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. Author manuscript; available in PMC: 2016 Nov 1.
Published in final edited form as: J Cardiopulm Rehabil Prev. 2015 Nov-Dec;35(6):390–398. doi: 10.1097/HCR.0000000000000140

Employment Status and Participation in Cardiac Rehabilitation: Does Encouraging Earlier Enrollment Improve Attendance?

Quinn R Pack 1,2,3,4, Ray W Squires 2, Claudia Valdez-Lowe 1, Mouhamad Mansour 1, Randal J Thomas 2, Steven J Keteyian 1
PMCID: PMC4713121  NIHMSID: NIHMS750216  PMID: 26468632

Abstract

Purpose

For patients hospitalized for a cardiac event, an earlier appointment to outpatient cardiac rehabilitation (CR) increases participation. However, it is unknown what effect hastening CR enrollment might have among employed patients planning to return to work (RTW).

Methods

Using two complementary datasets [Henry Ford Hospital (HFH) and Mayo Clinic] we assessed when employed patients eligible for CR anticipated a RTW, the impact of an earlier appointment on CR enrollment, and the effect of employment status on the number of CR sessions attended. Patients at HFH attended CR at either 8 or 42 days (through randomization,) while Mayo Clinic patients attended 10 days after hospital discharge per standard routines.

Results

Among 148 patients at HFH, 65 (44%) were employed and planned to RTW. Of these, 67% desired to RTW within 1–2 weeks, while 28% anticipated a RTW within 1–3 days. Home financial strain predicted non-participation in CR (p<0.001) and was associated with an earlier planned RTW. Among 1,030 patients at Mayo Clinic, 393 (38%) were employed. Employed (vs. non-employed) patients enrolled in CR 3.3 days sooner (p < 0.001), but attended 1.6 fewer CR sessions (p = 0.04). In employed patients from both health systems, an earlier (vs. later) appointment to CR did not result in additional exercise sessions of CR.

Conclusions

Employed patients plan to RTW quickly, in part due to home finances. They also enroll earlier into CR than non-employed patients. Despite these findings, earlier appointments do not appear to favorably impact overall CR participation.

Keywords: Cardiac rehabilitation, Timing, Appointment, Employment, Return to Work

Introduction

Each year, about 650,000 Americans experience a first heart attack and about half of these patients are employed.1 In addition to the tremendous direct costs of caring for these patients, there are also substantial indirect costs in the form of lost wages, lost productivity, and cardiac disability.2, 3 Return to work (RTW) is associated with improved mood and less emotional distress.4, 5 Consequently, it is important on many levels that patients who were employed prior to suffering a cardiac-related event eventually RTW and lead productive lives.6

However, the need to RTW is often cited by patients as a reason for non-participation in cardiac rehabilitation (CR).7 This is unfortunate because patients who participate in CR gain important long-term mental, physical, and survival benefits.8 Despite these positive findings, only 30–35% of eligible patients ever participate in CR.9 Consequently, in 2011, the American Heart Association issued both a Presidential and Scientific Advisory encouraging providers and health systems to improve patient participation rates in CR.10, 11

Although national CR guidelines recommend commencing CR within 1–3 weeks after hospital discharge,12 the time from hospital discharge to 1st CR session (enrollment) often extends beyond 1 month.13 Recently, several studies have suggested that an earlier appointment to CR improves enrollment.14, 15 In these studies, there was an approximate 1% loss of CR enrollment for every day of delay. Similarly, a delay in RTW beyond 12 weeks appears to strongly predict failure to RTW.16 Consequently, an earlier appointment to CR could be a key strategy to enroll and retain employed patients into CR.

Given the potential scheduling conflicts that can occur between a patient’s need to RTW and attend CR, we examined whether an earlier appointment to CR might improve CR enrollment or the total number of CR sessions among this group. We also assessed when patients desire to RTW and other key employment-related factors that might affect participation in CR.

Methods

In this paper, we present secondary analyses of two previously published studies15, 17 and an original, unpublished patient survey. These studies originated from Henry Ford Hospital in Detroit, MI and the Mayo Clinic in Rochester, MN. Institutional Review Board approval was obtained from each institution. The Henry Ford study was registered with clinical trials.gov; unique identifier NCT01596036.

