Abstract
Background
Using antibiotics without a prescription (non-prescription use) is common in the USA and contributes to antibiotic misuse, potentially harming individuals and threatening public health. At the individual level, safety issues related to non-prescription use include adverse drug reactions and disruption of healthy microbiomes. At the public health level, non-prescription use increases the risk of antimicrobial resistance.
Objectives
This qualitative study explored the reasons and motivations underlying non-prescription use among adult outpatients with varying healthcare coverage and education.
Methods
We used purposive sampling to recruit participants who endorsed using non-prescription antibiotics in a larger quantitative survey. Participants were patients recruited from six public and two private clinics in Houston and Katy, Texas. All interviews were semistructured and conducted remotely by trained research coordinators in the participant’s preferred language (English or Spanish). Interviews captured elements from two domains of the Kilbourne Theoretical Framework for Advancing Health Disparities Research, including patients’ attitudes and beliefs, resources and various healthcare-system factors that could impact non-prescription use. Thematic analysis revealed the factors and situations that contribute to non-prescription use.
Results
Of 86 participants surveyed, 72% were female and 24% had Medicare or private insurance. Our thematic analyses on why participants use non-prescription antibiotics are organised into two domains: (1) patient beliefs and experiences and (2) healthcare system barriers. Patient beliefs and experiences revealed four themes: (1) belief that antibiotics relieve many symptoms/illnesses (eg, pain, sore throat, if symptoms/illnesses are persistent, lingering or severe), (2) belief that patients know their own bodies (eg, participants’ perceived self-efficacy in knowing and using medications for their illnesses/symptoms), (3) belief that over-the-counter medicines do not work and (4) belief that antibiotics are like gold (eg, antibiotics are difficult to obtain, valuable and highly effective). Healthcare system barriers revealed two themes: (1) patients encounter obstacles to healthcare (eg, transportation, long wait times, high healthcare costs and lack of reliable telemedicine options) and (2) patients express convenience in using non-prescription antibiotics from multiple sources (eg, leftover prescriptions, social networks or purchased without a prescription).
Conclusions
Barriers to care, the convenience of obtaining non-prescription antibiotics, and patients’ beliefs regarding the powerful value of antibiotics and their agency to direct this aspect of care present challenges that need to be explored to design effective outpatient antibiotic stewardship programmes.
Keywords: Qualitative Research, Public Health, Community Health, Health Services Accessibility, Social Medicine
WHAT IS ALREADY KNOWN ON THIS TOPIC
Few qualitative studies have explored factors influencing the use of antibiotics without a prescription (non-prescription use). Prior studies were performed over a decade ago and were restricted to Spanish-speaking Hispanic and Latinx migrant individuals with low income and educational attainment.
WHAT THIS STUDY ADDS
Using a sociodemographically diverse sample of US outpatients, our study revealed the beliefs, practices and healthcare system-related obstacles underlying patients’ non-prescription antibiotic use. Even among more socioeconomically advantaged groups, patients reported using non-prescription antibiotics for symptoms/illnesses that do not typically warrant antibiotics (eg, common viral symptoms/illnesses and pain).
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Evidence-based interventions to decrease the use of antibiotics without a prescription are needed. To design effective outpatient antibiotic stewardship programmes, barriers to care, the convenience of obtaining non-prescription antibiotics and patients’ beliefs regarding the value of antibiotics and their agency to direct this aspect of care at present need to be explored.
