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Article ; Online: Advances in noninvasive measurement of liver function and physiology: The HepQuant DuO test.

McRae, Michael P / Kittelson, John / Helmke, Steve M / Everson, Gregory T

Basic & clinical pharmacology & toxicology

2024 Volume 134, Issue 3, Page(s) 385–395

Abstract: Current noninvasive liver tests are surrogates for fibrosis and lack ability to directly measure liver function. HepQuant tests measure liver function and physiology through hepatic uptake of stable cholate isotopes. HepQuant SHUNT (V1.0) involves oral ... ...

Abstract	Current noninvasive liver tests are surrogates for fibrosis and lack ability to directly measure liver function. HepQuant tests measure liver function and physiology through hepatic uptake of stable cholate isotopes. HepQuant SHUNT (V1.0) involves oral and intravenous dosing and six blood samples over 90 min. We developed simplified test versions: SHUNT V2.0 (oral and intravenous dosing, two blood samples over 60 min) and DuO (oral dosing only, two blood samples over 60 min). The aim of this study was to evaluate equivalency of the simplified tests to the original SHUNT test. Data from three studies comprising 930 SHUNT tests were retrospectively analysed by each method. Equivalence was evaluated in terms of proportion of tests in which the difference between methods was less than any clinically meaningful difference and additionally by two one-sided t-test and bioequivalence methods. DuO and SHUNT V2.0 were equivalent to the original SHUNT test for Disease Severity Index, with >99% and >96% of tests falling within equivalence bounds. DuO and SHUNT V2.0 met equivalency criteria by two one-sided t-tests and bioequivalence. DuO and SHUNT V2.0 are easier to administer, are less invasive than the original SHUNT test and have potential to be more accepted by patients and providers.
MeSH term(s)	Humans ; Retrospective Studies ; Liver ; Liver Cirrhosis/diagnosis ; Liver Function Tests ; Therapeutic Equivalency
Language	English
Publishing date	2024-01-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2134679-3
ISSN	1742-7843 ; 1742-7835
ISSN (online)	1742-7843
ISSN	1742-7835
DOI	10.1111/bcpt.13980
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Article ; Online: Within-individual reproducibility of a dual sample oral cholate challenge test (DuO) and simplified versions of the HepQuant SHUNT test.

McRae, Michael P / Kittelson, John / Helmke, Steve M / Everson, Gregory T

Clinical and translational science

2024 Volume 17, Issue 4, Page(s) e13786

Abstract: Current noninvasive liver tests measure fibrosis, inflammation, or steatosis and do not measure function. The HepQuant platform of noninvasive tests uniquely assesses both liver function and physiology through the hepatic uptake of stable isotopes of ... ...

Abstract	Current noninvasive liver tests measure fibrosis, inflammation, or steatosis and do not measure function. The HepQuant platform of noninvasive tests uniquely assesses both liver function and physiology through the hepatic uptake of stable isotopes of cholate. However, the prototypical HepQuant SHUNT test (SHUNT V1.0) is cumbersome to administer, requiring intravenous and oral administration of cholate and six peripheral venous blood samples over 90 min. To alleviate the burden of test administration, we explored whether an oral only (DuO) version, and other simplified versions, of the test could provide reproducible measurements of liver function. DuO requires only oral dosing and two blood samples over 60 min. The simplified SHUNT test versions were SHUNT V1.1 (oral and IV dosing but four blood samples) and SHUNT V2.0 (oral and IV dosing but only two blood samples over 60 min). In this paper, we describe the reproducibility of DuO and the simplified SHUNT tests relative to that of SHUNT V1.0; equivalency is described in a separate paper. Data from two studies comprising 236 SHUNT tests in 94 subjects were analyzed retrospectively by each method. All simplified methods were highly reproducible across test parameters with intraclass correlation coefficients >0.93 for test parameters Disease Severity Index (DSI) and Hepatic Reserve. DuO and SHUNT V2.0 improved reproducibility in measuring portal-systemic shunting (SHUNT%). These simplified tests, particularly DuO and SHUNT V2.0, are easier to administer and less invasive, thus, having the potential to be more widely accepted by care providers administering the test and by patients receiving the test.
MeSH term(s)	Humans ; Reproducibility of Results ; Retrospective Studies ; Liver Function Tests ; Liver ; Cholates
Chemical Substances	Cholates
Language	English
Publishing date	2024-04-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13786
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Article ; Online: Discussion on "Predictively Consistent Prior Effective Sample Sizes" by Beat Neuenschwander, Sebastian Weber, Heinz Schmidli, and Anthony O'Hagan.

