen for C. trachomatis and N. gonorrhoeae prior to IUD insertion has higher sensitivity than screening based on age alone or age and multiple sexual partners. IMPLICATIONS: Using a risk-based screening strategy (age≤25, multiple sexual partners, inconsistent condom use and/or history of an STI) to determine who should be screened for C. trachomatis and N. gonorrhoeae prior to IUD insertion will miss very few cases of infection and obviates the need for universal screening.

Medical contraindications in women seeking combined hormonal contraception.

OBJECTIVE: The objective of the study was to evaluate the prevalence of medical contraindications in a large group of women seeking combined hormonal contraception (CHC). STUDY DESIGN: The Contraceptive CHOICE Project is a prospective cohort study designed to promote the use of long-acting reversible contraceptive methods to reduce unintended pregnancies in the St Louis region. During baseline enrollment, participants were asked about their desired methods of contraception and medical history. Potential medical contraindications were defined as self-reported history of hypertension, myocardial infarction, cerebral vascular accidents, migraines with aura, any migraine and age 35 years or older, smoking in women older than 35 years, venous thromboembolism, or liver disease. We reviewed all research charts of women with self-reported medical contraindications to verify all conditions. Binomial 95% confidence intervals (CIs) were calculated around percentages. RESULTS: Between August 2007 and December 2009, 5087 women who enrolled in the CHOICE Project provided information about their medical history and 1010 women (19.9%) desired CHC at baseline. Seventy women (6.93%; 95% CI, 5.44-8.68%) were defined as having a potential medical contraindication to CHC at baseline. After chart review, only 24 of 1010 participants desiring CHC (2.38%; 95% CI, 1.53-3.52%) were found to have true medical contraindications to CHC including 17 with hypertension, 2 with migraines with aura, 2 with a history of venous thromboembolism, and 3 smokers aged 35 years or older. CONCLUSION: The prevalence of medical contraindications to CHC was very low in this large sample of reproductive-aged women. This low prevalence supports provision of CHC without a prescription.

The Human Microbiome Project strategy for comprehensive sampling of the human microbiome and why it matters.

The Human Microbiome Project used rigorous good clinical practice standards to complete comprehensive body site sampling in healthy 18- to 40-yr-old adults, creating an unparalleled reference set of microbiome specimens. To ensure that specimens represented minimally perturbed microbiomes, we first screened potential participants using exclusion criteria based on health history, including the presence of systemic diseases (e.g., hypertension, cancer, or immunodeficiency or autoimmune disorders), use of potential immunomodulators, and recent use of antibiotics or probiotics. Subsequent physical examinations excluded individuals based on body mass index (BMI), cutaneous lesions, and oral health. We screened 554 individuals to enroll 300 (149 men and 151 women, mean age 26 yr, mean BMI 24 kg/m, 20.0% racial minority, and 10.7% Hispanic). We obtained specimens from the oral cavity, nares, skin, gastrointestinal tract, and vagina (15 specimens from men and 18 from women). The study evaluated longitudinal changes in an individual's microbiome by sampling 279 participants twice (mean 212 d after the first sampling; range 30-359 d) and 100 individuals 3 times (mean 72 d after the second sampling; range 30-224 d). This sampling strategy yielded 11,174 primary specimens, from which 12,479 DNA samples were submitted to 4 centers for metagenomic sequencing. Our clinical design and well-defined reference cohort has laid a foundation for microbiome research.

Predictors of male partner treatment for sexually transmitted infection.

BACKGROUND: Patient-initiated notification is a commonly used practice for notifying sex partners of possible exposure to a sexually transmitted infection (STI); however, 46% to 75% of partners are never treated. The Contraceptive CHOICE Project (CHOICE) is a longitudinal cohort study of women that provides no-cost contraception, STI testing, treatment to participants, and free partner treatment. Our objective was to evaluate characteristics of women who tested positive for chlamydia, gonorrhea, or trichomoniasis, and their association with successful partner treatment. METHODS: We analyzed baseline survey and STI testing, notification, and treatment data from the first 5087 participants enrolled in CHOICE. We considered "treated partners" to be men who received antibiotic treatment at the study clinic or by a prescription through the study. Independent predictors of successful partner treatment were identified using univariate analysis and multivariable analysis using Poisson regression with robust error variance. RESULTS: Forty-four percent of male partners were successfully treated. Women whose partners were less likely to obtain treatment were black (adjusted Relative Risk (RR adj) RR adj = 0.6; 95% confidence interval [CI]: 0.5-0.8) or reported some concern about future STI with the partner (RR adj = 0.6; 95% CI: 0.4, 0.8). Women whose partners were more likely to receive treatment were living with their partner (RR adj = 1.4; 95% CI: 1.1-1.8) or reported recent inconsistent condom use (RR adj = 1.5; 95% CI: 1.1-2.1). CONCLUSIONS: The male partner treatment rate resulting from female patient-initiated partner notification in our study was low. Our findings highlight the need to develop novel notification interventions that yield higher partner treatment rates and consider patient-specific factors, such as race and relationship status.

