Cost-effectiveness analysis of expectant vs active management for treatment of persistent pregnancies of unknown location.

BACKGROUND: Persistent pregnancies of unknown location are defined by abnormally trending serum human chorionic gonadotropin with nondiagnostic ultrasound. There is no consensus on optimal management. OBJECTIVE: This study aimed to assess the cost-effectiveness of 3 primary management strategies for persistent pregnancies of unknown location: (1) expectant management, (2) empirical 2-dose methotrexate, and (3) uterine evacuation followed by methotrexate, if indicated. STUDY DESIGN: This was a prospective economic evaluation performed concurrently with the Expectant versus Active Management for Treatment of Persistent Pregnancies of Unknown Location multicenter randomized trial that was conducted from July 2014 to June 2019. Participants were randomized 1:1:1 to expectant management, 2-dose methotrexate, or uterine evacuation. The analysis was from the healthcare sector perspective with a 6-week time horizon after randomization. Costs were expressed in 2018 US dollars. Effectiveness was measured in quality-adjusted life years and the rate of salpingectomy. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were generated. Sensitivity analyses were performed to assess the robustness of the analysis. RESULTS: Methotrexate had the lowest mean cost ($875), followed by expectant management ($1085) and uterine evacuation ($1902) (P=.001). Expectant management had the highest mean quality-adjusted life years (0.1043), followed by methotrexate (0.1031) and uterine evacuation (0.0992) (P=.0001). The salpingectomy rate was higher for expectant management than for methotrexate (9.4% vs 1.2%, respectively; P=.02) and for expectant management than for uterine evacuation (9.4% vs 8.1%, respectively; P=.04). Uterine evacuation, with the highest costs and the lowest quality-adjusted life years, was dominated by both expectant management and methotrexate. In the base case analysis, expectant management was not cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year given an incremental cost-effectiveness ratio of $175,083 per quality-adjusted life year gained (95% confidence interval, -$1,666,825 to $2,676,375). Threshold analysis demonstrated that methotrexate administration would have to cost $214 (an increase of $16 or 8%) to favor expectant management. Moreover, expectant management would be favorable in lower-risk patient populations with rates of laparoscopic surgical management for ectopic pregnancy not exceeding 4% of pregnancies of unknown location. Based on the cost-effectiveness acceptability curves, the probability of expectant management being cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year gained was 50%. The results were dependent on the cost of surgical intervention and the expected rate of methotrexate failure. CONCLUSION: The management of pregnancies of unknown location with a 2-dose methotrexate protocol may be cost-effective compared with expectant management and uterine evacuation. Although uterine evacuation was dominated, expectant management vs methotrexate results were sensitive to modest changes in treatment costs of both methotrexate and surgical management.

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

BACKGROUND/AIMS: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. METHODS: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. RESULTS: While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. CONCLUSION: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health's goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

Evaluation of heparin induced thrombocytopenia using probability scores in a mechanical circulatory support population.

Patients on mechanical circulatory support (MCS) devices carry a high risk for thrombocytopenia and due to the routine use of heparin, heparin induced thrombocytopenia (HIT) is frequently suspected. HIT Expert Panel (HEP) and 4T scoring tools have been validated in the general medicine population to assess the probability of HIT diagnosis, however, these tests have not been validated for use in patients requiring MCS support. The objective of this study was to assess the association of 4T and HEP scores to available assess HIT diagnostic tests in patients requiring MCS. We conducted a retrospective review of patients requiring MCS who had heparin PF4 antibody optical density and/or serotonin release assay results reported. A 4T and HEP score at the time of heparin antibody ordering was calculated. Utilizing previously described ranges for HIT diagnostic tests, patients were categorized into two HIT probability categories: probable and not probable. Descriptive statistics were used for the 4T and HEP scores in both HIT probability categories and t-test and receiver operating characteristic (ROC) analysis were used to determine the association and agreement between each scoring tool and HIT probability. Eighty-five patients were identified who had HIT diagnostic tests ordered while on MCS; 7 patients were classified as HIT probable and 78 patients were classified as HIT not probable. Based on ROC analysis, 4T score and HEP score had an AUC of 0.88 (± 0.06) and 0.96 (± 0.02), respectively demonstrating high predictability of HIT. Utilizing sensitivity and specificity analysis through ROC curves, a cut off score of 3 for 4T score and 1 for HEP score was established. Based on our analysis, both 4T and HEP scores have high predictability of HIT in the mechanical circulatory support population.

