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Article ; Online: How representative are clinical trial cohorts of the general CF population? Implications for trial planning.

Dobra, Rebecca / Pinnell, Sophie / Jones, Andy / Madge, Susan / Simmonds, Nicholas J / Davies, Jane C

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

2023 Volume 23, Issue 1, Page(s) 68–72

Abstract: Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their ... ...

Abstract	Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their eligibility for trial participation based on common trial inclusion/exclusion criteria. 643 patients were included in the analysis, 31 were modulator ineligible(MI). Only 198(31 %) of the total cohort and 7(23 %) of the MI cohort were eligible for participation based on the hypothetical criteria. The most common reason for ineligibility was ppFEV1 ≥90 % followed by clinical instability, complex comorbidity and anticipated inability to adhere to the protocol. We suggest this would be a useful exercise for centres planning to either participate in, or refer subjects into, upcoming trials to undertake for their own cohort. We also make suggestions for protocol designs that optimise the number of patients who are eligible to participate.
MeSH term(s)	Humans ; Child ; Cystic Fibrosis
Language	English
Publishing date	2023-11-30
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2084724-5
ISSN	1873-5010 ; 1569-1993
ISSN (online)	1873-5010
ISSN	1569-1993
DOI	10.1016/j.jcf.2023.03.005
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Article ; Online: Associations between environmental exposures in the Middle East Area of Operations and pregnancy outcomes in Australian Defence Force veterans.

Warner, Rachelle / Avery, Jodie C / Neuhaus, Susan J / Davies, Michael J

Environmental research

2022 Volume 208, Page(s) 112688

Abstract: Military personnel deployed on operations may encounter a variety of hazards with the capacity to adversely affect reproductive health. This paper investigates the association between self-reported exposure to reproductive toxicants and adverse pregnancy ...

Abstract	Military personnel deployed on operations may encounter a variety of hazards with the capacity to adversely affect reproductive health. This paper investigates the association between self-reported exposure to reproductive toxicants and adverse pregnancy outcomes in Australian Defence Force veterans who deployed to Iraq and Afghanistan during the period 2001-2009. Utilising the Middle East Area of Operations (MEAO) Census Study data set, descriptive analyses of participants' self-reported exposure were compared with the occupational environmental monitoring data taken at their reported deployment location. Univariate analyses assessed the significance of unadjusted associations between self-reported exposures and reproductive outcomes. There is no systematic or consistent relationship between deployment to the MEAO and adverse pregnancy outcomes. Overall, self-reported adverse reproductive outcomes were significantly increased in veterans who deployed to both Afghanistan and Iraq (p = 0.04) compared to those who only deployed to only one of those locations; particularly in women (p = 0.009). Miscarriage was the most likely of these (p = 0.008). These figures would benefit from being confirmed against medical records but are worthy of further study. In this historical cohort study, causal inference cannot be made due to absence of control groups to exclude sources of potential bias. Imprecision in the assessment of environmental hazards in the MEAO and other methodological constraints make it impossible to calculate precise estimates of risk. The results warrant continued investigation, especially when combined with previous findings related to pregnancy outcomes in this population, the importance of reproductive outcomes, and the potential emergence of new hazards.
MeSH term(s)	Australia/epidemiology ; Cohort Studies ; Environmental Exposure ; Female ; Humans ; Middle East/epidemiology ; Military Personnel ; Pregnancy ; Pregnancy Outcome/epidemiology ; Veterans
Language	English
Publishing date	2022-01-10
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	205699-9
ISSN	1096-0953 ; 0013-9351
ISSN (online)	1096-0953
ISSN	0013-9351
DOI	10.1016/j.envres.2022.112688
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Article ; Online: Developmental trends of auditory novelty oddball P3 while accounting for N2 in 7- to 25-year-olds.

Mingils, Susan M / Davies, Patricia L / Stephens, Jaclyn A / Gavin, William J

Psychophysiology

2022 Volume 60, Issue 4, Page(s) e14214

Abstract: Many previous studies examining developmental trends in P3 amplitude or latency have used a two-stimulus (standard and target) oddball paradigm. Fewer studies exist using the novelty oddball paradigm, a three-tone (standard, target, and novel) paradigm. ... ...

