Randomized Controlled Trial of Nonsteroidal Anti-Inflammatory Drugs as a Safe and Effective Alternative to Opioids for Pain Relief Following Percutaneous Nephrolithotomy

Abstract

Introduction:

This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized.

Methods:

After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1–5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary.

Results:

The cohort had median age of 65 years (interquartile range [IQR]: 49–70), stone burden of 975 mm³ (IQR: 558–2356), STONE score of 6 (IQR: 5–7), and operative time of 66 minutes (IQR: 53–90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1–5 were similar across both treatment groups (p = 0.18 and p = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 vs 12, p < 0.01). All other secondary outcomes were not different between the groups.

Conclusion:

NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.

Introduction

Narcotic addiction and overdose in the United States led to an official declaration of a public health emergency in 2017.¹ Measures to reduce narcotic prescriptions and increase physician education regarding appropriate use have made inroads; however, urologists continue to contribute to the ongoing epidemic.² Opioid prescriptions for minor urologic operations have led to a significantly higher risk of overdose and long-term opioid use.³ There is also evidence for overprescribing for major urologic operations, with only 40% of prescribed opioid pills being used.⁴

Percutaneous nephrolithotomy (PCNL) is the gold standard for treating large kidney stones, and opioids are still widely used for managing post-PCNL pain. The American Urological Association (AUA) has issued an expert statement advocating for the minimization of opioid use and recommending procedure-specific regimens for prescribing narcotics, but is yet to issue procedure-specific guidelines.⁵ Although several randomized controlled trials (RCTs) have demonstrated that nonsteroidal anti-inflammatory drugs (NSAIDs) are a safe and effective alternative to opioids for pain following ureteroscopy,^6
–8 no RCTs to our knowledge have specifically evaluated post-PCNL pain management. We recently showed retrospectively that NSAIDs may be a safe and effective alternative to opioids for post-PCNL pain.^7,9 In this noninferiority RCT, we seek to address this gap by comparing the efficacy of NSAIDs (ketorolac [KET]) with opioids (oxycodone, OXY) for postoperative pain relief in patients undergoing PCNL for kidney stone disease.

Patients and Methods

Study protocol and outcomes

This is an institutional review board-approved (STUDY-23-00206, Icahn School of Medicine at Mount Sinai), single-center RCT of patients who underwent a standard PCNL at our large urban tertiary referral center between May 1, 2023, and December 31, 2024. The trial was registered with clinicaltrials.gov (NCT05924165). After signing informed consent, enrolled patients were adults over the age of 18 with a scheduled ambulatory standard (24F) unilateral PCNL for high stone burden with expected single access. Exclusion criteria included pregnant women, a history of chronic opioid abuse or chronic pain disorder, allergy, hypersensitivity or other accepted contraindications to either NSAIDs or opioids, estimated glomerular filtration rate ≤50 mL/min, reduced sensation of the abdomen or pelvis, preexisting stent or nephrostomy tube, anatomical abnormalities, concomitant nephrotoxic medication usage, or end-organ failure. Patients were also excluded from the study if they were hospitalized after the procedure.

As per the study protocol, patients were block randomized in a 1:1 ratio to one of two groups using a computer-generated algorithm as follows: OXY group or KET group. All surgeons (M.G., W.M.A.) were experienced PCNL providers with over 100 procedures annually and were blinded to the allocated study sequence before and during the procedure. Upon PCNL completion, a stent was placed in all patients as part of study protocol to standardize care, and no nephrostomy tubes were placed as per our usual and customary practice. At the end of the procedure, patients were transferred to the recovery room, where they received one dose of intravenous KET for pain management. They were discharged the same day after ambulating and voiding spontaneously, unless hospitalization was necessitated because of adverse events.

Patients received prescriptions for either OXY (20 tablets of 5 mg) Q6 PRN or KET (20 tablets of 10 mg) Q6 PRN for controlling the pain at home, in a nonblinded manner. Patients could take over-the-counter acetaminophen if they preferred not to use the prescribed medication and found it sufficient to manage their pain. Participants who could not tolerate their assigned medication during the postoperative period were offered an alternative from the same assigned medication class, the other study group medication, or acetaminophen, based on their preference. Adjunct medications for managing postoperative urinary symptoms were also prescribed and standardized, including 15 tablets of phenazopyridine (Q8 PRN) and 10 tablets of oxybutynin (daily PRN) for all participants.

