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Evidence Brief: The Quality of Care Provided by Advanced Practice Nurses

Ellen McCleery , MPH, Vivian Christensen , PHD, Kimberly Peterson , MS, Linda Humphrey , MD, MPH, and Mark Helfand , MD, MPH, MS.

PREFACE

Quality Enhancement Research Initiative's (QUERI) Evidence-based Synthesis Program (ESP) was established to provide timely and accurate syntheses of targeted healthcare topics of particular importance to Veterans Affairs (VA) managers and policymakers, as they work to improve the health and healthcare of Veterans. The ESP disseminates these reports throughout VA.

QUERI provides funding for 4 ESP Centers and each Center has an active VA affiliation. The ESP Centers generate evidence syntheses on important clinical practice topics, and these reports help:

guide the implementation of effective services to improve patient outcomes and to support VA clinical practice guidelines and performance measures, and

In 2009, the ESP Coordinating Center was created to expand the capacity of QUERI Central Office and the 4 ESP sites by developing and maintaining program processes. In addition, the Center established a Steering Committee comprised of QUERI field-based investigators, VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service Networks (VISN) Clinical Management Officers. The Steering Committee provides program oversight, guides strategic planning, coordinates dissemination activities, and develops collaborations with VA leadership to identify new ESP topics of importance to Veterans and the VA healthcare system.

Comments on this evidence brief are welcome and can be sent to Nicole Floyd, ESP Coordinating Center Program Manager, at vog.av@dyolf.elocin.

EXECUTIVE SUMMARY

This evidence brief discovered little new evidence regarding health outcomes of patients receiving care from an independent advanced practice nurse (APRN) or physician. In primary and urgent care settings, there was no difference in health status, quality or life, mortality, or hospitalizations favoring either APRN or physician care, although the strength of evidence was generally low (see Table 1).

Table 1

Recent publications promoting over-riding state scope-of-practice laws argue that a large body of evidence shows APRNs working independently provide the same quality of care as medical doctors. We found scarce long-term evidence to justify this position.

The generally low strength of evidence outlined in this brief does not necessarily mean that additional randomized trials are necessary to prove comparable health outcomes among patients cared for by APRNs and physicians. Data on performance measures and provider errors, which is routinely collected by the VA, may be a better source of information on the actual quality of care provided by independent VA APRNs.

Strong conclusions or policy changes relating to extension of autonomous APRN practice cannot be based solely on the evidence reviewed here. Although no differences in 4 outcome measures (health status, quality of life, mortality, hospitalizations) were detected, the evidence cannot rule out such differences. Published evidence about performance measures, satisfaction, resource use, and considerations of access to care—as well as the track record of VA facilities that use this model—should be considered.

INTRODUCTION

The term “Advanced Practice Registered Nurse” (APRN) encompasses the Nurse Practitioner (NP), Certified Registered Nurse Anesthetist (CRNA), Clinical Nurse Specialist (CNS), and Nurse Midwife (NM). 1

Today, most NPs practice in primary care. Autonomy or independence has always been central to the concept of a nurse practitioner as a primary care provider. 2 The National Council of State Boards of Nursing defines “independence” as practicing with “no requirement for a written collaborative agreement, no supervision, [and] no conditions for practice.” 3 Although the authority to diagnose and prescribe are the most frequently mentioned aspects of independence, the concept encompasses other dimensions including entry into practice; authority to bill for services independently; access to diagnostic services and hospital admitting privileges; and recognition as primary care providers. 4

Medical licensing is a state function and APRN scope-of-practice (SOP) laws vary from state to state. 5 In 16 states, APRNs have the authority to practice without a written agreement with a supervising physician, 9 states require physician involvement to prescribe but not to diagnose and treat, and in 24 states physician oversight is required to prescribe, diagnose, and treat. 6 The definition of “oversight,” however, varies by state, and most states allow collaboration or supervision to occur remotely. 7 There is also variation in SOP laws regarding APRNs' authority to supervise clinical staff. For example, one article notes a requirement in sections 2069–71 of the California Business and Professions Code that doctors and selected other professions— but not registered nurses—may supervise California medical assistants. 8

While there is disagreement about whether APRNs should practice independently, the seemingly arbitrary variation in SOP laws among the states is nearly universally criticized. As an editorial from the Commonwealth Fund put it, “objectively interpreted data on the competencies of professionals should guide policy, not rigid, often antiquated state laws.” 9

The National Governors Association 10 and the Institute of Medicine (IOM) 11 have criticized variation in SOP regulations among the states, and both argue that nurses should be able to practice to the “full extent of their education and training” in order to adapt to the changing health care system after the implementation of the Affordable Care Act (ACA), which authorizes nurse-managed health clinics and other innovations. In March, 2014, a report from the Federal Trade Commission, relying in large part on the IOM report, argued that physician supervision or collaborative practice agreement requirements “may sometimes restrict competition unnecessarily, which can be detrimental to health care consumers and have broader public health consequence,” that is, “decreased access to health care services, higher health care costs, reduced quality of care, and less innovation in health care delivery.” 12 In the context of the ACA, one emergent issue is whether some patient care teams should be led by a nurse practitioner instead of only a medical doctor. Other advocates for change argue that, nationally, removing restrictions on NP practice would improve access to primary care and allow NPs to emerge as leaders of the integrated teams that are an important component of new models for delivering primary care. 8 , 13 , 14

THE IMPACT OF STATE SOP REGULATION

Despite the strong statements from multiple groups, there has been very little formal study of the impact of SOP laws on access to and quality of care. The National Governors Association report, supporting the elimination of most SOP restrictions for APRNs, notes:

Although there is a growing body of evidence from health services research that suggests that NPs can deliver certain elements of primary care as well as physicians, there is a dearth of rigorous research that isolates the effect of NP scope of practice rules on health care quality, cost, and access at the state level. 10

More restrictive SOP rules are probably associated with slower growth in the number of NPs 15 and in the number of Medicare patients cared for by NPs. 16 In both 2006 and 2010, the odds of having an NP as a primary care provider were 2.5 times higher in the least restrictive states compared to the most restrictive states. 16 These findings have not been directly associated with overall access to primary care, and it is unclear whether SOP rules exert this effect directly, or indirectly via the policies of state and private payers. In an extensive provider survey, “at the point of care, scope-of-practice laws were not found to have substantial impact across the study states on what services NPs can deliver, despite significant differences across states in the level of NP autonomy…” 17 Rather, the study found that payer policies had more impact than SOP laws on how and where NPs can practice. 17 Payers in states with restrictive SOP laws often add additional restrictions, such as not recognizing NPs as primary care providers, that make independent NP practice difficult. In addition, Medicare policies do not permit a NP to order home health care or durable medical equipment, even in states in which NPs practice independently.