Examining the Role of Twitter in Response and Recovery During and After Historic Flooding in South Carolina.

CONTEXT: Social media has played an increasing role in the response to emergency situations through information exchange and efforts to promote recovery. Understanding more about how social media users share and re-share information is particularly important to help emergency response entities determine best strategies for expanding reach and impact through social media in disseminating emergency messages. OBJECTIVE: This study examined the role and use of Twitter as a response and recovery strategy before, during, and after historic rainfall and flooding in the Midlands region of the greater Columbia, South Carolina, area in October 2015. DESIGN: A cross-sectional, thematic, and descriptive examination of Twitter data across 4 time periods (before the historic rainfall and flooding, during, immediately after a boil water advisory period, and 6 months later) was conducted. SETTING: Twitter posts containing "#SCFlood" with a focus on the Midlands region were extracted and analyzed. RESULTS: The most common themes of tweets across all 4 time periods were weather conditions, devastation description, resource distribution, volunteerism, actions to reduce threats to health, and appreciation. Tweets mostly originated from individual users, followed by media outlets, governmental agencies, and nonprofit agencies. Tweets from the first 3 time periods were largely focused on built and natural environment devastation and action to reduce threats to health, and tweets from the fourth time period were primarily focused on cleanup and repair. CONCLUSIONS: Twitter was utilized widely as a communication tool to provide time-sensitive and critical information before, during, and after the event. Ensuring that key social media users have developed disaster communication strategies inclusive of Twitter seems important in aiding response to and recovery from natural disasters.

Uncharted Waters: Communicating Health Risks During the 2014 West Virginia Water Crisis.

This study is among the first to examine how health risks are communicated through traditional and social media during a public health crisis. Using an innovative research approach, the study combined a content analysis with in-depth interviews to examine and understand how stakeholders involved in crisis response perceived media coverage after a chemical spill contaminated the drinking water of 300,000 West Virginia residents. A content analysis of print, television, and online media stories and tweets revealed that health risk information was largely absent from crisis coverage. Although traditional media stories were significantly more likely to include health information compared to tweets, public health sources were underutilized in traditional media coverage. Instead, traditional media favored the use of government sources outside the public health field, which stakeholders suggested was problematic because of a public distrust of officials and official information during the crisis. Results also indicated that Twitter was not a common or reliable source for health information but was important in the spread of other types of information. Ultimately, the study highlights a need for more deliberate media coverage of health risks and provides insight into how Twitter is used to spread crisis information.

How to minimize the dropout and crossover in an infertility trial?

Randomized controlled trials and intent-to-treat analyses are important for infertility clinical studies. Dropouts or crossovers during the study process will disrupt the randomization design and affect the intent-to-treat analysis. In this review, we have briefly introduced the occurrence of dropout and crossover from our previous Reproductive Medicine Network and other related studies and provided some experience obtained from these studies on how to minimize and reduce the occurrence of dropout and crossover for infertility randomized clinical studies.

Written and spoken narratives about health and cancer decision making: a novel application of photovoice.

Photovoice is a community-based participatory research method that researchers have used to identify and address individual and community health needs. We developed an abbreviated photovoice project to serve as a supplement to a National Cancer Institute-funded pilot study focusing on prostate cancer (PrCA) that was set in a faith-based African American community in South Carolina. We used photovoice for three reasons: (a) to enhance communication between study participants and researchers, (b) to empower African American men and women to examine their health decisions through photographs, and (c) to better understand how participants from this community make health-related decisions. The 15 individuals participating in the photovoice project were asked to photograph aspects of their community that informed their health-related decisions. Participants provided written and oral narratives to describe the images in a small sample of photographs. Four primary themes emerged in participants' photographs and narratives: (a) food choices, (b) physical activity practices, (c) community environment and access to care, and (d) influences of spirituality and nature on health. Although written and audio-recorded narratives were similar in content, the audio-recorded responses were more descriptive and emotional. Results suggest that incorporating audio-recorded narratives in community photovoice presentations may have a greater impact than written narratives on health promotion, decision making, and policy makers because of an increased level of detail and personalization. In conclusion, photovoice strengthened the parent study and empowered participants by making them more aware of factors influencing their health decisions.

Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.

Prostate cancer (PrCA) is the most commonly diagnosed non-skin cancer among men. PrCA mortality in African-American (AA) men in South Carolina is ~50% higher than for AAs in the U.S as a whole. AA men also have low rates of participation in cancer research. This paper describes partnership development and recruitment efforts of a Community-Academic-Clinical research team for a PrCA education intervention with AA men and women that was designed to address the discordance between high rates of PrCA mortality and limited participation in cancer research. Guided by Vesey's framework on recruitment and retention of minority groups in research, recruitment strategies were selected and implemented following multiple brainstorming sessions with partners having established community relationships. Based on findings from these sessions culturally appropriate strategies are recommended for recruiting AA men and women for PrCA education research. Community-based research recruitment challenges and lessons learned are presented.

Children's Attention and Self-Regulatory Behavior Before and During the COVID-19 Pandemic.

OBJECTIVE: The goal of this study was to investigate changes in children's self-regulatory behavior before and during the COVID-19 pandemic. METHOD: Participants were parents of children aged 4 to 13 years (n = 45, mean 7.5, SD: 2.6) who participated in the Baltimore Generations Study before the pandemic. They reported on their child's self-regulation (SR) using the Parent Observation of Child Adaptation. During the pandemic, they were recontacted to report on child SR, disruptions to family life (Coronavirus Impact Scale), and parenting stress (Parenting Stress Index). Prepandemic to pandemic changes in SR were compared with repeated measures analysis of variance. RESULTS: There were significant decreases in child SR (poorer concentration, attention, task engagement and persistence, and greater impulsivity) prepandemic to pandemic. During the pandemic, parenting stress was correlated with lower child SR (r range = -0.52 to -0.34, p < 0.05). Pandemic-related family disruptions were associated with changes in children's impulsivity (F [1, 42] = 5.28, p = 0.03); children with 4 or more disruptions (67%) showed less ability to wait their turn during the pandemic compared with prepandemic (M [SD] = 3.34 [0.93] vs. 4.41 [1.21], t [28] = 3.93, p < 0.001). There was no change in SR for children with fewer than 4 disruptions. CONCLUSION: Results highlight modest pandemic-associated decreases in child attention, task persistence, and task engagement alongside increases in impulsivity. We did not find evidence of broad or severe impacts; however, children whose families have been disproportionately affected by the pandemic may need focused support in school and at home to avoid widening prepandemic health and educational disparities.

Patient attitudes and preferences for the management of pregnancy of unknown location.

Objective: To understand patient attitudes and preferences when faced with the uncertainty of pregnancy of unknown location (PUL). Design: Qualitative, interview-based study. Setting: University Hosptial. Patients: Patients aged >18 years sampled from the emergency department and a subspecialty fertility practice of a university hospital system. Interventions: Six to 8 weeks after resolution of a PUL, with an ultimate clinical outcome of either an intrauterine pregnancy, spontaneous abortion, or ectopic pregnancy. Participants underwent either surgical, medical, or expectant management. Main Outcome Measures: Thematic analysis of the virtual, semistructured interviews (45-60 minutes in length) conducted with participants to identify commonly expressed priorities was performed. Results: Interviews were completed from October 2020 to March 2021 until thematic saturation was achieved (n = 15). Resolution diagnoses included intrauterine pregnancy (26.7%, n = 4), ectopic pregnancy (40.0%, (n = 6), and spontaneous abortion (33.3%, n = 5). Moreover, 66.7% (n = 10) of the patients presented to the emergency department, whereas 33.3% (n = 5) presented to a subspecialty fertility clinic. All had desired pregnancies. Thematic analyses revealed 4 related priorities around PUL management: health of pregnancy; health of self; future fertility; and diagnostic prediction and diagnostic certainty. The relative balance of these priorities was dynamic and evolved throughout the course of management with different outcomes. A second set of themes related to logistical preferences included mental health support, clarity of treatment and next steps, and continuity of care. Interrater reliability was validated with a pooled κ of >0.8. Limitations include that all participants had desired pregnancies, and the experiences of those who experienced different pregnancy outcomes may have been affected by recall bias. Conclusions: These data demonstrate novel themes around related priorities in patients with desired pregnancies diagnosed with a PUL previously underappreciated by clinicians. The balance of these priorities evolved throughout management with increasing information and clarity. Continually reevaluating relevant patient priorities and preferences is essential to the comprehensive management of PUL.

