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ObjectiveIn recent years, U.S. states have passed many restrictive abortion policies with a rationale of protecting health and safety, in apparent contravention of abundant scientific evidence on abortion safety. This study explored whether and how state legislators use scientific evidence when deciding abortion policy.Study designWe conducted 29 semi-structured interviews with state legislators and their aides in Maryland, North Carolina, and Virginia in March through July 2017. We recruited via e-mail to members of all health-related committees of the General Assembly in each state, plus sponsors and co-sponsors of 2017 abortion bills, with follow-up via phone and in person. We conducted iterative thematic analysis of all interview transcripts.ResultsWe found no cases of lawmakers' decisions on abortion being shifted by evidence. However, some lawmakers used evidence in simplified form to support their claims on abortion. Lawmakers gave credence to evidence they received from trusted sources, and that which supported their pre-existing policy preferences. Personal stories appeared more convincing than evidence, with participants drawing broad conclusions from anecdotes. Democrats and Republicans had different views on bias in evidence.ConclusionsIn this sample, evidence did not drive state legislators' policymaking on abortion. However, evidence did help inform high-level understanding of abortion, if such evidence supported legislators' pre-existing policy preferences. This work may help public health practitioners and researchers develop more realistic expectations for how research interacts with policymaking.Implications of this workTo increase the utility of research, reproductive health researchers and practitioners should 1) work with established intermediaries to convey findings to lawmakers; 2) present stories that illustrate research findings; and 3) consider the evidence needs of the judicial branch, in addition to those of legislators.

OBJECTIVE:In recent years, U.S. states have passed many laws addressing alcohol use in pregnancy, despite limited evidence on the impact of such policies. This study explores how state legislators use evidence when making policy on alcohol use in pregnancy. METHOD:Study data are drawn from semistructured interviews with 29 state lawmakers and their aides in Maryland, North Carolina, and Virginia, conducted in March through July 2017. Interview transcripts were coded and analyzed by inductive and deductive methods. RESULTS:Despite evidence on the harms of alcohol use in pregnancy, most lawmakers did not express concern about this topic. Instead, they expressed concern about opioid use in pregnancy. Personal experiences, anecdotes, and known contacts influenced legislators' views on substance use in pregnancy, whereas evidence, for the most part, did not. The intermediaries who typically bring evidence about problems and solutions to legislators did not appear to be raising the issue of alcohol use in pregnancy on legislators' agenda. CONCLUSIONS:Basic evidence on the prevalence and harms of alcohol use in pregnancy did not appear to influence state lawmakers' policy priorities. Concern over opioid use in general may provide a window of opportunity to educate legislators on the relative scope and harms of alcohol and opioid use in pregnancy. It remains unclear why states are passing alcohol-in-pregnancy policies. More research is needed to explore how state lawmakers form their understanding of substance use in pregnancy and related policies.

OBJECTIVE: In recent years, U.S. states have passed many restrictive abortion policies with a rationale of protecting health and safety, in apparent contravention of abundant scientific evidence on abortion safety. This study explored whether and how state legislators use scientific evidence when deciding abortion policy. STUDY DESIGN: We conducted 29 semi-structured interviews with state legislators and their aides in Maryland, North Carolina, and Virginia in March through July 2017. We recruited via e-mail to members of all health-related committees of the General Assembly in each state, plus sponsors and co-sponsors of 2017 abortion bills, with follow-up via phone and in person. We conducted iterative thematic analysis of all interview transcripts. RESULTS: We found no cases of lawmakers' decisions on abortion being shifted by evidence. However, some lawmakers used evidence in simplified form to support their claims on abortion. Lawmakers gave credence to evidence they received from trusted sources, and that which supported their pre-existing policy preferences. Personal stories appeared more convincing than evidence, with participants drawing broad conclusions from anecdotes. Democrats and Republicans had different views on bias in evidence. CONCLUSIONS: In this sample, evidence did not drive state legislators' policymaking on abortion. However, evidence did help inform high-level understanding of abortion, if such evidence supported legislators' pre-existing policy preferences. This work may help public health practitioners and researchers develop more realistic expectations for how research interacts with policymaking.

