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Article ; Online: Protecting the herd with vaccination.

Dean, Natalie E / Halloran, M Elizabeth

2022 Volume 375, Issue 6585, Page(s) 1088–1089

Abstract: How much do COVID-19 vaccines reduce transmission? The answer is a moving target. ...

Abstract	How much do COVID-19 vaccines reduce transmission? The answer is a moving target.
MeSH term(s)	COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Immunity, Herd/immunology ; SARS-CoV-2 ; Vaccination/veterinary
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-03-10
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Comment
ZDB-ID	128410-1
ISSN	1095-9203 ; 0036-8075
ISSN (online)	1095-9203
ISSN	0036-8075
DOI	10.1126/science.abo2959
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Article ; Online: Advance care planning for patients with end-stage kidney disease on dialysis: narrative review of the current evidence, and future considerations.

Adenwalla, S F / O'Halloran, P / Faull, C / Murtagh, F E M / Graham-Brown, M P M

Journal of nephrology

2024

Abstract: Patients with end-stage kidney disease (ESKD) have a high symptom-burden and high rates of morbidity and mortality. Despite this, evidence has shown that this patient group does not have timely discussions to plan for deterioration and death, and at the ... ...

Abstract	Patients with end-stage kidney disease (ESKD) have a high symptom-burden and high rates of morbidity and mortality. Despite this, evidence has shown that this patient group does not have timely discussions to plan for deterioration and death, and at the end of life there are unmet palliative care needs. Advance care planning is a process that can help patients share their personal values and preferences for their future care and prepare for declining health. Earlier, more integrated and holistic advance care planning has the potential to improve access to care services, communication, and preparedness for future decision-making and changing circumstances. However, there are many barriers to successful implementation of advance care planning in this population. In this narrative review we discuss the current evidence for advance care planning in patients on dialysis, the data around the barriers to advance care planning implementation, and interventions that have been trialled. The review explores whether the concepts and approaches to advance care planning in this population need to be updated to encompass current and future care. It suggests that a shift from a problem-orientated approach to a goal-orientated approach may lead to better engagement, with more patient-centred and satisfying outcomes.
Language	English
Publishing date	2024-01-18
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	1093991-x
ISSN	1724-6059 ; 1120-3625 ; 1121-8428
ISSN (online)	1724-6059
ISSN	1120-3625 ; 1121-8428
DOI	10.1007/s40620-023-01841-3
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Article ; Online: Covariate-constrained randomization with cluster selection and substitution.

Crisp, Amy M / Halloran, M Elizabeth / Longini, Ira M / Vazquez-Prokopec, Gonzalo / Dean, Natalie E

Clinical trials (London, England)

2023 Volume 20, Issue 3, Page(s) 284–292

Abstract: Background: An ongoing cluster-randomized trial for the prevention of arboviral diseases utilizes covariate-constrained randomization to balance two treatment arms across four specified covariates and geographic sector. Each cluster is within a census ... ...

Abstract	Background: An ongoing cluster-randomized trial for the prevention of arboviral diseases utilizes covariate-constrained randomization to balance two treatment arms across four specified covariates and geographic sector. Each cluster is within a census tract of the city of Mérida, Mexico, and there were 133 eligible tracts from which to select 50. As some selected clusters may have been subsequently found unsuitable in the field, we desired a strategy to substitute new clusters while maintaining covariate balance. Methods: We developed an algorithm that successfully identified a subset of clusters that maximized the average minimum pairwise distance between clusters in order to reduce contamination and balanced the specified covariates both before and after substitutions were made. Simulations: Simulations were performed to explore some limitations of this algorithm. The number of selected clusters and eligible clusters were varied along with the method of selecting the final allocation pattern. Conclusion: The algorithm is presented here as a series of optional steps that can be added to the standard covariate-constrained randomization process in order to achieve spatial dispersion, cluster subsampling, and cluster substitution. Simulation results indicate that these extensions can be used without loss of statistical validity, given a sufficient number of clusters included in the trial.
MeSH term(s)	Humans ; Cluster Analysis ; Random Allocation ; Research Design ; Computer Simulation ; Algorithms
Language	English
Publishing date	2023-03-17
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	10.1177/17407745231160556
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Zs.A 5831: Show issues

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Article: Hypothesis testing and sample size considerations for the test-negative design.

Huo, Yanan / Yang, Yang / Halloran, M Elizabeth / Longini, Ira M / Dean, Natalie E

Research square

2023

Abstract: The test-negative design (TND) is an observational study design to evaluate vaccine effectiveness (VE) that enrolls individuals receiving diagnostic testing for a target disease as part of routine care. VE is estimated as one minus the adjusted odds ... ...