Development of the Prostate Cancer Treatment Decision Framework: A Context-Specific Expansion of the Risk-as-Feelings Hypothesis.

BACKGROUND: Over the past 2 decades, numerous decision-making interventions have been developed to guide the prostate cancer (PrCA) treatment choices of patients and families. These interventions are often supported by economic decision frameworks, which do not account for the role of emotions in treatment decisions. In some instances, emotion-driven decisions can override an individual's cognitive evaluation of a decision, leading to unfavorable outcomes such as decision regret. OBJECTIVES: To produce a Prostate Cancer Treatment Decision Framework based on the Risk-as-Feelings Hypothesis. METHODS: The authors reviewed seminal research in emotion and decision-making in an effort to create a context-specific decision framework. RESULTS: Five variables, not germane to the Risk-as-Feelings Hypothesis, play prominent roles in PrCA decision-making including age, spirituality, family support, healthcare provider communication, and perception of treatment outcomes. While family support only affects decision outcomes by influencing emotion and cognitive evaluation of a PrCA decision, age, spirituality, and healthcare provider communication can have direct effects on an individual's perception of treatment outcomes. CONCLUSIONS: The Prostate Cancer Treatment Decision Framework combines new variables with older models to explain the PrCA treatment decision-making process and elucidate relationships affecting treatment outcomes and survivors' perceptions of these outcomes. The core premise of this model can be applied to other high-risk health decisions. IMPLICATIONS FOR PRACTICE: Healthcare providers have the greatest influence on PrCA treatment decision-making. Using a shared decision-making approach, providers should take into account a patient's personal characteristics and values, in addition to clinical presentation, to help patients with treatment decisions.

Review of chemical signature databases.

This review assesses the current state of chemical signature databases, the primary characteristics that determine their applicability, characterization of their capability to support spectral identifications, and the target audience to which they are directed. Database file formats, spectrometer operating conditions, and spectral matching tools are found to be primary characteristics that determine the applicability of databases and their ability to support spectral identifications. Chemical signature databases have evolved in two very different directions. One movement offers a single portal for chemical signature determinations by multiple analytical techniques. The other movement is toward highly specialized databases that address narrow scientific disciplines. Both movements are necessary, and serve distinctly different needs in the analytical community.

What has changed about vaginal douching among African American mothers and daughters?

OBJECTIVES: To explore African American mothers' and daughters' practices and influences related to vaginal douching. DESIGN AND SAMPLE: Our overall study used a sequential mixed-method design with 3 phases. Phase 1, the focus of this report, used grounded theory methods and in-depth, semistructured individual interviews. Two generations of African American girls and women: 24 girls ("daughters") aged 14-18 and 17 women ("mothers" or "mother figures") aged 22-43, recruited from 1 adolescent health clinic in Baltimore, MD. MEASURES: In-depth interviews were taped and transcribed and data analysis used the constant comparison method. RESULTS: Daughters were much less likely to douche or to have been exposed to douching information than mothers. Many mothers and daughters were influenced by health care providers and/or family members to not initiate, to decrease, or to stop douching. Women who currently douche often do so because of the perception of improved smell and cleanliness around menstruation and sexual intercourse. CONCLUSIONS: These data indicate that although some women continue to believe that vaginal douching has therapeutic value, others have been influenced to stop or not start douching by family and health care providers. Health care providers should continue efforts to educate patients on the risks of vaginal douching.

Systematic Review of Commercially Available Mobile Phone Applications for Prostate Cancer Education.

