Full Text Journal Articles by
Author Stuart Nicholls

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Advanced consent for acute stroke trials.

Michel Shamy, Brian Dewar, Naomi Niznick, Stuart Nicholls, Dar Dowlatshahi,

Lancet Neurol (The Lancet. Neurology)
[2021, 20(3):170]

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Screening for depression in children and adolescents: a protocol for a systematic review update.

Andrew Beck, John C LeBlanc, Kate Morissette, Candyce Hamel, Becky Skidmore, Heather Colquhoun, Eddy Lang, Ainsley Moore, John J Riva, Brett D Thombs, Scott Patten, Heather Bragg, Ian Colman, Gary S Goldfield, Stuart Gordon Nicholls, Kathleen Pajer, Beth K Potter, Robert Meeder, Priya Vasa, Brian Hutton, Beverley J Shea, Eva Graham, Julian Little, David Moher, Adrienne Stevens,

<h4>Background</h4>Major depressive disorder is common, debilitating, and affects feelings, thoughts, mood, and behaviors. Childhood and adolescence are critical periods for the development of depression and adolescence is marked by an increased incidence of mental health disorders. This protocol outlines the planned scope and methods for a systematic review update that ... Read more >>

Syst Rev (Systematic reviews)
[2021, 10(1):24]

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Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders.

Stuart G Nicholls, Kelly Carroll, Charles Weijer, Cory E Goldstein, Jamie Brehaut, Manish M Sood, Ahmed Al-Jaishi, Erika Basile, Jeremy M Grimshaw, Amit X Garg, Monica Taljaard,

<h4>Background</h4>Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysis.<h4>Objective</h4>To ... Read more >>

Can J Kidney Health Dis (Canadian journal of kidney health and disease)
[2020, 7:2054358120964119]

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Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review.

Ahmed A Al-Jaishi, Kelly Carroll, Cory E Goldstein, Stephanie N Dixon, Amit X Garg, Stuart G Nicholls, Jeremy M Grimshaw, Charles Weijer, Jamie Brehaut, Lehana Thabane, P J Devereaux, Monica Taljaard,

<h4>Background</h4>The hemodialysis setting is suitable for trials that use cluster randomization, where intact groups of individuals are randomized. However, cluster randomized trials (CRTs) are complicated in their design, analysis, and reporting and can pose ethical challenges. We reviewed CRTs in the hemodialysis setting with respect to reporting of key methodological ... Read more >>

Trials (Trials)
[2020, 21(1):752]

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A protocol for a scoping review of equity measurement in mental health care for children and youth.

William Gardner, Stuart G Nicholls, Graham J Reid, Brian Hutton, Candyce Hamel, Lindsey Sikora, Mina Salamatmanesh, Laura Duncan, Katholiki Georgiades, Jason Gilliland,

<h4>Background</h4>Mental health (MH) problems are among the most important causes of morbidity and mortality for children and youth. Problems of lack of equity in child and youth MH services (CYMHS)-including, but not limited to, problems in inaccessibility and quality of services-are widespread. Characterizing the nature of equity in CYMHS is ... Read more >>

Syst Rev (Systematic reviews)
[2020, 9(1):233]

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What outcomes are important in the recovery from acromio-clavicular (AC) joint pathology? A focus group study with patients and surgeons.

Saif Aldhuhoori, Mahmoud Almasri, Stuart G Nicholls, J Whitcomb Pollock, Meaghan Rollins, Lisa Howard, Peter Lapner,

INTRODUCTION:Acromio-clavicular (AC) joint pathology is a disabling condition that can restrict quality of life through chronic pain and functional limitation. The objective of this study was to determine symptoms and patient-centred outcomes identified by patients with AC pathology and from experienced shoulder surgeons. METHODS:Qualitative research methods were undertaken with patient ... Read more >>

Disabil Rehabil (Disability and rehabilitation)
[2020, :1-9]

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The importance of decision intent within descriptions of pragmatic trials.

