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Article ; Online: Whole genome sequencing in the diagnosis of primary ciliary dyskinesia

Gabrielle Wheway / N. Simon Thomas / Mary Carroll / Janice Coles / Regan Doherty / Genomics England Research Consortium / Patricia Goggin / Ben Green / Amanda Harris / David Hunt / Claire L. Jackson / Jenny Lord / Vito Mennella / James Thompson / Woolf T. Walker / Jane S. Lucas

BMC Medical Genomics, Vol 14, Iss 1, Pp 1-

2021 Volume 21

Abstract: Abstract Background It is estimated that 1–13% of cases of bronchiectasis in adults globally are attributable to primary ciliary dyskinesia (PCD) but many adult patients with bronchiectasis have not been investigated for PCD. PCD is a disorder caused by ... ...

Abstract	Abstract Background It is estimated that 1–13% of cases of bronchiectasis in adults globally are attributable to primary ciliary dyskinesia (PCD) but many adult patients with bronchiectasis have not been investigated for PCD. PCD is a disorder caused by mutations in genes required for motile cilium structure or function, resulting in impaired mucociliary clearance. Symptoms appear in infancy but diagnosis is often late or missed, often due to the lack of a “gold standard” diagnostic tool and non-specific symptoms. Mutations in > 50 genes account for around 70% of cases, with additional genes, and non-coding, synonymous, missense changes or structural variants (SVs) in known genes presumed to account for the missing heritability. Methods UK patients with no identified genetic confirmation for the cause of their PCD or bronchiectasis were eligible for whole genome sequencing (WGS) in the Genomics England Ltd 100,000 Genomes Project. 21 PCD probands and 52 non-cystic fibrosis (CF) bronchiectasis probands were recruited in Wessex Genome Medicine Centre (GMC). We carried out analysis of single nucleotide variants (SNVs) and SVs in all families recruited in Wessex GMC. Results 16/21 probands in the PCD cohort received confirmed (n = 9), probable (n = 4) or possible (n = 3) diagnosis from WGS, although 13/16 of these could have been picked up by current standard of care gene panel testing. In the other cases, SVs were identified which were missed by panel testing. We identified variants in novel PCD candidate genes (IFT140 and PLK4) in 2 probands in the PCD cohort. 3/52 probands in the non-CF bronchiectasis cohort received a confirmed (n = 2) or possible (n = 1) diagnosis of PCD. We identified variants in novel PCD candidate genes (CFAP53 and CEP164) in 2 further probands in the non-CF bronchiectasis cohort. Conclusions Genetic testing is an important component of diagnosing PCD, especially in cases of atypical disease history. WGS is effective in cases where prior gene panel testing has found no variants or only heterozygous variants. In these cases it may detect SVs and is a powerful tool for novel gene discovery.
Keywords	Primary ciliary dyskinesia ; Non-CF bronchiectasis ; Whole genome sequencing ; Diagnosis ; Gene discovery ; Internal medicine ; RC31-1245 ; Genetics ; QH426-470
Subject code	610
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prospectively predicting Pseudomonas aeruginosa infection/s using routine data from the UK cystic fibrosis register

Nikki Totton / Mike Bradburn / Zhe Hui Hoo / Jen Lewis / Daniel Hind / Carla Girling / Elizabeth Shepherd / Julia Nightingale / Thomas Daniels / Jane Dewar / Sophie Dawson / Mary Carroll / Mark Allenby / Frank Edenborough / Rachael Curley / Charlotte Carolan / Martin Wildman

Health Science Reports, Vol 4, Iss 4, Pp n/a-n/a (2021)

2021

Abstract: Abstract Rationale and aims Lung health of people with cystic fibrosis (PwCF) can be preserved by daily use of inhaled therapy. Adherence to inhaled therapy, therefore, provides an important process measure to understand the success of care and can be ... ...