Other arguments made by advocates for APRNs about the adverse effects of SOP restrictions are based on hypothetical reasoning or on anecdotes concerning inefficient use of time and, in some cases, delay in needed care because a physician's approval was required to prescribe, order equipment, or admit a patient to the hospital.

PHYSICIAN GROUP PERSPECTIVES

Physician groups that support SOP restrictions envision a system in which physicians delegate the care of less complex patients to (supervised) nurse practitioners; one physician advocacy group has estimated that “nurse practitioners and physician assistants are capable of providing 70% or more of the care required for adults and 90% in pediatrics.” 18 According to J.K. Iglehart, the AMA supports team-based care but argues that teams should be led by medical doctors, as integrated systems such as Geisinger, Kaiser Permanente, and the VA have done. 5

These groups also argue that physicians may be better able to manage complicated diagnostic problems, patients with multiple chronic conditions, and unstable patients. These claims are plausible—as Blumenthal and Abrams note, “[p]hysicians and nurse practitioners receive very different training, and it would be surprising if their competencies were identical.” 9 However, no studies have been done to examine the validity of these beliefs.

Physician groups also argue that policymakers should take into account that patients prefer having a medical doctor as a primary care provider and that use of the title “doctor” by APRNs who have completed doctoral training could confuse patients about the training of their provider. 19 Evidence about patients' preferences regarding the type of provider is conflicting.

VETERANS HEALTH ADMINISTRATION PRACTICE ENVIRONMENT AND PREVIOUS RESEARCH

In the Veterans Health Administration (VHA), the use of APRNs in the delivery of health care, including primary, specialty, acute, and home health care, expanded greatly after the implementation of the Veterans Integrated Service Network (VISN) structure in October 1995 and the Veterans Health Care Eligibility Reform Act in 1996 (Public Law 104-262). 20 These changes resulted in a shift to local and regional networks grounded in ambulatory and primary care, 21 an increase in the number of patients served by the VHA, and an increase in the percentage of patients seeking primary care services: 20% in fiscal year 1994 to 76% in fiscal year 1996. In 1996, 75% of VHA primary care practices reported using NPs and by 1999, this proportion had risen to 90%. 22 Today the VHA employs over 4,700 nurse practitioner full time equivalents, 786 CRNAs, and 482 CNSs. 23

Currently, although a single unrestricted license allows APRNs to work at any VA facility, the VHA observes state-by-state rules regarding prescribing and admission privileges and physician supervision for APRNs. Each VA institution establishes its own policies regarding all other aspects of scope of practice. Advocates for “federal supremacy” argue that overriding state laws would “increase access to health care services, reduce costs and improve the quality and availability of health care” for Veterans by eliminating bureaucratic complexity and “artificial barriers” such as supervisory requirements. 23 , 24 They note that varying regulations for diagnosing and prescribing can delay appropriate care and waste time and resources, particularly for CNSs in cardiology and other specialties working in VA facilities that serve patients from more than one state.

Research on APRNs in the VHA has been sporadic, and has focused on NPs rather than CRNAs or CNSs. From 1995 to 1999, the VHA HSR&D conducted one single-center RCT 25 and several observational studies of the impact of NPs on access to specialty care, continuity of care, and resource use. 26 - 29 Some studies demonstrated improved continuity of and access to care after implementation of an interdisciplinary firm system, 27 - 29 however, little research was conducted in the 2000s. 20 , 30 The best recent data are from a 2011 cross-sectional study of all VISN 11 primary care patients who had hypertension and/or diabetes. 20 VISN 11 includes 2 states (Illinois, Michigan) with very restrictive scope of practice laws and 2 states (Ohio, Indiana) with moderately restrictive laws. The main findings were:

On average, primary care NPs cared for less complicated patients than primary care physicians. MDs were caring for the more complex patients within the study sites.

Provider type was not significantly associated with an elevated blood pressure or creatinine level in either diabetic or hypertensive patients nor with an elevated HbA1c in diabetics.

Increased use of resources by NPs was not demonstrated. NPs were less likely than physicians to obtain psychiatric referrals.

A survey of VISN 11 NPs and MD providers was also part of this study. The main findings were:

Over 80% of NPs said they assess acutely ill/unstable patients on their own, and about 70% said they also plan care and make medication changes on their own.

Nevertheless, there were “striking differences” between physicians' and nurses' beliefs about the NPs' scope of practice. About 50% of physicians (vs 21% of NPs) were apprehensive about the fact that NPs function on their own, particularly for acute/unstable patients.

A 2012 ESP report reviewed the evidence on the role of primary care providers' skill level (MD vs NP/PA) in ambulatory care settings in influencing patient outcomes from a VHA perspective. 31 The authors of the ESP report stated that they “did not review studies that examined the effect of skill levels on patient quality of care or patient safety as it is widely accepted that medical school or more training increases quality of care.” The best evidence the ESP identified came from 2 randomized controlled trials which consistently found no difference in patient satisfaction with provider interaction when seeing a NP/PA instead of an MD. The ESP report also noted that a large VA study of patient satisfaction among 1.6 million veterans seen in 21 VISNs provided some limited information about impact of skill level: patient satisfaction increased in 3 VISNs that hired more NP/PAs.