Abstract	The test-negative design (TND) is an observational study design to evaluate vaccine effectiveness (VE) that enrolls individuals receiving diagnostic testing for a target disease as part of routine care. VE is estimated as one minus the adjusted odds ratio of testing positive versus negative comparing vaccinated and unvaccinated patients. Although the TND is related to case-control studies, it is distinct in that the ratio of test-positive cases to test-negative controls is not typically pre-specified. For both types of studies, sparse cells are common when vaccines are highly effective. We consider the implications of these features on power for the TND. We use simulation studies to explore three hypothesis-testing procedures and associated sample size calculations for case-control and TND studies. These tests, all based on a simple logistic regression model, are a standard Wald test, a continuity-corrected Wald test, and a score test. The Wald test performs poorly in both case-control and TND when VE is high because the number of vaccinated test-positive cases can be low or zero. Continuity corrections help to stabilize the variance but induce bias. We observe superior performance with the score test as the variance is pooled under the null hypothesis of no group differences. We recommend using a score-based approach to design and analyze both case-control and TND. We propose a modification to the TND score sample size to account for additional variability in the ratio of controls over cases. This work expands our understanding of the data mechanisms of the TND.
Language	English
Publishing date	2023-12-28
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3783493/v1
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Article ; Online: Rapid review and meta-analysis of serial intervals for SARS-CoV-2 Delta and Omicron variants.

Madewell, Zachary J / Yang, Yang / Longini, Ira M / Halloran, M Elizabeth / Vespignani, Alessandro / Dean, Natalie E

BMC infectious diseases

2023 Volume 23, Issue 1, Page(s) 429

Abstract: Background: The serial interval is the period of time between symptom onset in the primary case and symptom onset in the secondary case. Understanding the serial interval is important for determining transmission dynamics of infectious diseases like ... ...

Abstract	Background: The serial interval is the period of time between symptom onset in the primary case and symptom onset in the secondary case. Understanding the serial interval is important for determining transmission dynamics of infectious diseases like COVID-19, including the reproduction number and secondary attack rates, which could influence control measures. Early meta-analyses of COVID-19 reported serial intervals of 5.2 days (95% CI: 4.9-5.5) for the original wild-type variant and 5.2 days (95% CI: 4.87-5.47) for Alpha variant. The serial interval has been shown to decrease over the course of an epidemic for other respiratory diseases, which may be due to accumulating viral mutations and implementation of more effective nonpharmaceutical interventions. We therefore aggregated the literature to estimate serial intervals for Delta and Omicron variants. Methods: This study followed Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. A systematic literature search was conducted of PubMed, Scopus, Cochrane Library, ScienceDirect, and preprint server medRxiv for articles published from April 4, 2021, through May 23, 2023. Search terms were: ("serial interval" or "generation time"), ("Omicron" or "Delta"), and ("SARS-CoV-2" or "COVID-19"). Meta-analyses were done for Delta and Omicron variants using a restricted maximum-likelihood estimator model with a random effect for each study. Pooled average estimates and 95% confidence intervals (95% CI) are reported. Results: There were 46,648 primary/secondary case pairs included for the meta-analysis of Delta and 18,324 for Omicron. Mean serial interval for included studies ranged from 2.3-5.8 days for Delta and 2.1-4.8 days for Omicron. The pooled mean serial interval for Delta was 3.9 days (95% CI: 3.4-4.3) (20 studies) and Omicron was 3.2 days (95% CI: 2.9-3.5) (20 studies). Mean estimated serial interval for BA.1 was 3.3 days (95% CI: 2.8-3.7) (11 studies), BA.2 was 2.9 days (95% CI: 2.7-3.1) (six studies), and BA.5 was 2.3 days (95% CI: 1.6-3.1) (three studies). Conclusions: Serial interval estimates for Delta and Omicron were shorter than ancestral SARS-CoV-2 variants. More recent Omicron subvariants had even shorter serial intervals suggesting serial intervals may be shortening over time. This suggests more rapid transmission from one generation of cases to the next, consistent with the observed faster growth dynamic of these variants compared to their ancestors. Additional changes to the serial interval may occur as SARS-CoV-2 continues to circulate and evolve. Changes to population immunity (due to infection and/or vaccination) may further modify it.
MeSH term(s)	Humans ; COVID-19 ; Epidemics ; Family ; SARS-CoV-2/genetics
Language	English
Publishing date	2023-06-26
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	2041550-3
ISSN	1471-2334 ; 1471-2334
ISSN (online)	1471-2334
ISSN	1471-2334
DOI	10.1186/s12879-023-08407-5
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Article ; Online: Moving forward: A review of continuous kinetics and kinematics during handcycling propulsion.