The Henry Ford study focused primarily upon increasing initial CR participation among hospitalized patients, whereas the Mayo Clinic study focused on increasing the number of CR sessions attended among those enrolling in CR. Due to the complementary strengths and limitations of each study, we felt that utilizing both data sets would more completely and thoroughly address the main aim of this study. However, at no point was data actually combined between studies due to significant differences in populations, methods, and study limitations.

Henry Ford Population and Patient Survey

The first study was a randomized controlled trial performed at Henry Ford Hospital and has been described previously.15 Briefly, between February and November 2011, hospitalized adult patients (≥18 years old) with a myocardial infarction, percutaneous coronary intervention, or stable angina with a positive stress test were recruited. Patients were excluded if they refused to consider attending CR, were medically unstable, were currently participating in CR, or had planned follow-up outside of the Henry Ford Health System. All patients gave written informed consent. Qualified patients were then randomized to an early (<10 days) or standard (5 weeks) appointment to CR.

All patients were asked if they were currently employed and if they planned to RTW at any point in the future. If patients answered affirmatively to both questions, they filled out a 12 question 1-page survey. Questions dealt with 1) timing of their anticipated RTW, 2) basic insurance and disability issues, 3) patient illness perceptions, and 4) patient attitudes towards CR. All questions were reviewed by co-authors for face validity and content, but formal survey validation was not undertaken. Exact survey questions are found in Table 2.

Table 2.

Survey Questions and Answers among Employed Patients At Henry Ford Hospital

Survey Question Category Results
n (%)
When would you like to return to work? 1–3 days 16 (28%)
1–2 weeks 22 (39%)
3–4 weeks 11 (19%)
1–2 months 4 (7%)
3–4 months 4 (7%)
How much time off from work (leave of absence) do you expect to be given by your employer as part of this hospitalization? 1–3 days 10 (19%)
1–2 weeks 24 (44%)
3–4 weeks 14 (26%)
1–2 months 3 (6%)
3–4 months 3 (6%)
How long could you afford to stay away from work before it would negatively affect your financial situation? 1–3 days 7 (12%)
1–2 weeks 22 (38%)
3–4 weeks 12 (21%)
1–2 months 2 (3%)
3–4 months 12 (21%)
5 months or more 3 (5%)
Do you have sick leave or paid time-off for illnesses? Yes 34 (54%)
Do you have disability insurance? Yes 30 (48%)
Will this hospitalization be covered by your insurance? Yes 56 (92%)
How physically strenuous is your work? very mild 24 (39%)
mild 12 (20%)
moderate 19 (31%)
heavy 3 (5%)
very heavy and strenuous 3 (5%)
How confident are you that you will be able to meet the physical demands of your job? not confident at all 2 (3%)
confident with significant reservations 2 (3%)
confident with mild reservations 16 (26%)
confident 7 (11%)
very confident 35 (56%)
From your perspective, how severe is your heart condition? very mild 3 (5%)
mild 10 (16%)
moderate 32 (52%)
severe 10 (16%)
very severe 6 (10%)
How important do you think Cardiac Rehabilitation is for treating your heart condition? not important at all 0 (0%)
possibly important 1 (2%)
moderately important 11 (17%)
very important 16 (25%)
essential to my full recovery 35 (56%)
How important do you think Cardiac Rehabilitation will be for helping prevent future heart problems? not important at all 0 (0%)
possibly important 2 (3%)
moderately important 6 (10%)
very important 19 (30%)
essential to my full recovery 36 (57%)
From your perspective, how helpful will Cardiac Rehabilitation be at helping you prepare to return to work? not helpful at all 4 (6%)
mildly helpful 5 (8%)
moderately helpful 14 (22%)
very helpful 22 (35%)
essential – could not go back to work without cardiac rehabilitation 18 (29%)

Employment status, as self-reported by survey participants, was utilized as the primary predictor for participation in CR. The primary outcome was attendance at CR orientation. Randomization group (early vs. standard) was utilized as the primary co-variate and interaction term between employment status and attendance at CR orientation. Secondary endpoints were participation in ≥ 1 exercise session of CR (usually occurred on a subsequent day after CR orientation) and the total number of CR exercise sessions attended.