Kaizer, Alexander / Kittelson, John

Biometrics

2020 Volume 76, Issue 2, Page(s) 588–590

MeSH term(s)	Research Design ; Sample Size
Language	English
Publishing date	2020-04-06
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	213543-7
ISSN	1541-0420 ; 0099-4987 ; 0006-341X
ISSN (online)	1541-0420
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13253
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Article ; Online: Group sequential designs for clinical trials with bivariate endpoints.

Hu, Junxiao / Blatchford, Patrick J / Goldenberg, Neil A / Kittelson, John M

Statistics in medicine

2020 Volume 39, Issue 26, Page(s) 3823–3839

Abstract: Although all clinical trials are designed and monitored using more than one endpoint, methods are needed to assure that decision criteria are chosen to reflect the clinically relevant tradeoffs that assure the trial's scientific integrity. This article ... ...

Abstract	Although all clinical trials are designed and monitored using more than one endpoint, methods are needed to assure that decision criteria are chosen to reflect the clinically relevant tradeoffs that assure the trial's scientific integrity. This article presents a framework for the design and monitoring clinical trials in a bivariate outcome space. The framework uses a rectangular hyperbola to define a bivariate null curve that divides outcome space into regions of benefit and lack of benefit. The curve is shown to be a flexible mapping of bivariate space that allows a continuous tradeoff between the two endpoints in a manner that captures many previous bivariate designs. The curve is extended to a distance function in bivariate space that allows different decisions in each of the four quadrants that comprise bivariate space. The distance function forms a statistic (
MeSH term(s)	Clinical Trials as Topic ; Humans ; Research Design
Language	English
Publishing date	2020-08-10
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	843037-8
ISSN	1097-0258 ; 0277-6715
ISSN (online)	1097-0258
ISSN	0277-6715
DOI	10.1002/sim.8696
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Article ; Online: Ultrasonic Bone Scalpel (USBS) Does Not Reduce Blood Loss During Posterior Spinal Fusion (PSF) in Patients with Adolescent Idiopathic Scoliosis (AIS): Randomized Clinical Trial.

Garg, Sumeet / Thomas, James / Darland, Hannah / Kim, Eun / Kittelson, John / Erickson, Mark / Carry, Patrick

Spine

2021 Volume 46, Issue 13, Page(s) 845–851

Abstract: Study design: Randomized Clinical Trial.: Objective: The aim of this study was to compare the efficacy of USBS with standard-of-care surgical instruments during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS) by ... ...