USE OF EVIDENCE IN POLICY DEBATES

In a policy paper, Newhouse and colleagues state “[o]nce the issue of comparability between APRN care and that delivered by physicians is set aside in favor of an integrated team concept, disciplines can focus on…overarching goals” such as developing patient-centered team care, reducing quality gaps, and educating an interprofessional workforce. 32 Their recent systematic review of RCTs and observational studies supports the emphasis on team care outlined in their policy paper. Including all types of APRNs, intermediate and health outcomes, and various patient populations and settings, Newhouse et al concluded that the outcomes of care provided by APRNs in collaboration with specialist or primary care physicians are similar to, or in some cases better than, the outcomes of care provided by a physician alone. 33

Although Newhouse et al's emphasis on the role of APRNs in integrated teams is more relevant to the current organization of primary care services in VHA, policy discussions about over-riding state SOP laws invoke the argument that APRNs working independently provide the same quality of care as medical doctors. 11 , 24 , 34 The Institute of Medicine, for example, claims that a large body of evidence “does not support the conclusion that APRNs are less able than physicians to provide safe, effective, and efficient care.” 11 Similarly, a publication from the Robert Wood Johnson Foundation (RWJF) asserts that “health outcomes are comparable for patients treated by primary care NPs and MDs.” 24

Most articles about the role of APRNs do not explicitly define the autonomy of the nurses, compare non-autonomous nurses with physicians, or evaluate nurse-direct protocol-driven care for patients with specific conditions. 35 However, studies like these are often cited in support of the claim that APRNs practicing autonomously provide the same quality of primary care as medical doctors. For example, the RWJF publication quoted above refers to a review by Naylor and Kurtzman 14 that relied on 2 systematic reviews published in 2002 and 2005 36 , 37 and 2additional randomized trials published in 2009. Many of the trials included in 2 older systematic reviews were considered by Naylor and Kurtzman. 36 , 37

The first additional trial comparing NP and general physician care was conducted 2 months after the NPs successfully completed a Masters-level training program. As nurses were not permitted to prescribe independently, physicians were “always available for consultation and to validate prescriptions and referrals.” 38 The second randomized trial included in the Naylor and Kurtzman review evaluated a 4-visit, computer-guided, nurse-led intervention for overweight and obese patients conducted in 11 general practice (GP) locations. 39

Most research on APRNs has evaluated team models of care or interventions designed to enhance care for patients with specific conditions (eg, incontinence, bronchiectasis, heart failure, etc.). 36 , 37 , 40 , 41 The evidence supporting the contributions of APRNs in team models of care, protocol-driven care and nurse-led intervention focusing on a specific patient population is relevant to VHA and reasonably up-to-date. 33 , 35 VA-ESP recently published a report that concluded there is strong evidence that nurse-managed protocols help to improve health outcomes among patients with moderate severity of diabetes, hypertension, hyperlipidemia, and chronic heart failure. 42

Nevertheless, the issue of the comparability of health outcomes of autonomous APRNs and physicians continues to be a cornerstone of the debate regarding state SOP rules. Because no previous systematic review has focused on this issue, the VHA Office of Quality, Safety and Value commissioned the VA Evidence-based Synthesis Program (ESP) Coordinating Center to reevaluate recent, original studies that reported health outcomes.

SCOPE

The objective of this evidence brief is to assess the strength and relevance of studies comparing autonomous APRNs with physicians in primary care, urgent care, and anesthesia settings for 4 important outcomes: health status, quality of life, hospitalizations, and mortality. We did not include process of care measures (such as access to care or resource use), performance measures (eg, blood pressure or glucose control), or patient satisfaction. We did not include studies of the work of APRNs (primarily CNSs) in team-based care or in interventions designed to augment usual care, nor care provided by nurse midwives.

The ESP Coordinating Center investigators and representatives of the Office of Quality, Safety and Value worked together to identify the population, intervention, comparator, outcome, timing, setting, and study design characteristics of interest. The Office of Quality, Safety and Value approved the following key questions and eligibility criteria to guide this review:

KEY QUESTIONS

Key Question 1. Do independent advanced practice nurses and physicians provide comparable quality of care?

Key Question 2. Does the quality of care provided by advanced practice nurses vary by the type of care (eg, primary or specialized care) being provided or by the setting of practice?

Key Questions 3. Does the quality of care provided by advanced practice nurses vary by their degree of autonomy?

INCLUSION CRITERIA

Intervention: A nurse or nurses practicing primary care, urgent care, or anesthesia with a high degree of autonomy. We included advanced practice nurses (including nurse practitioners (NP), clinical nurse specialists (CNS), specially-trained nurses, and certified registered nurse anesthetists (CRNA)). We did not include studies of Nurse Midwife (NM) care since the VA does not employ these providers.

Outcomes: hospitalizations, mortality, health status (resolution of symptoms, overall improvement, or functional status), quality of life.

To address Key Question 1, we searched for evidence for the direct comparison between care provided by an advanced practice nurse and care provided by a physician. In Key Questions 2 and 3, we sought to identify the factors that mediate the relationship between type of provider (advanced practice nurse or physician) and quality of care. Potential factors that might influence this relationship include the type of care being provided, the setting of practice, or the degree of autonomy of the advanced practice nurse.

METHODS

Brief or rapid review methodology is still developing and there is not yet consensus on what represents best practice. For example, limiting the number of electronic databases, excluding studies published in languages other than English, and forgoing a specific search for gray literature could introduce bias. An evidence brief differs from a full systematic review in that the scope is narrowly defined and the traditional review methods are streamlined in order to synthesize evidence within a shortened timeframe. An evidence brief does not outline the context in which the information is to be used and does not present a comprehensive assessment of knowledge on the topic.

Reference lists from existing systematic reviews and meta-analyses provided literature dating from 1969 to 2009. Additionally, we searched PubMed and CINAHL (2008-November 2013) using terms for advanced practice nurse and quality of care (see Supplemental Materials for complete search strategies). Additional citations were identified from hand searching reference lists, and consultation with content experts. We limited the search to published and indexed articles involving human subjects available in the English language. Study selection was based on the eligibility criteria described above. Titles, abstracts, and full-text articles were reviewed by one investigator and checked by another. All disagreements were resolved by consensus.

We rated the internal validity (quality) of controlled trials using methods from the Agency for Healthcare Research and Quality (AHRQ). 43 We abstracted data from all included studies on intervention and patient characteristics and results for each included outcome. All data abstraction and internal validity ratings were first completed by one reviewer and then checked by another. All disagreements were resolved by consensus.

We graded the strength of the evidence based on the AHRQ version of the GRADE working group system. 44 This approach incorporates 4 key domains: risk of bias (includes study design and aggregate quality), consistency, directness, and precision of the evidence. It also considers other optional domains that may be relevant for some scenarios, such as a dose-response association, plausible confounding that would decrease the observed effect, strength of association (magnitude of effect), and publication bias. Strength of evidence is graded for each key outcome measure and ratings range from high to insufficient, reflecting our confidence that the evidence reflects the true effect. For example, “low” strength of evidence means “[o]ur confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.” 45

A previous version was reviewed by 4 invited peer reviewers. Reviewer comments and author responses can be found in the Supplemental Materials.

