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The Cochrane Database of Systematic... May 2016Hyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for hospitalization during pregnancy. While a previous Cochrane review examined interventions for nausea and vomiting in pregnancy, there has not yet been a review examining the interventions for the more severe condition of hyperemesis gravidarum.
OBJECTIVES
To assess the effectiveness and safety, of all interventions for hyperemesis gravidarum in pregnancy up to 20 weeks' gestation.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register and the Cochrane Complementary Medicine Field's Trials Register (20 December 2015) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomized controlled trials of any intervention for hyperemesis gravidarum. Quasi-randomized trials and trials using a cross-over design were not eligible for inclusion.We excluded trials on nausea and vomiting of pregnancy that were not specifically studying the more severe condition of hyperemesis gravidarum.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed the eligibility of trials, extracted data and evaluated the risk of bias. Data were checked for accuracy.
MAIN RESULTS
Twenty-five trials (involving 2052 women) met the inclusion criteria but the majority of 18 different comparisons described in the review include data from single studies with small numbers of participants. The comparisons covered a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various pharmaceutical interventions. The methodological quality of included studies was mixed. For selected important comparisons and outcomes, we graded the quality of the evidence and created 'Summary of findings' tables. For most outcomes the evidence was graded as low or very low quality mainly due to the imprecision of effect estimates. Comparisons included in the 'Summary of findings' tables are described below, the remaining comparisons are described in detail in the main text.No primary outcome data were available when acupuncture was compared with placebo, There was no clear evidence of differences between groups for anxiodepressive symptoms (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.40; one study, 36 women, very low-quality evidence), spontaneous abortion (RR 0.48, 95% CI 0.05 to 5.03; one study, 57 women, low-quality evidence), preterm birth (RR 0.12, 95% CI 0.01 to 2.26; one study, 36 women, low-quality evidence), or perinatal death (RR 0.57, 95% CI 0.04 to 8.30; one study, 36 women, low-quality evidence).There was insufficient evidence to identify clear differences between acupuncture and metoclopramide in a study with 81 participants regarding reduction/cessation in nausea or vomiting (RR 1.40, 95% CI 0.79 to 2.49 and RR 1.51, 95% CI 0.92 to 2.48, respectively; very low-quality evidence).In a study with 92 participants, women taking vitamin B6 had a slightly longer hospital stay compared with placebo (mean difference (MD) 0.80 days, 95% CI 0.08 to 1.52, moderate-quality evidence). There was insufficient evidence to demonstrate a difference in other outcomes including mean number of episodes of emesis (MD 0.50, 95% CI -0.40 to 1.40, low-quality evidence) or side effects.A comparison between metoclopramide and ondansetron identified no clear difference in the severity of nausea or vomiting (MD 1.70, 95% CI -0.15 to 3.55, and MD -0.10, 95% CI -1.63 to 1.43; one study, 83 women, respectively, very low-quality evidence). However, more women taking metoclopramide complained of drowsiness and dry mouth (RR 2.40, 95% CI 1.23 to 4.69, and RR 2.38, 95% CI 1.10 to 5.11, respectively; moderate-quality evidence). There were no clear differences between groups for other side effects.In a single study with 146 participants comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness, dizziness, and dystonia (RR 0.70, 95% CI 0.56 to 0.87, RR 0.48, 95% CI 0.34 to 0.69, and RR 0.31, 95% CI 0.11 to 0.90, respectively, moderate-quality evidence). There were no clear differences between groups for other important outcomes including quality of life and other side effects.In a single trial with 30 women, those receiving ondansetron had no difference in duration of hospital admission compared to those receiving promethazine (MD 0.00, 95% CI -1.39 to 1.39, very low-quality evidence), although there was increased sedation with promethazine (RR 0.06, 95% CI 0.00 to 0.94, low-quality evidence) .Regarding corticosteroids, in a study with 110 participants there was no difference in days of hospital admission compared to placebo (MD -0.30, 95% CI -0.70 to 0.10; very low-quality evidence), but there was a decreased readmission rate (RR 0.69, 95% CI 0.50 to 0.94; four studies, 269 women). For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, there was insufficient evidence to identify differences between groups (very low-quality evidence for all outcomes). In other single studies there were no clear differences between groups for preterm birth or side effects (very low-quality evidence).For hydrocortisone compared with metoclopramide, no data were available for primary outcomes and there was no difference in the readmission rate (RR 0.08, 95% CI 0.00 to 1.28;one study, 40 women).In a study with 80 women, compared to promethazine, those receiving prednisolone had increased nausea at 48 hours (RR 2.00, 95% CI 1.08 to 3.72; low-quality evidence), but not at 17 days (RR 0.81, 95% CI 0.58 to 1.15, very low-quality evidence). There was no clear difference in the number of episodes of emesis or subjective improvement in nausea/vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth.
