Exploring Reasons for Loss to Follow-up in Pregnancy of Unknown Location: A Mixed-Methods Study

Abstract

Objective:

To quantify proportions of loss to follow-up in patients presenting with a pregnancy of unknown location and explore patients’ perspectives on follow-up for pregnancy of unknown location. A pregnancy of unknown location is a scenario in which a patient has a positive pregnancy test but the pregnancy is not visualized on transvaginal ultrasound.

Study Design:

We conducted a retrospective cohort study of patients with pregnancy of unknown location who presented to an urban academic emergency department or complex family planning outpatient office. We sought to calculate the proportion of patients lost to follow-up, defined as inability to contact the patient within 2 weeks. We then conducted focus groups of patients diagnosed with a pregnancy of unknown location. We used thematic analysis to identify themes related to follow-up.

Results:

We reviewed 464 charts of patients diagnosed with pregnancy of unknown location. The median age in this cohort was 27 with most patients identifying as Black (80%, n = 370) and using public insurance (67%, n = 315). When looking at loss to follow-up rates, Black patients experienced loss to follow-up (20%, n = 72) more often than White patients (4%, n = 2; p = 0.003). Focus group participants had a mean age of 31.8+/−4.8, and the majority were of Black race (n = 16, 72.7%). Participants identified barriers to follow-up including the long duration of management, general inconvenience, and poor communication with their health care team. Participants felt a burden of responsibility to learn about their condition and to self-advocate for their follow-up and communication of results.

Conclusions:

These data indicate that Black patients are more likely to experience loss to follow-up compared with White patients during monitoring for pregnancy of unknown location. Patients identified many barriers to follow-up and felt that successful follow-up required substantial self-efficacy.

Introduction

Improved follow-up of pregnancies of unknown location can prevent ruptured ectopic pregnancy, a condition that accounts for 2.7% of all pregnancy-related deaths and was the leading cause of hemorrhage-related mortality from 2011 to 2013.^1,2 A pregnancy of unknown location is a descriptive term for a clinical situation in which an individual has a positive pregnancy test but the pregnancy cannot be identified on transvaginal ultrasound.³ After classifying a patient as having a pregnancy of unknown location, follow-up is necessary to establish a definitive diagnosis. Often, serial laboratory testing is needed to exclude the diagnosis of ectopic pregnancy, which may occur in up to 18% of pregnant individuals in the first trimester presenting to the emergency department (ED) with abdominal pain and cramping.^1,4 Delayed diagnosis during follow-up for a pregnancy of unknown location can lead to ectopic pregnancy progression, unscheduled interventions, tubal rupture, and morbidity.

There are known health disparities in patients diagnosed with ectopic pregnancies. The occurrence of an ectopic pregnancy is 1.26 times more likely in Black patients,⁵ and the risk of death from ectopic pregnancy is 6.8 times higher for Black patients compared with White patients.⁶ A population-based cross-sectional study also found a higher incidence of ectopic pregnancy among non-Hispanic Black patients who were medically insured, suggesting that this disparity is not linked to insurance status alone.⁷ Although studies have most consistently found Black patients at higher risk for ectopic pregnancy complications, another study found that within a population insured by Medicaid, Black, Hispanic, Asian, American Indian/Alaskan Native, and Native Hawaiian/Pacific Islander patients were also at a higher risk of complications from ectopic pregnancy compared with White patients.⁸ Research exploring the connection between care delays and health disparities is insufficient. Furthermore, there is limited literature on the rate of patients lost to follow-up during monitoring for pregnancy of unknown location. To explore this potential contributor to a major health disparity, we sought to investigate risk factors for being lost-to-follow-up during monitoring for pregnancy of unknown location, including race, ethnicity, insurance status, and possible barriers and facilitators to successful follow-up.

Materials and Methods

We conducted a mixed-methods study of patients classified as having a pregnancy of unknown location at a single academic institution, including a retrospective cohort study and four focus group discussions. This study was reviewed and approved by the University of Pennsylvania Institutional Review Board.