Abstract	Study design: Randomized Clinical Trial. Objective: The aim of this study was to compare the efficacy of USBS with standard-of-care surgical instruments during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS) by evaluating the difference in estimated blood loss per level fused (EBL/level). Summary of background data: PSF surgery for AIS is often associated with high blood loss. Use of an ultrasonic bone scalpel (USBS) has been proposed to reduce blood loss during scoliosis surgery. Methods: This was a single-blinded (patient-blinded), randomized, controlled superiority trial. We randomized 66 patients with AIS undergoing PSF to the control group (osteotome) or the experimental group (USBS). The primary outcome was intraoperative EBL/level obtained from red blood cell salvage reports. One-year follow-up was available for 57 of 62 (92%) of patients. Results: EBL/level averaged 35 and 39 mL/level in the experimental and control groups, respectively [adjusted mean difference USBS - osteotome -8 mL/level, 95% CI: -16.4 to 0.3 mL/level, P = 0.0575]. There was no difference in curve correction [adjusted mean difference: -1.7%, 95% CI: -7.0 to 3.6%, P = 0.5321] or operative time [adjusted mean difference: -3.55 minutes, 95% CI: -22.45 to 15.46 min, P = 0.7089] between groups. Complications requiring change in routine postoperative care were noted in eight patients: two occurred in patients assigned to the experimental group and six occurred in patients assigned to the control group. Conclusion: There was no clinically significant difference in total blood loss, EBL/level, or complications between the two groups. In contrast to reports from other centers, at our high-volume spine center, USBS did not lead to reduced blood loss during PSF for AIS. These results may not be generalizable to centers with longer baseline operative times or higher baseline average blood loss during PSF for AIS.Level of Evidence: 1.
Language	English
Publishing date	2021-06-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	752024-4
ISSN	1528-1159 ; 0362-2436
ISSN (online)	1528-1159
ISSN	0362-2436
DOI	10.1097/BRS.0000000000003990
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Article ; Online: The within-individual reproducibility of the disease severity index from the HepQuant SHUNT test of liver function and physiology.

Burton, James R / Helmke, Steven / Lauriski, Shannon / Kittelson, John / Everson, Gregory T

Translational research : the journal of laboratory and clinical medicine

2021 Volume 233, Page(s) 5–15

Abstract: The HepQuant SHUNT test quantifies liver function and blood flow using systemic and portal clearances of cholate. The test can identify the risk of well-compensated patients to develop complications of cirrhosis. To confirm the reliability of a single ... ...

Abstract	The HepQuant SHUNT test quantifies liver function and blood flow using systemic and portal clearances of cholate. The test can identify the risk of well-compensated patients to develop complications of cirrhosis. To confirm the reliability of a single HepQuant SHUNT test we defined its within-individual reproducibility. Healthy subjects (n = 16), 16 with nonalcoholic steatohepatitis (NASH), and 16 with chronic hepatitis C virus (HCV) underwent 3 HepQuant SHUNT tests on 3 separate days within 30 days. The test involves simultaneous administration of 20 mg 13C-cholate IV and 40 mg d4-cholate PO, and subsequent collection of 3 mL blood samples at 5, 20, 45, 60, and 90 minutes. Clearances are expressed as systemic and portal hepatic filtration rate. Portal-systemic shunting (SHUNT), a disease severity index (DSI), and an estimate of DSI (STAT) are calculated from the clearances. Reproducibility was determined by the intraclass correlation coefficient (ICC > 0.70) and Bland-Altman analysis. Equal numbers of NASH and HCV patients had either early (F0-F2) or advanced (F3/F4) stages of fibrosis. All F3/F4 subjects were clinically compensated. The intraclass correlation coefficient (ICC) for DSI was 0.94 (0.90-0.96 95% confidence interval) indicating excellent reproducibility. The other test parameters had ICCs ranging from 0.74 (SHUNT) to 0.90 (STAT). In Bland-Altman analysis, the mean of differences between measurements of DSI was 0.13 with standard deviation 2.12. The excellent reproducibility of the HepQuant SHUNT test, particularly DSI, supports the use this minimally invasive, blood-based test as a reliable test of liver function and physiology.
MeSH term(s)	Adult ; Carbon Isotopes ; Cholates/administration & dosage ; Cholates/blood ; Cholates/chemistry ; Deuterium ; Female ; Healthy Volunteers ; Hepatitis C, Chronic/physiopathology ; Humans ; Liver/blood supply ; Liver/physiology ; Liver Circulation/physiology ; Liver Function Tests/methods ; Liver Function Tests/statistics & numerical data ; Male ; Middle Aged ; Non-alcoholic Fatty Liver Disease/physiopathology ; Reference Values ; Reproducibility of Results ; Severity of Illness Index ; Translational Medical Research ; Young Adult
Chemical Substances	Carbon Isotopes ; Cholates ; Deuterium (AR09D82C7G) ; Carbon-13 (FDJ0A8596D)
Language	English
Publishing date	2021-01-02
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2246684-8
ISSN	1878-1810 ; 1532-6543 ; 1931-5244
ISSN (online)	1878-1810 ; 1532-6543
ISSN	1931-5244
DOI	10.1016/j.trsl.2020.12.010
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Article ; Online: Does disability level impact the relationship of muscle strength to walking performance in people with multiple sclerosis? a cross-sectional analysis.