AUTHORS' CONCLUSIONS
On the basis of this review, there is little high-quality and consistent evidence supporting any one intervention, which should be taken into account when making management decisions. There was also very limited reporting on the economic impact of hyperemesis gravidarum and the impact that interventions may have.The limitations in interpreting the results of the included studies highlights the importance of consistency in the definition of hyperemesis gravidarum, the use of validated outcome measures, and the need for larger placebo-controlled trials.
Topics: Acupuncture Therapy; Adrenal Cortex Hormones; Antiemetics; Female; Humans; Hydrocortisone; Hyperemesis Gravidarum; Metoclopramide; Ondansetron; Placebo Effect; Prednisolone; Pregnancy; Promethazine; Pyridoxine
PubMed: 27168518
DOI: 10.1002/14651858.CD010607.pub2 -
The Journal of Clinical Psychiatry Jun 2020Ondansetron is a 5-HT₃ receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and... (Review)
Review
Ondansetron is a 5-HT₃ receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery. Ondansetron has also been studied in the treatment of many neuropsychiatric and medical conditions. The drug is commonly used off-label to treat nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum (HG). Ondansetron crosses the placental barrier, and concerns have been expressed that using ondansetron for NVP/HG during the first trimester of pregnancy may increase the risk of major congenital malformations (MCMs) in the offspring. In this context, findings from a meta-analysis of 6 cohort and 2 case-control studies, read along with the results of subsequently published cohort (n = 3) and case-control (n = 1) studies, suggest that a signal does exist to associate early gestational exposure to ondansetron with an increased risk of heart defects and orofacial defects. Arguments both for and against confounding by indication have been proposed to explain these findings. Nevertheless, even if ondansetron is causally implicated in MCM risk, the absolute increase in risk, such as for orofacial clefts (by 0.03%) and ventricular septal defect (by 0.3%), is small. These small risks should be balanced against the risks associated with inadequately treated NVP/HG, and decision-making must be shared between clinician and patient. Repeated fetal scanning during the second trimester can help in the early detection of malformations, if present.
Topics: Abnormalities, Drug-Induced; Administration, Intravenous; Administration, Oral; Antiemetics; Female; Humans; Morning Sickness; Ondansetron; Pregnancy; Pregnancy Trimester, First; Risk Factors
PubMed: 32526103
DOI: 10.4088/JCP.20f13472 -
Journal of Orthopaedic Surgery and... Nov 2020Arthroscopic rotator cuff repair is a painful procedure, and treatment of emetic events associated with drugs used in the current multimodal pain management remains... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Arthroscopic rotator cuff repair is a painful procedure, and treatment of emetic events associated with drugs used in the current multimodal pain management remains challenging. This study aimed to evaluate the effectiveness of ramosetron or ondansetron to relieve postoperative nausea and vomiting (PONV) and pain after arthroscopic rotator cuff repair.