Halloran, Kellie M / Focht, Michael D K / Teague, Alexander / Peters, Joseph / Rice, Ian / Kersh, Mariana E

Journal of biomechanics

2023 Volume 159, Page(s) 111779

Abstract: Wheelchair users (WCUs) face high rates of shoulder overuse injuries. As exercise is recommended to reduce cardiovascular disease prevalent among WCUs, it is becoming increasingly important to understand the mechanisms behind shoulder soft-tissue injury ... ...

Abstract	Wheelchair users (WCUs) face high rates of shoulder overuse injuries. As exercise is recommended to reduce cardiovascular disease prevalent among WCUs, it is becoming increasingly important to understand the mechanisms behind shoulder soft-tissue injury in WCUs. Understanding the kinetics and kinematics during upper-limb propulsion is the first step toward evaluating soft-tissue injury risk in WCUs. This paper examines continuous kinetic and kinematic data available in the literature. Attach-unit and recumbent handcycling are examined and compared. Athletic modes of propulsion such as recumbent handcycling are important considering the higher contact forces, speed, and power outputs experienced during these activities that could put users at increased risk of injury. Understanding the underlying kinetics and kinematics during various propulsion modes can lend insight into shoulder loading, and therefore injury risk, during these activities and inform future exercise guidelines for WCUs.
MeSH term(s)	Humans ; Biomechanical Phenomena ; Shoulder ; Upper Extremity ; Kinetics ; Sports ; Wheelchairs ; Soft Tissue Injuries
Language	English
Publishing date	2023-08-30
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	218076-5
ISSN	1873-2380 ; 0021-9290
ISSN (online)	1873-2380
ISSN	0021-9290
DOI	10.1016/j.jbiomech.2023.111779
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Article ; Online: Propulsion kinetics of recumbent handcycling during high and moderate intensity exercise.

Halloran, Kellie M / Peters, Joseph / Focht, Michael D K / Rice, Ian / Kersh, Mariana E

Journal of biomechanics

2023 Volume 156, Page(s) 111672

Abstract: People with spinal cord injuries (PwSCI) are at high risk of developing cardiovascular disease (CVD). While regular exercise can reduce risk of CVD, PwSCI face various barriers to exercise, including high rates of upper limb injuries, especially in the ... ...

Abstract	People with spinal cord injuries (PwSCI) are at high risk of developing cardiovascular disease (CVD). While regular exercise can reduce risk of CVD, PwSCI face various barriers to exercise, including high rates of upper limb injuries, especially in the shoulder. Handcycling high intensity interval training (HIIT), which consists of periods of high intensity exercise followed by rest, is a potential exercise solution, but the musculoskeletal safety of HIIT is still unknown. In this study, we characterized three-dimensional continuous applied forces at the handle during handcycling HIIT and moderate intensity continuous training (MICT). These applied forces can give an early indication of joint loading, and therefore injury risk, at the shoulder. In all three directions (tangential, radial, and lateral), the maximum applied forces during HIIT were larger than those in MICT at all timepoints, which may indicate higher contact forces and loads on the shoulder during HIIT compared to MICT. The tangential and radial forces peaked twice in a propulsion cycle, while the lateral forces peaked once. Throughout the exercises, the location of tangential peak 2 and radial peak 1 was later in HIIT compared to MICT. This difference in maximum force location could indicate either altered kinematics or muscular fatigue at the end of the exercise protocol. These changes in kinematics should be more closely examined using motion capture or other modeling techniques. If we combine this kinetic data with kinematic data during propulsion, we can create musculoskeletal models that more accurately predict contact forces and injury risk during handcycling HIIT in PwSCI.
MeSH term(s)	Humans ; Kinetics ; Exercise ; Exercise Therapy ; Shoulder ; Spinal Cord Injuries ; Cardiovascular Diseases
Language	English
Publishing date	2023-06-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	218076-5
ISSN	1873-2380 ; 0021-9290
ISSN (online)	1873-2380
ISSN	0021-9290
DOI	10.1016/j.jbiomech.2023.111672
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Article ; Online: Evaluating the Effectiveness of Vaccines Using a Regression Discontinuity Design.

Basta, Nicole E / Halloran, M Elizabeth

American journal of epidemiology

2019 Volume 188, Issue 6, Page(s) 987–990

Abstract: The regression discontinuity design (RDD), first proposed in the educational psychology literature and popularized in econometrics in the 1960s, has only recently been applied to epidemiologic research. A critical aim of infectious disease ... ...