Prostate cancer is the most commonly diagnosed non-skin cancer among all men and the second most common cause of death. To ameliorate the burden of prostate cancer, there is a critical need to identify strategies for providing men with information about prostate cancer screening and the importance of informed decision making. With mobile phones becoming more ubiquitous, many individuals are adopting their phones as sources for health information. The objective of this systematic review is to identify and evaluate commercially available apps for promoting informed prostate cancer screening decisions. Two keywords "prostate cancer screening" and "prostate cancer" were entered into the search engines of Google and iOS app stores in May 2017. Evaluations were conducted on apps' (a) quality, (b) grade-level readability, (c) cultural sensitivity, and (d) usability heuristics. None of the 14 apps meeting the inclusion criteria contained the full breadth of information covered in the 2016 American Cancer Society's Prostate Cancer Prevention and Early Detection Guidelines, but over half were inclusive of topics consistent with these guidelines. Most apps' readability was higher than an eighth-grade reading level. Most apps were also not framed and had a neutral tone. Only four apps met most criteria for being culturally sensitive to African Americans. Usability among apps was variable, but some contained major usability concerns. Recommendations for improving educational apps for prostate cancer screening include: disseminating evidence-based information; using culturally sensitive language; knowing the implications of the one and framing of content; making apps interactive; and following common usability principles.

Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation.

OBJECTIVE: Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker study was designed by the NICHD Reproductive Medicine Network (RMN) to obtain well characterized and phenotyped bio specimens in a standardized fashion from women with and without endometriosis. DESIGN: Development of a diagnostic test. SETTING: Academic medical centers. PATIENTS: This study will enroll up to 500 participants, and follow them for up to 5 months. Included subjects are aged 18-44, scheduled to undergo gynecologic surgery (laparoscopy/laparotomy) for clinical reasons. INTERVENTIONS: Presence and stage of endometriosis (or its absence) is characterized by visual examination at the time of surgery. Subjects will undergo extensive clinical evaluation pre-operatively and at visits one and four months postoperatively. Endometrial biopsy, blood, urine and disease specific questionnaires will be collected at each visit. MAIN OUTCOME: Samples will be placed in a bio-repository to be used to validate and optimize the clinical use of genomic classifiers of the endometrium alone or in combination with serum cytokines as a non-surgical composite marker of endometriosis. CONCLUSION: This protocol can serve as a reference for objective collection of high quality bio specimens for discovery or validation of potential nonsurgical diagnosis of presence or severity of disease.

Staying strong: gender ideologies among African-American adolescents and the implications for HIV/STI prevention.

This paper explores adolescents' definitions of what it means to be a man and a woman, the psycho-social context surrounding the formation of gender ideologies and their relationship to HIV/STI prevention. Semi-structured, in-depth interviews were conducted with fifty African-American adolescents living in Baltimore, Maryland. Female gender ideologies included economic independence, emotional strength and caretaking. Male gender ideologies emphasized financial responsibility, toughness and sexual prowess. Findings suggest that stronger adherence to male gender ideologies related to toughness and sexual prowess is influenced by male participants' perceived inability to fulfill their primary gender role as economic providers and the importance of gaining approval from male peers in the absence of adult male role models. Stronger adherence to female gender ideologies related to emotional strength and caretaking may be linked to a heightened desire for male intimacy and tolerance of male sexual risk behavior. Implications of the gender ideologies documented and their commonalities are discussed in terms of HIV/STI prevention.

Identification of anthranilate and benzoate metabolic operons of Pseudomonas fluorescens and functional characterization of their promoter regions.

BACKGROUND: In an effort to identify alternate recombinant gene expression systems in Pseudomonas fluorescens, we identified genes encoding two native metabolic pathways that were inducible with inexpensive compounds: the anthranilate operon (antABC) and the benzoate operon (benABCD). RESULTS: The antABC and benABCD operons were identified by homology to the Acinetobacter sp. anthranilate operon and Pseudomonas putida benzoate operon, and were confirmed to be regulated by anthranilate or benzoate, respectively. Fusions of the putative promoter regions to the E. coli lacZ gene were constructed to confirm inducible gene expression. Each operon was found to be controlled by an AraC family transcriptional activator, located immediately upstream of the first structural gene in each respective operon (antR or benR). CONCLUSION: We have found the anthranilate and benzoate promoters to be useful for tightly controlling recombinant gene expression at both small (< 1 L) and large (20 L) fermentation scales.