Introduction
Reducing inappropriate antibiotic use for primary care patients is a global health priority and a core objective of the 2020–2025 US National Action Plan for Combatting Antibiotic-Resistant Bacteria.1,8 As of 2021, antimicrobial resistance was estimated to cause over 4.7 million deaths worldwide.9 Using antibiotics without a prescription (non-prescription use) contributes to this problem, potentially harming individuals and threatening public health. Non-prescription use can increase the risks of adverse drug reactions, drug interactions, superinfection and disruption of the person’s microbiome and may contribute to antimicrobial resistance globally.1,4
Unfortunately, non-prescription use is common in all WHO regions, including the USA and some other high-income countries, with global prevalence at 43%.310,16 In the USA, the prevalence of non-prescription antibiotic use in adult patient populations is one of the highest among developed countries, ranging from 20% to 45%.1017,19 Individuals obtain non-prescription antibiotics from a variety of sources in the USA, including leftover previously prescribed courses, social networks (friends, family), the internet, herbalist stores, ethnic markets (yerberias), flea markets, veterinary sources and abroad.10 17 20 21
A few qualitative studies have examined the factors influencing non-prescription use in the USA, finding that occupational vulnerability, lack of health insurance and availability of non-prescribed antibiotics (under-the-counter) drove this unsafe practice.22,26 However, these studies were performed over a decade ago and were restricted to predominantly Spanish-speaking Hispanic and Latinx migrant individuals with low income and educational attainment.22,26 The findings from these studies indicate that non-prescription use may be driven by barriers to care among those with lower socioeconomic status and lower educational levels. In this current study, we explore non-prescription use among patients with higher income levels, educational attainment and health coverage. To our knowledge, no other study has sought to understand why patients with presumably greater healthcare access might also use antibiotics without medical guidance. This current study aims to fill this gap in the literature by including a sociodemographically diverse sample of outpatients with varying incomes, education levels and healthcare coverage. We question whether there are salient differences between patients with different health insurance or coverage. Specifically, we explore participants’ viewpoints on non-prescription antibiotic use to characterise any emerging factors contributing to this unsafe practice.
Methods
Participants and setting
This qualitative study includes adult (18 years or older) outpatients living in Harris County, Texas, who endorsed using non-prescription antibiotics in a larger quantitative survey (ie, answered yes to “In general, would you use antibiotics without contacting a doctor/nurse/dentist/clinic?”).27 Participants were recruited from six public clinics (three same-day and three continuity) and two private emergency departments (EDs) in Houston and surrounding suburban areas (Katy, Texas).
Recruitment of participants and data collection
The previous survey27 queried participants on their demographics (eg, race, ethnicity), overall health status28 and health literacy.29 30 We recruited participants using purposive sampling based on race, ethnicity and setting (primary care clinics vs EDs). If participants identified as non-prescription antibiotic users in a prior quantitative survey and agreed to participate, they were recruited for a follow-up semistructured interview. Participants received US$25 to complete the interview.
The qualitative interviews lasted up to 1 hour and were conducted by telephone, with audio recording (see online supplemental appendix 1 for Interview Guide). All interviews were conducted between May 2020 and October 2021 by two trained bilingual research assistants. Interviews were administered in English or Spanish, according to the participants’ language preference, and were professionally transcribed. The bilingual research assistants translated Spanish transcripts into English for analysis and coding.
Patient and public involvement
We engaged with 12 patient representatives with diverse racial and ethnic backgrounds from our public healthcare system. These patients comprised our Community Advisory Board (CAB). The CABs’ contributions informed many aspects of our study including the study design, recruitment, interview guide and the interpretations of our findings. Their feedback was instrumental in shaping our project’s dissemination plan and ensuring that results were clear, appropriate, accessible and relevant to the patient populations surveyed. CAB members were compensated for their time and invaluable contributions to the project.
Interview guide and theoretical framework
The interview guide was pretested with educationally diverse individuals and revised for reading level, clarity and cultural appropriateness (see online supplemental appendix 1 for Interview Guide). Interviews were semistructured and designed to explore the factors and situations that contribute to non-prescription use. Interviews captured elements from two domains of the Kilbourne Theoretical Framework for Advancing Health Disparities Research,31 including patients’ attitudes and beliefs, resources and various healthcare-system factors that could impact non-prescription use.
Analysis
Qualitative coding occurred from June to December 2021 using a team-based approach. Coding and transcript management were conducted using ATLAS.ti Web (V.22.1.5.0),32 allowing synchronous coding in real-time and for analysts to view others’ transcripts and make changes as needed. An inductive coding approach was used, drawing from interview participants’ words to create code names and allowing themes to emerge.33 The researchers used constant and iterative comparison techniques to associate information across transcripts, grouping similar codes to create a codebook.34 On completion of team coding, thematic analysis was used to explore how, when and why participants with different healthcare coverage would endorse non-prescription antibiotic use and considered whether any salient differences existed between health insurance/healthcare coverage groups. Further details on the coding approach for this study are published elsewhere.20
Results
Participant characteristics
To ensure the representation of all patient sociodemographics among our non-homogenous study participants, we anticipated a need to interview a total of 88 patients. Of the 88 participants who qualified and agreed to participate in a one-on-one scheduled interview, 86 completed their interviews. After completing and coding all interviews, our research team determined that the study had adequately met theme/data saturation across all groups.35 The sociodemographic characteristics of the participants interviewed are presented in table 1.