Stuart G Nicholls, Merrick Zwarenstein, Spencer Phillips Hey, Bruno Giraudeau, Marion K Campbell, Monica Taljaard,

OBJECTIVE:It is now more than 50 years since the concepts of explanatory and pragmatic attitudes toward trials were first discussed by Schwartz and Lellouch in their influential 1967 paper. Since then, there has been increasing focus on design aspects that may be consistent with more pragmatic attitudes within clinical trials, and ... Read more >>

J Clin Epidemiol (Journal of clinical epidemiology)
[2020, 125:30-37]

Cited: 1 time

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A search filter to identify pragmatic trials in MEDLINE was highly specific but lacked sensitivity.

Monica Taljaard, Steve McDonald, Stuart G Nicholls, Kelly Carroll, Spencer P Hey, Jeremy M Grimshaw, Dean A Fergusson, Merrick Zwarenstein, Joanne E McKenzie,

OBJECTIVES:Identifying pragmatic trials from among all randomized trials is challenging because of inconsistent reporting. Our objective was to develop and validate a search filter to identify reports of pragmatic trials from Ovid MEDLINE. STUDY DESIGN AND SETTING:Two sets of known and probable pragmatic trial records were analyzed using text mining ... Read more >>

J Clin Epidemiol (Journal of clinical epidemiology)
[2020, 124:75-84]

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Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.

Monica Taljaard, Cory E Goldstein, Bruno Giraudeau, Stuart G Nicholls, Kelly Carroll, Spencer Phillips Hey, Jamie C Brehaut, Vipul Jairath, Alex John London, Sandra M Eldridge, Jeremy M Grimshaw, Dean A Fergusson, Charles Weijer,

<h4>Background</h4>Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need ... Read more >>

Clin Trials (Clinical trials (London, England))
[2020, 17(3):253-263]

Cited: 1 time

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Outcomes in pediatric studies of medium-chain acyl-coA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU): a review.

Michael Pugliese, Kylie Tingley, Andrea Chow, Nicole Pallone, Maureen Smith, Alvi Rahman, Pranesh Chakraborty, Michael T Geraghty, Julie Irwin, Laure Tessier, Stuart G Nicholls, Martin Offringa, Nancy J Butcher, Ryan Iverson, Tammy J Clifford, Sylvia Stockler, Brian Hutton, Karen Paik, Jessica Tao, Becky Skidmore, Doug Coyle, Kathleen Duddy, Sarah Dyack, Cheryl R Greenberg, Shailly Jain Ghai, Natalya Karp, Lawrence Korngut, Jonathan Kronick, Alex MacKenzie, Jennifer MacKenzie, Bruno Maranda, John J Mitchell, Murray Potter, Chitra Prasad, Andreas Schulze, Rebecca Sparkes, Monica Taljaard, Yannis Trakadis, Jagdeep Walia, Beth K Potter, ,

<h4>Background</h4>Inherited metabolic diseases (IMDs) are a group of individually rare single-gene diseases. For many IMDs, there is a paucity of high-quality evidence that evaluates the effectiveness of clinical interventions. Clinical effectiveness trials of IMD interventions could be supported through the development of core outcome sets (COSs), a recommended minimum set ... Read more >>

Orphanet J Rare Dis (Orphanet journal of rare diseases)
[2020, 15(1):12]

Cited: 1 time

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The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders.

Stuart G Nicholls, Kelly Carroll, Merrick Zwarenstein, Jamie C Brehaut, Charles Weijer, Spencer P Hey, Cory E Goldstein, Ian D Graham, Jeremy M Grimshaw, Joanne E McKenzie, Dean A Fergusson, Monica Taljaard, ,

<h4>Background</h4>There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of research ... Read more >>

Trials (Trials)
[2019, 20(1):765]

Cited: 2 times

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The Importance of Describing as Well as Defining Usual Care.

Stuart G Nicholls, Merrick Zwarenstein, Monica Taljaard,

Am J Bioeth (The American journal of bioethics : AJOB)
[2020, 20(1):56-58]

Cited: 1 time

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La déclaration RECORD-PE (Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement for Pharmacoepdemiology) : directives pour la communication des études realisées à partir de données de santé observationelles collectées en routine en pharmacoépidémiologie.