Abstract	Abstract Rationale and aims Lung health of people with cystic fibrosis (PwCF) can be preserved by daily use of inhaled therapy. Adherence to inhaled therapy, therefore, provides an important process measure to understand the success of care and can be used as a quality indicator. Defining adherence is problematic, however, since the number of prescribed treatments varies considerably between PwCF. The problem is less pronounced among those with Pseudomonas aeruginosa (PA), for whom at least three daily doses of nebulized therapy should be prescribed and who thus constitute a more homogeneous group. The UK CF Registry provides routine data on PA status, but data are only available 12 months after collection. In this study, we aim to prospectively identify contemporary PA status from historic registry data. Method UK CF Registry data from 2011 to 2015 for PwCF aged ≥16 was used to determine a pragmatic prediction rule for identifying contemporary PA status using historic registry data. Accuracy of three different prediction rules was assessed using the positive predictive value (PPV). The number and proportion of adults predicted to have PA infection were determined overall and per center for the selected prediction rule. Known characteristics linked to PA status were explored to ensure the robustness of the prediction rule. Results Having CF Registry defined chronic PA status in the two previous years is the selected definition to predict a patient will have PA infection within the current year (population‐level PPV = 96%‐97%, centre level PPV = 85%‐100%). This approach provides a subset of data between 1852 and 1872 patients overall and a range of 8 to 279 patients per center. Conclusion Historic registry data can be used to contemporaneously identify a subgroup of patients with chronic PA. Since this patient group has a narrower treatment schedule, this can facilitate a better benchmarking of adherence across centers.
Keywords	adherence ; cystic fibrosis ; outcome ; process ; quality improvement ; Medicine ; R
Subject code	310
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
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Article ; Online: In Vitro and In Vivo Characterization of a Preclinical Irradiation-Adapted Model for Ewing Sarcoma.

Shapiro, Mary Carroll / Tang, Tien / Dasgupta, Atreyi / Kurenbekova, Lyazat / Shuck, Ryan / Gaber, M Waleed / Yustein, Jason T

International journal of radiation oncology, biology, physics

2018 Volume 101, Issue 1, Page(s) 118–127

Abstract: Purpose: Radiation therapy (RT) is a viable therapeutic option for Ewing sarcoma (ES) patients. However, little progress has been made to elucidate the mechanisms of radioresistance. This study establishes a novel ES irradiation-adapted model designed ... ...

Abstract	Purpose: Radiation therapy (RT) is a viable therapeutic option for Ewing sarcoma (ES) patients. However, little progress has been made to elucidate the mechanisms of radioresistance. This study establishes a novel ES irradiation-adapted model designed to assess molecular and Methods and materials: Radiation-adapted cell lines (RACLs) were created in vitro by exposing ES human cell lines to fractionated doses of radiation. Assays to assess migration or invasion potential and RNA expression were performed on the RACLs. Orthotopic intratibial in vivo investigations were performed with irradiation-sensitive and irradiation-adapted ES cells to generate tumors. Transplanted mice were imaged using Results: Exposure to fractionated doses of radiation caused a significant increase in migratory and invasive properties in the RACLs when compared with nonirradiated wild-type ES cells. RACL transcriptomic and proteomic analysis suggests enhanced activation of the mammalian target of rapamycin-AKT pathway when compared with wild-type ES cells. Irradiation-adapted tumors demonstrated significantly less tumor regression (P = .03) than wild-type tumors. Wild-type tumors also had decreased expression of lactate dehydrogenase A protein and significantly lower metabolic activity after RT compared with irradiation-adapted tumors (P = .03). Conclusions: We developed novel in vitro and in vivo irradiation-adapted ES models. In vitro investigations revealed increased migratory and invasive phenotypes in the RACLs. In vivo investigations demonstrated increased metabolic activity and significantly decreased sensitivity to RT in the irradiation-adapted tumors as demonstrated by growth response curves and
Language	English
Publishing date	2018-02-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	197614-x
ISSN	1879-355X ; 0360-3016
ISSN (online)	1879-355X
ISSN	0360-3016
DOI	10.1016/j.ijrobp.2018.01.095
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Article ; Online: Nebulised heparin as a treatment for COVID-19

Frank M. P. van Haren / Clive Page / John G. Laffey / Antonio Artigas / Marta Camprubi-Rimblas / Quentin Nunes / Roger Smith / Janis Shute / Mary Carroll / Julia Tree / Miles Carroll / Dave Singh / Tom Wilkinson / Barry Dixon

Critical Care, Vol 24, Iss 1, Pp 1-

scientific rationale and a call for randomised evidence

2020 Volume 11

Abstract: Abstract Nebulised unfractionated heparin (UFH) has a strong scientific and biological rationale and warrants urgent investigation of its therapeutic potential, for COVID-19-induced acute respiratory distress syndrome (ARDS). COVID-19 ARDS displays the ... ...