Table 1. Sociodemographic characteristics of participants (N=86).
| n (%) | |
|---|---|
| Median age (year and range) | 49 (21–73) |
| Gender | |
| Female | 62 (72) |
| Male | 24 (28) |
| Race and ethnicity | |
| Non-Hispanic white | 15 (17) |
| Non-Hispanic black | 35 (41) |
| Hispanic or Latinx | 35 (41) |
| Asian | 1 (1) |
| Education level | |
| Less than high school education | 12 (14) |
| High school graduate or GED | 35 (41) |
| Some college/university and above | 39 (45) |
| Health literacy* | |
| Adequate | 67 (78) |
| Inadequate | 19 (22) |
| Healthcare system and setting | |
| Private emergency departments | 15 (17) |
| Public safety-net continuity primary care clinics | 32 (45) |
| Public safety-net same-day clinics | 39 (55) |
| Health insurance status | |
| Medicare or private insurance | 21 (24) |
| Medicaid or County Financial Assistance Programme (CFAP)† | 60 (70) |
| Uninsured or self-pay | 5 (6) |
| Household income | |
| <US$20 000 | 45 (52) |
| ≥US$20 000 but <US$40 000 | 15 (17) |
| ≥US$40 000 but <US$100 000 | 7 (8) |
| Prefer not to say/don’t know household income | 19 (23) |
| Country of birth | |
| Born in USA | 60 (70) |
| Born outside the USA‡ | 26 (30) |
| Language preference | |
| English | 65 (76) |
| Spanish | 21 (24) |
Calculated using the three questions from the Brief Health Literacy Screen measure.29 30
CFAP (ie, Harris Health) includes those who have benefits from the county, allowing access to public clinic providers at either extremely low cost or no cost.
Includes: 2 Cuba, 2 Guatemala, 5 Honduras, 1 India, 15 México and 1 Panama.
GED, general equivalency degree (or diploma).
Most participants interviewed were female (72%), non-Hispanic black (41%) or Hispanic and Latinx (41%), low-income (52%), were born in the USA (70%) and preferred to speak in English (76%). Over three-quarters of all participants were educated above the high school level (86%) and had adequate health literacy (78%). In addition, approximately three-quarters of all participants surveyed had health insurance either through Medicaid or the County Financial Assistance Program (CFAP) (70%) or were uninsured/self-pay (5%). Our thematic analyses were stratified using the dimension of health insurance status because participants with Medicaid and CFAP coverage, in particular, were poorer and of lower socioeconomic status compared with participants with Medicare or private insurance plans. Participants who were uninsured or self-pay shared similar sentiments to participants with Medicaid and CFAP coverage.
Themes: reasons for non-prescription antibiotic use
The Kilbourne framework guided and structured our thematic analysis. Our analyses revealed two primary domains, including (1) patient beliefs and experiences and (2) healthcare system barriers. For the first domain, patient beliefs and experiences, four themes emerged, including (1) the belief that antibiotics relieve many symptoms/illnesses, (2) the belief that patients know their own bodies, (3) the belief that over-the-counter (OTC) medicines do not work and (4) the belief that antibiotics are ‘like gold’. For the second domain, healthcare system barriers, two additional themes emerged, including (1) patients encounter obstacles to healthcare and (2) patients express convenience in using non-prescription antibiotics from multiple sources (eg, leftover prescriptions, social networks or purchasing without a prescription outside the USA) (figure 1). Interestingly, our analysis found more similarities than differences among the sentiments shared by participants with private insurance (Medicare) and public insurance (Medicaid or CFAP).
Figure 1. Overview of the reasons participants use antibiotics without a prescription: domains and themes.
Domain 1: patient beliefs and experiences
Participants discussed their knowledge, attitudes, beliefs and experiences concerning non-prescription antibiotic use.
Theme 1: belief that antibiotics relieve many symptoms/illnesses
Participants primarily use antibiotics to treat symptoms/illnesses that they believe are related to cold and influenza, COVID-19 and pneumonia. They also take antibiotics for symptoms of pain, sore throat and when their symptoms are persistent, lingering or severe. For instance, one participant with public healthcare coverage states that “Antibiotics help tremendously. Especially when it’s cold or flu symptoms or say pneumonia, [and] even with COVID-19” (Participant 9 [Medicaid/CFAP]). Similarly, another participant, with presumably better health insurance, expressed, “I guess if it lingers for a few days [I would take an antibiotic…[like a] persistent cough or cold and [also]…the severity of the symptoms…when my symptoms are…severe vs…allergies or something [less severe]” (Participant 7 [Private/Medicare]).