Abstract	Many previous studies examining developmental trends in P3 amplitude or latency have used a two-stimulus (standard and target) oddball paradigm. Fewer studies exist using the novelty oddball paradigm, a three-tone (standard, target, and novel) paradigm. In this study with 204 typically developing participants aged 7-25 years, the influence of participant traits-age and sex-on the developmental trends of P3 peak-to-peak amplitude and latency were examined. Additionally, interactions between the three tones of the novelty oddball paradigm and scalp sites on P3 amplitude and latency were evaluated. While previous studies using baseline-to-peak measures have shown smaller P3 amplitude in children compared with adults, this study, using peak-to-peak measures (P3 minus N2 amplitude), found the opposite effect with children having larger P3 amplitudes than adults. This finding is explained by further analyses of N2, representing discrimination. N2 baseline-to-peak amplitude significantly predicted P3 baseline-to-peak amplitude; a mediation effect such that as N2 becomes less negative, P3 becomes larger. Regression analyses revealed that developmental trends of the P3 amplitude were primarily linear, but trends in P3 latency were mostly non-linear. Sex differences were observed, although limited to latency measures. Results from ancovas found significant interactions between the three tones and between frontal (Fz) and parietal (Pz) sites, with larger P3 amplitude during target and novel tones at Pz than Fz, and larger amplitudes during frequent tones at Fz than Pz. These findings highlight the importance of considering more than P3 amplitude in understanding developmental trends in cognitive processing during oddball paradigms.
MeSH term(s)	Adult ; Child ; Humans ; Male ; Female ; Evoked Potentials, Auditory ; Reaction Time ; Mental Processes ; Electroencephalography
Language	English
Publishing date	2022-11-09
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	209486-1
ISSN	1540-5958 ; 0048-5772
ISSN (online)	1540-5958
ISSN	0048-5772
DOI	10.1111/psyp.14214
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Article ; Online: Cost of Cancer in Adolescents and Young Adults in the United States: Results of the 2021 Report by Deloitte Access Economics, Commissioned by Teen Cancer America.

Parsons, Susan K / Keegan, Theresa H M / Kirchhoff, Anne C / Parsons, Helen M / Yabroff, K Robin / Davies, Simon J

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2023 Volume 41, Issue 17, Page(s) 3260–3268

Abstract: Purpose: The purpose of this report, commissioned by Teen Cancer America and performed by Deloitte Access Economics in 2021, was to estimate the total costs incurred by adolescent and young adults (AYAs) after cancer diagnosis in the United States (US) ... ...

Abstract	Purpose: The purpose of this report, commissioned by Teen Cancer America and performed by Deloitte Access Economics in 2021, was to estimate the total costs incurred by adolescent and young adults (AYAs) after cancer diagnosis in the United States (US) over their life course. Methods: The incidence of cancer in 2019 among AYAs age 15-39 years was estimated from the US Cancer Statistics Public Use Database, and relative survival was projected from the Surveillance, Epidemiology, and End Results Program. Cost domains included health system, productivity, and well-being costs. Components were estimated with published literature and pooled data from the Medical Expenditure Panel Survey from 2008 to 2012 and inflated to 2019 dollars. Results: The economic and human costs of cancer in AYAs are substantial-$23.5 billion overall, corresponding to $259,324 per person over the lifetime. The majority of costs are borne by AYA cancer survivors themselves in the form of lost productivity, loss of well-being, and loss of life. Conclusion: These findings underscore the need to address the burden of cancer in AYAs through targeted programs for AYAs, such as financial navigation and health insurance literacy interventions, as well as local and national policy initiatives to address access to and enhanced coverage for clinical trials participation, fertility services, and survivorship care.
MeSH term(s)	Humans ; Adolescent ; Young Adult ; United States/epidemiology ; Adult ; Insurance, Health ; Efficiency ; Neoplasms/epidemiology ; Neoplasms/therapy
Language	English
Publishing date	2023-02-24
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.22.01985
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Article ; Online: Key Points for Clinicians About the SEER Oral Cancer Survival Calculator.