Singing voice outcomes following singing voice therapy.

OBJECTIVES/HYPOTHESIS: The objectives of this study were to describe singing voice therapy (SVT), describe referred patient characteristics, and document the outcomes of SVT. STUDY DESIGN: Retrospective. METHODS: Records of patients receiving SVT between June 2008 and June 2013 were reviewed (n = 51). All diagnoses were included. Demographic information, number of SVT sessions, and symptom severity were retrieved from the medical record. Symptom severity was measured via the 10-item Singing Voice Handicap Index (SVHI-10). Treatment outcome was analyzed by diagnosis, history of previous training, and SVHI-10. RESULTS: SVHI-10 scores decreased following SVT (mean change = 11, 40% decrease) (P < .001). Approximately 18% (n = 9) of patient SVHI-10 scores decreased to normal range. The average number of sessions attended was three (± 2); patients who concurrently attended singing lessons (n = 10) also completed an average of three SVT sessions. Primary muscle tension dysphonia (MTD1) and benign vocal fold lesion (lesion) were the most common diagnoses. Most patients (60%) had previous vocal training. SVHI-10 decrease was not significantly different between MTD and lesion. CONCLUSIONS: This is the first outcome-based study of SVT in a disordered population. Diagnosis of MTD or lesion did not influence treatment outcomes. Duration of SVT was short (approximately three sessions). Voice care providers are encouraged to partner with a singing voice therapist to provide optimal care for the singing voice. This study supports the use of SVT as a tool for the treatment of singing voice disorders. LEVEL OF EVIDENCE: 4 Laryngoscope, 126:2546-2551, 2016.

Prostate Cancer Knowledge and Decision Making Among African-American Men and Women in the Southeastern United States.

This study used multiple methods for assessing African-American (AA) men's and their female relatives, friends, and significant others' knowledge and cancer-related decision-making practices within the context of a prostate cancer (PrCA) education program. Data were collected from 81 participants using qualitative focus groups and 49 participants also completed quantitative pre/post surveys. Findings showed that men often relied on their female "significant other" and doctors for guidance on cancer-related decisions. Women described their role in assisting with their male partners' cancer decisions. AA men's and women's knowledge scores increased between pre- and post-tests which can indicate a greater likelihood of future participation in informed cancer-related decision making. Also, using multiple methods in formative research can provide relevant information for developing effective cancer-related interventions.

Predictors of participant retention in infertility treatment trials.

OBJECTIVE: To identify variables associated with retention (or dropout) in infertility clinical trials. Retention of subjects in randomized controlled clinical trials (RCTs) has received considerable attention, but there have been few consistent findings. DESIGN: Secondary analysis of data from RCTs. SETTING: Academic medical centers. PATIENT(S): Women with polycystic ovary syndrome (PCOS) or couples with unexplained infertility, aged 18-40 years. INTERVENTION(S): This study is not an intervention study, but the patients in the original RCTs were treated with any or combination of metformin, clomiphene citrate (CC), letrozole, and gonadotropins. MAIN OUTCOME MEASURE(S): Successful retention versus dropout during the RCTs. RESULT(S): Race, ethnicity, body mass index (BMI), insurance coverage, history of smoking, and history of alcohol use were significantly associated with retention whether they were considered in bivariate analyses or a multivariable logistic model. Specifically, white race, higher income, having graduate degrees, normal weight, better insurance coverage, nonsmokers, and those who reported current use of alcohol at the start of the trial, had higher retention rates. CONCLUSION(S): We identified several additive and persistent predictors of retention that can be used to guide the conduct of RCTs and improve the retention rate. Given the limitation of our association analysis, methodologically sound and theoretically grounded research are warranted so that high quality data can be collected to improve our understanding on the causes of dropout. CLINICAL TRIAL REGISTRATION NUMBER: NCT00068861 (PPCOS-I), NCT00719186 (PPCOS-II), and NCT01044862 (AMIGOS).