Mayo Clinic Population

The second study retrospectively analyzed the effects of several quality improvement activities within the Mayo Clinic CR program in Rochester MN.17 Briefly, we included all patients who attended their first session of outpatient CR at Mayo Clinic in Rochester MI between May 2009 and January 2012 with participation in CR occurring through May 2012. During this time period, we instituted three sequential quality improvement projects: 1) a policy of maximizing CR attendance for all patients, 2) an inpatient and outpatient recruiting video about the benefits of CR, and 3) a motivational program in which patients were rewarded with T-shirts, parking passes, and other token items for reaching CR participation milestones. Combined, these projects significantly improved the overall number of CR sessions.17 None of these projects focused on improving CR participation among employed patients or shortening the time interval between hospital discharge and CR enrollment.

We excluded patients without a valid consent for medical record chart review, patients without a recent hospitalization, and those with unknown employment status. The primary predictor was the time interval between hospital discharge and CR enrollment. The primary study outcome was the number of CR sessions attended. Employment status was utilized as the primary co-variate and interaction term.

Statistical Analysis

For the survey, we tallied all answers, calculated answer frequencies, and assessed if survey answers predicted CR orientation attendance. When necessary, we grouped survey answers into two categories around the median response for the purpose of statistical testing.

For both analyses, patients were grouped by employment status and compared using patient characteristics such as age, gender, and primary diagnosis. Continuous variables were presented as mean ± standard deviation, skewed variables as median [interquartile range] and count data were presented as proportions. Statistical testing utilized the Student T-test, Fischer’s exact test, the Wilcoxon-ranked sum test, and Chi-Square test as appropriate. All tests were two sided with significance set at α < 0.05.

Among patient at Henry Ford Hospital, we assessed whether employment status was associated with attendance at CR orientation, exercising ≥ 1 session, and total number of CR sessions attended. We tested the role of an early appointment (by randomization group) on attendance at CR orientation by using an interaction term (employment status * randomization group.) Analyses were performed with SAS 9.2 (SAS Institute, Cary, NC). Due to the limited numbers of patients and statistical power, multi-variate modeling was not performed.

Among Mayo Clinic patients, linear regression was utilized to identify if employment status was associated with the time interval between hospital discharge and CR enrollment, and if employment status was associated with the total number of CR sessions. All tests were non-parametric due to skewed distributions in both variables. Interaction terms (employment status * time interval, and employment status * total number of CR session) were utilized to test the association between enrollment timing, employment status and the number of CR sessions attended. Analyses were performed with JMP 9.0.1 (SAS Institute, Cary, NC.)

Results

Patient Populations

In the Henry Ford Hospital study, 203 patients with coronary artery disease were assessed for trial eligibility, 150 patients were randomized, 2 withdrew consent after randomization, and 148 patients comprised the study population. Of these, 65 (44%) were employed prior to their cardiac event. In the Mayo Clinic study, a total of 1,151 patients enrolled in CR during the study period. We excluded 48 patients due to lack of informed consent, 55 patients without a recent hospitalization, and 18 patients with unknown employment status, leaving a total of 1,030 patients available for analysis. Of these, 393(38%) were employed, 502(49%) were retired, 60(6%) were unemployed, and 75(7%) were disabled. Patient characteristics for both groups are found in Table 1. In general, employed patients were younger than non-employed patients, were more likely to be male, were less likely to have a history of diabetes or hypertension, and were more likely to have insurance coverage for CR. The Henry Ford Hospital cohort was predominantly Black, whereas the Mayo Clinic population was predominantly White.

Table 1.