The primary outcome was the assessment of pain from postoperative days (PODs) 1–5 using the Visual Analog Scale (VAS). On each POD, patients were contacted via phone to report their current pain level on a scale of 1–10.^10,11 For each patient, both average and maximal VAS scores were calculated. Secondary outcomes were evaluated on POD 10, when patients presented to the office for stent removal, and included VAS pain score assessment, pill counts, office calls, emergency department (ED) visits, patient-reported outcomes measurement information system (PROMIS) results, and reported drug-related side effects. PROMIS is a standardized tool developed to measure patient-reported health outcomes across a variety of conditions and populations. It encompasses domains such as physical health, mental health, and social well-being, enabling researchers and clinicians to assess the impact of diseases and treatments on patients’ quality of life. The PROMIS survey provides precise, reliable, and flexible measurements, offering both fixed-form and computerized adaptive tests for tailored assessments. Its robust development ensures validity and applicability across diverse clinical and research settings.¹² We focused on the domains of pain interference and gastrointestinal (GI) symptoms to reflect the quality of life in patients experiencing postoperative pain and potential GI symptoms associated with their analgesics. We also collected data regarding 30-day complications, including overall, major (Clavien–Dindo ≥3), and bleeding related.

Surgical technique

Intravenous antibiotics were administered in accordance with the AUA guidelines for antibiotic prophylaxis. Patients were positioned in supine flank-free position following induction of general anesthesia. Cystoscopy was performed, followed by the placement of an occlusion balloon catheter over a guidewire. Ultrasound guidance was used to access a calix selected by the surgeon and confirmed by fluoroscopy. Balloon dilation (NephroMax, 24F, Boston Scientific, USA) was utilized, and a 24F access sheath was advanced into the collecting system. Nephroscopy was performed using gravity irrigation from 3-L saline bags positioned 80 cm above the patient, and lithotripsy was conducted with a dual-energy lithotripter (Swiss LithoClast Trilogy, Boston Scientific, USA). Following stone removal, flexible pyeloscopy was performed to confirm the absence of residual fragments. A 6F silicon stent was placed at the end of the procedure in all patients as per study protocol, along with a Foley catheter. The tract was sealed using a hemostatic matrix kit (SURGIFLO™) with a dressing on top. Foley catheters were removed in the recovery room after 1 hour.

Statistical analyses

For sample size calculations, a noninferiority limit of 1.4 was chosen based on prior studies exploring the minimum clinically significant difference in VAS pain scores.¹³ To obtain a statistical power of 80% and 5% significance level (α), with an acceptable standard deviation (SD) of 2.5 of the VAS score, we estimated a minimum sample size of 80 subjects. To account for screen failures and dropouts, 10 patients were added for a total of 90 enrolled patients. Categorical variables were described as frequencies and percentages, and continuous variables were expressed as mean/medians and SDs/interquartile ranges (IQRs). The Mann–Whitney U test and t-test were used to compare VAS scores, pill counts, and PROMIS scores. ED visits, patient telephone calls, and side effects were analyzed as categorical outcomes using the chi-squared test. Since this is a noninferiority study, statistical analyses were one-sided for pain and patient-related outcomes with p < 0.05 considered significant. All other analyses were two-sided with p < 0.05 considered significant. SPSS software (IBM SPSS Statistics, Version 29, IBM Corp., USA, 2022) was used for all statistical analyses.