RESULTS

OVERVIEW

Figure 1 provides the results of the study selection process. We included 4 controlled trials conducted in urgent care settings, 46 - 49 3 controlled trials in primary care settings, 25 , 50 - 53 and 3 observational studies in inpatient anesthesia care 54 - 56 (see Data Abstraction Table in Supplemental Materials, pages 6-9).

Figure 1

Literature Flow Chart.

The primary outcome measures in the 3 urgent care trials were cost-effectiveness, 49 patient satisfaction, 48 processes of care, 47 and health status. 46 The primary outcomes in the 3 primary care trials were cost-effectiveness, 50 resource use, 25 and health status, 53 but they also reported on quality of life, 50 mortality, 25 , 50 and hospitalizations. 25 , 50 , 53

Classic studies such as the Burlington Randomized Trial of the Nurse Practitioner, 57 the St. John's Randomized Trial of the Family Practice Nurse, 58 and others demonstrated that advanced practice nurses in primary care could perform the activities traditionally associated with primary care physician practice and, in the short term, maintain comparable clinical outcomes among their patients. 59 However, since the 1970s, the content and complexity of primary care practice and nurse and physician education has changed substantially. These studies are now outdated and will not be considered in this evidence brief.

KEY QUESTION 1. Do independent advanced practice nurses and physicians provide comparable quality of care?

Health Status

Urgent Care. Four studies conducted in “urgent care” (same day consultation) settings that compared independent APRNs with physicians found no difference in resolution of symptoms 2 weeks after the encounter (Table 1). 46 - 49 The urgent care practices examined in these studies included general practices ranging from rural to urban settings, serving 3,000 to over 16,000 patients, and with one to more than 5 partners, although several studies did not provide practice characteristics. 46 - 49 Two studies compared Nurse Practitioners and physicians 47 , 49 while 2 studies compared specially-trained nurses and physicians. 46 , 48 The urgent care study samples were mostly female and the most common presenting condition in all 4 studies was respiratory infection or other acute conditions. 46 - 49 Comorbidities of the patients included in the urgent care studies were not reported (see the Supplemental Materials for additional details of the patients).

None provided information on longer-term outcomes. While the studies are reassuring in that they found no differences, additional research that followed patients longer and used more detailed measures of health status might uncover differences (Strength of Evidence: low). See the Supplemental Materials for additional details of these trials.

Primary Care. A randomized controlled trial by Mundinger and colleagues is the best available evidence regarding the effectiveness of independent primary care NPs in the primary care setting. 53 Patients recruited from an urgent care center and 2 emergency rooms were randomly assigned to a provider in a clinic staffed exclusively by NPs or to a clinic staffed by physicians (Table 1). 53 There was no difference between the nurse practitioner group and the physician group in physical or mental Medical Outcomes Study Short-Form Health Survey (SF-36) scores for the 79% of enrolled patients who completed the 6-month follow-up interview (physical component summary scores (adjusted for age, sex, baseline scores, and selected chronic conditions): NP group: 40.53; physician group: 40.60; P=0.92).

Table 1

Effect of care by an APRN on health status.

Strengths of this large study (1,316 patients, 7 NPs, 11 physicians) were that NP and MD practices were not co-located and practitioners were not necessarily aware of patient's involvement in the study. Patients were also new to both groups of providers and NPs had the same authority as MDs to prescribe, consult, refer, and admit patients.

The main weakness of the study was that 6 months is not an adequate follow-up time for the outcome of health status. The care provided in 6 months was too short to represent continuity care. Within the 6-month follow-up period, for example, 42% of patients had 0 or 1 primary care visits. As Sox noted in an editorial that accompanied the trial, “The short duration of the trial limits its ability to test a health professional's competence across the broad spectrum of primary health care.” 60 After 2 years, researchers were able to contact 66% of the enrolled patients, and 55% of them had returned to their originally assigned provider. 52 In this subsample, there were differences in NP-assigned patients (n=222) and the physician-assigned patients (N=184) in the proportion of Hispanics (94.5 vs 89.6%), Medicaid enrollees (87.4 vs 95.7%) and other characteristics, so that the benefits of randomization had been lost. Another weakness is that the data, which were collected between 1995 and 1997, are now over 20 years old.

Quality of Life

Primary Care. Information about quality of life is insufficient to draw any conclusions. Only one randomized controlled trial measured quality of life using the EQ-5D questionnaire, which captures 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 50 Respondents were asked to rate each domain using a 3 point scale (no problems, some/moderate problems, and extreme problems). The authors reported no statistically significant changes in EQ-5D scores for each of the patient groups over time or between groups, but did not provide any data.

Table 2 Effect of care by an APRN on quality of life

Strength of evidence: Insufficient (medium risk of bias, consistency unknown, direct, precision unknown)

Mortality

Primary Care. Two randomized controlled trials reported on mortality among patients cared for by APRNs and physicians (Table 3). These studies were not designed to test differences in mortality between the 2 groups of patients. While both studies directly compared care provided by an APRN and care provided by a physician and consistently reported no difference between the 2 groups after follow-up, small sample sizes make these estimates imprecise.

Table 3

Effect of care by a NP or CNS on mortality.

In the first study with 2 years of follow-up, 50 researchers found no difference in mortality between the nurse and physician group (5/149 (3.3%) and 4/145 (2.7%), respectively). The second study, with 1 year of follow-up, 25 found no statistically significant differences in mortality between patients cared for by APRNs or physicians (5/150 (3.3%) and 3/150 (2%), respectively).

Mortality is not a practical measure of quality for primary care. While the evidence on this outcome is sparse, it is a priori unlikely that studies comparing different practitioners (APRNs vs MDs, APRNs vs other APRNs, or MDs vs other MDs) would find differences in mortality except for very high-risk patient panels. While the available evidence is imprecise, it is unlikely that additional evidence from studies of unselected primary care patients would change the conclusion.