Risk of bacterial vaginosis in users of the intrauterine device: a longitudinal study.

BACKGROUND: Users of the intrauterine device (IUD) may be at increased risk for bacterial vaginosis (BV). Our objective was to compare the incidence of BV in women using the IUD with women using combined oral contraceptives (COC), the contraceptive vaginal ring, and the contraceptive patch. METHODS: We prospectively recruited women negative for BV at baseline. Monthly, for 6 months, participants returned a self-obtained vaginal smear for Gram stain by mail. BV was diagnosed by a Nugent score ≥7. We performed Cox proportional hazards regression to investigate associations between demographic and behavioral characteristics, contraceptive method, and incident BV. RESULTS: We enrolled 153 women negative for BV at baseline; 90 (59%) women who chose the IUD and 63 (41%) who chose COC, ring, or patch. There were 35 women with BV at one or more time points. The incidence of BV was 37.0% among IUD users and 19.3% in COC, ring, and patch users (P = 0.03). In the univariate analysis, race, IUD use, intermediate flora, and irregular vaginal bleeding were significantly associated with BV. In the adjusted model, IUD users were no more likely to acquire BV (hazards ratio [HRadj]: 1.28, 95% confidence interval [CI]: 0.53-3.06) than COC, ring, and patch users. The associations between intermediate flora and irregular bleeding and BV remained significant (HRadj: 3.30, 95% CI: 1.51-7.21, and HRadj: 2.54, 95% CI: 1.03-6.24, respectively). CONCLUSIONS: The association between IUD use and BV appears to be mediated by irregular vaginal bleeding. Intermediate flora is associated with an increased incidence of BV.

Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system. STUDY DESIGN: We conducted a randomized controlled trial of naproxen, estradiol, or placebo that was administered over the first 12 weeks of levonorgestrel-releasing intrauterine system use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis. RESULTS: There were 129 women who were assigned randomly to naproxen (n = 42 women), estradiol (n = 44 women), or placebo (n = 43 women). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared with placebo (42.9% vs 16.3%; P = .03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (adjusted relative risk, 0.90; 95% confidence interval, 0.84-0.97) compared with placebo. More frequent bleeding and spotting was observed in the estradiol group (adjusted relative risk, 1.25; 95% confidence interval, 1.17-1.34). CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.

Women's knowledge about intrauterine contraception.

OBJECTIVES: To survey knowledge and attitudes about intrauterine contraception among reproductive-aged women in the area of Saint Louis, Missouri. METHODS: We mailed an eight-page written survey to 12,500 randomly selected households in the St. Louis area that asked English-literate, reproductive-aged, adult women to respond. The survey asked about obstetric and contraceptive history and effectiveness of contraceptive methods, as well as appropriate candidates for, side effects of, and perceived risks of intrauterine contraception. The results from 1,665 (13.3%) returned surveys were weighted for the analysis, which included descriptive statistics and polynomial logistic regression. RESULTS: Almost 8% of respondents were currently using or had previously used intrauterine contraception, and use was higher in women who reported discussing the method with their health care provider (adjusted odds ratio [OR] 13.4, 95% confidence interval [CI] 6.5-27.8). Sixty-one percent of respondents underestimated the effectiveness of intrauterine contraception, and up to one half of survey respondents were unable to correctly answer knowledge questions about intrauterine contraception use and safety. An additional 11%-36% of respondents indicated concern that intrauterine contraception is associated with complications such as infection, infertility, and cancer. Current and past intrauterine contraception users were more likely to be knowledgeable about intrauterine contraception. Women who were currently using intrauterine contraception were more likely to correctly estimate the effectiveness of intrauterine contraception (adjusted OR 7.6, 95% CI 3.2-18.0). CONCLUSION: Reproductive-aged women's specific knowledge of the benefits and risks of intrauterine contraception is limited. More educational interventions are needed to increase women's knowledge about the effectiveness and benefits of intrauterine contraception. LEVEL OF EVIDENCE: II.