Davies, Louise / Hankey, Benjamin F / Wang, Zhuoqiao / Zou, Zhaohui / Scott, Susan / Lee, Minjung / Cho, Hyunsoon / Feuer, Eric J

JAMA otolaryngology-- head & neck surgery

2023 Volume 149, Issue 11, Page(s) 1042–1046

Abstract: Importance: In the setting of a new cancer diagnosis, the focus is usually on the cancer as the main threat to survival, but people may have other conditions that pose an equal or greater threat to their life than their cancer: a competing risk of death. ...

Abstract	Importance: In the setting of a new cancer diagnosis, the focus is usually on the cancer as the main threat to survival, but people may have other conditions that pose an equal or greater threat to their life than their cancer: a competing risk of death. This is especially true for patients who have cancer of the oral cavity, because prolonged exposure to alcohol and tobacco are risk factors for cancer in this location but also can result in medical conditions with the potential to shorten life expectancy, competing as a cause of death that may intervene in conjunction with or before the cancer. Observations: A calculator designed for public use has been released that allows patients age 20 to 86 years who have a newly diagnosed oral cancer to obtain estimates of their health status-adjusted age, life expectancy in the absence of the cancer, and probability of surviving, dying of the cancer, or dying of other causes within 1 to 10 years after diagnosis. The models in the calculator showed that patients with oral cavity cancer had a higher than average risk of death from other causes than the matched US population, and this risk increases by stage. Conclusions and relevance: The Surveillance, Epidemiology and End Results Program Oral Cancer Survival Calculator supports a holistic approach to the life of the patient, and the risk of death of other causes is treated equally to consideration of the probability of death of the cancer. This tool may be usefully paired with the other available prognostic calculators for oral cancer and is an example of the possibilities now available with registry linkages to partially overlapping or independent data sets and statistical techniques that allow the use of 2 time scales in 1 analysis.
MeSH term(s)	Humans ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; SEER Program ; Prognosis ; Registries ; Risk Factors ; Mouth Neoplasms
Language	English
Publishing date	2023-07-10
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	2701825-8
ISSN	2168-619X ; 2168-6181
ISSN (online)	2168-619X
ISSN	2168-6181
DOI	10.1001/jamaoto.2023.1977
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Article: Corrigendum: Reduced insulin signaling targeted to serotonergic neurons but not other neuronal subtypes extends lifespan in

Dravecz, Nikolett / Shaw, Tommy / Davies, Isabella / Brown, Casey / Ormerod, Lewis / Vu, Gin / Walker, Tyler / Taank, Taran / Shirras, Alan D / Broughton, Susan J

Frontiers in aging neuroscience

2023 Volume 15, Page(s) 1307495

Abstract: This corrects the article DOI: 10.3389/fnagi.2022.893444.]. ...

Abstract	[This corrects the article DOI: 10.3389/fnagi.2022.893444.].
Language	English
Publishing date	2023-10-17
Publishing country	Switzerland
Document type	Published Erratum
ZDB-ID	2558898-9
ISSN	1663-4365
ISSN	1663-4365
DOI	10.3389/fnagi.2023.1307495
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Article ; Online: A New Personalized Oral Cancer Survival Calculator to Estimate Risk of Death From Both Oral Cancer and Other Causes.

Davies, Louise / Hankey, Benjamin F / Wang, Zhuoqiao / Zou, Zhaohui / Scott, Susan / Lee, Minjung / Cho, Hyunsoon / Feuer, Eric J

JAMA otolaryngology-- head & neck surgery

2023 Volume 149, Issue 11, Page(s) 993–1000

Abstract: Importance: Standard cancer prognosis models typically do not include much specificity in characterizing competing illnesses or general health status when providing prognosis estimates, limiting their utility for individuals, who must consider their ... ...

