Abstract
Background
The opioid epidemic in the US has led prescribers to reevaluate postoperative pain control particularly in the field of spine surgery, where postoperative analgesia requirements and consumption have historically been high. There is a need to mitigate the quantity of unused pills after surgery by adjusting prescribing practices. Achieving the balance of pain control after surgery without overprescribing opioids may be accomplished by developing a modified approach to prescribing practices; however, there is a need to first understand the opioid requirements of the modern spine surgery patient with respect to their elective spine surgery. Therefore, the primary aim of this study was to determine the percentage of opioids not utilized at 90-days after elective spine surgery. Secondary aims were to identify differences in the percentage of unused opioids between surgical subgroups and preoperative opioid status, to determine factors associated with opioid utilization, and to estimate the distribution of opioids consumed to control pain up to the 90th percentile in each surgical subgroup.
Methods
In this prospective, observational cohort study, adults undergoing elective spine surgery at a multi-surgeon, single center were prospectively enrolled and divided into subgroups: anterior cervical, lumbar decompression, and short-segment lumbar fusion. Prescribed MMEs were identified from prescriptions, consumed MMEs were obtained from pill counts, and the percent leftover was calculated. Distributions of MMEs consumed were analyzed to compare utilization between preoperative opioid users or non-users within each surgical subgroup.
Results
Of 117 patients, 41.9% were preoperative opioid users. The percentage of unused opioids by surgical subgroup was: 45.4% cervical, 57.3% lumbar decompression, and 37.4% lumbar fusion (p=0.066). The percentage of unused opioids by preoperative opioid exposure was greater in the opioid non-users (58.0%) than users (28.4%, p<0.001)). Regression analysis showed that surgical subgroup and preoperative opioid exposure were associated with leftover opioids.
Conclusions
At 90-days, the percentage of unused opioids was over 45% in this cohort of elective spine surgery patients and was nearly double in the group without preoperative opioid exposure. These results suggest the modern elective spine surgery patient is using less opioids than prescribed, supporting the conclusion that the number of MMEs prescribed can be reduced to minimize quantities of leftover pills available for diversion, without sacrificing the priority of appropriate postoperative pain control.
Keywords: Opioid, Pain, Overprescribing, Pain management, Spine surgery, ESR
Introduction
In 2017, the U.S. Department of Health and Human Services declared a public health emergency to address the national opioid crisis after more than 40,000 deaths occurred as a result of opioid overdoses in 2016, which exceeded all preceding years. In 2020, 10.1 million people misused prescription opioids and 1.6 million people suffered from opioid use disorder in the United States. The Center for Disease Control and Prevention (CDC) projects the total economic burden of prescription opioid misuse in the United States is an estimated $78.5 billion per year [1], [2], [3], [4].
The postoperative stakes are high, as prescriptions for postoperative opioids are often the first time patients are exposed to opioid pain medications and are a well-documented risk for chronic opioid dependence in the opioid naïve. What's more, the majority of prescription opioid misusers receive them through diversion, obtaining unused pills from legitimate prescriptions of friends and family 55% of the time [5,6]. Surgeons often prescribe opioid pain medication to control postoperative pain, with orthopedic surgeons rated as the third highest prescribers of opioids given the nature of the pain associated with orthopedic conditions and surgeries [7], [8], [9]. Therefore, opioids not used after surgery contribute to the quantity of unused pills available for diversion.
Achieving the balance of pain control without overprescribing may be accomplished by developing a modified approach to prescribing practices after surgery. To accurately change prescribing habits, we must first understand what the requirements are in today's approach to spine surgery and recovery. The modern-day elective spine surgery patient generally has an awareness of the ongoing opioid epidemic, is exposed to more minimally invasive surgical options, and may benefit from recovery with enhanced surgical recovery pathways that focus on opioid-sparing analgesia. Together, these factors contribute to less pain and greater pain control after surgery; yet postoperative prescribing practices for pain control are often similar to what they were prior to these modern advances. Therefore, the next logical step is to determine if postoperative opioid consumption is less than what is prescribed. The primary purpose of this study was to determine the percentage of unused postoperative opioids up to 90 days by patients undergoing elective spine surgery; with a hypothesis that the unused percentage would be substantial. Secondarily we aimed to identify differences in the percentage of unused opioids between surgical subgroups and preoperative opioid status, to determine factors associated with opioid utilization and to estimate the distribution of opioids consumed to control pain up to the 90th percentile in each surgical subgroup.