BackgroundIn recent years, an increasing number of states have enacted laws that impose specific requirements for facilities in which abortions are performed. In this study, we sought to understand the processes used to develop facility standards in the context of other, less politically charged areas of health care and consider implications for the context of abortion.MethodsWe conducted key informant interviews with 20 clinicians and accreditation professionals involved in facility standards development for common outpatient procedures (endoscopy, gynecology, oral surgery, plastic surgery). We examined the motivations for and processes used in facility standards development, use of scientific evidence in standards development, and decision-making in the absence of evidence. Interview data were thematically coded and analyzed using an iterative approach.ResultsIn contrast to U.S. state laws that target abortion facilities, standards for other outpatient procedures are commonly set by committees of clinicians organized by professional associations or accreditation organizations. These committees seek to establish standards that ensure patient safety without placing unnecessary burden on clinicians in practice. They aim to create evidence-based standards but can be hampered by lack of relevant research. In the absence of research evidence, committees rely on their clinical expertise and sense of best practices in decision-making. According to respondents, considerations of potential harm (e.g., deeper levels of sedation, invasiveness), rather than the specific procedure, should prompt additional requirements.ConclusionsIf facility standards in the context of abortion were developed through processes similar to other outpatient procedures, 1) professionals who perform the procedure would be involved in standards development and 2) in the absence of clear research evidence, the expertise of clinicians, and the guidelines and standards of other organizations, are used to describe a best practice standard of care.

BackgroundIn recent years, an increasing number of states have enacted laws that impose specific requirements for facilities in which abortions are performed. In this study, we sought to understand the processes used to develop facility standards in the context of other, less politically charged areas of health care and consider implications for the context of abortion.MethodsWe conducted key informant interviews with 20 clinicians and accreditation professionals involved in facility standards development for common outpatient procedures (endoscopy, gynecology, oral surgery, plastic surgery). We examined the motivations for and processes used in facility standards development, use of scientific evidence in standards development, and decision-making in the absence of evidence. Interview data were thematically coded and analyzed using an iterative approach.ResultsIn contrast to U.S. state laws that target abortion facilities, standards for other outpatient procedures are commonly set by committees of clinicians organized by professional associations or accreditation organizations. These committees seek to establish standards that ensure patient safety without placing unnecessary burden on clinicians in practice. They aim to create evidence-based standards but can be hampered by lack of relevant research. In the absence of research evidence, committees rely on their clinical expertise and sense of best practices in decision-making. According to respondents, considerations of potential harm (e.g., deeper levels of sedation, invasiveness), rather than the specific procedure, should prompt additional requirements.ConclusionsIf facility standards in the context of abortion were developed through processes similar to other outpatient procedures, 1) professionals who perform the procedure would be involved in standards development and 2) in the absence of clear research evidence, the expertise of clinicians, and the guidelines and standards of other organizations, are used to describe a best practice standard of care.

BackgroundPublic health agencies in the United States have engaged in abortion-related activities for nearly 50years. Prior research indicates that, while most state health departments engage in some abortion-related work, their efforts reflect what is required by law rather than the breadth of core public health activities. In contrast, local health departments appear to engage in abortion-related activities less often but, when they do, initiate a broader range of activities.MethodsThis study aimed to: 1) describe the abortion-related activities undertaken by maternal and child health (MCH) and family planning professionals in state and local health departments; 2) understand how health departments approach their programmatic work on abortion, and 3) examine the facilitators and barriers to whether and how abortion work is implemented. Between November 2017 and June 2018, we conducted key informant interviews with 29 professionals working in 22 state and local health departments across the U.S. Interview data were thematically coded and analyzed using an iterative approach.ResultsMCH and family planning professionals described a range of abortion-related activities undertaken within their health departments. We identified three approaches to this work: those mandated strictly by law or policy; those initiated when mandated by law but informed by public health principles (e.g., scientific accuracy, expert engagement, lack of bias, promoting access to care) in implementation; and those initiated by professionals within the department to meet identified needs. More state health departments engaged in activities when mandated, and more local health departments initiated activities based on identified needs. Key barriers and facilitators included political climate, funding opportunities and restrictions, and departmental leadership.ConclusionsAlthough state health departments are tasked with implementing legally-required abortion-related activities, some agencies bring public health principles to their mandated work. Efforts are needed to engage public health professionals in developing and implementing best practices around engaging in abortion-related activities.

BackgroundPublic health agencies in the United States have engaged in abortion-related activities for nearly 50years. Prior research indicates that, while most state health departments engage in some abortion-related work, their efforts reflect what is required by law rather than the breadth of core public health activities. In contrast, local health departments appear to engage in abortion-related activities less often but, when they do, initiate a broader range of activities.MethodsThis study aimed to: 1) describe the abortion-related activities undertaken by maternal and child health (MCH) and family planning professionals in state and local health departments; 2) understand how health departments approach their programmatic work on abortion, and 3) examine the facilitators and barriers to whether and how abortion work is implemented. Between November 2017 and June 2018, we conducted key informant interviews with 29 professionals working in 22 state and local health departments across the U.S. Interview data were thematically coded and analyzed using an iterative approach.ResultsMCH and family planning professionals described a range of abortion-related activities undertaken within their health departments. We identified three approaches to this work: those mandated strictly by law or policy; those initiated when mandated by law but informed by public health principles (e.g., scientific accuracy, expert engagement, lack of bias, promoting access to care) in implementation; and those initiated by professionals within the department to meet identified needs. More state health departments engaged in activities when mandated, and more local health departments initiated activities based on identified needs. Key barriers and facilitators included political climate, funding opportunities and restrictions, and departmental leadership.ConclusionsAlthough state health departments are tasked with implementing legally-required abortion-related activities, some agencies bring public health principles to their mandated ...