METHODS
In total, 122 consecutive patients undergoing arthroscopic rotator cuff repair were randomly allocated into three groups: ramosetron group (n = 39), ondansetron group (n = 43), and control group (n = 40). Then, 0.3 mg of ramosetron or 8 mg of ondansetron was administered intravenously at the end of surgery according to group. All patients received general anesthesia and multimodal pain management protocol including preemptive analgesic medication, fentanyl-based intravenous patient-controlled analgesia, and postoperative analgesic medication. Incidence of emetic events, rescue antiemetic requirements (10 mg of metoclopramide, IV), complete response, pain level, and side effects were recorded in three periods: 0-6, 6-24, and 24-48 h postoperatively. The severity of nausea and pain was evaluated using a visual analog scale.
RESULTS
The ramosetron group tended to have a lower incidence and severity of nausea during the 6- to 24-h postoperative period and fewer rescue antiemetic drug requirements during the 0- to 48-h period than the control group, showing statistical significance. Additionally, the frequency of complete response of the ramosetron and ondansetron groups was significantly higher than that of the control group. No difference was found among the groups in the pain level except during the 0- to 6-h period. The two groups have a higher complete response during the 6- to 24-h period than the control group.
CONCLUSIONS
Ramosetron use led to a lower incidence, mild severity of nausea, and reduced use of rescue antiemetic drug after arthroscopic rotator cuff repair during the 6- to 24-h postoperative period than the control.
LEVEL OF EVIDENCE
Level I, randomized controlled trials, treatment study.
Topics: Aged; Antiemetics; Arthroscopy; Benzimidazoles; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Ondansetron; Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Period; Rotator Cuff; Severity of Illness Index; Time Factors; Treatment Outcome
PubMed: 33176845
DOI: 10.1186/s13018-020-02060-3 -
Annals of Emergency Medicine Jan 2022This study aimed to explore oral ondansetron usage and impact on outcomes in clinical practice. (Observational Study)
Observational Study
STUDY OBJECTIVE
This study aimed to explore oral ondansetron usage and impact on outcomes in clinical practice.
METHODS
This observational study was a planned secondary analysis of 2 trials conducted in 10 US and 6 Canadian institutions between 2014 and 2017. Children 3 to 48 months old with gastroenteritis and ≥3 episodes of vomiting in the 24 hours preceding emergency department (ED) presentation were included. Oral ondansetron was administered at the discretion of the provider. The principal outcomes were intravenous fluid administration and hospitalization at the index visit and during the subsequent 72 hours and diarrhea and vomiting frequency during the 24 hours following the ED visit.
RESULTS
In total, 794 children were included. The median age was 16.0 months (interquartile range 10.0 to 26.0), and 50.1% (398/794) received oral ondansetron. In propensity-adjusted analysis (n=528), children administered oral ondansetron were less likely to receive intravenous fluids at the index visit (adjusted odds ratio [aOR] 0.50; 95% confidence interval [CI] 0.29 to 0.88). There were no differences in the frequencies of intravenous fluid administration within the first 72 hours (aOR 0.65; 95% CI 0.39 to 1.10) or hospitalization at the index visit (aOR 0.31; 95% CI 0.09 to 1.10) or the subsequent 72 hours (aOR 0.52; 95% CI 0.21 to 1.28). Episodes of vomiting (aRR 0.86; 95% CI 0.63 to 1.19) and diarrhea (aRR 1.11; 95% CI 0.93 to 1.32) during the 24 hours following ED discharge also did not differ.
CONCLUSION
Among preschool-aged children with gastroenteritis seeking ED care, oral ondansetron administration was associated with a reduction in index ED visit intravenous fluid administration; it was not associated with intravenous fluids administered within 72 hours, hospitalization, or vomiting and diarrhea in the 24 hours following discharge.
Topics: Acute Disease; Administration, Oral; Antiemetics; Child, Preschool; Diarrhea; Emergency Service, Hospital; Female; Fluid Therapy; Gastroenteritis; Hospitalization; Humans; Infant; Male; Ondansetron; Propensity Score; Vomiting
PubMed: 34389195
DOI: 10.1016/j.annemergmed.2021.06.003 -
Saudi Medical Journal Jul 2021To compare the efficacy of prophylactic ondansetron and tropisetron for postoperative nausea and vomiting (PONV). (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To compare the efficacy of prophylactic ondansetron and tropisetron for postoperative nausea and vomiting (PONV).