Sinéad M Langan, Sigrún A J Schmidt, Kevin Wing, Vera Ehrenstein, Stuart G Nicholls, Kristian B Filion, Olaf Klungel, Irene Petersen, Henrik T Sørensen, William G Dixon, Astrid Guttmann, Katie Harron, Lars G Hemkens, David Moher, Sebastian Schneeweiss, Liam Smeeth, Miriam Sturkenboom, Erik von Elm, Shirley V Wang, Eric I Benchimol,

CMAJ (CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne)
[2019, 191(25):E689-E708]

Cited: 1 time

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What is in a Name? Parent, Professional and Policy-Maker Conceptions of Consent-Related Language in the Context of Newborn Screening.

Stuart G Nicholls, Holly Etchegary, Laure Tessier, Charlene Simmonds, Beth K Potter, Jamie C Brehaut, Daryl Pullman, Robin Z Hayeems, Sari Zelenietz, Monica Lamoureux, Jennifer Milburn, Lesley Turner, Pranesh Chakraborty, Brenda J Wilson,

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. ... Read more >>

Public Health Ethics (Public health ethics)
[2019, 12(2):158-175]

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Long term tapering versus standard prednisolone treatment for first episode of childhood nephrotic syndrome: phase III randomised controlled trial and economic evaluation.

Nicholas J A Webb, Rebecca L Woolley, Tosin Lambe, Emma Frew, Elizabeth A Brettell, Emma N Barsoum, Richard S Trompeter, Carole Cummins, Jonathan J Deeks, Keith Wheatley, Natalie J Ives, ,

<h4>Objective</h4>To determine whether extending initial prednisolone treatment from eight to 16 weeks in children with idiopathic steroid sensitive nephrotic syndrome improves the pattern of disease relapse.<h4>Design</h4>Double blind, parallel group, phase III randomised placebo controlled trial, including a cost effectiveness analysis.<h4>Setting</h4>125 UK National Health Service district general hospitals and tertiary paediatric ... Read more >>

BMJ (BMJ (Clinical research ed.))
[2019, 365:l1800]

Cited: 2 times

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Development of a robotic walker for individuals with cerebral palsy.

Hana Alazem, Anna McCormick, Stuart G Nicholls, Elizabeth Vilé, Roselle Adler, Genevieve Tibi,

<b>Objective:</b> This study describes the first use of a robotic walker in youth and young adults with cerebral palsy (CP) Gross Motor Function Classification (GMFCS) IV.<b>Methods:</b> Semi-structured interviews were conducted before and after each robotic walker trial. Interviews were recorded, then transcribed and subjected to thematic analysis.<b>Results:</b> Five participants (4 ... Read more >>

Disabil Rehabil Assist Technol (Disability and rehabilitation. Assistive technology)
[2020, 15(6):643-651]

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A Parent-Targeted and Mediated Video Intervention to Improve Uptake of Pain Treatment for Infants During Newborn Screening: A Pilot Randomized Controlled Trial.

Carolina Lavin Venegas, Monica Taljaard, Jessica Reszel, Sandra Dunn, Ian D Graham, JoAnn Harrold, Catherine Larocque, Becky Nicholls, Stuart Nicholls, Pat OʼFlaherty, Janet Squires, Bonnie Stevens, Marie-Josée Trépanier, Denise Harrison,

Most newborns undergo newborn screening blood tests. Breastfeeding, skin-to-skin care, and sweet solutions effectively reduce pain; however, these strategies are inconsistently used. We conducted a 2-armed pilot randomized controlled trial in a mother-baby unit to examine the feasibility and acceptability of a parent-targeted and -mediated video demonstrating use of these ... Read more >>

J Perinat Neonatal Nurs (The Journal of perinatal & neonatal nursing)
[2019, 33(1):74-81]

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Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.