Theme 2: belief that patients know their own bodies
Regardless of healthcare coverage status, participants proclaimed, ‘I know my body’. Participants reported that they knew when antibiotics were needed, including when they felt sick, infected and bad:
My method [regarding taking a non-prescription antibiotic] is based on my own knowledge of my own body of my own health…I know when I’m sick and when I feel bad. …I’m pretty hyper-aware of my own health. (Participant 6 [Medicaid/CFAP])
It just depends on how bad my situation is… if I can feel the infection, then I’ll take it [referring to a leftover antibiotic] … because I pretty much know my body. (Participant 8 [Private/Medicare])
Theme 3: belief that OTC medicines do not work
Participants with high and low healthcare coverage also reported that OTCs do not work in all situations as a reason for non-prescription use. Typical examples of this theme include the following statements:
We tried the over-the-counter [medicines], [but] there was no relief. So, I took the [leftover antibiotic]. (Participant 2 [Medicaid/CFAP])
When I could not take the pain anymore, and I tried Tylenol or ibuprofen…and Theraflu…but it felt the same, and that is when I had to make the decision to take a stronger antibiotic. (Participant 11 [Medicare/Private])
Theme 4: belief that antibiotics are “like gold”
Regardless of insurance status, many participants held remarkably high regard for antibiotics, describing them as ‘like gold’. The participants quoted below expressed that antibiotics are highly effective against colds and many other sicknesses but are difficult to get by prescription.
When I’m getting a cold or when…I’m sick enough…I have [a] fever… [and] I’m sick in bed…I would take my antibiotic, amoxicillin. I keep them and save them because they’re like gold…it’s hard to get. When you’re really sick, [antibiotics] turn into gold…it knocks whatever it is within a few days. (Participant 12 [Medicaid/CFAP])
Because one, I get sick most of the year—the weather changes, and I get sick. Two, it is difficult to get them; and three, well, it is as if it were gold in the market—the antibiotic has a lot of effect on me…since I know [that] I am going to get sick,…I like to have it on hand, and that is why I keep it [referring to leftover antibiotics]. (Participant 11 [Private/Medicare])
Thus, participants expressed beliefs that antibiotics are very valuable, good to have on hand, able to cure ailments and worth storing for future use.
Domain 2: healthcare system barriers
The second domain structuring our analysis was ‘healthcare system barriers’. Many participants described experiencing a multitude of barriers to accessing healthcare despite having healthcare coverage, which influenced their decisions to use non-prescribed antibiotics.
Theme 5: patients encounter obstacles to healthcare
Participants reported difficulties such as a lack of transportation, long wait times (eg, getting an appointment with the doctor or long delays while at the clinic waiting for the doctor’s appointment to start), high healthcare costs (eg, for the appointment, prescriptions and parking), and a lack of reliable telemedicine options. These barriers impacted patients regardless of their level of healthcare coverage. The participants quoted below collectively described these challenges.
If…I can't get an appointment. It could even be…as simple as that I’ve got an appointment, but I don’t have the gas to pay to even fill the car up to get there. And, not only that, but we still have to pay when we get there. For me…it’s $8, but right about now, somebody…like me, who is only getting $300 a week in employment and got almost $2000 worth of bills, it’s horrible. Participant 5 (Medicaid/CFAP)
I mean it’s probably never a good practice [referring to taking leftover antibiotics], but…I know for me, between scheduling and working on the other side of town and trying to get in to [see] a doctor….Like this last time that I got sick, by the time that I was able to get in to the doctor, I had—full-blown pneumonia, [and] I was [in] the emergency room. So that right there is a great example of why sometimes you’ll take what you’ve got [referring to using leftover antibiotics] because it’s impossible. Participant 16 (Medicare/Private)
Additionally, some participants expressed their approval of virtual or telephone appointments with their doctors (eg, telemedicine or E-visits) in order to get their health needs assessed quicker, and possibly avert using a non-prescribed antibiotic. One participant explains, “I have found that taking the doctor’s appointment over the phone during my lunch break at work has helped…especially [Zoom] video [calls]”. Participant 18 (Medicaid/CFAP)
However, these participants also mentioned barriers to accessing these types of appointments more regularly, including experiencing issues with connectivity and information technology (IT) more broadly. These connectivity/IT issues can create barriers for participants being able to sign in and have their appointments. The participant below describes experiencing some of these problems, yet still preferred to speak to the doctor over the phone rather than physically coming in for the appointment.