METHODS
A literature search was performed to identify studies that compare the efficiency of ondansetron with that of tropisetron in preventing PONV. Only randomized controlled trials updated to January, 2021 were included.
RESULTS
The final pooled analysis included 14 studies totaling 1705 patients and indicated that ondansetron was 39% less effective than tropisetron in preventing postoperative vomiting with a higher incidence of dizziness. However, no significant difference was detected between ondansetron and tropisetron in PONV, postoperative nausea, antiemetic treatment, and headache.
CONCLUSIONS
Tropisetron is superior to ondansetron in preventing postoperative vomiting.PROSPERO No: CRD42021237368.
Topics: Antiemetics; Double-Blind Method; Humans; Ondansetron; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Tropisetron; Vomiting
PubMed: 34187913
DOI: 10.15537/smj.2021.42.7.20210135 -
Frontiers in Endocrinology 2023Pregnant women with gestational diabetes mellitus (GDM) require more analgesics after cesarean delivery than those who do not have GDM. Uncontrolled pain following... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Pregnant women with gestational diabetes mellitus (GDM) require more analgesics after cesarean delivery than those who do not have GDM. Uncontrolled pain following cesarean delivery is a major problem in women with GDM. We investigate the efficacy of low-dose esketamine combined with sufentanil intravenous patient-controlled analgesia (PCA)for postcesarean analgesia in women with GDM.
METHODS
One hundred forty pregnant women with GDM were enrolled participate in this randomized controlled trial and were randomized into two groups (70 in each group). The esketamine (S) group was given esketamine +sufentanil + ondansetron, and the control (C) group was given sufentanil +ondansetron. The primary outcome is sufentanil consumption at 24 hours postoperatively, the secondary outcomes are sufentanil consumption at 6 hours postoperatively, pain scores at 6, 24 and 48 hours postoperatively.
RESULTS
Compared with group C, group S had significantly lower sufentanil consumption at 6 and 24 hours postoperatively (P= 0.049 and P<0.001), significantly lower activities VAS(pain during activities)scores at 6 hours postoperatively, rest and activities VAS (pain at rest and pain during activities)scores at 24 hours postoperatively, and activities VAS scores at 48 hours postoperatively(P=0.022, P =0.002, P=0.001 and P=0.007). Compared to group C, the time to bowel function return was significantly shorter in group S. There was no significant difference in rest VAS (pain at rest) scores at 6 and 48 hours postoperatively (P>0.05). The time to first lactation was not significantly different between the two groups (P>0.05). There was no significant difference in neonatal neurobehavioral scores between the two groups (P>0.05).
CONCLUSION
Compared to sufentanil PCA, adding low dose of esketamine significantly reduced the consumption of sufentanil while providing equally effective post cesarean analgesia in the patients with gestational diabetes.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Sufentanil; Diabetes, Gestational; Double-Blind Method; Ondansetron; Prospective Studies; Pain; Analgesia
PubMed: 37635978
DOI: 10.3389/fendo.2023.1202734 -
Biomedical Chromatography : BMC Nov 2019Ondansetron, a widely used antiemetic agent, is a P-glycoprotein (P-gp) substrate and therefore expression of P-gp at the blood-brain barrier limits its distribution to...