Materials and methods
Patient selection
This prospective observational cohort study was performed at a single, multi-surgeon spine center and was approved by an Institutional Review Board. Consecutive adult (>18 years) patients undergoing elective spine surgery in one of three main categories were identified between August 2020 and June 2021. The center's most common elective spine surgeries were subdivided into three categories: (1) anterior cervical subgroup, including fusion (ACDF), arthroplasty (ACDR), or a combination (anterior cervical hybrid, ACH); (2) lumbar decompression subgroup, including posterior lumbar laminectomy, microdiscectomy, or a combination; and (3) lumbar fusion subgroup, including short segment (< 4 levels) circumferential (staged or same day anterior/posterior) fusions. Patients were further categorized as preoperative opioid users (any opioid use in the 3 months prior to surgery) or non-users (no opioid use in the 3 months prior to surgery).
Patients were excluded or withdrawn if: the prescriber of their postoperative opioids was not part of the surgical team, an additional surgical procedure was performed outside of the index surgery(s) within the 90-day postoperative period, they had an allergy to opioid medications, they could not comply with the pill count protocol, or they were lost to follow up.
Postoperative protocol
This center implemented a standardized enhanced surgical recovery (ESR) protocol in 2017, which targets the preoperative, intraoperative, and postoperative phases of the surgical process to optimize recovery, with a focus on opioid-sparing analgesia [10]. Preoperatively, opioid naïve patients were administered the following medications in preop holding: 600 mg PO gabapentin, 1000 mg PO acetaminophen, 200mg PO celecoxib, 750 mg PO methocarbamol, 15 mg PO extended-release morphine, 4mg PO ondansetron, and a scopolamine patch was placed. The dose of extended-release oral morphine was adjusted depending on preoperative opioid use. This spine-specific ESR protocol was utilized in the recovery of all subjects enrolled in this study, regardless of inpatient or outpatient status. As part of ESR, no patient-controlled analgesia (PCA) pumps were used during the hospital stay. Postoperatively, patients were prescribed an oral multi-modal pain regimen including opioids, once able to swallow pills. In 2016, the American Pain Society published thirty-two guidelines on the management of postoperative pain. Of those, twenty-two of the guidelines pertain to this study's patient population; twenty were included in this center's ESR protocol (guidelines: 1, 3–6, 10–11, 13–21, 28–30, 32) [11]. Prescriptions for home use were given based on the medications, dosages, and directions used prior to hospital discharge. For outpatient procedures, prescriptions were given prior to surgery.
Although not standardized, patients in the anterior cervical and lumbar decompression subgroups were most often prescribed oxycodone 5 mg for home use; patients in the lumbar fusion subgroup were most often prescribed long-acting morphine 15 mg and short-acting oxycodone 5 mg for home use. Non-opioid medications commonly prescribed to all three subgroups as part of their multi-modal therapy were methocarbamol 750 mg and acetaminophen 500–1000 mg; gabapentin 300 mg was often added in the lumbar fusion subgroup along with an over the counter NSAID for arthroplasties and non-fusions, unless otherwise contraindicated. The quantity and direction of opioid and non-opioid medications prescribed after surgery were also not standardized, however opioids were only given as a 2-week supply to comply with state regulations.
Data collection
Demographics and surgical details were verified through the center's electronic medical recording (EMR) system and hospital records. All pre- and postoperative opioid prescriptions were recorded and tracked within the EMR system, and then verified via the state prescription monitoring program's (PMP) electronic record. Opioid doses were converted to morphine milligram equivalents (MMEs). Up to 90 days postoperatively, patients were instructed to bring all pill bottles with them to each office visit where opioid pills were counted by a surgical team member. The quantity of unused pills was recorded and compared to the prescribed amount. If unused opioids were no longer needed, these were disposed of per clinic policy: in the presence of the patient, unneeded pills were placed in a bottle containing a drug disposal solution. The solution dissolves the pills, and these bottles are then collected by a biohazard company. If patients were unable to return to the office in person, for example due to the COVID-19 pandemic, they were contacted by phone. During the phone interview, patients were asked a series of questions regarding opioid usage, refills, and were asked to count their opioid pills. Both the EMR and PMP were cross-checked for opioid refills at each postoperative encounter. Opioid medication stop dates were recorded but each patient was followed to 90 days postoperatively to capture anyone that may have resumed their opioid medication after reporting discontinuation.