Hospitalizations

Urgent Care. Information about hospitalizations in an urgent care setting is insufficient to draw any conclusions. One urgent care randomized controlled trial reported hospitalizations as an outcome (Table 4). 48 This study reported no difference in hospitalizations between the nurse practitioner and physician groups after 2 weeks (1/675 (< 1%) and 3/664 (< 1%), respectively).

Table 4

Effect of care by an APRN on hospitalization.

Primary Care. Three primary care studies examined hospitalizations among patients treated by an APRN or a physician and found no difference between the 2 groups (Table 4). 25 , 50 , 53 As with mortality, these studies were not designed to test differences in hospitalizations between the 2 groups of patients. All 3 studies compared care provided by an APRN and care provided by a physician and consistently reported no difference in hospitalizations between the 2 groups. However, small sample sizes make these estimates imprecise.

Mundinger et al found no statistically significant difference between patients assigned to the nurse practitioner and physician group at one year (68/800 (8.5%) and 50/509 (9.8%), respectively; P=0.42). 53 Another randomized controlled trial by Arts et al 50 reported no statistically significant difference in hospitalizations between the group receiving care from a nurse specialist and the group receiving care from a physician after 2 years (43 (4.3%) and 42 (5.4%), respectively). 50 The remaining primary care study found a trend towards more hospitalizations for the nurse practitioner group, but results were not statistically significant (mean hospitalizations per patient-year for NPs=0.43, attending physicians=0.31). 25

Patient case mix and policies on hospitalization vary widely among settings. For primary care, care by a NP or CNS versus a physician probably does not affect the risk of hospitalization in published studies, but applicability to the VA is limited; only one of the studies was conducted in a VA setting. With the background of this literature, observational data from current VA clinics would be valuable to assess applicability. While not as rigorous as evidence from randomized trials, observational data would reflect the quality that results from current VA policies on assignment of patients to nurse practitioners in primary and urgent care and would be applicable to VA facilities in states that do not permit independent APRN practice.

CRNAs

In anesthesia, 2 major issues are whether CRNAs should be candidates to lead teams specializing in outpatient chronic pain management and which surgical patients can be managed independently by a CRNA.

Chronic Pain Management. VA-based CRNAs have argued that an expanded SOP is needed to permit them to practice independently, particularly in pain management clinics. While nurse-led pain management clinics are described in numerous studies, we found no studies comparing a nurse-led pain clinic to one led by a physician.

Surgical and Procedural Anesthesia. VHA anesthesiologists have objected to expanding the scope of practice of CRNAs on the grounds that CRNAs lack experience in the care of higher-risk surgical patients.

No randomized trials compared outcomes of surgical patients managed by an independent CRNA with those managed by teams, anesthesiologists, or other physicians.

In 2004, a narrative review provided an excellent critical appraisal of older observational studies, concluding “it is not possible to draw a conclusion regarding differences in patient safety as a function of provider type.” 61 The limitations of the older studies were “difficulty in risk adjustment, failure to define precisely how hospital anesthesia providers are utilized, and lack of consideration of resources and processes beyond the anesthesia provider model that may also affect outcomes.” 62

For this evidence brief, we reviewed 3 frequently cited observational studies that used claims data to compare mortality and length of stay (Table 5). 54 - 56

Table 5

Effect of care by a CRNA on mortality.

The first study (Silber) analyzed Pennsylvania Medicare claims from 1991 to 1994 for 194,430 major surgical and orthopedic operations billed as “personally performed” or directed by an anesthesiologist and 23,010 not billed as performed or directed by an anesthesiologist. 56 The latter group represented a mix of cases supervised by a surgeon, a staff CRNA, or an anesthesiology resident. After accounting for hospital and patient characteristics, the adjusted 30- day mortality rate (OR =1.08; 95% CI: 1.00, 1.15; P<0.04) and the adjusted mortality rate after complications (OR=1.10; 95% CI: 1.01, 1.18; P<0.01) were higher among patients managed without medical direction by an anesthesiologist. The rates of complications were similar.

Although it is very frequently cited in debates about CRNA care, 63 we found this study had little relevance to the current question because the comparison group does not directly represent care provided by an independent CRNA. It is also unlikely that the methods for risk adjustment were adequate; for example, undirected cases were performed in smaller hospitals, and, by itself, hospital size does not adequately explain differences in mortality due to failure to rescue.

The second study (Pine) used 1995 -1997 Medicare claims from 22 states to compare adjusted inpatient mortality when anesthesia was provided by an anesthesiologist alone, a CRNA alone, or a team consisting of an anesthesiologist and a CRNA. 55 To avoid some of the limitations of the previous study, the sample excluded emergency cases, cases from hospitals with low surgical volumes, and cases that had no Medicare Part B data, no anesthesia bill or an incomplete bill, or ambiguous provider codes. A total of 182,000 of 586,422 potentially eligible surgeries were excluded because of these criteria. Only 33,151 (8.2%) of the remaining 404,194 cases were managed by a CRNA alone. Risk-adjusted mortality rates were not significantly different between type of anesthesia provider or practice organization.

The third study (Dulisse and Cromwell) suggests that, for patients with low complexity (surgeries comparable in complexity to a thyroid biopsy), care by a CRNA alone is comparable to care by a team or a solo MD. 54 This study compared 1999 to 2005 Medicare data from states that opted out versus states that did not opt out of a requirement for physician supervision of CRNAs. This study found:

In opt-out states (14 primarily rural states ‡ ), surgical mortality and complication rates for patients managed by independent CRNAs did not change after the states opted out of the CMS supervision requirement.

In non-opt-out states, surgical mortality among patients whose anesthesia was provided by a CRNA was lower compared with patients whose anesthesia was provided by a physician, and there was no difference in complications between these 2 groups.

Mortality and complication rates were lower for all patients (physician, CRNA, and team care) in opt-out states (both before and after opting out) compared with physician patients in non-opt-out states.

In general, patients managed by solo CRNAs were less complex than those managed by solo MDs. Despite adjustment for patient characteristics (age, sex, and race), procedure complexity (captured with procedure base units), and year, the methods used in the study to capture the complexity of surgery and relevant comorbidity were not adequate to exclude selection bias as an explanation for the results. That is, the lack of differences in patient outcomes might be due to triage of less complex cases to CRNAs. 64

The results of these studies do not provide any guidance on how to assign patients for management by a solo CRNA, or whether more complex surgeries can be safely managed by CRNAs, particularly in small or isolated VA hospitals where preoperative and postoperative health system factors may be less than optimal. To determine how CRNAs function within the VA or which procedures or surgeries would best be managed by which provider (CRNA, physician, or team), studies conducted within the VHA would be optimal.