Results

Participant characteristics

Between May 2023 and December 2024, based on the inclusion and exclusion criteria and along with the patients’ willingness to participate, a total of 90 patients were enrolled in the study, aligning with our sample size calculations. Three patients were excluded because of intraoperative findings that met the exclusion criteria as follows: two patients were found to have duplicated systems not identified in the preoperative CT scan, and one patient had contralateral hydronephrosis necessitating a bilateral procedure. Two more patients required hospitalization after the procedure and were excluded. The remaining 85 patients were included in the intention-to-treat analysis; 42 patients were randomized into KET, whereas 43 patients randomized into OXY (Fig. 1). Two patients (one in each group) deviated from their assigned medication regimen, opting for different types of analgesics, and one patient from the KET group received additional opioids during the first PODs that were prescribed by other external provider not familiar with the study. Baseline demographic, clinical, stone, and intraoperative characteristics were comparable between the treatment groups (Table 1). The overall median age was 65 years (IQR: 49–70), stone burden was 975 mm³ (IQR: 558–2356), STONE score was 6 (IQR: 5–7), and operative time was 66 minutes (IQR: 53–90). The majority of accesses were directed toward the lower pole (68%) and located below the 12th rib (80%).

FIG. 1.

Study CONSORT diagram illustrating enrollment and randomization. ED = emergency department; eGFR = estimated glomerular filtration rate; NSAID = nonsteroidal anti-inflammatory drug; PCNL = percutaneous nephrolithotomy; POD = postoperative day; PROMIS = Patient-Reported Outcomes Measurement Information System; VAS = Visual Analog Scale.

Table 1.

Baseline Characteristics Stratified by Treatment Groups

Variable	Oxycodone (N = 43)	Ketorolac (N = 42)	p
Clinical characteristics
Age, years	65 (57–70)	63 (45–74)	0.48
Sex, M:F	25:18	24:18	1.00
BMI, kg/m²	27.98 (24.14–31.38)	27.42 (25.07–31.94)	0.89
ASA score			0.09
1	2 (5%)	0 (0%)
2	34 (79%)	28 (67%)
3	7 (16%)	14 (33%)
Blood thinners
Antiplatelets	6 (14%)	10 (24%)	0.28
Anticoagulation	5 (11%)	1 (2%)	0.20
Laterality			1.00
Right	21 (49%)	21 (50%)
Left	22 (51%)	21 (50%)
Ipsilateral prior PCNL	3 (7%)	4 (10%)	0.71
Stone characteristics
Overall stone burden volume, mm³	1113 (585–2298)	845 (495–2175)	0.23
Number of stones			0.77
1	24 (56%)	24 (57%)
2	9 (21%)	10 (24%)
3	6 (14%)	5 (12%)
4+	4 (9%)	3 (7%)
Tract length >10 cm	5 (12%)	7 (17%)	0.54
Hounsfield units	1052 (742–1236)	885 (624–1107)	0.10
STONE score	6 (5–7)	5 (5–6)	0.14
Guy’s stone score			0.12
1	19 (45%)	24 (57%)
2	13 (30%)	14 (33%)
3	7 (16%)	1 (3%)
4	4 (9%)	3 (7%)
Main composition			0.85
Calcium oxalate	31 (72%)	32 (76%)
Uric acid	6 (14%)	6 (14%)
Calcium phosphate	3 (7%)	1 (3%)
Brushite	2 (5%)	2 (5%)
Struvite	1 (2%)	1 (2%)
Intraoperative characteristics
Position			1.00
Supine	41 (95%)	41 (97%)
Prone	2 (5%)	1 (3%)
Location of access			0.25
Upper pole/interpolar	11 (26%)	16 (38%)
Lower pole	32 (74%)	26 (62%)
Relative to ribs			0.44
Below 12th	34 (79%)	34 (81%)
11th–12th	9 (21%)	7 (17%)
Above 11th	0	1 (2%)
Number of needle attempts			0.47
1	37 (86%)	38 (90%)
2	5 (11%)	4 (10%)
3	1 (3%)	0
Total operative time	69 (53–94)	60 (51–88)	0.24

Continuous variables are presented as medians (IQR) and categorical as n (%).

ASA = American Society of Anesthesiologists; BMI = body mass index; PCNL = percutaneous nephrolithotomy; IQR = interquartile range.

VAS pain scores

VAS pain scores for PODs 1–5 are shown in Figure 2. Both groups exhibited a linear decrease in pain, with an approximate 1-point reduction in VAS score per day. Maximal and averaged VAS pain scores over PODs 1–5 were comparable between the two treatment groups (p = 0.18 and p = 0.17, respectively, Fig. 3) with median maximal scores being 7 (5–9) for OXY vs 8 (6–10) for KET and median averaged scores being 4.5 (3–7) for OXY vs 5 (3–6) for KET.