Abstract	Abstract Nebulised unfractionated heparin (UFH) has a strong scientific and biological rationale and warrants urgent investigation of its therapeutic potential, for COVID-19-induced acute respiratory distress syndrome (ARDS). COVID-19 ARDS displays the typical features of diffuse alveolar damage with extensive pulmonary coagulation activation resulting in fibrin deposition in the microvasculature and formation of hyaline membranes in the air sacs. Patients infected with SARS-CoV-2 who manifest severe disease have high levels of inflammatory cytokines in plasma and bronchoalveolar lavage fluid and significant coagulopathy. There is a strong association between the extent of the coagulopathy and poor clinical outcomes. The anti-coagulant actions of nebulised UFH limit fibrin deposition and microvascular thrombosis. Trials in patients with acute lung injury and related conditions found inhaled UFH reduced pulmonary dead space, coagulation activation, microvascular thrombosis and clinical deterioration, resulting in increased time free of ventilatory support. In addition, UFH has anti-inflammatory, mucolytic and anti-viral properties and, specifically, has been shown to inactivate the SARS-CoV-2 virus and prevent its entry into mammalian cells, thereby inhibiting pulmonary infection by SARS-CoV-2. Furthermore, clinical studies have shown that inhaled UFH safely improves outcomes in other inflammatory respiratory diseases and also acts as an effective mucolytic in sputum-producing respiratory patients. UFH is widely available and inexpensive, which may make this treatment also accessible for low- and middle-income countries. These potentially important therapeutic properties of nebulised UFH underline the need for expedited large-scale clinical trials to test its potential to reduce mortality in COVID-19 patients.
Keywords	COVID-19 ; ARDS ; SARS ; Nebulised heparin ; Unfractionated heparin ; SARS-CoV-2 ; Medical emergencies. Critical care. Intensive care. First aid ; RC86-88.9 ; covid19
Subject code	610
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Multiple breath washout in bronchiectasis clinical trials

ERJ Open Research, Vol 6, Iss

is it feasible?

2020 Volume 4

Abstract: Background Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central “over-reading” for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies. Aims To assess ... ...

Abstract	Background Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central “over-reading” for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies. Aims To assess the outcomes of a MBW training, certification and central over-reading programme. Methods MBW training and certification was conducted in European sites collecting lung clearance index (LCI) data in the BronchUK Clinimetrics and/or i-BEST-1 studies. The blended training programme included the use of an eLearning tool and a 1-day face-to-face session. Sites submitted MBW data to trained central over-readers who determined validity and quality. Results Thirteen training days were delivered to 56 participants from 22 sites. Of 22 sites, 18 (82%) were MBW naïve. Participant knowledge and confidence increased significantly (p<0.001). By the end of the study recruitment, 15 of 22 sites (68%) had completed certification with a mean (range) time since training of 6.2 (3–14) months. In the BronchUK Clinimetrics study, 468 of 589 (79%) tests met the quality criteria following central over-reading, compared with 137 of 236 (58%) tests in the i-BEST-1 study. Conclusions LCI is feasible in a bronchiectasis multicentre clinical trial setting; however, consideration of site experience in terms of training as well as assessment of skill drift and the need for re-training may be important to reduce time to certification and optimise data quality. Longer times to certification, a higher percentage of naïve sites and patients with worse lung function may have contributed to the lower success rate in the i-BEST-1 study.
Keywords	Medicine ; R
Subject code	796
Language	English
Publishing date	2020-10-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
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Article ; Online: BronchUK

ERJ Open Research, Vol 7, Iss

protocol for an observational cohort study and biobank in bronchiectasis

2021 Volume 2

Abstract: Bronchiectasis has been a largely overlooked disease area in respiratory medicine. This is reflected by a shortage of large-scale studies and lack of approved therapies, in turn leading to a variation of treatment across centres. BronchUK (Bronchiectasis ...