Quantitative methods

We performed a retrospective cohort study with the objective of determining whether there were differences in loss to follow-up rates by patient race. We included patients who initially presented to one of two urban academic Emergency Medicine departments or a Complex Family Planning outpatient office and were classified as having a pregnancy of unknown location. After initial presentation and identification, patients were added to a database (“Quantbook”) for providers to track management. Study patients were identified on removal from the Quantbook. We excluded patients if they were ultimately diagnosed with a molar pregnancy or were diagnosed with an ectopic pregnancy upon initial presentation. The primary outcome was to determine the proportion of patients lost to follow-up after the initial encounter, defined as being unable to contact the patient by phone for 2 weeks or more after last contact. This definition of lost to follow-up was adopted from an institutional protocol. The protocol states that the provider should send a certified letter at 5 days without contact and a final letter at 2 weeks without contact, at which point no further telephone calls are made unless the patient reestablishes contact with the team.

Three of the authors abstracted patient information from the electronic medical record, including patient race and ethnicity. Standard definitions for the final diagnosis were agreed upon a priori and based on previous literature.³ We collected demographic characteristics, time between first two blood draws, whether a patient was lost to follow-up, occurrence of unscheduled procedures, any treatment that occurred, and the location at which the initial consultation took place. Race and ethnicity were collected from the chart demographic information. We summarized baseline and demographic characteristics using Students t-tests to compare continuous variables and Pearson chi-square or Fisher’s exact tests to compare categorical variables between those lost to follow-up and those who were not lost to follow-up. We used logistic regression to determine whether particular patient characteristics were independent risk factors for being lost to follow-up. Using institutional historical data, we assumed a ratio of 6:1 Black to White patients followed for pregnancy of unknown location, and rates of loss to follow-up of 20% for Black patients and 5% for White patients. With these assumptions, we calculated that including at least 49 White patients and 294 Black patients would allow 80% power to detect a clinically significant difference of 15% in loss to follow-up. We chose this as our primary outcome to investigate given the known health disparities in care for patients ultimately diagnosed with ectopic pregnancy. STATA 15.1 was used for all analyses (State College, TX).

Qualitative methods

We contacted patients with a diagnosis of pregnancy of unknown location from an institutional database within the previous month for participation in virtual focus groups. All participants were required to be 18 years or older and English speaking. We excluded patients who were clinically unstable at the time of presentation for pregnancy of unknown location or if they were ultimately diagnosed with a molar pregnancy. Patients self-identified their race and ethnicity categories and were allowed to choose multiple options. We created a focus group guide based on the Health Belief Model and Socioecological Model to identify patients’ health behaviors in relation to follow-up for pregnancy of unknown location.^9,10 All focus groups were recorded, transcribed, and anonymized. Data were analyzed by applying modified grounded theory, with thematic analysis, after double coding of the transcripts by authors A.F. and A.J.^11,12 The study team reviewed any coding discrepancies and reached consensus through group discussion. We concluded enrollment for focus groups once thematic saturation had been reached. Participants were compensated for their participation in the study.

Results

Quantitative results

We reviewed 464 charts of patients diagnosed with pregnancy of unknown location from September 2019 to January 2021. The majority of patients were Black (77.5%, n = 296) and were on public insurance (67%, n = 310). The final diagnoses included intrauterine pregnancy (32.5%, n = 151), early pregnancy loss (8.0%, n = 37), resolved pregnancy of unknown location (29.1%, n = 135), cesarean scar ectopic pregnancy (0.2%, n = 1), retained products of conception (0.2%, n = 1), and ectopic pregnancy (9.5%, n = 44); 13 (2.8%) patients transferred care before final diagnosis. Eighty-two (18%) patients were lost to follow-up before receiving a final diagnosis. Patients that were lost to follow-up were younger and more frequently uninsured or enrolled in public insurance compared with those not lost to follow-up (Table 1). We found differences in loss to follow-up rates by race (Table 1). Black patients experienced loss to follow-up (20%, n = 72) more often than White patients (4%, n = 2) (p = 0.003). When adjusting for age and insurance status, participants who were Black were more likely to be lost to follow-up than White patients (adjusted odds ratio: 4.4, 95% confidence interval [CI]: 1.01–19.1) (Table 2).

Table 1.