Mañago, Mark M / Callesen, Jacob / Dalgas, Ulrik / Kittelson, John / Schenkman, Margaret

Multiple sclerosis and related disorders

2020 Volume 42, Page(s) 102052

Abstract: Background and purpose: Strength training can improve muscle weakness in people with multiple sclerosis (MS), but does not consistently improve walking. Disability level may impact the relationship of muscle weakness and walking performance in people ... ...

Abstract	Background and purpose: Strength training can improve muscle weakness in people with multiple sclerosis (MS), but does not consistently improve walking. Disability level may impact the relationship of muscle weakness and walking performance in people with MS, but few studies have investigated the impact of disability on the relationship of strength and walking. The purpose of this study was to compare the relationships of strength in lower body and trunk muscles to walking performance between mild and moderate disability groups in people with MS. Methods: Data from 36 participants with MS who had mild disability (Expanded Disability Status Scale - EDSS 0 to 3.5) and 36 participants who had moderate disability (EDSS 4.0 to 5.5) were analyzed. Hand-held dynamometry measured strength in eight muscle groups from the ankle, knee, hip, and trunk. Timed 25-Foot Walk (T25FW) and 6-Minute Walk Test (6MWT) measured walking speed and endurance, respectively. Pearson correlations and beta coefficients (ß) were reported for each bivariate relationship of muscle strength to T25FW and 6MWT from both mild and moderate disability groups. Linear regression was then used to compare differences in beta coefficients (Δß) between disability groups for the relationship of each muscle variable to T25FW and 6MWT. A positive Δß indicated a stronger relationship of strength to walking performance in the mild disability group, while a negative Δß favored the moderate disability group. Results: Overall, there were stronger Pearson correlations between muscle strength variables to T25FW and 6MWT in the mild (r = 0.57 to 0.77) compared to moderate disability group (r = 0.10 to 0.54). The mild disability group had significantly greater beta coefficients for T25FW with ankle dorsiflexion (Δß = 0.67, 95%CI: 0.27-1.07), knee extension (Δß = 0.68, 95%CI: 0.28-1.08), and hip abduction (Δß = 0.77, 95%CI: 0.01-1.52); and for 6MWT with knee extension (Δß = 0.47, 95%CI: 0.06 to 0.88). Discussion and conclusion: For people with MS, muscle strength in the lower extremity and trunk may be a more important contributor to T25FW in mild versus moderate disability, but not for 6MWT. While more studies are needed, these results may help to inform rehabilitation intervention when prioritizing strength training to improve walking.
MeSH term(s)	Adult ; Cross-Sectional Studies ; Disabled Persons ; Female ; Humans ; Lower Extremity/radiation effects ; Male ; Middle Aged ; Multiple Sclerosis/physiopathology ; Muscle Strength/physiology ; Muscle, Skeletal/physiopathology ; Severity of Illness Index ; Torso/physiopathology ; Walk Test ; Walking/physiology ; Walking Speed/physiology
Language	English
Publishing date	2020-03-13
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2020.102052
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Article ; Online: Contributions of Ankle, Knee, Hip, and Trunk Muscle Function to Gait Performance in People With Multiple Sclerosis: A Cross-Sectional Analysis.