Now, some of the drawbacks that I’ve had…[are] getting the Zoom to work on my phone…. Sometimes their [referring to the clinic’s internet connection] end isn't working or they’re having IT problems, or they can't connect for some reason. Because I missed an appointment like that…where I couldn’t get the connection [to work], and [the issue] was on their end [so] I missed the appointment…I had to wait another week or two to get an appointment with somebody else….but [I still prefer] to [have the appointment] over the phone, voice-to-voice, [and] I think that that worked out really well. Participant 18 (Medicaid/CFAP)
Theme 6: patients express convenience in using non-prescription antibiotics from multiple sources
Most participants indicated that having access to non-prescribed antibiotics was more convenient, expressing a preference to use their leftover (previously prescribed) antibiotics instead of going to a doctor. In addition, participants discussed using non-prescribed antibiotics purchased abroad (without a prescription) and from family members instead of going to the doctor and getting a prescription (if warranted).
For instance, one participant with private healthcare coverage stated that she took leftover antibiotics because she did not want to go to the doctor, “I got a sore throat, but [I was] pretty sure that it was strep….and [I] don’t want to mess with the whole going to the doctor…[I] just take it [ref. a leftover antibiotic]” (Participant 15 [Medicare/Private]). Similarly, another participant with public health insurance also discussed the convenience of using non-prescribed antibiotics instead of making an appointment with his/her doctor. This participant even stated a preference to purchase antibiotics without a prescription outside the USA.
[In my country], the doctor always prescribed ampicillin for my [sore]throat. So now…I prefer to buy them outside [abroad] instead of going to the doctor or getting [a] prescription or going the pharmacy…because it is much faster and more comfortable…it is just for convenience. (Participant 10 [Medicaid/CFAP])
Moreover, one participant acknowledges her routine of contacting family for non-prescribed antibiotics when feeling sick, “[When I feel sick], I would contact a family member…[to] see if they have any antibiotics for [those] same symptoms leftover that I could borrow or take” (Participant 3 [Medicaid/CFAP]).
Discussion
Our study revealed salient beliefs, experiences and healthcare system-related obstacles underlying patients’ non-prescription use that must be addressed to advance community-based antibiotic stewardship efforts. Regardless of participants having health insurance or coverage, a majority reported non-prescription antibiotic use to relieve symptoms that do not typically warrant antibiotics (eg, viral symptoms and pain). Participants with different health insurance status also reported that they knew their bodies, particularly when sick and what medications would be needed for their illnesses/symptoms. Additionally, participants reflected that OTC medicines do not always work and that antibiotics were valuable (‘like gold’) and effective. Lastly, healthcare system barriers and the relative convenience and accessibility of non-prescribed antibiotics were influential factors in patients’ decisions to use antibiotics without a prescription.
Our results support another US-based study investigating the patient and healthcare system-level factors influencing non-prescription use, including symptom relief, convenience and cost.21 26 Similar findings were expressed in a qualitative review of non-prescription antibiotic use in lower-income and middle-income countries where non-prescription antibiotic use was driven by incorrect knowledge of the indications for the use of antibiotics, limited access to healthcare and economic factors such as cost.36 However, most US-based and international literature on non-prescription use has focused on immigrant populations who were uninsured, had language barriers and were socioeconomically disadvantaged.2123,26 36 The majority of our interviewees had healthcare coverage (eg, Medicare/private insurance and Medicaid/CFAP). Our survey also captured a wide range of participants, varying by race/ethnicity, insurance status, language preferences, income and educational attainment. Specifically, many of our interviewees had higher educational attainment (eg, high school and college graduates) and adequate health literacy.