Demographic and Pregnancy Characteristics for Participants Completing or Lost to Follow-up for Treatment of Pregnancy of Unknown Location at the University of Pennsylvania During 2019–2021

	Not lost to follow-up(n = 382); N (%) or median (IQR)	Lost to follow-up(n = 82) N (%) or median (IQR)	p-value
Age	28 (24–32)	25 (21–30)	<0.001
Gravidity			0.72
1	76 (19.9%)	13 (16.0%)
2	88 (23.1%)	20 (24.7%)
3+	215 (56.4%)	48 (59.3%)
Parity			0.69
0	129 (33.9%)	30 (37.0%)
1	119 (31.2%)	20 (24.7%)
2	64 (16.8%)	14 (17.3%)
3	69 (18.1%)	17 (21.0%)
Ectopic pregnancy risk factors			0.04
Yes	141 (36.9)	34 (41.5)
No	214 (56.0)	36 (43.9)
Unknown	27 (7.1)	12 (14.6)
First visit in ED			0.12
Yes	335 (87.7%)	77 (93.9%)
No	47 (12.3%)	5 (6.1%)
Insurance			0.03
None	38 (9.9%)	13 (15.9%)
Public	251 (65.7)	59 (72.0%)
Private	93 (24.3)	10 (12.2%)
Race			0.02
Asian	13 (3.4%)	2 (2.4%)
Black	296 (77.5%)	74 (90.2%)
Unknown or Other^a	25 (6.5%)	4 (4.9%)
White	48 (12.6)	2 (2.4)
Ethnicity			0.05
Hispanic/Latinx	20 (5.2)	0
Non-Hispanic/Latino	361 (94.5)	82 (100)
Declined	1 (0.3)	0
Gestational age (days)	38.5 (32–49)	42 (36–51)	0.10
Time between blood draws	2 (2–3)	3 (2–4)	0.12
Unscheduled procedure	7 (1.8%)	0	0.36

Nine participants identified as “Latinx” and four identified as “Latinx/Black.”

IQR, interquartile range.

Table 2.

Logistic Regression Model of Predictors of Lost to Follow-up during Monitoring for Pregnancy of Unknown Location at the University of Pennsylvania Between 2019 and 2021

	Unadjusted OR	p-value	95% CI	Adjusted or	p-value	95% CI
White	1	—	—	1	—	—
Black	6	0.02	1.43–25.25	4.4	0.05	1.01–19.1
Other^a	3.79	0.12	0.72–19.85	2.9	0.22	0.53–15.4
Age	0.93	0.002	0.89–0.98	0.95	0.01	0.91–0.99
Public insurance	1	—	—	1	—	—
None	1.46	0.29	0.73–2.90	1.6	0.18	0.80–3.27
Private insurance	0.46	0.03	0.22–0.93	0.7	0.31	0.32–1.43

In the logistic regression, the category “other” combines Asian and unknown/other from Table 1.

CI, confidence interval; OR, odds ratio.

Qualitative results

From July to October 2021, we conducted four focus groups (n = 22). Participants had a mean age of 31.8 ± 4.8, and the majority self-identified their race as Black (n = 16, 72.7%) (Table 3). Final pregnancy diagnoses included resolved pregnancy of unknown location (n = 8, 36.4%), intrauterine pregnancy (n = 5, 22.7%), early pregnancy loss (n = 2, 9%), and ectopic pregnancy (n = 2, 9%); five patients in our qualitative study did not receive a final diagnosis because of loss to follow-up during their management (22.7%) (Table 3).

Table 3.

Demographic Characteristics for Participants in the Qualitative Study Assessing Facilitators and Barriers to Follow-up for Pregnancy of Unknown Location at the University of Pennsylvania in 2021

	n = 22 (%) or Median (IQR)
Age	31 (30–36)
Gravidity
1	3 (14)
2	2 (9)
3+	17 (77)
Parity
0	5 (23)
1	3 (14)
2	6 (28)
3	8 (36)
Insurance
Public	17 (77)
Private	5 (23)
Race
Black	16 (73)
Multiracial or Other^a	3 (14)
White	3 (14)
Ethnicity
Hispanic/Latinx	2 (9)
Non-Hispanic/Latino	20 (91)
Final diagnosis
Early pregnancy loss	2 (9)
Ectopic pregnancy	2 (9)
Intrauterine pregnancy	5 (23)
Resolved pregnancy of unknown location	8 (36)
Lost to follow-up	5 (23)

Patient declined to specify and the other two selected multiple races.