Abstract	Importance: Standard cancer prognosis models typically do not include much specificity in characterizing competing illnesses or general health status when providing prognosis estimates, limiting their utility for individuals, who must consider their cancer in the context of their overall health. This is especially true for patients with oral cancer, who frequently have competing illnesses. Objective: To describe a statistical framework and accompanying new publicly available calculator that provides personalized estimates of the probability of a patient surviving or dying from cancer or other causes, using oral cancer as the first data set. Design, setting, and participants: The models used data from the Surveillance, Epidemiology, and End Results (SEER) 18 registry (2000 to 2011), SEER-Medicare linked files, and the National Health Interview Survey (NHIS) (1986 to 2009). Statistical methods developed to calculate natural life expectancy in the absence of the cancer, cancer-specific survival, and other-cause survival were applied to oral cancer data and internally validated with 10-fold cross-validation. Eligible participants were aged between 20 and 94 years with oral squamous cell carcinoma. Exposures: Histologically confirmed oral cancer, general health status, smoking, and selected serious comorbid conditions. Main outcomes and measures: Probabilities of surviving or dying from the cancer or from other causes, and life expectancy in the absence of the cancer. Results: A total of 22 392 patients with oral squamous cell carcinoma (13 544 male [60.5%]; 1476 Asian and Pacific Islander [6.7%]; 1792 Black [8.0%], 1589 Hispanic [7.2%], 17 300 White [78.1%]) and 402 626 NHIS interviewees were included in this calculator designed for public use for patients ages 20 to 86 years with newly diagnosed oral cancer to obtain estimates of health status-adjusted age, life expectancy in the absence of the cancer, and the probability of surviving, dying from the cancer, or dying from other causes within 1 to 10 years after diagnosis. The models in the calculator estimated that patients with oral cancer have a higher risk of death from other causes than their matched US population, and that this risk increases by stage. Conclusions and relevance: The models developed for the calculator demonstrate that survival estimates that exclude the effects of coexisting conditions can lead to underestimates or overestimates of survival. This new calculator approach will be broadly applicable for developing future prognostic models of cancer and noncancer aspects of a person's health in other cancers; as registries develop more linkages, available covariates will become broader, strengthening future tools.
MeSH term(s)	Humans ; Aged ; Male ; United States/epidemiology ; Young Adult ; Adult ; Middle Aged ; Aged, 80 and over ; Carcinoma, Squamous Cell ; Mouth Neoplasms ; Squamous Cell Carcinoma of Head and Neck ; SEER Program ; Medicare ; Head and Neck Neoplasms
Language	English
Publishing date	2023-07-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2701825-8
ISSN	2168-619X ; 2168-6181
ISSN (online)	2168-619X
ISSN	2168-6181
DOI	10.1001/jamaoto.2023.1975
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Article ; Online: Structural dissection of two redox proteins from the shipworm symbiont Teredinibacter turnerae.

Rajagopal, Badri S / Yates, Nick / Smith, Jake / Paradisi, Alessandro / Tétard-Jones, Catherine / Willats, William G T / Marcus, Susan / Knox, J Paul / Firdaus-Raih, Mohd / Henrissat, Bernard / Davies, Gideon J / Walton, Paul H / Parkin, Alison / Hemsworth, Glyn R

IUCrJ

2024 Volume 11, Issue Pt 2, Page(s) 260–274

Abstract: The discovery of lytic polysaccharide monooxygenases (LPMOs), a family of copper-dependent enzymes that play a major role in polysaccharide degradation, has revealed the importance of oxidoreductases in the biological utilization of biomass. In fungi, a ... ...

Abstract	The discovery of lytic polysaccharide monooxygenases (LPMOs), a family of copper-dependent enzymes that play a major role in polysaccharide degradation, has revealed the importance of oxidoreductases in the biological utilization of biomass. In fungi, a range of redox proteins have been implicated as working in harness with LPMOs to bring about polysaccharide oxidation. In bacteria, less is known about the interplay between redox proteins and LPMOs, or how the interaction between the two contributes to polysaccharide degradation. We therefore set out to characterize two previously unstudied proteins from the shipworm symbiont Teredinibacter turnerae that were initially identified by the presence of carbohydrate binding domains appended to uncharacterized domains with probable redox functions. Here, X-ray crystal structures of several domains from these proteins are presented together with initial efforts to characterize their functions. The analysis suggests that the target proteins are unlikely to function as LPMO electron donors, raising new questions as to the potential redox functions that these large extracellular multi-haem-containing c-type cytochromes may perform in these bacteria.
MeSH term(s)	Oxidation-Reduction ; Gammaproteobacteria ; Mixed Function Oxygenases ; Polysaccharides
Chemical Substances	Mixed Function Oxygenases (EC 1.-) ; Polysaccharides
Language	English
Publishing date	2024-03-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2754953-7
ISSN	2052-2525 ; 2052-2525
ISSN (online)	2052-2525
ISSN	2052-2525
DOI	10.1107/S2052252524001386
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Article: Associations between environmental exposures in the Middle East Area of Operations and pregnancy outcomes in Australian Defence Force veterans