Some participants compared antibiotics to the value of ‘gold in the market’. In other words, antibiotics were something of great value, hard to attain and worth storing. The strong positive feelings about the value of antibiotics for symptom relief, even symptoms of viral respiratory infections, were striking. The fact that most participants expressed using non-prescription antibiotics to treat symptoms that may not warrant an antibiotic (eg, viral infections, pain) underscores the need for patient education but also shows that antibiotics’ healing powers are held on a pedestal in the minds of many. This high regard for the curative properties of antibiotics presents a challenge for any outpatient stewardship programme and probably needs to be acknowledged and addressed directly in such efforts. Antibiotic stewardship interventions that focus on teaching patients about the individual (patient-level) harms (eg, adverse effects, side effects, interactions with other medications) rather than societal-level harms (eg, antibiotic resistance) associated with inappropriate antibiotic use may help counter this faith in antibiotics for all ailments (including pain) and thus help reduce reliance on non-prescription antibiotic use.37 Furthermore, in addition to patient education, substantive efforts to provide additional patient resources, such as improving telemedicine services and providing more non-antibiotic prescriptions and OTC alternatives that can be used for the symptoms that patients commonly experience, may be useful.
Clinician and community pharmacist-led antibiotic stewardship programmes may be uniquely situated to provide information on antibiotic safety and proper use. Indeed, several pharmacist-led interventions have been effective in promoting safe antibiotic use.38,40 For instance, one systematic review showed the scaled impact of pharmacist-led interventions on antibiotic stewardship programmes, including improving antibiotic prescribing practices at the health system level, reducing unnecessary antibiotic use and improving patient health outcomes.38 Our prior qualitative analysis showed that some participants expressed trust and preference for receiving drug (eg, antibiotics) recommendations and education from pharmacists and preferred medical diagnostics and advice from clinicians.20 In addition, recent studies in Europe and Canada have shown that pharmacists are interested in promoting antibiotic stewardship.41,44 While pharmacist-led stewardship initiatives have been rare in US primary care, they have the potential to decrease misuse of antibiotics and, ultimately, decrease antibiotic resistance.40
Limitations of our study design include that the interview format may have introduced social desirability response bias despite our best efforts to phrase questions neutrally. Some participants may have answered questions obliquely or suppressed opinions due to the topic’s sensitivity. Additionally, the participants interviewed were invited to participate based on their own indication of using antibiotics without a prescription in a prior quantitative survey. Thus, we cannot account for patients surveyed who are non-prescription antibiotic users but were not comfortable admitting this in the prior survey. Therefore, it may be unclear whether the themes revealed in this study would be the same or different for people who did not self-report non-prescription antibiotic use. Also, the study methodology of phone interviews may have impacted participants’ responses and rapport with the interviewers. However, because interviews were conducted during the COVID-19 pandemic, in-person interviews were not permitted. Despite this limitation, we conducted interviews when participants’ schedules would permit and were comfortable to have a discussion about these topics. Moreover, COVID-19 pandemic-driven contextual changes may have impacted responses and increased inappropriate antibiotic use to treat or prevent COVID-19-related symptoms.45 Our findings are unlikely to represent the perspectives of all primary care patients in the USA. Still, they may apply to other US cities with diverse demographics like Houston and similar non-prescription use practices.
Conclusions
Patients hold antibiotics in high regard and attribute healing properties beyond what antibiotics can accomplish. A complex interplay between patient beliefs and experiences and the barriers of the healthcare system contributes to non-prescription use in adults in outpatient settings. Patients believe that antibiotics are precious commodities and find treating themselves with antibiotics to be more convenient and less expensive than making a trip to a clinic or seeing a doctor. Accordingly, designing antibiotic stewardship interventions tailored to educating patients on safe antibiotic use and the risks of inappropriate antibiotic use is needed. Moreover, interventions to improve the convenience and reduce the costs associated with doctor visits and prescription medications may be impactful in reducing non-prescription antibiotic use.
Supplementary material
The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality or the Government of the USA. The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. This work does not represent the views of the US Government.
Footnotes
Funding: This work was supported by grant number R01HS026901 from the Agency for Healthcare Research and Quality. LAL’s and AC’s work is supported by a Ruth L. Kirschstein National Research Service Award (NRSA) (6T32HC10031). BWT’s work is supported in part by the US Department of Veterans Affairs Health Services Research and Development Service (grant no. CIN 13-413) at the Center for Innovations in Quality, Effectiveness and Safety. BWT is an employee of the US Government and thus cannot assign copyright.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Ethics approval: This study involves human participants and was approved by the Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals (protocol H-45709). Participants gave informed consent to participate in the study before taking part.
Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Data availability statement
Data are available on reasonable request.
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Data Availability Statement
Data are available on reasonable request.