IQR, interquartile range.

Facilitators to follow-up

We identified four major themes under facilitation of patient follow-up during pregnancy of unknown location: patient desire for information about pregnancy outcome, severity of symptoms and illness, social support systems, and self-advocacy.

Desire for information

Participants felt that a significant benefit of following up was to obtain more information and a final diagnosis; participants desired information about the outcome of the pregnancy. Some participants also noted a sense of optimism or hope for good information (for example, an appropriately rising beta-human chorionic gonadotropin) as a benefit of obtaining follow-up laboratory testing: “I sobbed like a baby. I just wasn’t too sure about anything, and I was determined to go back to the appointment so we can find out where the baby is.”(Age: 31, Race: Black, Final diagnosis: resolved pregnancy of unknown location).

Participants also wanted to confirm that they were safe, and their health would not be compromised: “Just to confirm that everything was doing what it was supposed to be doing. I knew like the young lady just said, if I didn’t make sure that the levels were where they were supposed to be, then something potentially harmful could happen to me.” (Age: 37, Race: Black, Final diagnosis: resolved pregnancy of unknown location).

Symptoms and severity of illness

While most participants were unfamiliar with the classification of pregnancy of unknown location at the time of diagnosis, many of them had a better understanding of the severity of ectopic pregnancies, which motivated follow-up. Some participants learned about this potential outcome through their health care providers, whereas others learned about them from other connections such as family members: “What is it called? Where it’s in the tubes? I have a few family members that had that, so I was I really worried. It was more so that, I was worried about that because I was having some cramping and pain.” (Age: 30, Race: Black, Final diagnosis: lost to follow-up).

Participants also judged the seriousness of their condition based on the symptoms they were experiencing, such as bleeding and cramping, that prompted them to think something was wrong and therefore make initial presentations for care or seek follow-up care after the pregnancy of unknown location diagnosis: “Now, I know, during your first trimester, in early pregnancy, a person spots and stuff like that so I didn't think anything of it. But the pain started getting worse and worse, and I kept telling my boyfriend, something is wrong. I need to go to the hospital check on the baby, make sure everything’s okay, make sure the pregnancy is going well, because I don't want to experience losing another child.”(Age: 31, Race: Multiracial, Final diagnosis: resolved pregnancy of unknown location).

Social support systems

Participants described close family and friends as driving factors in encouraging them to return for follow-up. Having had a family member who previously experienced ectopic pregnancy especially motivated some participants to follow-up: “My aunt, when she was younger, she had an ectopic pregnancy, and she didn’t find out until it was about to bust, and they said lucky she got there in time because she could have died. So that’s what really made me keep going each and every single day because I didn’t want that to happen to me.”(Age: 30, Race: Black, Final diagnosis: lost to follow-up).

Participants also talked about how people in their life provided emotional support. This support helped maintain their mental health amid the stress of the follow-up process, as well as motivating them to follow-up with care. Lastly, participants’ relationships with others provided them practical support, such as transportation and childcare during appointments, which also aided them in following up.

Self-advocacy

Focus group participants identified facility flexibility and automatic appointment reminders as factors that made follow-up more feasible. In contrast, participants also described the need to self-educate about their condition as well as make their own arrangements as barriers to follow-up. These additional steps made follow-up feel unnecessarily difficult for participants. Some participants were able to endure this burden and actively self-advocate for themselves, asking questions or persisting in communication with health care providers. Similarly, most participants reported doing further research online to understand the pregnancy of unknown location characterization: “You have to be a really, really strong advocate for yorself in dealing with doctors and hospitals and your medical care. You really do. Doing your own research is very, very important, but also being able to speak up and remember that doctors are human beings, just like us, and if you don’t speak up, then you could be missing an opportunity for something positive or to prevent something negative from happening.” (Age: 37, Race: Black, Final diagnosis: resolved pregnancy of unknown location).