Baseline Characteristics According to Employment Status

Characteristic Henry Ford Hospital
p-value Mayo Clinic
p-value
Employed
(n = 65)
Non-employed
(n = 83)
Employed
(n = 393)
Non-employed
(n= 637)
Age (years, mean ± SD) 56 ± 11 63 ± 12 <0.001 57 ± 10 69 ± 12 <0.001
Male 45 (69%) 37 (45%) 0.003 303 (77%) 433 (68%) 0.002
Race (Black) 24 (37%) 49 (59%) 0.03
Race (Non-Hispanic White) 357 (91%) 594 (93%) 0.16
Body mass index (mean ± SD) 32 ± 8 33 ± 8 0.09 31 ± 6 30 ± 6 0.03
Past medical history
 • CABG 3 (5%) 6 (7%) 0.73
 • PCI 11 (17%) 29 (35%) 0.02
 • MI 15 (23%) 27 (33%) 0.27
Risk Factors
 • Diabetes 19 (29%) 46 (55%) 0.001 103 (27%) 204 (33%) 0.03
 • Hypertension 50 (77%) 76 (92%) 0.01 256 (67%) 498 (81%) <0.001
 • Current smoking 19 (29%) 27 (33%) 0.67 43 (11%) 57 (9%) 0.47
 • Hyperlipidemia 47 (72%) 70 (84%) 0.07
Index event 0.90 0.001
 • STEMI 12 (18%) 13 (16%)
 • NSTEMI 31 (48%) 38 (46%)
 • PCI 9 (14%) 15 (18%) 90 (23%) 128 (20%)
 • Angina 13 (20%) 17 (20%) 59 (15%) 87 (14%)
 • CABG 54 (14%) 126 (20%)
 • Valve 36 (9%) 74 (12%)
 • MI 121 (31%) 137 (22%)
 • Heart Transplant 15 (4%) 46 (7%)
 • Other 18 (5%) 39 (6%)
Insurance for CR 0.03
 • Full 28 (43%) 19 (23%)
 • Partial/co-pays 28 (43%) 52 (63%)
 • None 9 (14%) 12 (14%)
Distance to CR (miles) 9 ± 7 8 ± 5 0.28
Olmsted County 246 (63%) 388 (61%) 0.59

CR = Cardiac Rehabilitation; CABG = Coronary Artery Bypass Graft Surgery; PCI = Percutaneous Coronary Intervention; STEMI = ST-elevation myocardial infarction; NSTEMI = non ST-segment myocardial infarction; MI = Myocardial Infarction

Results for Henry Ford Hospital and Survey

Survey results are shown in Table 2. Among the 57employed patients answering question #1, “When would you like to return to work?” a total of 38 (67%) desired to RTW within 2 weeks, while a subgroup of 16 (28%) hoped to RTW within just 1–3 days. Approximately half of patients reported having disability insurance, paid time off for illnesses, or enough financial reserves to take leave from work for > 2 weeks. Patients perceived the physical demands of their work to be mild, their heart condition severity as moderate, and expressed a high value in attending CR. Insurance status and home financial strain predicted attendance at CR orientation, whereas the physical demands of work, heart condition severity, and the perceived value of CR did not (Table 3.) Home financial strain was strongly correlated with a desire for an earlier RTW (χ2= 41, p = 0.003.)

Table 3.

Univariate Predictors of Attendance at Cardiac Rehabilitation Orientation Among Employed Patients At Henry Ford Hospital

Characteristic Attended CR
N = 49
Did not Attend CR
N = 16
p-value
Desire to RTW (less than 2 weeks) 31 (69%) 7 (58%) 0.51
Time off Work (less than 2 weeks) 26 (62%) 8 (67%) 1.00
Home Financial Strain (less than 2 weeks) 17 (38%) 12 (92%) <0.001
Sick Leave Policy (yes) 26 (55%) 8 (50%) 0.78
Disability Insurance (yes) 25 (53%) 5 (33%) 0.24
Hospitalization covered by Insurance (yes) 45 (98%) 11 (73%) 0.01
Physically Strenuous Work (Mild or Very Mild) 18 (40%) 6 (38%) 1.00
Able to meet physical demands of job, (very confident) 26 (57%) 9 (56%) 1.00
Perceived severity of heart condition (severe to very severe) 10 (22%) 6 (40%) 0.19
Importance of CR for treating heart condition (essential to full recovery) 26 (54%) 9 (60%) 0.77
Importance of CR for Preventing future heart problems (essential to full recovery) 30 (63%) 6 (40%) 0.15
CR as helpful for returning to work (essential for returning to work.) 14 (29%) 4 (27%) 1.00

CR = Cardiac Rehabilitation; CABG = Coronary Artery Bypass Graft Surgery; PCI = Percutaneous Coronary Intervention; STEMI = ST-elevation myocardial infarction; NSTEMI = non ST-segment myocardial infarction; MI = Myocardial Infarction

Time to enrollment was controlled by random assignment with the early and standard groups attending CR orientation at a median (95% confidence interval) of 8.5 days (7, 13) and 42 days (35 to NA, not applicable), respectively. Among the 65 employed patients, 49 (75%) attended CR orientation and of the 33 (51%) patients assigned to the early appointment group, 26 (78%) attended CR. Employed (versus non-employed) patients appeared as equally likely to attend CR orientation [odds ratio (OR) 1.83 (95% CI 0.89, 3.75), p = 0.10], were marginally more likely to exercise ≥ 1 session [OR 1.81 (95% CI 0.93, 3.49), p = 0.08], but these endpoints were probably underpowered. An early appointment to CR among employed patients did not predict improved attendance at CR orientation (interaction p = 0.52).