In the United States, groups advocating for and against abortion rights often deploy public health arguments to advance their positions. Recently, these arguments have evolved into state laws that use the government health department infrastructure to increase law enforcement and regulatory activities around abortion. Many major medical and public health associations oppose these new laws because they are not evidence-based and do not protect women's health. Yet state health departments have been defending these laws in court. We propose a 21st-century public health approach to abortion based in an accepted public health framework. Specifically, we apply the Centers for Disease Control and Prevention's 10 Essential Public Health Services framework to abortion to describe how health departments should engage with abortion. With this public health framework as our guide, we argue that health departments should be facilitating women's ability to obtain an abortion in the state and county where they reside, researching barriers to abortion care in their states and counties, and promoting the use of a scientific evidence base in abortion-related laws, policies, regulations, and implementation of essential services.

ContextRecent legislation in states across the United States has required governmental health agencies to take on new and different roles in relation to abortion. While there has been media attention to health department roles in regulating abortion providers, there has been no systematic investigation of the range of activities in which state and local health departments are engaged.ObjectiveTo systematically investigate health department activities related to abortion.MethodsWe searched state health department Web sites of the 50 states and District of Columbia using key words such as "abortion" and "pregnancy termination". Two trained coders categorized 6093 documents using the 10 Essential Public Health Services (EPHS) framework. We then applied these methods to 671 local health department documents.SettingState and local health department Web sites.ParticipantsN/A.ResultsOn average, states engaged in 5.1 of 10 Essential Services related to abortion. Most (76%-98%) state health departments engaged in activities to Monitor Health Status (EPHS1), Enforce Laws (EPHS6), and Evaluate Effectiveness, Accessibility, and Quality (EPHS9). Many (47%-69%) engaged in activities to Inform and Educate (EPHS3), Develop Policies (EPHS5), and Link to Services (EPHS7). A minority (4%-29%) engaged in activities to Diagnose and Investigate Health Problems (EPHS2), Mobilize Community Partnerships (EPHS4), and Assure Competent Workforce (EPHS8). No state engaged in Innovative Research (EPHS10). Few local health departments engaged in abortion-related activities.ConclusionsWhile most state health departments engage in abortion-related activities, they appear to reflect what the law requires rather than the range of core public health activities. Additional research is needed to assess whether these services meet quality standards for public health services and determine how best to support governmental health agencies in their growing tasks. These findings raise important questions about the role of public health agencies and professionals in defining how health departments should be engaging with abortion.

BackgroundOver recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes-for any procedure-is unclear.Methods and findingsWe conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions.ConclusionsMore and higher quality research is needed to determine if there is a public health problem to be addressed through facility regulation and, if so, which facility characteristics may result in consistent improvements to patient safety while not adversely affecting patient experience or service availability.

BackgroundOver recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes-for any procedure-is unclear.Methods and findingsWe conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions.ConclusionsMore and higher quality research is needed to determine if there is a public health problem to be addressed through facility regulation and, if ...

PurposeThe extent that state-mandated informed consent scripts affect women's knowledge about abortion is unknown. We examine women's endorsement of common abortion myths before and after receiving state-mandated information that included accurate and inaccurate statements about abortion.MethodsIn Utah, women presenting for an abortion information visit completed baseline surveys (n=494) and follow-up interviews 3 weeks later (n=309). Women answered five items about abortion risks, indicating which of two statements was closer to the truth (as established by prior research) or responding "don't know." We developed a continuous myth endorsement scale (range, 0-1) and, using multivariable regression models, examined predictors of myth endorsement at baseline and change in myth endorsement from baseline to follow-up.ResultsAt baseline, many women reported not knowing about abortion risks (range, 36%-70% across myths). Women who were younger, non-White, and had previously given birth but not had a prior abortion reported higher myth endorsement at baseline. Overall, myth endorsement decreased after the information visit (0.37-0.31; p<.001). However, endorsement of the myth that was included in the state script-describing inaccurate risks of depression and anxiety-increased at follow-up (0.47-0.52; p<.05).ConclusionsLack of knowledge about the effects of abortion is common. Knowledge of information that was accurately presented or not referenced in state-mandated scripts increased. In contrast, inaccurate information was associated with decreases in women's knowledge about abortion, violating accepted principles of informed consent. State policies that require or result in the provision of inaccurate information should be reconsidered.

BackgroundIn February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.Methods and findingsWe used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law.ConclusionsOhio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

BackgroundIn February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.Methods and findingsWe used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common ...