Barriers to follow-up

We identified four major barriers to follow-up during management of pregnancy of unknown location: lengthy follow-up process, inconvenience of follow-up, inefficient communication with the health care team, and lack of peer support.

Lengthy follow-up process

Participants felt that follow-up was drawn out and that the time to resolution was long, especially given the frequency of blood draws. This was particularly true for participants if their follow-up was lengthy, and they believed they had a resolved pregnancy. For these participants, there was a strong desire to move on and not be constantly reminded of the pregnancy loss. “You’d be like, all right, I'm over it. I don't want to talk about it, I don't want to think about it. It happened. Can we move on to something else? But it didn't go like that because I just got a text yesterday. So how do I feel, what are my symptoms? Been over 4 weeks now. I'm fine.” (Age: 37, Race: Black, Final diagnosis: ectopic pregnancy).

Inconvenience of follow-up

Focus group participants reported that aspects of follow-up were inconvenient because of both the time and travel that was necessary to attend follow-up appointments. Participants cited issues with parking, locations for blood draw, and issues with or lack of transportation. Participants also had difficulty arranging childcare during their appointments and often had to miss work to get their blood drawn: “It was a lot of trips. When you have to work—or luckily like I don’t have any kids, but I can imagine somebody who has kids and has a day-to-day routine, fitting that in was a little bit much, especially because I—the place I went is in the city… So traveling, having to work through it all and be able to go that often—even with the trip. Like because as soon as I came back, I had to go again, and then pretty much every couple of days I had to keep going back until it went all the way down, and that took some time. So it was really time consuming.” (Age: 24, Race: Black, Final diagnosis: lost to follow-up). Because follow-up is generally on short notice, participants often referenced existing plans as a barrier to follow-up. These existing plans would either be unable to be rescheduled or were prioritized over follow-up.

Inefficient communication with the health care team

Lack of communication from a provider or inability to connect with a provider often led to inconsistencies in follow-up or delays from the patient perspective. Participants described “playing phone tag” with providers and being unable to reach their doctor: “You missed their call. They leave a message. You call back. You call back and you can’t get in touch with them. You leave a message. They don’t contact you back. And then you call in and it’s like you got to find time and find time in your memory on top of dealing with this devastating news, to call back to see what’s going on with this doctor’s office. So it was a real headache.”(Age: 31, Race: Black, Final diagnosis: resolved pregnancy of unknown location).

Furthermore, there was a sense of a lack of centralized care. Participants referenced a disconnect in care from provider to provider, and throughout the follow-up process, leading to responsibility falling on the patient to coordinate follow-up. They found the waiting time to hear results particularly challenging, especially if providers did not call for days at a time.

Lack of peer support

Most focus group discussions included conversations about a lack of peer support currently available for patients experiencing pregnancy of unknown location. They desired an outlet for discussion and enjoyed talking to others who had been through a similar experience. Participating in the focus groups allowed them to realize they were not alone and get empathy/sympathy from others who had been through a similar experience: “We are all women and we are all going through this situation, not together. I mean we’re together expressing it now, but it’s very devastating. And we do need to open up more and have a little bit more of these types of sessions.” (Age: 31, Race: Black, Final diagnosis: Resolved pregnancy of unknown location).

Discussion

Our quantitative data showed Black patients experiencing a pregnancy of unknown location are lost to follow-up at higher rates than White patients. Our qualitative data highlighted four significant barriers to care: lengthy follow-up process, lack of peer support, inconvenience of follow-up, and inefficient communication with the health care team. While all patients requiring follow-up for a pregnancy of unknown location face barriers, the quantitative inequities in follow-up rates demonstrated in our data are likely because of structural racism that contributes to these barriers being higher and more difficult to overcome for Black patients than White patients.