Abstract	Bronchiectasis has been a largely overlooked disease area in respiratory medicine. This is reflected by a shortage of large-scale studies and lack of approved therapies, in turn leading to a variation of treatment across centres. BronchUK (Bronchiectasis Observational Cohort and Biobank UK) is a multicentre, prospective, observational cohort study working collaboratively with the European Multicentre Bronchiectasis Audit and Research Collaboration project. The inclusion criteria for patients entering the study are a clinical history consistent with bronchiectasis and computed tomography demonstrating bronchiectasis. Main exclusion criteria are 1) patients unable to provide informed consent, 2) bronchiectasis due to known cystic fibrosis or where bronchiectasis is not the main or co-dominant respiratory disease, 3) age <18 years, and 4) prior lung transplantation for bronchiectasis. The study is aligned to standard UK National Health Service (NHS) practice with an aim to recruit a minimum of 1500 patients from across at least nine secondary care centres. Patient data collected at baseline includes demographics, aetiology testing, comorbidities, lung function, radiology, treatments, microbiology and quality of life. Patients are followed up annually for a maximum of 5 years and, where able, blood and/or sputa samples are collected and stored in a central biobank. BronchUK aims to collect robust longitudinal data that can be used for analysis into current NHS practice and patient outcomes, and to become an integral resource to better inform future interventional studies in bronchiectasis.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2021-04-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Ethical issues

Sullivan, MaryCarroll / Christopher, Myra J

Creating nursing's future : issues, opportunities, and challenges

1999

Author's details	MaryCarroll Sullivan, Myra J. Christopher
MeSH term(s)	Ethics, Nursing ; Nurse's Role ; Advance Directives ; Managed Care Programs ; Moral Obligations ; Nurse-Patient Relations ; Palliative Care ; Patient Advocacy ; Professional Autonomy ; Social Responsibility ; Spirituality ; Terminal Care
Keywords	United States ; Bioethics and Professional Ethics
Language	English
Size	p. 241-251.
Publisher	Mosby
Publishing place	St. Louis
Document type	Article
Note	Book editor: Eleanor J. Sullivan.
ISBN	0323002390 ; 9780323002394
Database	Catalogue of the US National Library of Medicine (NLM)

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Article ; Online: A 2 × 2 factorial, randomised, open-label trial to determine the clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis

Trials, Vol 20, Iss 1, Pp 1-

a protocol for the CLEAR clinical trial

2019 Volume 10

Abstract: Abstract Background Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We ... ...

Abstract	Abstract Background Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We hypothesise that mucoactive agents (HTS or carbocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care. Methods This is a 52-week, 2 × 2 factorial, randomized, open-label trial to determine the clinical effectiveness and cost effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care - the Clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care (CLEAR) trial. Patients will be randomised to (1) standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine (750 mg three times per day until visit 3, reducing to 750 mg twice per day), (3) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum. Discussion This trial’s pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigour in other areas of trial delivery. The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE. Trial registration EudraCT number: 2017-000664-14 (first entered in the database on 20 October 2017). ISRCTN.com, ISRCTN89040295. Registered on 6 July/2018. Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01). Sponsor: Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 ...
Keywords	Clinical trial protocol ; Factorial design ; Bronchiectasis ; Hypertonic saline ; Carbocisteine ; Exacerbation ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2019-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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Article: Violence against women increases the risk of infant and child mortality: a case-referent study in Nicaragua.

Asling-Monemi, Kajsa / Peña, Rodolfo / Ellsberg, Mary Carroll / Persson, Lars Ake

Bulletin of the World Health Organization

2003 Volume 81, Issue 1, Page(s) 10–16

Abstract: Objective: To investigate the impact of violence against mothers on mortality risks for their offspring before 5 years of age in Nicaragua.: Methods: From a demographic database covering a random sample of urban and rural households in Le n, ... ...