Mañago, Mark M / Hebert, Jeffrey R / Kittelson, John / Schenkman, Margaret

Physical therapy

2018 Volume 98, Issue 7, Page(s) 595–604

Abstract: Background: The relative importance of lower extremity and trunk muscle function to gait in people with multiple sclerosis (MS) is unknown.: Objective: This study aimed to investigate the association of lower extremity and trunk muscle function with ... ...

Abstract	Background: The relative importance of lower extremity and trunk muscle function to gait in people with multiple sclerosis (MS) is unknown. Objective: This study aimed to investigate the association of lower extremity and trunk muscle function with gait performance in people who have MS and mild-to-moderate disability. Design: This was a cross-sectional, observational study. Methods: Participants were people who had an Expanded Disability Status Scale score of ≤ 5.5. Eleven lower extremity and trunk muscles were assessed using handheld dynamometry or endurance tests. Gait performance was assessed with the Timed 25-Foot (7.62 m) Walk (T25FW) and 6-Minute Walk Test (6MWT). Regression analysis was used to quantify the association between gait outcomes and muscle variables. Results: Seventy-two participants with MS and a mean Expanded Disability Status Scale score of 3.5 (SD = 1.14) were enrolled. Adjusted for age and sex, the multivariate model including hip abduction, ankle plantar flexion, trunk flexion, and knee flexion explained 57% of the adjusted variance in the T25FW; hip abduction, ankle plantar flexion, and trunk flexion explained 61% of the adjusted variance in the 6MWT. The strongest predictors were ankle plantar flexion endurance for the T25FW and hip abduction strength for the 6MWT: a 1-SD increase in ankle plantar flexion (15.2 heel-raise repetitions) was associated with a 0.33-second reduction in the T25WT (95% CI = - 0.71 to - 0.14 seconds); a 1-SD increase in normalized hip abduction strength (0.14 kg/body mass index) was associated with a 54.4-m increase in the 6MWT (28.99 to 79.81 m). Limitations: Different measurement scales for independent variables were included because the muscle function assessment used either force or endurance. Conclusions: For the major muscles in the lower extremity and trunk, hip abduction, ankle plantar flexion, trunk flexion, and knee flexion were the strongest predictors of gait performance.
MeSH term(s)	Adult ; Ankle Joint ; Cross-Sectional Studies ; Disability Evaluation ; Female ; Humans ; Knee Joint ; Male ; Multiple Sclerosis/physiopathology ; Muscle Strength/physiology ; Muscle, Skeletal/physiopathology ; Range of Motion, Articular
Language	English
Publishing date	2018-04-16
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	415886-6
ISSN	1538-6724 ; 0031-9023
ISSN (online)	1538-6724
ISSN	0031-9023
DOI	10.1093/ptj/pzy048
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Article ; Online: Feasibility of a targeted strengthening program to improve gait in people with multiple sclerosis: a brief report.

Mañago, Mark M / Hebert, Jeffrey R / Kittelson, John / Schenkman, Margaret

International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation

2018 Volume 41, Issue 4, Page(s) 364–367

Abstract: This study aims to determine feasibility of strengthening muscles that are important contributors to gait for people with multiple sclerosis, yet are not routinely targeted in the literature. An 8-week strengthening intervention targeted ankle ... ...