Ondansetron, a widely used antiemetic agent, is a P-glycoprotein (P-gp) substrate and therefore expression of P-gp at the blood-brain barrier limits its distribution to the central nervous system (CNS), which was observed to be reversed by coadministration with P-gp inhibitors. Tariquidar is a potent and selective third-generation P-gp inhibitor, and coadministration with ondansetron has shown improved ondansetron distribution to the CNS. There is currently no reported bioanalytical method for simultaneously quantifying ondansetron with a third-generation P-gp inhibitor. Therefore, we aimed to develop and validate a method for ondansetron and tariquidar in rat and human plasma samples. A full validation was performed for both ondansetron and tariquidar, and sample stability was tested under various storage conditions. To demonstrate its utility, the method was applied to a preclinical pharmacokinetic study following coadministration of ondansetron and tariquidar in rats. The presented method will be valuable in pharmacokinetic studies of ondansetron and tariquidar in which simultaneous determination may be required. In addition, this is the first report of a bioanalytical method validated for quantification of tariquidar in plasma samples.
Topics: Animals; Chromatography, High Pressure Liquid; Humans; Limit of Detection; Linear Models; Male; Ondansetron; Quinolines; Rats; Rats, Sprague-Dawley; Reproducibility of Results; Spectrophotometry, Ultraviolet
PubMed: 31322284
DOI: 10.1002/bmc.4653 -
BMC Anesthesiology Apr 2022Direct stimulation of the afferent nerve endings in the venous endothelium is one explanation of propofol injection pain. Previous studies found that ondansetron can... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Direct stimulation of the afferent nerve endings in the venous endothelium is one explanation of propofol injection pain. Previous studies found that ondansetron can also block sodium channels. This effect is similar to that of lidocaine.
OBJECTIVE
The primary outcome was the efficacy of ondansetron compared to lidocaine and placebo for the reduction of propofol injection pain.
METHOD
This trial was conducted in 240 patients, American Society of Anesthesiologists classification I-III and aged between 18-65 years old, undergoing elective surgery, and having a 20-gauge intravenous catheter at the hand dorsum. Each group of 80 patients received 8 mg. of ondansetron in the O Group, 40 mg. of lidocaine in the L Group and normal saline in the C Group. The study medications were blindly administered to the patients through a 20-gauge intravenous catheter placed on the hand dorsum, and then 1 min later, the small dose of propofol (50 mg.) was infused via the syringe pump at a rate of 600 ml/hr. for 30 s. Following that, the syringe pump of propofol was temporarily stopped, and the patients were asked to rate their pain at the injection site.
RESULT
The incidence of pain was lowest in the L group (66.2%) compared with the O (82.5%) and the C groups (85.0%) (P < 0.01). The median pain score in the L, O, and C groups were 2 (0-4), 4 (2-5), and 4.5 (2-6), respectively (P < 0.01). The incidences of no pain, mild, moderate, and severe pain were also significantly different in the L group (33.8%, 37.5%, 21.2%, and 7.5%, respectively) compared with those in the O group (17.5%, 31.2%, 31.2%, and 20.0%, respectively) and the C groups (15.0%, 22.5%, 40.0%, and 22.5%, respectively) (P < 0.01).
CONCLUSION
Pretreatment with intravenous lidocaine, rather than ondansetron, can reduce the incidence and intensity of propofol-induced pain.
Topics: Adolescent; Adult; Aged; Anesthetics, Intravenous; Anesthetics, Local; Double-Blind Method; Humans; Injections, Intravenous; Lidocaine; Middle Aged; Ondansetron; Pain; Pain Measurement; Propofol; Young Adult
PubMed: 35436859
DOI: 10.1186/s12871-022-01650-4 -
Cureus Sep 2022Background and objective The antiemetic drug is one of the most common armamentariums in an anaesthesiologist's pharmacopoeia to prevent postoperative nausea and...
A Randomised Controlled Trial to Compare the Effect of Ramosetron and Ondansetron in Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Procedures.
