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Article ; Online: Understanding the role of mask-wearing during COVID-19 on the island of Ireland

Nicola Fitz-Simon / John Ferguson / Alberto Alvarez-Iglesias / Mircea T. Sofonea / Tsukushi Kamiya

Royal Society Open Science, Vol 10, Iss

2023 Volume 7

Abstract: Non-pharmaceutical interventions have played a key role in managing the COVID-19 pandemic, but it is challenging to estimate their impacts on disease spread and outcomes. On the island of Ireland, population mobility restrictions were imposed during the ... ...

Abstract	Non-pharmaceutical interventions have played a key role in managing the COVID-19 pandemic, but it is challenging to estimate their impacts on disease spread and outcomes. On the island of Ireland, population mobility restrictions were imposed during the first wave, but mask-wearing was not mandated until about six months into the pandemic. We use data on mask-wearing, mobility, and season, over the first year of the pandemic to predict independently the weekly infectious contact estimated by an epidemiological model. Using our models, we make counterfactual predictions of infectious contact, and ensuing hospitalizations, under a hypothetical intervention where 90% of the population wore masks from the beginning of community spread until the dates of the mask mandates. Over periods including the first wave of the pandemic, there were 1601 hospitalizations with COVID-19 in Northern Ireland and 1521 in the Republic of Ireland. Under the counterfactual mask-wearing scenario, we estimate 512 (95% CI 400, 730) and 344 (95% CI 266, 526) hospitalizations in the respective jurisdictions during the same periods. This could be partly due to other factors that were also changing over time.
Keywords	COVID-19 ; mask-wearing ; hospitalizations ; counterfactuals ; Ireland ; Science ; Q
Language	English
Publishing date	2023-07-01T00:00:00Z
Publisher	The Royal Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Visualising statistical models using dynamic nomograms.

Amirhossein Jalali / Alberto Alvarez-Iglesias / Davood Roshan / John Newell

PLoS ONE, Vol 14, Iss 11, p e

2019 Volume 0225253

Abstract: Translational Statistics proposes to promote the use of Statistics within research and improve the communication of statistical findings in an accurate and accessible manner to diverse audiences. When statistical models become more complex, it becomes ... ...

Abstract	Translational Statistics proposes to promote the use of Statistics within research and improve the communication of statistical findings in an accurate and accessible manner to diverse audiences. When statistical models become more complex, it becomes harder to evaluate the role of explanatory variables on the response. For example, the interpretation and communication of the effect of predictors in regression models where interactions or smoothing splines are included can be challenging. Informative graphical representations of statistical models play a critical translational role; static nomograms are one such useful tool to visualise statistical models. In this paper, we propose the use of dynamic nomogram as a translational tool which can accommodate models of increased complexity. In theory, all models appearing in the literature could be accompanied by the corresponding dynamic nomogram to translate models in an informative manner. The R package presented will facilitate this communication for a variety of linear and non-linear models.
Keywords	Medicine ; R ; Science ; Q
Subject code	310
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

Christopher P. Dwyer / Alberto Alvarez-Iglesias / Robert Joyce / Timothy J. Counihan / Dympna Casey / Sinéad M. Hynes

Trials, Vol 21, Iss 1, Pp 1-

protocol for a feasibility cluster-randomised controlled trial

2020 Volume 12

Abstract: Abstract Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high prevalence of cognitive ... ...

Abstract	Abstract Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high prevalence of cognitive difficulties seen in MS, there is a lack of developed programmes that target cognition, while also supporting patients by helping them to function well in everyday life. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention. It addresses the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the current research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. The focus is on feasibility outcomes as well as functioning associated with cognitive difficulty and secondary outcomes related to cognition, fatigue and quality of life. Methods One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment as usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The primary outcome measure is the goal attainment scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention and at 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants’ perspectives will also be examined as part of the feasibility study. Discussion Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. In the event that results indicate efficacy, study findings will suggest that COB-MS requires consideration as a means of enhancing cognitive and daily functioning in people living with MS. Trial registration ISRCTN: ISRCTN11462710 . Registered on 9 September 2019.
Keywords	Multiple sclerosis ; Occupational therapy ; Cognitive occupation-based programme ; Cognitive rehabilitation ; Feasibility ; Protocol ; Medicine (General) ; R5-920
Subject code	120
Language	English
Publishing date	2020-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding

Christopher P. Dwyer / Robert A. Joyce / Eimear M. Bane / Anusha Moses / Alberto Alvarez-Iglesias / Sinéad M. Hynes

HRB Open Research, Vol

Protocol for a study-within-a-trial [version 2; peer review: 2 approved, 1 not approved]

2020 Volume 3

Abstract: Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant ... ...