KEY QUESTION 2. Does the quality of care provided by advanced practice nurses vary by the type of care being provided or by the setting of practice?

We did not identify any studies that were designed to study whether the quality of care provided by advanced practice nurses varies by the type of care being provided or by the setting of practice. While previous systematic reviews have included studies of APRNs in a variety of settings, none have compared outcomes across these settings. Due to the small number of included studies we cannot conclude that the quality of care provided by APRNs does or does not vary by setting of practice (eg, hospital vs free-standing clinics, multispecialty vs solo practice, or differing case mix managed by a CRNA).

KEY QUESTION 3. Does the quality of care provided by advanced practice nurses vary by their degree of autonomy?

We did not identify any studies that examined whether the quality of care provided by advanced practice nurses varied by their degree of autonomy. Such a study would compare the outcomes of care provided by advanced practice nurses who were required to have physician involvement to diagnose, treat, and prescribe; those that were required to have physician involvement to prescribe; and those that were not required to have any physician involvement. The variation in scope-of-practice regulations throughout the US may hinder the feasibility of such a study.

While there was variation among the included studies regarding the autonomy or supervision of APRNs, there were not enough studies or data to make a meaningful comparison of the quality of care provided by APRNs compared with physicians by the degree of autonomy or supervision. Two controlled trials included nurses that worked according to a protocol. 46 , 50 In another study, physicians were required to review and countersign all charts but approval was not required for referrals, tests, or treatment plans. 25 In the 3 studies conducted in the UK, nurses required a doctor's signature in order to prescribe. 47 - 49 Finally, in one RCT nurse practitioners and physicians had the same authority to prescribe, consult, refer, and admit patients. 53 In this study, nurse practitioners and physicians worked with a collaborative agreement that required 1) doctors to respond when a nurse requested consultation and 2) quarterly meetings to review charts.

SUMMARY OF MAIN FINDINGS

Table 6 summarizes the main findings of this evidence brief.

Table 6

There was insufficient information on whether the quality of care provided by advanced practice nurses varies by the setting of practice to draw any conclusions. Similarly, there was no information on whether the quality of care provided by advanced practice nurses varies by degree of autonomy.

DISCUSSION

This evidence brief found that evidence regarding 4 important outcomes of patients cared for by a nurse working autonomously is inconclusive. Other systematic reviews have noted the small body of evidence regarding health outcomes of patients receiving care from an APRN or physician. 37 , 41 , 61

The studies we reviewed did not demonstrate a difference between APRN care and physician care in primary and urgent care settings with regard to health status, quality of life, mortality, or hospitalizations. However, these studies were not large enough, and did not follow patients long enough, to exclude a possible difference. Only 2 controlled trials 46 , 53 determined their necessary sample size based on the outcomes included in this evidence brief. While one study was conducted in a VAMC, 25 the applicability of the findings of other studies may be limited given that the VA population has poorer health status and a higher rate of comorbidities compared with other patient populations. 65 A study of all General Internal Medicine Clinic patients (n=5,478) at 7 VAMCs reported that patients had an average of 3.79 comorbidities, 23.6% had diabetes, 59.4% had hypertension, and 19.2% had coronary artery disease. 66 The proportion of hypertensive patients was much lower in 2 studies reporting this condition. 25 , 53 Similarly, in the study that was not specifically recruiting diabetic patients, the proportion of diabetic patients was lower. 53 One included study focused on patients with type 1 and 2 diabetes recruited from an inpatient setting, but excluded more complex patients that the investigators thought should not be treated by a CNS. 50 Again, this demonstrates the higher complexity of VA patients compared with other populations.

The lack of rigorous new evidence comparing care provided by an autonomous primary care APRN versus a physician alone is not surprising. Well-publicized, well-conducted randomized trials conducted in the 1970s proved the concept that an autonomous primary care APRN can deliver care comparable to that provided by a primary physician. These studies may have made further proof of equivalence seem unnecessary, particularly since independent APRN practice in primary care and urgent care were widely implemented in many states and throughout the VA, where rigorous quality assessment has been applied since the 1990s.

It is less clear why the practice of anesthesiologists and CRNAs has not been evaluated in prospective studies. We identified 3 observational studies, the largest and most recent of which suggest that there is not an increased risk of mortality due to CRNA care. 54 , 55 However, these studies have a number of limitations, as described above. Our findings were similar to those of Newhouse et al, who characterized the available evidence regarding independent practice by nurse anesthetists as “sparse data from single observational studies of low quality.” 33

The generally low strength of evidence outlined in this brief does not necessarily mean that additional randomized trials are necessary to prove comparable health outcomes among patients cared for by APRNs and physicians. The historical studies and recent literature provide little reason to suspect that there is a difference between APRN care and physician care in primary and urgent care settings with regard to health status, quality of life, mortality, or hospitalizations. Data on performance measures and provider errors, which is routinely collected by the VA, may be a better source of information on the actual quality of care provided by independent VA APRNs.

We did not address the roles of advanced practice nurses in teams, nurse-managed protocols, or nurse-led interventions supplemental to usual care. These roles are well-accepted and have been shown to improve target outcomes. 33 , 42 These roles of APRNs are well-accepted. The decision to expand the use of such models within the VA should be based on the results of the review by Newhouse et al and on quality and performance data from VA facilities that employ such models (eg, VA Patient Aligned Care Teams (PACTs)).

Instead, our focus was on major health outcomes of patients cared for by a nurse working autonomously because arguments against scope-of-practice regulations are predicated on the argument that the quality of care provided by APRNs is no different from that provided by physicians. We did not find any papers that evaluated nurse-led patient care teams similar to the VA-PACT or medical home model.

This review also addresses a narrower range of outcomes than may be of interest to broader audiences of healthcare providers and policymakers, such as resource use beyond hospitalizations, processes of care, and intermediate outcomes. The evidence outlined in this brief is not the only pertinent information relating to independent APRN practice within the VA. All but 2 of the studies were designed to evaluate measures we did not evaluate: resource use, patient satisfaction, or processes of care. A review on resource use, patient satisfaction, quality measures, or errors among APRNs and physicians would have included additional studies beyond those evaluated here.