Abstract	Objective: To investigate the impact of violence against mothers on mortality risks for their offspring before 5 years of age in Nicaragua. Methods: From a demographic database covering a random sample of urban and rural households in Le n, Nicaragua, we identified all live births among women aged 15-49 years. Cases were defined as those who had died before the age of 5 years, between January 1993 and June 1996. For each case, two referents, matched for sex and age at death, were selected from the database. A total of 110 mothers of the cases and 203 mothers of the referents were interviewed using a standard questionnaire covering mothers' experience of physical and sexual violence. The data were analysed for the risk associated with maternal experience of violence of infant and under-5 mortality. Findings: A total of 61% of mothers of cases had a lifetime experience of physical and/or sexual violence compared with 37% of mothers of referents, with a significant association being found between such experiences and mortality among their offspring. Other factors associated with higher infant and under-5 mortality were mother's education (no formal education), age (older), and parity (multiparity). Conclusions: The results suggest an association between physical and sexual violence against mothers, either before or during pregnancy, and an increased risk of under-5 mortality of their offspring. The type and severity of violence was probably more relevant to the risk than the timing, and violence may impact child health through maternal stress or care-giving behaviours rather than through direct trauma itself.
MeSH term(s)	Adolescent ; Adult ; Case-Control Studies ; Cause of Death ; Child, Preschool ; Domestic Violence/statistics & numerical data ; Female ; Humans ; Infant ; Infant Mortality ; Infant, Newborn ; Interviews as Topic ; Maternal Welfare ; Middle Aged ; Nicaragua/epidemiology ; Pregnancy ; Risk Factors
Language	English
Publishing date	2003
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80213-x
ISSN	1564-0604 ; 0042-9686 ; 0366-4996 ; 0510-8659
ISSN (online)	1564-0604
ISSN	0042-9686 ; 0366-4996 ; 0510-8659
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Article ; Online: Violence against women increases the risk of infant and child mortality

Åsling-Monemi Kajsa / Peña Rodolfo / Ellsberg Mary Carroll / Persson Lars Åke

Bulletin of the World Health Organization, Vol 81, Iss 1, Pp 10-

a case-referent study in Nicaragua

2003 Volume 16

Abstract: OBJECTIVE: To investigate the impact of violence against mothers on mortality risks for their offspring before 5 years of age in Nicaragua. METHODS: From a demographic database covering a random sample of urban and rural households in León, Nicaragua, we ...

Abstract	OBJECTIVE: To investigate the impact of violence against mothers on mortality risks for their offspring before 5 years of age in Nicaragua. METHODS: From a demographic database covering a random sample of urban and rural households in León, Nicaragua, we identified all live births among women aged 15-49 years. Cases were defined as those who had died before the age of 5 years, between January 1993 and June 1996. For each case, two referents, matched for sex and age at death, were selected from the database. A total of 110 mothers of the cases and 203 mothers of the referents were interviewed using a standard questionnaire covering mothers' experience of physical and sexual violence. The data were analysed for the risk associated with maternal experience of violence of infant and under-5 mortality. FINDINGS: A total of 61% of mothers of cases had a lifetime experience of physical and/or sexual violence compared with 37% of mothers of referents, with a significant association being found between such experiences and mortality among their offspring. Other factors associated with higher infant and under-5 mortality were mother's education (no formal education), age (older), and parity (multiparity). CONCLUSIONS: The results suggest an association between physical and sexual violence against mothers, either before or during pregnancy, and an increased risk of under-5 mortality of their offspring. The type and severity of violence was probably more relevant to the risk than the timing, and violence may impact child health through maternal stress or care-giving behaviours rather than through direct trauma itself.
Keywords	Domestic violence ; Infant mortality ; Maternal welfare ; Sex offenses ; Sexual partners ; Pregnancy complications ; Cause of death ; Risk factors ; Socioeconomic factors ; Odds ratio ; Case-control studies ; Nicaragua ; Public aspects of medicine ; RA1-1270 ; Medicine ; R ; DOAJ:Public Health ; DOAJ:Health Sciences
Subject code	360
Language	English
Publishing date	2003-01-01T00:00:00Z
Publisher	World Health Organization
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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