Abstract	Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.
Keywords	Medicine ; R
Language	English
Publishing date	2020-03-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding

Christopher P. Dwyer / Robert A. Joyce / Eimear M. Bane / Anusha Moses / Alberto Alvarez-Iglesias / Sinéad M. Hynes

HRB Open Research, Vol

Protocol for a study-within-a-trial [version 1; peer review: 2 approved, 1 not approved]

2020 Volume 3

Abstract	Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.
Keywords	Medicine ; R
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases

Alberto Alvarez-Iglesias / Claire Kerins / Salim Yusuf / Roisin Dineen / Aoife Nolan / Colette Corcoran / Suzanne McDermott / Andrew Smyth / John Ferguson / Ritika Ranjan / Orlaith Hernon / Martin O'Donnell / Paula O'Shea / Matthew Griffin / Michelle Canavan

HRB Open Research, Vol

a study protocol for two randomised controlled trials [version 2; peer review: 2 approved, 1 approved with reservations]

2022 Volume 4

Abstract: Background: While low sodium intake (<2.3g/day) is recommended for all, there is uncertainty about feasibility and net cardiovascular effects. In COSTICK, we evaluated the effects of a dietary counselling intervention (reduced sodium intake) on ... ...

Abstract	Background: While low sodium intake (<2.3g/day) is recommended for all, there is uncertainty about feasibility and net cardiovascular effects. In COSTICK, we evaluated the effects of a dietary counselling intervention (reduced sodium intake) on intermediate cardiorenal outcomes in patients with (STICK) and without (COSIP) mild/moderate kidney disease. Methods: This is a protocol for two phase IIb randomised, two-group, parallel, open-label, controlled, single centre trials. Participants were aged >40 years with stable blood pressure, unchanged anti-hypertensive medications, willing to modify diet and provided written informed consent. Participants were excluded for abnormal sodium handling, heart failure, high dose diuretics, immunosuppression, pregnancy/lactation, postural hypotension, cognitive impairment, high or low body mass index (BMI) or inclusion in another trial. STICK participants had estimated glomerular filtration rate (eGFR) 30-60ml/min/1.73m2 and were excluded for acute kidney Injury, rapidly declining eGFR; known glomerular disease or current use of non-steroidal anti-inflammatory drugs. For COSIP, participants were excluded for known kidney or cardiovascular disease. Participants were randomized to usual care only (healthy eating) or an additional sodium lowering intervention (target <100mmol/day) through specific counseling (sodium use in foods, fresh over processed foods, sodium content of foods and eating outside of home). In STICK the primary outcome is change in 24-hour urinary creatinine clearance. In COSIP, the primary outcome is change in five biomarkers (renin, aldosterone, high sensitivity troponin T, pro-B-type natriuretic peptide and C-reactive protein). Our primary report (COSTICK), reports six biomarker outcome measures in the entire population at 2 years follow-up. Discussion: These Phase II trials will explore uncertainty about low sodium intake and cardiovascular and kidney biomarkers, and help determine the feasibility of low sodium intake. Trial results will also ...
Keywords	Cardiovascular Disease ; Chronic Kidney Disease ; Sodium Reduction ; Renal Insufficiency ; Biomarkers ; Clinical Trial ; eng ; Medicine ; R
Subject code	610
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Feasibility study protocol of a pragmatic, randomised controlled pilot trial

Elaine M. Finucane / Linda Biesty / Deirdre Murphy / Amanda Cotter / Eleanor Molloy / Martin O’Donnell / Shaun Treweek / Paddy Gillespie / Marian Campbell / John J. Morrison / Alberto Alvarez-Iglesias / Gill Gyte / Declan Devane

Trials, Vol 22, Iss 1, Pp 1-

membrane sweeping to prevent post-term pregnancy—the MILO Study

2021 Volume 15

Abstract: Abstract Background Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset ...

Abstract	Abstract Background Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). Methods/design Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment. Discussion The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to ...
Keywords	Feasibility ; Pilot trial ; SWAT ; Induction of labour ; Membrane sweep ; Post-term ; Medicine (General) ; R5-920
Subject code	420
Language	English
Publishing date	2021-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Arsenic in Groundwater in South West Ireland

Ellen McGrory / Emma Holian / Alberto Alvarez-Iglesias / Norma Bargary / Eoin J. McGillicuddy / Tiernan Henry / Eve Daly / Liam Morrison

Frontiers in Environmental Science, Vol

Occurrence, Controls, and Hydrochemistry

2018 Volume 6

Abstract: Globally numerous regions have been identified with elevated arsenic within groundwater which can result in potential adverse health risks. In Ireland, a previous national-scale research assessment of groundwater identified isolated clusters of elevated ... ...