The inconvenience of follow-up care was highlighted as a barrier by patients in our qualitative focus groups. This highlights a possible area to improve education and expectations with patients at the time of diagnosis of pregnancy of unknown location. We know that the inconvenience of follow-up care is magnified by socioeconomic disadvantage; for example, lower-income patients may miss appointments because of limited access to reliable transportation, childcare, or paid time off from work.¹³ Because Black Americans are disproportionately lower income, these economic obstacles may partially explain the racial disparity in follow-up care.^14,15 However, race alone—specifically, racialized treatment of Black patients—may also contribute to the disparity by exacerbating the barrier of poor communication. Previous research has shown that the communication style of health care providers is more domineering and less patient-centered with Black and Latinx patients and caregivers.^16,17 From the patient perspective, Black patients are likely to attribute poor communication and health care experiences to racial discrimination, which produces medical mistrust and reduced adherence to health care recommendations.^14,18,19 Both from previous data and from our study findings, health care providers should strive to improve and streamline communication for patients with a pregnancy of unknown location to reduce the burden of follow-up on the patients. This may need to include offering a variety of communication options for patients such as phone calls, texting, or messaging through an electronic health platform.

There is limited research on patients’ disengagement in care or loss to follow-up during monitoring for pregnancy of unknown location outside of clinical trial settings. In one retrospective pre-post study, investigators found that patients were lost to follow-up approximately 22% of the time during monitoring for pregnancy of unknown location.²⁰ However, loss to follow-up or disengagement in care has been studied more extensively in other areas of medicine. In a retrospective analysis, patients receiving primary care who were lost to follow-up were found to more often be younger, non-White, and using public insurance.²¹ This is consistent with what we found in our study. In another retrospective study, patients who were seen in the emergency room for an eye-related complaint and were discharged with a recommendation for outpatient care were studied to identify possible risk factors for being lost to follow-up. This study found that younger patients, people with nonurgent conditions, and using Medicaid or having no insurance were associated with being lost to follow-up.²² Furthermore, patients who were lost to follow-up were more likely to revisit the emergency room within 4 months of their index visit. Although these studies were performed in areas of medicine different from pregnancy care, they found similar findings when looking at patients who are more likely to be lost to follow-up.

This study was completed at a single academic hospital system with English-speaking patients and with a small number of Latinx patients, limiting the generalizability of our findings. Our institution uses a resident physician-managed system to track patients with pregnancies of unknown location and determine follow-up plans. This system is common among academic medical centers; however, differences between systems for coordination and planning of follow-up may impact loss to follow-up rates. Furthermore, we cannot rule out that there may have been selection bias in the participants of the qualitative portion. The strengths of this study include the comprehensive chart review, as we captured data for 464 patients followed by focus groups to better understand the identified disparity. Non-White patients were over-represented; although 60% of Philadelphia residents are non-White, 77% of our retrospective cohort were Black and 72% of our focus group participants identified as Black. This demonstrates the inequities in how White and Black patients with early pregnancy concerns are able to access care, which has been previously shown.²³

Conclusions

This mixed-methods study found that Black patients are more likely to be lost to follow-up than White patients after presenting with a pregnancy of unknown location. This difference may contribute to subsequent racial disparities in adverse maternal outcomes.^8,9 Through qualitative focus groups, participants discussed multiple barriers as reasons why follow-up is challenging; participants felt that successful follow-up required a high level of self-advocacy to engage with the health care system.

Footnotes

Author Disclosure Statement

S.S. disclosed that money was paid to her institution from Myovant and that she is a consultant for the World Health Organization. No other authors have disclosed any potential conflicts of interest.

Funding Information

This work was supported by a grant from the Women’s Health Innovation Incubator Program at the University of Pennsylvania. However, the funder had no role in the data collection or preparation of this manuscript.

Authors’ Contributions

A.N.F.: conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, and writing (original draft/review and editing). A.M.: formal analysis, methodology, project administration, and writing (review and editing). A.J.: project administration, data curation, formal analysis, and writing (review and editing). S.G.: data curation, and writing (review and editing). Allen: data curation and writing (review and editing). C.K.: methodology, formal analysis, project administration, and writing (review and editing). N.S.: conceptualization, funding acquisition, investigation, project administration, and writing (review and editing). N.K.: methodology, formal analysis, and writing (review and editing). S.S.: conceptualization, funding acquisition, methodology, formal analysis, writing (review and editing), and supervision.

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