FIG. 2.

Daily VAS pain scores from POD 1 to POD 5. POD = postoperative day; VAS = Visual Analog Scale.

FIG. 3.

Box plots for integrated pain assessment of PODs 1–5, stratified by treatment groups. POD = postoperative day; VAS = Visual Analog Scale.

Secondary outcomes

Median VAS scores on POD 10 were 1 (0–2) for OXY and 1 (0–3) for KET, with no significant difference (p = 0.25). Similarly, the results of the PROMIS questionnaire showed no differences between the treatment groups for both pain-related and GI items. The median PROMIS pain-related scores were 10 (7–13) for OXY and 10 (8–15) for KET (p = 0.23). The median PROMIS GI symptom scores were 9 (6.5–11) for OXY and 8 (6–10) for KET (p = 0.12). OXY patients consumed fewer pills over the 10-day period, with a mean of 6.5 pills (±5) compared with 12 pills (±6) for KET (p < 0.001). However, there were no significant differences between the groups in the consumption of adjunct phenazopyridine (mean of 5.5 vs 8 pills, p = 0.05) or oxybutynin (median of 4.5 vs 5.5 pills, p = 0.36). Rates of office calls (5 patients [12%] vs 8 patients [19%], p = 0.26) and drug-related adverse events (3 patients [7%] vs 3 patients [7%], p = 0.65) were also comparable between the two groups. All office calls were either about drug-related events or expected stent symptoms (reddish urine, pain, and lower urinary tract symptoms). The drug-related events were mainly GI ones. The three OXY patients experienced drug-related constipation, whereas 2 out of 3 KET patients complained about persistent pain, and one patient had dyspepsia. No statistically significant differences were observed between the groups for any of the complication outcomes. Overall, 12 patients experienced a 30-day complication as follows: 8 patients (18%) in the OXY group and 4 patients (10%) in the KET group (p = 0.35). One major complication occurred in the KET group (2%)—a pseudoaneurysm necessitating angioembolization—whereas no major complications were reported in the OXY group (p = 0.49). Bleeding complications were documented in 1 patient (2%) in the OXY group (hematuria with clot retention) and in 2 patients (5%) in the KET group (1 pseudoaneurysm, 1 renal hematoma) (p = 0.61). The secondary outcomes are summarized in Table 2.

Table 2.

Results of Secondary Outcomes Stratified by Treatment Groups

Variable	Oxycodone (N = 43)	Ketorolac (N = 42)	p
VAS score on POD10; median (IQR)	1 (0–2)	1 (0–3)	0.25
PROMIS pain-related score; median (IQR)	10 (7–13)	10 (8–15)	0.23
PROMIS GI symptoms score; median (IQR)	9 (6.5–11)	8 (6–10)	0.12
Number of study pills; mean (SD)	6.5 (±5)	12 (±6)	<0.001
Number of pyridium pills; mean (SD)	5.5 (±4.6)	8 (±5)	0.05
Number of oxybutynin pills; mean (SD)	4.5 (±4)	5.5 (±5)	0.32
Office calls; n (%)	5 (12%)	8 (19%)	0.26
Drug-related adverse events; n (%)	3 (7%)	3 (7%)	0.65
30-day overall complication rate; n (%)	8 (18%)	4 (10%)	0.35
30-day major complication rate; n (%)	0 (0%)	1 (2%)	0.49
Bleeding complications; n (%)	1 (2%)	2 (5%)	0.61

Bold indicates significance.

GI = gastrointestinal; IQR = interquartile range; POD = postoperative day; PROMIS = Patient-Reported Outcomes Measurement Information System; VAS = Visual Analog Scale; SD = standard deviation.