Abstract	Globally numerous regions have been identified with elevated arsenic within groundwater which can result in potential adverse health risks. In Ireland, a previous national-scale research assessment of groundwater identified isolated clusters of elevated arsenic and indicated that lithology was a major controlling factor on arsenic in groundwater. Complementary comparisons of national-scale and regional-scale groundwater assessments of arsenic are lacking in Europe when compared to other global regions. The aims of this study were to demonstrate the value of a regional-scale groundwater hydrochemistry dataset with an existing national-scale approach, describe anomalies that can become the focus of attention for public health and economic reasons, and to provide a wider context for arsenic in groundwater within Ireland and Europe. Regional-scale data using 470 locations comprising 1,493 analyses using several hydrochemical parameters (arsenic, pH, conductivity, iron, manganese, sodium, potassium, calcium, magnesium, and total hardness) in south west Ireland were integrated with geological, hydrogeological, and land use datasets. Statistical analysis was performed using a combination of methods including score tests of geological groups using an empirical cumulative distribution function plot in addition to spatial analysis. Results revealed that hydrochemical parameters exhibited different spatial clusters, which was generally associated with lithology. Arsenic was elevated in sandstone derived bedrock. Weak correlation of arsenic with other hydrochemical parameters were observed and redox-sensitive elements like manganese and iron showed a greater diversity in spatial occurrence. This study has shown that the variation of hydrochemical parameters are controlled by regional geology. Finally, the paper focuses on anomalies identified by concentrations of individual ions or statistical associations in the context of, for example, historical mineral exploration and mining in the area and also discusses whether ...
Keywords	arsenic ; geology ; spatial analysis ; groundwater ; iron ; manganese ; Environmental sciences ; GE1-350
Subject code	550
Language	English
Publishing date	2018-12-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: How to Simplify the Evaluation of Newly Introduced Chemotherapeutic Interventions in Myeloma

Treen Carson Michael Morris / Mary B. Drake / Paul J. Kettle / Tracey McGuigan / Maeve Leahy / Michael O’Dwyer / Helen Enright / Tanya O’Shea / Rakesh Popat / Heather E. Oakervee / Kwee Yong / Jamie D. Cavenagh / David A. Cairns / Alberto Alvarez-Iglesias / Gordon Cook

Clinical Hematology International, Vol 3, Iss

2021 Volume 1

Abstract: When the bortezomib [PS341], adriamycin and dexamethasone (PAD) regimen was first evaluated, the response rate in untreated patients was much superior to that elicited by conventional chemotherapeutic agents. We demonstrated the efficacy of PAD in ... ...

Abstract	When the bortezomib [PS341], adriamycin and dexamethasone (PAD) regimen was first evaluated, the response rate in untreated patients was much superior to that elicited by conventional chemotherapeutic agents. We demonstrated the efficacy of PAD in relapsed or refractory patients by comparing the response rate obtained in 53 patients who received vincristine, adriamycin and dexamethasone (VAD) or equivalent regimen as induction therapy, using a comparative design in which each patient acted as their own control. Whereas 25 patients had a positive response to VAD, 37 patients had a response to PAD ≤ partial remission (PR) (p = 0.023). Using the more stringent response level of very good PR (VGPR) the results favored the PAD regimen very significantly (p = 0.006) (McNemars test). Similar results were seen using paired M-protein levels from individual patient comparisons. As the PAD regimen was subsequently adopted as the re-induction therapy in the British Society for Blood and Marrow Transplantation/United Kingdom Myeloma Forum Myeloma X (Intensive) trial, now concluded, we have retrospectively analyzed the findings from both studies. Comparison of response rates and adverse effects of patients having had previous autologous transplantation (Cohort 1) with the corresponding data from Myeloma X showed close correlation. These findings provide evidence that rapid results may be obtained in the evaluation of newly introduced, and potentially highly effective, anti-tumour agents by direct comparison to the response to the immediately preceding standard regimen, particularly in relatively resistant tumours.
Keywords	Myeloma ; relapse ; bortezomib ; adriamycin ; dexamethasone ; response ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-02-01T00:00:00Z
Publisher	Atlantis Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study

Pilot and Feasibility Studies, Vol 8, Iss 1, Pp 1-

a protocol for a cross-border pilot cluster randomised controlled trial

2022 Volume 16

Abstract: Abstract Background While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review ... ...

Abstract	Abstract Background While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). Methods A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic ...
Keywords	Feasibility study ; Behavioural intervention ; Primary care ; Behaviour change ; Multimorbidity ; Medication review ; Medicine (General) ; R5-920
Subject code	420
Language	English
Publishing date	2022-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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