Statistical analysis
All analyses were performed using IBM SPSS V 27.0 (Armonk, New York). Descriptive statistics are presented as frequencies (percentages) or means and standard deviations. Continuous variables were compared among the surgical subgroups using one-way ANOVA. Categorical variables were compared using Fisher's exact test. For the primary outcome, the percentage of average MMEs unused was calculated as mean MMEs prescribed minus mean MMEs consumed divided by mean MMEs prescribed. For the secondary outcomes, (1) the percentage of unused MMEs was compared between the three surgical subgroups: anterior cervical, lumbar decompression, and lumbar fusion, (2) multivariable regression analysis was used to determine factors associated with leftover opioids, and (3) consumed MME distributions were analyzed according to the preoperative opioid status to identify the 50th, 75th, and 90th percentiles within each surgical subgroup.
MMEs were converted to quantities of oxycodone 5mg tablets using the Center for Disease Control and Prevention (CDC) opioid prescribing guideline mobile application (www.cdc.gov/drugoverdose/prescribing/app.html) as a method of demonstrating the quantity of a commonly used postoperative opioid following elective spine surgery. It should be noted that the tablet quantity presented does not represent what was actually prescribed, as other opioids, opioid combinations, and doses varied between patients.
Results
Demographics
A total of 130 patients met the initial criteria for enrollment and were subdivided into surgical categories; 13 patients were withdrawn or lost to follow up (Fig. 1). The final cohort of 117 patients who completed the 90-day follow-up was 48.7% male and had a mean age of 51.1 ± 13.5 years. In the anterior cervical subgroup (n=48), 52.1% were ACDFs, 31.3% were ACDRs, and 16.7% were ACHs. In the lumbar decompression subgroup (n=28), 53.6% were microdiscectomies, 32.1% were laminectomies, and 14.3% were a combination of both (Table 1). In the lumbar fusion subgroup, all surgeries were circumferential and less than 4 levels. Across all surgical subgroups, 49 (41.9%) patients were opioid users preoperatively with a subgroup breakdown of: 17 (35.4%) anterior cervical opioid users, 11 (39.3%) lumbar decompression opioid users, and 21 (51.2%) lumbar fusion opioid users (p=0.333) (Table 2).
Fig. 1.
Flow diagram of patient enrollment and categorization.
Table 1.
Demographics – within anterior cervical and lumbar decompression subgroups.
| Mean age (years) | Male sex | Nicotine use^ | Mean BMI (kg/m2) | Mean CCI score | Opioid User* | |
|---|---|---|---|---|---|---|
| All Cervical (n=48): | 52.3 | 43.8% | 6.3% | 29.5 | 1.2 | 35.4% |
| ACDF (n=25) | 57.4 | 52.0% | 4.0% | 31.0 | 1.2 | 40.0% |
| ACDR (n=15) | 43.4 | 33.3% | 0.0% | 28.0 | 1.4 | 26.7% |
| ACH (n=8) | 52.9 | 37.5% | 25.0% | 27.6 | 0.9 | 37.5% |
| All Decompression (n=28): | 45.9 | 60.7% | 17.9% | 29.8 | 1.1 | 39.3% |
| Microdiscectomy (n=15) | 39.9 | 50.0% | 14.9% | 29.1 | 1.1 | 50.0% |
| Laminectomy (n=9) | 52.9 | 77.8% | 22.0% | 32.8 | 1.4 | 11.1% |
| Combination (n=4) | 49.8 | 60.0% | 20.0% | 26.8 | 0.80 | 60.0% |
Nicotine use within 3 months prior to surgery
Opioid consumption within 3 months prior to surgery
ACDF anterior cervical discectomy and fusion ACDR anterior cervical disc replacement
ACH anterior cervical hybrid BMI body mass index CCI Charlson Comorbidity Index
Table 2.