Warner, Rachelle / Avery, Jodie C. / Neuhaus, Susan J. / Davies, Michael J.

Environmental research. 2022 May 15, v. 208

2022

Abstract	Military personnel deployed on operations may encounter a variety of hazards with the capacity to adversely affect reproductive health. This paper investigates the association between self-reported exposure to reproductive toxicants and adverse pregnancy outcomes in Australian Defence Force veterans who deployed to Iraq and Afghanistan during the period 2001–2009. Utilising the Middle East Area of Operations (MEAO) Census Study data set, descriptive analyses of participants' self-reported exposure were compared with the occupational environmental monitoring data taken at their reported deployment location. Univariate analyses assessed the significance of unadjusted associations between self-reported exposures and reproductive outcomes. There is no systematic or consistent relationship between deployment to the MEAO and adverse pregnancy outcomes. Overall, self-reported adverse reproductive outcomes were significantly increased in veterans who deployed to both Afghanistan and Iraq (p = 0.04) compared to those who only deployed to only one of those locations; particularly in women (p = 0.009). Miscarriage was the most likely of these (p = 0.008). These figures would benefit from being confirmed against medical records but are worthy of further study. In this historical cohort study, causal inference cannot be made due to absence of control groups to exclude sources of potential bias. Imprecision in the assessment of environmental hazards in the MEAO and other methodological constraints make it impossible to calculate precise estimates of risk. The results warrant continued investigation, especially when combined with previous findings related to pregnancy outcomes in this population, the importance of reproductive outcomes, and the potential emergence of new hazards.
Keywords	abortion (animals) ; cohort studies ; data collection ; military personnel ; research ; risk ; toxic substances ; Afghanistan ; Iraq ; Middle East
Language	English
Dates of publication	2022-0515
Publishing place	Elsevier Inc.
Document type	Article
ZDB-ID	205699-9
ISSN	1096-0953 ; 0013-9351
ISSN (online)	1096-0953
ISSN	0013-9351
DOI	10.1016/j.envres.2022.112688
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Article ; Online: Expanding the Anti-Phl p 7 Antibody Toolkit: An Anti-Idiotype Nanobody Inhibitor.

Vester, Susan K / Davies, Anna M / Beavil, Rebecca L / Sandhar, Balraj S / Beavil, Andrew J / Gould, Hannah J / Sutton, Brian J / McDonnell, James M

Antibodies (Basel, Switzerland)

2023 Volume 12, Issue 4

Abstract: We have previously produced a toolkit of antibodies, comprising recombinant human antibodies of all but one of the human isotypes, directed against the polcalcin family antigen Phl p 7. In this work, we complete the toolkit of human antibody isotypes ... ...

Abstract	We have previously produced a toolkit of antibodies, comprising recombinant human antibodies of all but one of the human isotypes, directed against the polcalcin family antigen Phl p 7. In this work, we complete the toolkit of human antibody isotypes with the IgD version of the anti-Phl p 7 monoclonal antibody. We also raised a set of nanobodies against the IgD anti-Phl p 7 antibody and identify and characterize one paratope-specific nanobody. This nanobody also binds to the IgE isotype of this antibody, which shares the same idiotype, and orthosterically inhibits the interaction with Phl p 7. The 2.1 Å resolution X-ray crystal structure of the nanobody in complex with the IgD Fab is described.
Language	English
Publishing date	2023-11-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2661514-9
ISSN	2073-4468 ; 2073-4468
ISSN (online)	2073-4468
ISSN	2073-4468
DOI	10.3390/antib12040075
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