Discussion

In this RCT comparing NSAIDs to opioids for postoperative pain management after PCNL, we observed no significant difference in patient-reported pain scores between the two groups. The study protocol required a stent to be placed at the end of the procedure. This was done to standardize patients, since stents are commonly placed after PCNL and can be a source of pain that any pain regimen needs to be able to address.^14,15 NSAIDs were not inferior for either short-term (PODs 1–5) or intermediate-term (POD 10) results, nor for direct outcomes (VAS pain scores), indirect outcomes (pill counts, phone calls, ED visits, complications), or quality of life (PROMIS). These results suggest that compared with NSAIDs, opioids do not offer superior analgesia after PCNL. Moreover, this study offers insights into the natural history of postoperative pain following PCNL, under oral analgesic therapy. The findings clearly demonstrate that pain decreases linearly from moderate-to-severe levels to mild within the first 5 days. By day 10, the pain ultimately resolves.

Prescribing opioids after PCNL is exceptionally common. A recent large study conducted within the United States veteran population revealed that 95.8% of patients were prescribed opioids postoperatively.¹⁶ Similarly, a national survey distributed to urology trainees found that 93.9% prescribed opioids after PCNL.¹⁷ Although the AUA has not yet published a formal guideline on postoperative pain management, they have produced a position statement imploring urologists to adhere to opioid stewardship principles.¹⁸ Inside this statement, they recommend minimizing the amount of opioids prescribed within what is necessary and leave this definition to the discretion of the practitioner. Specifically, they state that “Non-narcotic methods of managing pain, including anti-inflammatories…should be used when appropriate and adequate.” The main question then becomes the following: What constitutes “adequate” analgesia to warrant abstaining from opiate prescription? Our study does not answer what is adequate but does indicate that compared with the “gold standard” for pain management, KET is noninferior.

PCNL postoperative pain has been an interest for many years with over 60 articles having been published in the last 20 years specifically targeting pain after PCNL. Aside from oral medications, practitioners have proposed numerous analgesic strategies for ameliorating PCNL postoperative pain, including local anesthetics injected adjacent to the nephrostomy tract and long-lasting regional nerve blocks.^19

–23 Alternative therapies have also been studied; promising results have been demonstrated in aromatherapy and acupuncture.^24,25 Nonetheless, opioid prescriptions are still prevalent after PCNL.¹⁶ Although the efficacy of NSAID and opioid analgesics is equivalent in their intended effects, the harms caused by unintended effects from opioids contribute to the epidemic and add tremendous weight to tip the pragmatist’s scale against the prescription of opioids after PCNL. Nearly 1-in-16 previously opioid-naive ureteroscopy patients continue to use opioids after the postoperative period, and this likelihood is associated with the amount of opioid prescribed.^26,27 Despite the known risks of overprescription and downstream drug diversion, urologists are poorly adherent to unused drug disposal programs.²⁸

The present study critically highlights the real-life experiences of patients after PCNL who are coping with pain after operation. No good physician wants to overlook their patient’s suffering when a remedy is available to help the pain, and we provide level 1 evidence to counter the claim that opioids provide superior pain relief, as NSAIDs offer comparable efficiency not only in reducing severity but also in providing rapid relief. NSAIDs were also found to demonstrate noninferior PROMIS results, indicating comparable effects on patients’ well-being. We utilized the PROMIS to ascertain a more comprehensive assessment of the impact of pain on the patients’ lives and a more granular characterization of the impact that opioids and NSAIDs can have on the patients’ GI system.¹² Namely, this instrument permitted investigation of how pain impacted socializing, enjoyment in life, concentration, performing chores, and sleep quality and homed in on specific GI symptoms, such as nausea, bloating, abdominal discomfort, changes in bowel movements, and appetite suppression. In addition, this study is generalizable as it encompasses both the standard tubeless PCNL approach (with a stent left in place upon completion) and a representative wide population. Patients were represented from a wide range of ages, both males and females, body mass index, stone burden, and procedural factors such as location of access, including upper, lower, interpolar, and both above and below the 12th rib.