Demographics – comparison between all subgroups.
| Total n=117 | Anterior Cervical n=48 | Lumbar Decompression n=28 | Lumbar Fusion, < 4 levels n=41 | p-value | |
|---|---|---|---|---|---|
| Age (years) | 51.1 ± 13.5 | 52.3 ± 12.9 | 45.9 ± 14.5 | 53.4 ± 12.7 | 0.054 |
| Male sex | 50.3% | 43.8% | 60.7% | 46.3% | 0.352 |
| Nicotine use^ | 12.9% | 6.3% | 17.9% | 14.6% | 0.259 |
| BMI (kg/m2) | 30.4 ± 5.8 | 29.5 ± 4.8 | 29.8 ± 6.2 | 31.9 ± 6.4 | 0.116 |
| CCI score | 1.2 ± 1.3 | 1.2 ± 1.3 | 1.1 ± 1.3 | 1.2 ± 1.0 | 0.977 |
| Preoperative Opioid User* | 42.0% | 35.4% | 39.3% | 51.2% | 0.333 |
| Fusion + decompression | n/a | n/a | n/a | 41.5% | — |
Values represent the number of patients (%) or mean ± SD
Nicotine use within 3 months prior to surgery
Opioid consumption within 3 months prior to surgery
n/a not applicable A/P anteroposterior
Unused MMEs by 90 days
The mean percentage of MMEs unused at 90-days was 45.4% in the anterior cervical subgroup, 57.3% in the lumbar decompression subgroup, and 37.4% in the lumbar fusion subgroup (p=0.066). Across all subgroups, the mean percentage of unused MMEs was 57.9% in preoperative opioid non-users and 28.4% in preoperative opioid users (p<0.001). Combining both surgical subgroup and preoperative opioid status to obtain the mean percent of MMEs unused resulted in: 57.2% and 24.7% anterior cervical opioid non-users and users, respectively; 69.5% and 38.3% lumbar decompression opioid non-users and users, respectively; and 49.3% and 26.2% lumbar fusion opioid non-users and users, respectively (p<0.001) (Table 3, Fig. 2). Multivariable regression analysis showed that surgical subgroup (p<0.001) and preoperative opioid exposure (p=0.001) were associated with opioid utilization, while age, sex, nicotine use, CCI score, and BMI were not (Table 4).
Table 3.
Proportion of MMEs unused at 90 days.
| N | Mean MME | SD | p-value | |
|---|---|---|---|---|
| By Surgical Subgroup | 0.066 | |||
| Anterior cervical | 48 | 0.454 | 0.364 | |
| Lumbar decompression | 28 | 0.573 | 0.364 | |
| Lumbar fusion | 41 | 0.374 | 0.280 | |
| By Preoperative Opioid Exposure | <0.001 | |||
| Opioid non-user | 68 | 0.579 | 0.327 | |
| Opioid user* | 49 | 0.284 | 0.302 | |
| By Subgroup and Opioid Exposure | <0.001 | |||
| Anterior cervical, non-user | 31 | 0.572 | 0.354 | |
| Anterior cervical, user* | 17 | 0.247 | 0.287 | |
| Lumbar decompression, non-user | 17 | 0.695 | 0.287 | |
| Lumbar decompression, user* | 11 | 0.383 | 0.401 | |
| Lumbar fusion, non-user | 20 | 0.493 | 0.302 | |
| Lumbar fusion, user* | 21 | 0.262 | 0.257 | |
| Total | 117 | 0.454 | 0.348 | |
Statistically significant p-values are presented as bold type
MMEs Morphine milligram equivalents
Opioid consumption within 3 months prior to surgery
Fig. 2.
Bar graph demonstrating MME utilization within each surgical subgroup by preoperative opioid exposure.
Table 4.
Summary of multivariable regression analysis.
| Dependent variable:Mean percent MMEs Unused | β | p-value |
|---|---|---|
| Surgical subgroup | 8.569 | <0.001 |
| Preoperative opioid exposure | −6.605 | 0.001 |
| Age | 0.131 | 0.144 |
| Sex | −0.104 | 0.246 |
| Nicotine use | −0.048 | 0.588 |
| CCI | −0.043 | 0.624 |
| BMI | −0.005 | 0.955 |
Statistically significant p-values are presented as bold type
MME s Morphine milligram equivalents
Distribution of MMEs used throughout 90 days
The distribution of opioids consumed between preoperative opioid non-users and users within each surgical subgroup in the 50th, 75th, and 90th percentiles is shown in Table 5. The 90th percentile for MMEs consumed in each surgical subgroup and the corresponding number of oxycodone 5mg tablets by preoperative opioid status (non-users vs. users) was: 660 MMEs (88 tablets) vs. 6728 MMEs (897 tablets) anterior cervical, 300 MMEs (40 tablets) vs. 2490 MMEs (332 tablets) lumbar decompression, and 4995 MMEs (666 tablets) vs. 7710 MMEs (1028 tablets) lumbar fusion (Table 5, Fig. 3, Fig. 4).
Table 5.