Strong conclusions or policy changes relating to extension of autonomous APRN practice cannot be based solely on the evidence reviewed here. Although no differences in 4 outcome measures (health status, quality of life, mortality, hospitalizations) were detected, the evidence cannot rule out such differences. Published evidence about performance measures, satisfaction, resource use, and considerations of access to care—as well as the track record of VA facilities that use this model—should be considered.

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SUPPLEMENTAL MATERIALS

SEARCH STRATEGIES

CINAHL Search (November 26, 2013)

Advanced Nursing Practice

(MH “Anesthesia Nursing”) OR (MH “Advanced Nursing Practice+”) OR (MH “Advanced Practice Nurses+”) OR (MH “Scope of Nursing Practice”) OR (MH “Nurse Practitioners+”) OR (MH “Clinical Nurse Specialists”)

(MH “Quality of Health Care+”) OR (MH “Fatal Outcome”) OR (MH “Treatment Failure”) OR (MH “Treatment Outcomes+”) OR (MH “Outcome Assessment”) OR (MH “Nursing Outcomes”) OR (MH “Medical Futility”) OR (MH “Outcomes (Health Care)+”) OR (MH “Quality Assessment”) OR (MH “Program Evaluation”) OR (MH “Clinical Indicators”)

Limits

NOT (MH “Midwifery+”)

2008 to present

PubMed Search (November 26, 2013)

(((“Outcome and Process Assessment (Health Care)”[Mesh]))

(((((APRN[Title/Abstract]) OR NP[Title/Abstract]) OR CRNA[Title/Abstract])) OR (((((“Nurse Practitioners”[Mesh]) OR “Nurse Clinicians”[Mesh]) OR “Nurse Anesthetists”[Mesh])) OR “Advanced Practice Nursing”[Mesh]))) NOT (“Midwifery”[Mesh] OR “Nurse Midwives”[Mesh])

(((((“Cohort Studies”[Mesh]) OR “Controlled Clinical Trial”[Publication Type]) OR “Case-Control Studies”[Mesh])) OR ((“Evaluation Studies”[Publication Type]) OR “Comparative Study”[Publication Type])) OR ((“Comparative Study”[Publication Type]) OR “Follow-Up Studies”[Mesh])

evaluation studies[pt] OR evaluation studies as topic[mesh] OR program evaluation[mesh] OR validation studies as topic[mesh] OR (effectiveness[tiab] OR (pre-[tiab] AND post-[tiab])) OR (program*[tiab] AND evaluat*[tiab]) OR intervention*[tiab]

“Case-Control Studies”[Mesh] OR “Control Groups”[Mesh] OR (case[TIAB] AND control[TIAB]) OR (cases[TIAB] AND controls[TIAB]) OR (cases[TIAB] AND controlled[TIAB]) OR (case[TIAB] AND comparison*[TIAB]) OR (cases[TIAB] AND comparison*[TIAB]) OR “control group”[TIAB] OR “control groups”[TIAB]

((“Veterans Health”[Mesh])) OR (((VA OR Veteran OR VAMC OR Veterans)) OR (“Veterans”[Mesh] OR “United States Department of Veterans Affairs”[Mesh] OR “Hospitals, Veterans”[Mesh]))

Limits

2008 to present

LIST OF EXCLUDED STUDIES

(testing nurse-led intervention supplemental to usual care, intervention not compared to physician care, study population not relevant to VA, clinical outcomes not reported)

Becker DM, Yanek LR, Johnson WR Jr., et al. Impact of a community-based multiple risk factor intervention on cardiovascular risk in black families with a history of premature coronary disease. Circulation. 2005 Mar 15; 111 (10):1298–1304. [PubMed : 15769772 ]

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Caine N, Sharples LD, Hollingworth W, et al. A randomised controlled crossover trial of nurse practitioner versus doctor-led outpatient care in a bronchiectasis clinic. Health technology assessment (Winchester, England). 2002; 6 (27):1–71. [PubMed : 12433318 ]

Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA : the journal of the American Medical Association. 2006 May 10; 295 (18):2148–2157. [PubMed : 16684985 ]

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Colligan M, Collins C, Foley B, Jones P, Miles J, Zeng I. Emergency nurse practitioners: do they provide an effective service in managing minor injuries, compared to emergency medicine registrars? The New Zealand medical journal. 2011 Oct 14; 124 (1344):74–80. [PubMed : 22016166 ]

Conlon P. Diabetes outcomes in primary care: evaluation of the diabetes nurse practitioner compared to the physician. Primary Health Care. 2010; 20 (5):26–31.

Counsell SR, Callahan CM, Clark DO, et al. Geriatric care management for low-income seniors: a randomized controlled trial. JAMA : the journal of the American Medical Association. 2007 Dec 12; 298 (22):2623–2633. [PubMed : 18073358 ]

Deshefy-Longhi T, Swartz MK, Grey M. Characterizing nurse practitioner practice by sampling patient encounters: an APRNet study. Journal of the American Academy of Nurse Practitioners. 2008 May; 20 (5):281–287. [PubMed : 18460169 ]

Dierick-van Daele AT, Metsemakers JF, Derckx EW, Spreeuwenberg C, Vrijhoef HJ. Nurse practitioners substituting for general practitioners: randomized controlled trial. Journal of advanced nursing. 2009 Feb; 65 (2):391–401. [PubMed : 19191937 ]

Dinh M, Walker A, Parameswaran A, Enright N. Evaluating the quality of care delivered by an emergency department fast track unit with both nurse practitioners and doctors. Australasian Emergency Nursing Journal. 2012; 15 (4):188–194. [PubMed : 23217651 ]

Everett CM, Schumacher JR, Wright A, Smith MA. Physician assistants and nurse practitioners as a usual source of care. Journal of Rural Health. 2009; 25 (4):407–414. [PMC free article : PMC2794129 ] [PubMed : 19780923 ]

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Findlay J, Boulton C, Forward D, Moran C. ‘Hospital-at-night’ expedites review of trauma patients without affecting outcome from hip fracture. Journal of Perioperative Practice. 2011; 21 (10):346–351. [PubMed : 22132478 ]