Results for Mayo Clinic

The median time to enrollment in CR (IQR) was 10 (7, 15) days, with 90% of patients attending by day 27, while average time to enrollment (SD) was 14.7 ± 17.8 days. Patients attended a median (IQR) of 15 (6, 29) sessions of CR, while average number of CR sessions was 17.3 ± 12.1. Employed patients enrolled at a median (IQR) of 9 (6, 13) days after hospital discharge, 3.3 days sooner (p<0.001) than non-employed patients, but completed 1.6 fewer sessions patients (p<0.05). See Table 4.

Table 4.

Patient Characteristics and Predicted Enrollment Time and Session Attendance at Mayo Clinic

Time Δ to Enrollment (days) P-Value Difference in Attendance (sessions) P-value
Employed − 3.3 <0.001 − 1.6 0.04
Age (per 10 years) + 1.6 <0.001 + 1.0 <0.001
Female sex + 2.6 0.03 − 0.7 0.43
Olmsted county − 0.4 0.77 + 5.4 <0.001
Non-Hispanic white − 1.7 0.42 + 4.5 0.001
Diabetes − 1.4 0.92 0.0 0.97
Hypertension + 2.0 0.13 + 0.8 0.65
BMI (per 5, kg/m2) + 0.2 0.63 + 0.5 0.15
Qualifying Diagnosis
 Angina + 2.8 0.60 − 5.0 <0.001
 Valve Surgery + 2.0 0.11 − 0.7 0.43
 CABG + 0.3 0.84 + 4.3 <0.001
 Heart Transplant/LVAD + 0.9 0.054 − 1.3 0.87
 MI − 3.2 0.07 + 1.9 0.009
 PCI − 1.4 0.01 − 0.6 0.31
 Other + 4.1 0.95 − 2.4 0.15
Time to Enrollment (per 10 days) 0.0 0.95

CABG = Coronary Artery Bypass Graft; MI = myocardial infarction; PCI = percutaneous coronary intervention; Time Δ = Time Difference

However, after adjustment for univariate significant baseline predictors of enrollment time, employment status was no longer associated with enrollment time (−0.6 days, p = 0.51.) Additionally, employment status was only marginally associated with total number of exercise sessions attended (−0.7 sessions, p = 0.06) after adjustment for other univariate significant baseline predictors of the total number of CR sessions. Furthermore, there was no interaction between employment status, enrollment timing, and total number of sessions of CR attended, p = 0.19.

Discussion

The primary finding of this project was that, in two diverse patient populations using both interventional and observational study methods, an early appointment to CR among employed patients did not differentially improve CR enrollment or the total number of CR sessions attended when compared to non-employed patients. This was true despite the fact that approximately two thirds of employed patients wanted to RTW within 2 weeks, expected to be given <2 weeks leave of absence, and placed a high value on CR. Furthermore, in the Mayo cohort, actual attendance at first session of CR occurred at a median of 7–8 days post discharge, 3 days earlier that non-employed patients, yet no added difference was found. Rather, it appears the primary driver of participation in CR among employed patients is a complicated intertwining of multiple factors such as insurance status and home financial strain. Additionally, age, race, and medical diagnosis (angina, CABG, or MI) also seemed to play a more important role in the number of CR sessions attended than did employment status. Based on these findings, we conclude that while employment status may help predict enrollment and withdrawal from CR (at least on univariate analysis), many additional and perhaps more important factors are involved in an employed patient’s decision to participate in CR.

These findings should help professionals working in CR appreciate the complex interplay between cardiac disease, the desire to RTW, and CR attendance. Although it is often assumed that employed patients uniformly are not interested in, do not attend, and quickly drop out from CR, these associations do not appear to hold up under closer scrutiny. In particular, when an employed patient does not participate in CR, it seems necessary to inquire beyond “employment status” for other reasons for non-participation. Furthermore, it appears we should shift our focus from employment status “per se”, to better understanding and addressing the actual underlying issues that may be preventing greater participation in CR.