Distribution at 90 Days.
| Consumed Opioid Distribution |
||||||
|---|---|---|---|---|---|---|
| 50th |
75th |
90th |
||||
| MME | #Oxycodone 5 mg tabs | MME | #Oxycodone 5 mg tabs | MME | #Oxycodone 5 mg tabs | |
| Cervical Opioid Non-user | 165 | 22 | 420 | 56 | 660 | 88 |
| Cervical Opioid User* | 1350 | 180 | 2812 | 375 | 6728 | 897 |
| Lumbar Decompression Opioid Non-user | 65 | 9 | 240 | 32 | 300 | 40 |
| Lumbar Decompression Opioid User* | 240 | 32 | 788 | 105 | 2490 | 332 |
| Lumbar Fusion Opioid Non-user | 885 | 118 | 1998 | 266 | 4995 | 666 |
| Lumbar Fusion Opioid User* | 2422 | 323 | 4155 | 554 | 7710 | 1028 |
MME s Morphine milligram equivalents
Opioid consumption within 3 months prior to surgery
Fig. 3.
Bar graph demonstrating distribution of MME utilization by subgroup and preoperative opioid exposure (a: opioid non-users, b: opioid users).
Fig. 4.
Bar graph demonstrating distribution of utilization of oxycodone 5mg tablets by subgroup and preoperative opioid exposure (a: opioid non-users, b: opioid users).
Discussion
This study showed that 45% of prescribed opioids were unused at 90-days after elective spine surgery, and that surgical subgroup and preoperative opioid exposure were predictors of unused opioids. In the full cohort of 117 patients, nearly half (42%) were using opioids in the 3 months leading up to surgery. Unused opioids at 90-days was on average 58% in preoperative opioid non-users and 28% in preoperative opioid users (p<0.001), resulting in less unused opioids available for diversion in the latter group. Patients undergoing lumbar decompression that were not using opioids prior to surgery had the largest percentage of unused opioids (70%) after surgery.
It is well established in the literature that spine surgery is among the more painful forms of orthopedic surgery and that preoperative opioid users require higher doses of opioids for longer durations [12, 13, 6]. This was demonstrated in our unique study specific to spine surgery, which characterized the high opioid requirements in preoperative opioid users compared to non-users. To achieve pain control up to the 90th percentile, the average number of oxycodone 5mg tablets consumed was more than 10 times greater in the anterior cervical preoperative opioid users than non-users (897, 88), more than 8 times greater between lumbar decompression preoperative opioid users than non-users (332, 40), and more than 1.5 times greater for lumbar fusion preoperative opioid users than non-users (1028, 666). This center is dedicated to achieving adequate postoperative pain control while limiting overprescribing and will use this information to guide its future opioid prescribing practices.
In two similarly designed studies, by Krauss et al. and Eley et al., the neurosurgery departments implemented procedure-specific guidelines for postoperative opioid prescribing and compared prescribing practices before and after implementation [5,14]. In the study by Krauss et al., the authors found a 25% reduction of the median prescribed MME (300 MME to 225 MME, p<0.001) after implementation of the prescribing guidelines without an increase in the 30-day refill rate (24.4% pre-guidelines and 20.2% post-guidelines, p=0.079) [15]. Eley et al.’s study demonstrated that a standardized discharge protocol for outpatient neurosurgical procedures can lead to significant reductions in quantities (52 tabs pre-protocol, 27 tabs post-protocol, p=0.001) of opioids given at discharge without an increase in refill requests or costly usage of healthcare through emergency room visits or readmissions [14]. Both of these authors concluded that interventions in prescribing practices can reduce opioids prescribed after spine surgery without increasing the refill needs for pain control. However, these studies report only on prescribing practices rather than actual opioid consumption, which provides a unique and necessary perspective.
Alternatively, Sabatino et al. go one step further by analyzing prescribing data for common elective orthopedic joint and non-joint procedures as well as analyzing opioid utilization through telephone surveys. Their results showed that, on average, the lumbar decompression patients were prescribed 107.4 ± 64.4 oxycodone 5mg equivalent pills while the mean number of unconsumed pills was 29.3 ± 37.1 (approximately 30% unused) [16]. In another telephone survey study, Bicket et al. estimated the prevalence of unused opioids after joint and spine surgery. At 1 month after surgery, 73% of patients reported having unused opioid pills, while 34% had unused pills at 6 months after surgery [17].