Similar findings were reproduced in analogous trials conducted in ureteroscopy populations, including the SKOPE trial, where there was no difference in pain scores between KET and OXY; however, the KET had significantly earlier postoperative mobilization (1.3 ± 1.3 days vs 2.3 ± 2.6 days, p = 0.02).^7,8 A randomized trial consisting of a heterogeneous group of 90 ureteroscopy and PCNL patients, stented and nonstented, found slightly superior analgesia with KET vs OXY. Using an 11-point ordinal numeric pain scale on POD 7, they found an average pain score of 3.20 ± 1.94 and 4.17 ± 1.84 in the KET and OXY groups, respectively (p = 0.018), similar to our results.²⁹ A retrospective study of a PCNL population similarly failed to show a significant difference in rates of health care encounters related to postoperative pain when NSAIDs or opioids were used (11.4% vs 14.3%, p = 0.614).⁹ However, they did find a statistically significant increase in pain-related phone calls to the office in the OXY group (60% vs 34.3%, p = 0.004). The present randomized clinical trial adds important high-quality evidence to underscore the futility of prescribing opioids after PCNL instead of safer available alternatives, particularly in stented patients. It is supported by a recent analgesia consensus statement that encourages adherence to enhanced recovery practice guidelines to abate the reliance on opioids for postoperative analgesia.¹⁸ Nevertheless, a contradiction persists between the evidence of therapy and real-world practice. The key to changing this behavior may rest in physician-centered interventions, including formal education, individual feedback, and peer comparison performance feedback.³⁰ Urologists who have already made inroads to eliminating opioid prescriptions after oncologic procedures cite the importance of patient education as another key element for effectiveness.³¹ They also advocate for setting expectations with patients preoperatively about the eventuality of pain and discussing multimodal strategies for reducing pain, including early mobilization.

One significant difference observed between the two treatment groups in our study was that the number of pills taken by the opioid group was significantly less compared with the KET group. Since the pain scores for this group were still elevated, the reason cannot be that their pain had gone away. When patients in the OXY group were asked “off the record” why they used fewer pills, most mentioned concerns about addiction, influenced by public awareness raised by the media over the past decade. Indeed, several studies have documented hesitancy from patients to take opioids for fear of addiction in numerous clinical contexts.^32
–34 Another reason for taking fewer opioid pills is explained by tolerability issues, particularly those pertaining to the GI tract. Opioids are known to cause constipation, nausea, and vomiting. This syndrome affects between 40% and 80% of patients taking chronic opioid therapy.³⁵

Our study is not free of limitations. Analgesics were administered alongside adjunct medications such as anticholinergics and phenazopyridine, which interfered with the ability to observe their isolated effects. However, these medications operate through different mechanisms to alleviate symptoms that are not specifically related to pain. We also permitted patients to take their own over-the-counter analgesics (such as acetaminophen) if they wished, which could potentially influence our outcomes. However, since our goal was to conduct a real-world study, we considered this an acceptable practice, as it reflects typical patient behavior when prescription medications are either not desired or inadequate for symptom relief. In addition, this cohort was limited to stented patients, which we believe experience more pain than nonstented patients. Finally, we assessed short-to-intermediate pain outcomes without focusing on the long-term development of chronic pain. Nevertheless, as pain was almost entirely resolved by day 10, the development of chronic pain disorders seems to be rare following PCNL. Despite those limitations, we provide level 1 evidence that once corroborated should allow urology organizations such as the AUA and EAU, to take a clear stance and issue stronger recommendations in their guidelines regarding nonopioid protocols for postoperative management of endourologic procedures.

Conclusion

NSAIDs are not inferior to opioids in managing postoperative pain following standard PCNL. Their effectiveness is evident in reducing pain to mild levels within 5 days and achieving complete resolution by day 10.

Ethics of Approval Statement

Ethical approval to report this study was obtained from our institutional review board. All patients signed informed consent before enrollment.

Footnotes

Authors’ Contributions

Conception and design—Z.S., K.G., R.K., A.J.Y., W.M.A., and M.G. Acquisition of data—Z.S., K.G., E.F., V.D., C.C., A.R., R.K., and A.J.Y. Statistical analysis—Z.S. Analysis and interpretation—Z.S., K.G., E.F., V.D., and M.G. Drafting of the article—Z.S. and A.M. Critical revision of the article—W.M.A. and M.G. Supervision—M.G.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to ethical issues and the privacy of the participants.

Author Disclosure Statement

All authors have nothing to disclose.

Funding Information

The authors received no financial support for the research, authorship, and/or publication of this article.

Abbreviations Used

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