Finucane AM, Stevenson B, Moyes R, Oxenham D, Murray SA. Improving end-of-life care in nursing homes: Implementation and evaluation of an intervention to sustain quality of care. Palliative Medicine. 2013; 27 (8):772–778. [PubMed : 23612957 ]

Fletcher CE, Baker SJ, Copeland LA, Reeves PJ, Lowery JC. Nurse practitioners' and physicians' views of NPs as providers of primary care to veterans. Journal of Nursing Scholarship. 2007; 39 (4):358–362. [PubMed : 18021137 ]

Fletcher CE, Copeland LA, Lowery JC, Reeves PJ. Nurse practitioners as primary care providers within the VA. Military Medicine. 2011; 176 (7):791–797. [PubMed : 22128721 ]

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Fry M. Literature review of the impact of nurse practitioners in critical care services. Nursing in Critical Care. 2011; 16 (2):58–66. [PubMed : 21299758 ]

Gershengorn HB, Wunsch H, Wahab R, et al. Impact of nonphysician staffing on outcomes in a medical ICU. Chest. 2011; 139 (6):1347–1353. [PubMed : 21393397 ]

Goldie CL, Prodan-Bhalla N, Mackay M. Nurse practitioners in postoperative cardiac surgery: are they effective? Canadian journal of cardiovascular nursing = Journal canadien en soins infirmiers cardio-vasculaires. 2012 Fall; 22 (4):8–15. [PubMed : 23488361 ]

Hoffman LA, Tasota FJ, Zullo TG, Scharfenberg C, Donahoe MP. Outcomes of care managed by an acute care nurse practitioner/attending physician team in a subacute medical intensive care unit. American journal of critical care : an official publication, American Association of Critical-Care Nurses. 2005 Mar; 14 (2):121–130. quiz 131-122. [PubMed : 15728954 ]

Hopkins M. A comparative analysis of ENP's and SHO's in the application of the Ottawa ankle rules. International Emergency Nursing. 2010; 18 (4):188–195. [PubMed : 20869659 ]

Houweling ST, Kleefstra N, van Hateren KJ, et al. Diabetes specialist nurse as main care provider for patients with type 2 diabetes. The Netherlands journal of medicine. 2009 Jul-Aug; 67 (7):279–284. [PubMed : 19687522 ]

Jack K, Willott S, Manners J, Varnam MA, Thomson BJ. Clinical trial: a primary-care-based model for the delivery of anti-viral treatment to injecting drug users infected with hepatitis C. Alimentary pharmacology & therapeutics. 2009 Jan; 29 (1):38–45. [PubMed : 18945252 ]

Jarman B, Hurwitz B, Cook A, Bajekal M, Lee A. Effects of community based nurses specialising in Parkinson's disease on health outcome and costs: randomised controlled trial. BMJ (Clinical research ed.). 2002 May 4; 324 (7345):1072–1075. [PMC free article : PMC104336 ] [PubMed : 11991913 ]

Jessee BT, Rutledge CM. Effectiveness of nurse practitioner coordinated team group visits for type 2 diabetes in medically underserved Appalachia. Journal of the American Academy of Nurse Practitioners. 2012; 24 (12):735–743. [PubMed : 23190131 ]

Kennedy F, McDonnell A, Gerrish K, Howarth A, Pollard C, Redman J. Evaluation of the impact of nurse consultant roles in the United Kingdom: a mixed method systematic literature review. Journal of advanced nursing. 2012; 68 (4):721–742. [PubMed : 21950655 ]

Krichbaum K. GAPN postacute care coordination improves hip fracture outcomes. West J Nurs Res. 2007 Aug; 29 (5):523–544. [PubMed : 17526868 ]

Kroese MEA, Schulpen GJC, Bessems MCM, et al. Substitution of specialized rheumatology nurses for rheumatologists in the diagnostic process of fibromyalgia: a randomized controlled trial. Arthritis & Rheumatism: Arthritis Care & Research. 2008; 59 (9):1299–1305. [PubMed : 18759317 ]

Lattimer V, George S, Thompson F, et al. Safety and effectiveness of nurse telephone consultation in out of hours primary care: randomised controlled trial. The South Wiltshire Out of Hours Project (SWOOP) Group. BMJ (Clinical research ed.). 1998 Oct 17; 317 (7165):1054–1059. [PMC free article : PMC28690 ] [PubMed : 9774295 ]

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EVIDENCE TABLES

Data Abstraction of Included Studies by Setting

Quality Assessment of Included Controlled Trials

REVIEW COMMENTS/RESPONSES

Footnotes

The editorial also lists additional principles for policymaking concerning APRN's SOP: “Second, policy should be dynamic and flexible in response to changing knowledge about the roles and abilities of health care professionals, as well as changes in the organization and financing of health care. Third, patients' preferences with respect to who provides their care should play a much more prominent role in the debate than such data have in the past. Fourth, the United States must give higher priority to the development of a high-performing primary care infrastructure if it hopes to attract and retain a competent, satisfied workforce. Finally, unless physicians and nurse practitioners collaborate to improve primary care, neither will be happy with the outcome. We urgently need a facilitated, open dialogue about the roles of physicians and nurse practitioners that includes representatives of the public.”

The AANP commissioned a survey that found that 70% of the US adult population would support legislation to make it easier to choose NPs as their primary care provider. At this time, we have not assessed the validity of the survey methods. The AAFP refer to a different survey conducted by the Colorado Academy of Family Physicians.19 We were not able to find any additional information about this survey.

Alaska, Idaho, Iowa, Kansas, Minnesota, Montana, Nebraska, North Dakota, New Hampshire, New Mexico, Oregon, South Dakota, Washington, and Wisconsin

Prepared for: Department of Veterans Affairs, Veterans Health Administration, Quality Enhancement Research Initiative, Health Services Research & Development Service, Washington, DC 20420

Prepared by: Evidence-based Synthesis Program (ESP), Coordinating Center, Portland VA Medical Center, Portland, OR, Mark Helfand, MD, MPH, MS, Director

Recommended citation: McCleery E, Christensen V, Peterson K, Humphrey L, Helfand M. Evidence Brief: The Quality of Care Provided by Advanced Practice Nurses, VA-ESP Project #09-199; 2014.

This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Coordinating Center located at the Portland VA Medical Center, Portland, OR funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report.

Created: September 2014.