There have been several studies performed across seven US centers comparing prescribed and utilized opioids after orthopedic surgeries, all demonstrating overprescribing patterns [9,15,[18], [19], [20], 7]. Thiels et al. and Wyles et al. conducted similar prospective studies from the same three institutions between 2017 and 2018 where surgical patients participated in telephone surveys regarding postoperative opioid use 21–35 days after surgery. Thiels et al.’s study was larger (n=2486) and included 25 elective surgical procedures of which 3.7% were lumbar decompressions and 3% were lumbar fusions. Wyles et al. studied a group of elective orthopedic surgeries (n=919), of which 9.3% were lumbar laminectomies and 7.9% were lumbar fusions. Both studies showed that overall, 77% of patients had leftover opioids at the time of the survey (approximately 30-days after surgery) and 60% of prescribed opioids were unused [7,20]. These findings demonstrate the same overprescribing pattern across a variety of orthopedic surgeries as shown in our spine-specific study of 45% leftover opioids.
Furthermore, both studies by Thiels et al. and Wyles et al. reported that the lumbar decompression group had 72.5% unused opioids while the lumbar fusion group had 26.4% unused opioids at approximately 30-days after surgery [7,20]. Our study similarly found differences in leftover opioids between surgical subgroups. Together these results suggest that patients undergoing lumbar decompressions consume less opioids than prescribed compared to fusion patients.
The database analysis by Cook et al. found that opioid naïve spine surgery patients use less postoperative opioids than chronic users (defined as those filling two or more opioid prescriptions in the 6 months preceding surgery). They also reported that the duration of opioid use after surgery was less in the opioid naïve patients, similar to our study's findings [21]. Thiels et al. analyzed several characteristics of patients that consumed fewer postoperative opioids, which included: opioid naïveté, older age, BMI<30, low pain scores on hospital discharge, longer hospital stays, and no diagnosis of anxiety. Patients aged 80 years and above had the strongest association of low opioid consumption (OR=4.72, p=0.001) compared to patients aged 18-39 years. Preoperative opioid users were nearly twice as likely to be in the highest opioid consumption group (13.6% opioid naïve and 25.1% opioid tolerant, p=0.001) [20]. Evaluating patient characteristics for risk factors of increased opioid use allows for a more accurate projection of opioid requirements after surgery.
Together, these studies have shed light on the disparity between opioids prescribed and consumed following spine surgery, providing an understanding of the magnitude of overprescribing and unused medications available for diversion. Limitations of this study include: a small cohort, data collection from one institution which may introduce unknown biases and may not be generalized to other spine centers, and the pill count method could introduce recall or response bias for those not done in person. Additionally, subjects in this study were aware that opioid utilization behaviors were being observed in the context of research, therefore the Hawthorne effect is another potential source of bias. The strengths of this study include: narrowing the focus to the most common elective spine surgeries, analyzing the differences between preoperative opioid users and non-users within those groups, following this complex group of patients to 90-days postoperatively, and providing valuable information regarding distributions of consumed opioids in both MME and tablet formats.
Conclusion
At 90-days, just over half of the opioids prescribed to this cohort of spine patients were utilized for postoperative pain control, leaving the other half available for potential misuse or diversion. Furthermore, although preoperative opioid users consumed the majority of their prescribed opioids, they required up to 10 times more opioids than their opioid naïve counterparts. Finally, we found that the opioid naïve lumbar decompression patients required the least amount of opioids and were subsequently overprescribed the most. These findings suggest that the modern-day elective spine surgery patient consumes fewer opioids than prescribed which demonstrates the need to develop standardized prescribing practices to appropriately control pain without overprescribing.
Research Ethics Statement
This study was approved by a centralized IRB and was conducted in accordance with the 1964 Helsinki Declaration, its amendments, and other equivalent ethical standards. All study participants or their legally authorized representative signed written informed consent, included in the Notice of Privacy Practices, for study enrollment and publication prior to study.
Financial Disclosure Statement
This study has not received any outside funding.
Declaration of Competing Interest
None
Footnotes
FDA device/drug status: Not applicable.
Author disclosures: LDO: Nothing to disclose. AET: Nothing to disclose. TY: Nothing to disclose. FRB: Nothing to disclose. BA: Nothing to disclose. TCS: Nothing to disclose. RR: Nothing to disclose. CRG: Nothing to disclose. CMH: Nothing to disclose. CMH: Nothing to disclose. EJ: Nothing to disclose.
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