Background and objective The antiemetic drug is one of the most common armamentariums in an anaesthesiologist's pharmacopoeia to prevent postoperative nausea and vomiting (PONV). PONV is one of the usual side effects after general anaesthesia, especially in female patients (21%) and after laparoscopic surgery (60%). This study aimed to compare the efficacy of ondansetron with ramosetron. Methodology After institutional ethical clearance and informed written consent, one hundred female patients scheduled for laparoscopic gynaecological surgeries were selected for this prospective, double-blinded, randomised interventional study. These patients were further subdivided into two equal groups (50 in groups R and O). Group R received ramosteron 0.3mg, and group O received ondansetron 8mg 30 minutes before the end of surgery. Patients were assessed between 0-2, 2-6, 6-12 and 12-24 hrs in the postoperative period. The primary objective of this study was to compare the effect of a single dose of ramosetron (0.3mg) with a single dose of ondansetron (8mg) for the prevention of PONV after general anaesthesia in laparoscopic surgeries. The secondary goal was to record the time of occurrence of the first episode of PONV, the need for rescue antiemetics, patient satisfaction scores, and to look for any side effects. Results This study shows no significant difference in the reduction of PONV incidence between group O and group R in the first 24 hours of the postoperative period. The overall incidence of PONV was significantly higher in the early postoperative (0-6 hrs) than in the late postoperative period (6-24 hrs), i.e., 51% and 13%, respectively. The requirement of rescue antiemetic was higher in group O than in group R but not statistically significant. In our study, both groups had similar patient satisfaction scores. Headache was the most common side effect and was noted in 9% of the patient population. Conclusion We conclude that ramosetron is as effective as ondansetron in preventing the incidence and severity of PONV up to 24 hours postoperatively.
PubMed: 36258972
DOI: 10.7759/cureus.29200 -
Journal of Veterinary Pharmacology and... Nov 2022The purpose of this study was to evaluate the pharmacokinetics of intravenous (IV) ondansetron in a population of hospitalized dogs exhibiting clinical signs of nausea....
The purpose of this study was to evaluate the pharmacokinetics of intravenous (IV) ondansetron in a population of hospitalized dogs exhibiting clinical signs of nausea. The causes of nausea included pancreatitis, gastroenteritis, endocarditis, chemotherapy-induced nausea, diabetes mellitus and ketoacidosis, acute kidney injury with aspiration pneumonia, pyometra, uroabdomen, neoplasia, and hepatopathy. Twenty-four dogs were randomly assigned to one of the following IV ondansetron protocols: 1 mg/kg q12h, 0.5 mg/kg q12h, 1 mg/kg q8h, 0.5 mg/kg q8h. Serum was collected at 0, 0.25, 0.5, 1, 2, 4, 8, 16, and 24 h after the first dose, and nausea scores were recorded at multiple time points. Ondansetron and arginine vasopressin (AVP) concentrations were measured via high-performance liquid chromatography coupled to tandem mass spectrometry and ELISA, respectively. Noncompartmental pharmacokinetic modeling and dose interval modeling were performed. Ondansetron displayed linear pharmacokinetics. In the 0.5 mg/kg group, mean C = 214 ng/ml, AUC = 463 ng/ml*h, and calculated half-life was 1.9 h. In the 1 mg/kg group, mean C = 541 ng/ml, AUC = 1057 ng/ml*h and calculated half-life was 1.6 h. Serum ondansetron concentrations were not significantly different between dogs that required rescue anti-nausea medication (non-responders) and dogs that did not require rescue therapy (responders). In total, 83.3% of patients in the 0.5 mg/kg q8h, 0.5 mg/kg q12h, and 1 mg/kg q8h groups had improvement in nausea scores. In total, 66.7% of patients in the 1 mg/kg q12h group had improvement in nausea scores. In total, 33% of patients had resolution of nausea in the 0.5 mg/kg q8h, 1 mg/kg q8h, and 1 mg/kg q12h groups, and 16% of patients had resolution of nausea in the 0.5 mg/kg q12h group. AVP concentrations were highly variable and did not correlate with nausea scores. Nausea scores significantly decreased regardless of dosage protocol. AVP was not a reliable biomarker of nausea in this group of dogs.
Topics: Dogs; Animals; Ondansetron; Antiemetics; Nausea; Half-Life; Area Under Curve; Double-Blind Method
PubMed: 35899472
DOI: 10.1111/jvp.13087