Although we did not find that employed patients were particularly helped by an early appointment, it should be emphasized that an earlier appointment was still an effective tool for increasing patient enrollment in CR. In our original trial at Henry Ford, we noted an overall enrollment rate in CR of 75% among our employed patients, which is much higher than national enrollment rates of 30–35%.9 Also, it has been shown that encouraging a prompt RTW appears to be a key strategy in preventing long-term disability.16 Thus, it still seems reasonable that all potentially eligible patients (including employed patients) should commence CR as soon as possible.

It is important to note that, although a few vocational rehabilitation programs have successfully increased the rate of RTW,18, 19 CR participation, as currently structured in the US, does not appear to appreciably improve rates of RTW.20 Rather, the decision to RTW is complicated by multiple social, economic, mental, and disease-related processes.2125 For those who do RTW, however, CR does appear to improve long-term health related quality of life26 and should be encouraged.

One additional finding in our study that may be underappreciated by CR programs is that employed patients were somewhat more likely to participate in CR, rather than less. This is consistent with prior publications2730 and runs counter to the presumptions of many CR staff members. This effect probably occurs because employed patients tend to be younger and more insured, two key factors that are strong predictors of CR participation.

Study Strengths and Limitations

Notable strengths of this study include the use of two very different and ethnically-diverse populations in which the main findings were similar. In addition, we also directly manipulated appointment timing at Henry Ford Hospital and, as a result, findings from that site are unlikely affected by participation bias. While the Henry Ford Hospital cohort was limited due to the necessity of inclusion/exclusion criteria, our Mayo Clinic population included all patients (including surgical patients) and better represents the “real world.” Furthermore, although the main results from Henry Ford Hospital were limited in statistical power and multi-variate modeling could not be performed, it did have detailed survey and referral information. Also, while the Mayo Clinic study was limited by lack of inpatient referral information, it was large, better classified employment types, and had sufficient statistical power for multi-variate modeling. Thus, by presenting these studies together, we more confidently assessed our aims and drew upon the relative strengths of each study while limiting study weaknesses.

This study has several additional important limitations. First, it is unknown which patients actually returned to gainful employment. This was not assessed in either study and limits what conclusions can be drawn, particularly in assessing the relationship between CR participation and actual RTW. Second, we did not have detailed employment descriptions (e.g., professional, clerical, manual labor) in either study, which could play an important role in a patient’s decision to attend CR. Third, we did not explore the differences in CR participation among the various types of non-employment statuses (e.g., retired, unemployed, disabled), because we did not have this information in the Henry Ford Hospital data set and the numbers of unemployed and disabled patients at Mayo Clinic (135, 13%) were small. Fourth, although patients play a part in deciding enrollment time and the extent of participation, CR staff may have also influenced time to enrollment (by speeding up appointment time for a employed patient) or CR participation (by recommending a shorter course of CR if the patient is doing well and wants to RTW.)

Conclusion

Although employed patients expressed a sense of urgency relative to returning to work and valued the role of CR, an early appointment did not appear to preferentially improve attendance at CR orientation or improve the total number of CR sessions attended in this subgroup of patients. Rather, the decision to participate in CR was predicted by a complex interplay of medical, economic, and social factors rather than simply by employment status. CR programs should look beyond employment status and a patient’s desire to RTW when assessing and motivating patients to attend CR.

Acknowledgments

We would like to acknowledge Meredith G. Mahan, MS for her help with data analysis at Henry Ford Hospital. We also acknowledge staff members in the CR programs at both Henry Ford Hospital and Mayo Clinic for their continued dedication to excellence.

Funding: Funding for statistical analysis came from the Department of Graduate Medical Education at Henry Ford Hospital. Statistical consultation at Mayo Clinic was supported by CTSA grant TL1 TR000137 from the National Center for Advancing Translational Science. Funding for manuscript preparation was supported in part by the National Center for Research Resources Award Number KL2 RR025751 and the National Center for Advancing Translational Sciences, National Institutes of Health, Award Numbers KL2TR000074 and KL2TR001063. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Footnotes

Disclosures: All authors report no conflicts of interest relative to the contents of this manuscript.

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