Facility Standards for Abortion and Other Outpatient Procedures Nancy Berglas, DrPH Sarah Roberts, DrPH Bonnie Scott Jones, JD June 7, 2017 Abortion Researcher Incubator

Targeted Regulation of Abortion Providers (TRAP) Source: UCSF.ANSIRH (Internal)

Targeted Regulation of Abortion Providers (TRAP) Requirements for clinics and physician offices including sites that use medication abortion only Licensing standards comparable to ASCs Physical plant requirements Admitting privileges at local hospital Transfer agreements with local hospital or physician Board certification

Whole Women’s Health v. Hellerstedt SCOTUS decision: Burdens of a restriction cannot outweigh its benefits Assessment must be based on credible scientific evidence Abortion should be treated like other health care services in evaluating facility requirements What would evidence-based facility standards look like in the context of abortion?

Looking to Other Procedures There isn’t direct evidence on the relationship between facility requirements and patient outcomes for abortion Provided in offices/clinics for 40+ years, with established safety record Is there evidence for other procedures? Academic/policy discussions of facility standards are new Emerged as procedures moved from hospital  outpatient

Research Studies 1. How are facility standards set for other outpatient procedures, and how do they incorporate research evidence? Key Informant Interviews 2. What is the state of the evidence base for facility standards for outpatient procedures? Systematic Review 3. How do state facility laws governing abortion procedures compare to those governing office-based procedures? Legal Research 4. What are the complications and costs of abortion in different types of outpatient settings? Claims Data Analysis

What is the state of the evidence base for facility standards for outpatient procedures? Team: Nancy Berglas, DrPH, Molly Battistelli, MPH, Richard Urman, MD, MBA, Wanda Nicholson, MD, MPH, MBA, Mindy Sobota, MD, Sarah Roberts, DrPH

Defining the Systematic Review What facility standards? What procedures? What outcomes? What study designs?

What Facility Standards? Setting ASC vs. Office/Clinic Accreditation Joint Commission/AAAASF/AAAHC Emergency response Transfer protocols/plans Hospital admitting privileges Staffing Board certification Residency training Levels of nursing staff Physical plant Operating/procedure room Instrument processing rooms Separate recovery room Hall/door widths Emergency power Temperature/ventilation NFPA for healthcare occupancies etc. Required policies Quality improvement Infection control Risk management

Is there good comparison for abortion? What Procedures? Is there good comparison for abortion? Other gynecology/primary care? Relatively low-risk? Commonly performed in outpatient settings? Targeted by state laws or regulations?

What Outcomes? Patient safety Patient satisfaction Service availability (“access”) Cost

Two Research Questions Q1: What is the effect of outpatient setting (ASC vs. office/clinic on patient safety, patient satisfaction, and service availability? Q2: What are the effect of specific facility factors on patient safety, patient satisfaction, and service availability? Accreditation Emergency Response Staffing Physical Plant Policies

Systematic Review Methods Develop search strategy with reference librarian Register study protocol Set inclusion/exclusion criteria Search EMBASE, PubMed, Web of Science, and gray lit Title and abstract screen by 2 reviewers Full text review by 2 reviewers Assess risk of bias of included studies Extract data from studies meeting minimum quality standards Synthesize findings

Search Language Setting Outcome Facility Standard AND (‘ambulatory care’ OR 'outpatient care'/exp OR 'outpatient care' OR 'outpatient department'/exp OR 'outpatient department' OR 'ambulatory care facility' OR 'ambulatory care facilities' OR 'outpatient clinics' OR 'outpatient clinic' OR 'urgent care centers' OR 'urgent care center' OR 'urgent care clinics' OR 'urgent care clinic' OR 'family planning centers' OR 'family planning center' OR 'ambulatory health center' OR 'ambulatory health centers' OR 'abortion centers' OR 'abortion center' OR 'abortion clinics' OR 'abortion clinic' OR ‘abortion facility’ OR ‘abortion facilities’ OR 'free-standing clinic' OR 'free-standing clinics' OR 'outpatient surgery facilities' OR 'ambulatory setting' OR 'physician office' OR 'physician offices' OR 'physicians office' OR 'office procedure' OR 'office procedures' OR 'office-based surgery' OR 'office-based surgeries' OR 'office-based anesthesia' OR 'office based anesthetic' OR 'office based anesthetics' OR 'ambulatory surgery center' OR 'ambulatory surgery centers' OR 'ambulatory surgery centre' OR 'ambulatory surgery centres' OR ‘ambulatory surgical center’ OR ‘ambulatory surgical centers’ OR ‘ambulatory surgical centre’ OR ‘ambulatory surgical centres’) AND ('treatment outcome'/exp OR 'patient satisfaction'/exp OR ‘patient satisfaction’ OR 'patient safety'/exp OR ‘patient safety’ OR 'patient outcomes' OR 'treatment outcome' OR 'clinical effectiveness/exp' OR ‘clinical effectiveness’ OR 'patient-relevant outcome' OR 'patient relevant outcome' OR 'patient-relevant outcomes' OR 'clinical efficacy' OR 'treatment effectiveness' OR 'treatment efficacy' OR 'outcome assessment' OR 'outcome assessments' OR 'hospital admission' OR 'hospital admissions' OR 'adverse event' OR 'adverse events' OR 'adverse incident' OR 'adverse incidents' OR ‘morbidity’ OR ‘access’ OR ‘medication discrepancies’) (‘Procedure room’ OR ‘Operating room’ OR ‘Operating room’/exp OR ‘Sterilization room’ OR ‘Soiled instruments’ OR ‘Recovery room ‘ OR 'recovery room'/exp OR ‘Hall widths’ OR ‘Door widths’ OR ‘Design requirements’ OR ‘Layout’ OR ‘Emergency power’ OR ‘Power supply’ OR ‘Temperature requirements’ OR ‘Temperature control’ OR ‘Ventilation requirements’ OR ‘Air flow’ OR ‘Air exchanges’ OR ‘Air filtration’ OR ‘Air filters’ OR ‘National Fire Protection Association’ OR ‘Business occupancy’ OR ‘Health care occupancy’ OR ‘Facility design’ OR ‘Facility designs’ OR ‘Health facility environment’ OR ‘Built environment’ OR ‘Physical environment’ OR ‘Physical design’ OR ‘Facility design’) Setting Outcome Facility Standard