Abstract	This study aims to determine feasibility of strengthening muscles that are important contributors to gait for people with multiple sclerosis, yet are not routinely targeted in the literature. An 8-week strengthening intervention targeted ankle plantarflexion, hip abduction, and trunk muscles using a repeated-measures design. Outcomes included satisfaction, adherence, muscle strength, gait speed (timed 25-foot walk), gait endurance (6-min walk test), and self-reported gait-related participation (Multiple Sclerosis Walking Scale-12). Ten participants (Expanded Disability Status Scale: 3.5-5.5) completed the intervention. All participants were at least 'satisfied'; adherence was 87% (supervised sessions) and 75% (home sessions). All quantitative measures improved: muscle strength (23.1-47.6%, P<0.001-0.039), timed 25-foot walk (-13.4%, P<0.001), 6-min walk test (41.56 m, P=0.019), and Multiple Sclerosis Walking Scale-12 (-10.5, P=0.007). Strengthening of ankle plantarflexion, hip abduction, and trunk muscles was feasible and associated with improvements in gait performance.
MeSH term(s)	Adult ; Ankle/physiopathology ; Cohort Studies ; Exercise Therapy/methods ; Feasibility Studies ; Female ; Gait Disorders, Neurologic/rehabilitation ; Hip/physiopathology ; Humans ; Male ; Middle Aged ; Multiple Sclerosis/rehabilitation ; Muscle Strength/physiology ; Patient Satisfaction ; Range of Motion, Articular/physiology ; Walking/physiology
Language	English
Publishing date	2018-07-24
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	533323-4
ISSN	1473-5660 ; 0342-5282
ISSN (online)	1473-5660
ISSN	0342-5282
DOI	10.1097/MRR.0000000000000306
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Article ; Online: Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data.

Jackson, Conner L / Colborn, Kathryn / Gao, Dexiang / Rao, Sangeeta / Slater, Hannah C / Parikh, Sunil / Foy, Brian D / Kittelson, John

Clinical trials (London, England)

2021 Volume 18, Issue 5, Page(s) 582–593

Abstract: Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector- ... ...

Abstract	Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector-borne diseases, it may be difficult to assess a large number of clusters while performing the additional work needed to monitor participants, vectors, and environmental factors associated with the disease. One such example of a cluster-randomized trial with few clusters was the "efficacy and risk of harms of repeated ivermectin mass drug administrations for control of malaria" trial. Although previous work has provided recommendations for analyzing trials like repeated ivermectin mass drug administrations for control of malaria, additional evaluation of the multiple approaches for analysis is needed for study designs with count outcomes. Methods: Using a simulation study, we applied three analysis frameworks to three cluster-randomized trial designs (single-year, 2-year parallel, and 2-year crossover) in the context of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria. Mixed-effects models, generalized estimating equations, and cluster-level analyses were evaluated. Additional 2-year parallel designs with different numbers of clusters and different cluster correlations were also explored. Results: Mixed-effects models with a small sample correction and unweighted cluster-level summaries yielded both high power and control of the Type I error rate. Generalized estimating equation approaches that utilized small sample corrections controlled the Type I error rate but did not confer greater power when compared to a mixed model approach with small sample correction. The crossover design generally yielded higher power relative to the parallel equivalent. Differences in power between analysis methods became less pronounced as the number of clusters increased. The strength of within-cluster correlation impacted the relative differences in power. Conclusion: Regardless of study design, cluster-level analyses as well as individual-level analyses like mixed-effects models or generalized estimating equations with small sample size corrections can both provide reliable results in small cluster settings. For 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria, we recommend a mixed-effects model with a pseudo-likelihood approximation method and Kenward-Roger correction. Similarly designed studies with small sample sizes and count outcomes should consider adjustments for small sample sizes when using a mixed-effects model or generalized estimating equation for analysis. Although the 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria is already underway as a parallel trial, applying the simulation parameters to a crossover design yielded improved power, suggesting that crossover designs may be valuable in settings where the number of available clusters is limited. Finally, the sensitivity of the analysis approach to the strength of within-cluster correlation should be carefully considered when selecting the primary analysis for a cluster-randomized trial.
MeSH term(s)	Cluster Analysis ; Follow-Up Studies ; Humans ; Ivermectin ; Malaria/drug therapy ; Malaria/prevention & control ; Mass Drug Administration ; Randomized Controlled Trials as Topic ; Research Design ; Sample Size
Chemical Substances	Ivermectin (70288-86-7)
Language	English
Publishing date	2021-07-03
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/17407745211028581
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