Abstract	The regression discontinuity design (RDD), first proposed in the educational psychology literature and popularized in econometrics in the 1960s, has only recently been applied to epidemiologic research. A critical aim of infectious disease epidemiologists and global health researchers is to evaluate disease prevention and control strategies, including the impact of vaccines and vaccination programs. RDDs have very rarely been used in this context. This quasi-experimental approach using observational data is designed to quantify the effect of an intervention when eligibility for the intervention is based on a defined cutoff such as age or grade in school, making it ideally suited to estimating vaccine effects given that many vaccination programs and mass-vaccination campaigns define eligibility in this way. Here, we describe key features of RDDs in general, then specific scenarios, with examples, to illustrate that RDDs are an important tool for advancing our understanding of vaccine effects. We argue that epidemiologic researchers should consider RDDs when evaluating interventions designed to prevent and control diseases. This approach can address a wide range of research questions, especially those for which randomized clinical trials would present major challenges or be infeasible. Finally, we propose specific ways in which RDDs could advance future vaccine research.
MeSH term(s)	Communicable Disease Control/organization & administration ; Data Interpretation, Statistical ; Epidemiologic Methods ; Epidemiologic Studies ; Humans ; Immunization Programs/organization & administration ; Models, Statistical ; Observational Studies as Topic ; Vaccines/administration & dosage ; Vaccines/immunology
Chemical Substances	Vaccines
Language	English
Publishing date	2019-03-26
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwz043
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Article ; Online: Temporal Confounding in the Test-Negative Design.

Dean, Natalie E / Halloran, M Elizabeth / Longini, Ira M

American journal of epidemiology

2020 Volume 189, Issue 11, Page(s) 1402–1407

Abstract: In the test-negative design, routine testing at health-care facilities is leveraged to estimate the effectiveness of an intervention such as a vaccine. The odds of vaccination for individuals who test positive for a target pathogen is compared with the ... ...

Abstract	In the test-negative design, routine testing at health-care facilities is leveraged to estimate the effectiveness of an intervention such as a vaccine. The odds of vaccination for individuals who test positive for a target pathogen is compared with the odds of vaccination for individuals who test negative for that pathogen, adjusting for key confounders. The design is rapidly growing in popularity, but many open questions remain about its properties. In this paper, we examine temporal confounding by generalizing derivations to allow for time-varying vaccine status, including out-of-season controls, and open populations. We confirm that calendar time is an important confounder when vaccine status varies during the study. We demonstrate that, where time is not a confounder, including out-of-season controls can improve precision. We generalize these results to open populations. We use our theoretical findings to interpret 3 recent papers utilizing the test-negative design. Through careful examination of the theoretical properties of this study design, we provide key insights that can directly inform the implementation and analysis of future test-negative studies.
MeSH term(s)	Communicable Disease Control/methods ; Communicable Diseases/epidemiology ; Confounding Factors, Epidemiologic ; Humans ; Infectious Disease Medicine/methods ; Models, Theoretical ; Research Design ; Seasons ; Time Factors ; Vaccination/statistics & numerical data
Language	English
Publishing date	2020-05-16
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwaa084
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Article ; Online: Altered larval activation response associated with multidrug resistance in the canine hookworm

McKean, Elise L / Grill, Emilia / Choi, Young-Jun / Mitreva, Makedonka / O'Halloran, Damien M / Hawdon, John M

Parasitology

2024 Volume 151, Issue 3, Page(s) 271–281

Abstract: Parasitic gastrointestinal nematodes pose significant health risks to humans, livestock, and companion animals, and their control relies heavily on the use of anthelmintic drugs. Overuse of these drugs has led to the emergence of resistant nematode ... ...

Abstract	Parasitic gastrointestinal nematodes pose significant health risks to humans, livestock, and companion animals, and their control relies heavily on the use of anthelmintic drugs. Overuse of these drugs has led to the emergence of resistant nematode populations. Herein, a naturally occurring isolate (referred to as BCR) of the dog hookworm,
MeSH term(s)	Humans ; Dogs ; Animals ; Ancylostoma/genetics ; Ancylostomatoidea ; Larva/genetics ; Anthelmintics/pharmacology ; Drug Resistance, Multiple/genetics ; Drug Resistance/genetics
Chemical Substances	Anthelmintics
Language	English
Publishing date	2024-01-02
Publishing country	England
Document type	Journal Article
ZDB-ID	207627-5
ISSN	1469-8161 ; 0031-1820
ISSN (online)	1469-8161
ISSN	0031-1820
DOI	10.1017/S0031182023001385
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