Covidence Software

Q1: Effect of ASC vs. Office on Patient Outcomes Records identified through databases and “Grey Literature” (n=1418) Records after duplicates removed (n=1070) Records screened (n=1070) Records excluded (n=886) Full-text articles assessed for eligibility (n=182) Full-text articles excluded (n=173) Studies included in synthesis (n=9)

Q1: Effect of Facility Factors on Patient Outcomes Records identified through databases and “Grey Literature” (n=2690) Records after duplicates removed (n=2100) Records screened (n=2100) Records excluded (n=1838) Full-text articles assessed for eligibility (n=262) Full-text articles excluded (n=250) Studies included in synthesis (n=12)

Assessing Risk of Bias

ROBINS-I Tool Domains of Bias Confounding Selection of participants into study Classification of interventions Deviations from intended interventions Due to missing data Measurement of outcomes Selection of reported result Risk of Bias: Low / Moderate / Serious / Critical

Common Methodological Problems Studies with critical bias = Do not meet minimum quality criteria Adverse event counts, with no denominator Critically biased sample Studies meeting minimum quality criteria (n=10) No control for confounders Imprecise classification of exposure Risk of Bias # Papers Low Moderate 4 Serious 6 Critical 11

Highest quality studies come from claims data Preliminary Findings Little research that examines the relationship between facility setting or factors and patient outcomes for outpatient procedures Much of the research: is poor quality focuses on plastic surgery Highest quality studies come from claims data Inconclusive evidence about relationship between facility requirements and patient outcomes

“Evidence-Informed” Facility Standards Do not look like this: They look more like this:

Nancy Berglas, DrPH Public Health Researcher Nancy.Berglas@ucsf.edu Sarah Roberts, DrPH Associate Professor Sarah.Roberts@ucsf.edu Bonnie Scott Jones, JD Senior Policy Advisor Bonnie.Jones@ucsf.edu

How are facility standards set for other outpatient procedures, and how do they incorporate research evidence? Team: Nancy Berglas, DrPH, Bonnie Scott Jones, JD, Sarah Roberts, DrPH

Key informant interviews (n=20) Study Design Key informant interviews (n=20) Endoscopy, oral surgery, gynecology, plastic surgery Interested in: Motivations for developing standards Processes used to develop standards Use of research evidence in developing standards Decision-making in absence of evidence Lessons learned that may be applicable to abortion?

A Few Findings Concerns about involvement of state legislatures. Support for professional and accreditation organizations Volunteer clinician committees Review existing guidelines, consider research, make recommendations Requirements should be driven by anesthesia / invasiveness, not particular procedure Interest in research evidence, but uncommon  In part because research doesn’t exist! In absence of evidence: Rely on clinical expertise, best practices, provider feedback Ensure standards are not more burdensome than necessary

What are Lessons Learned for Abortion? Typical to have those who perform the procedure involved in developing guidelines for patient safety Evidence matters, but not realistic to expect a clear answer from randomized controlled trials In the absence of evidence Balance of patient safety and burden of requirement Rely on clinical expertise of those who do the procedure

Conclusions No evidence that facility requirements for outpatient procedures are associated with improvements in patient safety, patient satisfaction, or service availability In the absence of conclusive evidence – if the goal is to treat abortion similar to other health care – it is important to Ensure that facility requirements are not more burdensome than the procedure requires Incorporate expertise of those who perform the procedure