Stuart G Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E Goldstein, Merrick Zwarenstein, Ian D Graham, Joanne E McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K Campbell, Jeremy M Grimshaw, Dean A Fergusson, Monica Taljaard,

<h4>Background</h4>Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action ... Read more >>

BMC Med Ethics (BMC medical ethics)
[2018, 19(1):90]

Cited: 2 times

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Screening for depression in women during pregnancy or the first year postpartum and in the general adult population: a protocol for two systematic reviews to update a guideline of the Canadian Task Force on Preventive Health Care.

Candyce Hamel, Eddy Lang, Kate Morissette, Andrew Beck, Adrienne Stevens, Becky Skidmore, Heather Colquhoun, John LeBlanc, Ainsley Moore, John J Riva, Brett D Thombs, Ian Colman, Sophie Grigoriadis, Stuart Gordon Nicholls, Beth K Potter, Kerri Ritchie, Julie Robert, Priya Vasa, Bianca Lauria-Horner, Scott Patten, Simone N Vigod, Brian Hutton, Beverley J Shea, Shamila Shanmugasegaram, Julian Little, David Moher,

<h4>Background</h4>In 2018, the World Health Organization reported that depression is the most common cause of disability worldwide, with over 300 million people currently living with depression. Depression affects an individual's physical health and well-being, impacts psychosocial functioning, and has specific negative short- and long-term effects on maternal health, child health, ... Read more >>

Syst Rev (Systematic reviews)
[2019, 8(1):27]

Cited: 5 times

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Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight.

Holly Fernandez Lynch, Stuart Nicholls, Michelle N Meyer, Holly A Taylor, ,

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how ... Read more >>

J Empir Res Hum Res Ethics (Journal of empirical research on human research ethics : JERHRE)
[2019, 14(3):190-196]

Cited: 2 times

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The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).

Sinéad M Langan, Sigrún Aj Schmidt, Kevin Wing, Vera Ehrenstein, Stuart G Nicholls, Kristian B Filion, Olaf Klungel, Irene Petersen, Henrik T Sorensen, William G Dixon, Astrid Guttmann, Katie Harron, Lars G Hemkens, David Moher, Sebastian Schneeweiss, Liam Smeeth, Miriam Sturkenboom, Erik von Elm, Shirley V Wang, Eric I Benchimol,

BMJ (BMJ (Clinical research ed.))
[2018, 363:k3532]

Cited: 23 times

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Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol.

Monica Taljaard, Charles Weijer, Jeremy M Grimshaw, Adnan Ali, Jamie C Brehaut, Marion K Campbell, Kelly Carroll, Sarah Edwards, Sandra Eldridge, Christopher B Forrest, Bruno Giraudeau, Cory E Goldstein, Ian D Graham, Karla Hemming, Spencer Phillips Hey, Austin R Horn, Vipul Jairath, Terry P Klassen, Alex John London, Susan Marlin, John C Marshall, Lauralyn McIntyre, Joanne E McKenzie, Stuart G Nicholls, P Alison Paprica, Merrick Zwarenstein, Dean A Fergusson,

<h4>Background</h4>There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered ... Read more >>

Trials (Trials)
[2018, 19(1):525]

Cited: 3 times

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Call for a pan-Canadian approach to ethics review in Canada.

Stuart G Nicholls, Karine Morin, Laurel Evans, Holly Longstaff,

CMAJ (CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne)
[2018, 190(18):E553-E555]

Cited: 1 time

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Commentary on "Regulatory Support Improves Subsequent IRB/REC Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution's Experience".

Stuart G Nicholls,

In response to researcher concerns a number of initiatives have been developed to support individual researchers seeking ethics review and approval. In this issue, Sonne et al. (2017) outline an example of an intervention to support researchers, which they refer to as a Regulatory Knowledge Support (RKS) service. While the ... Read more >>

J Empir Res Hum Res Ethics (Journal of empirical research on human research ethics : JERHRE)
[2018, 13(2):145-147]

Cited: 0 times

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Establishing core outcome sets for phenylketonuria (PKU) and medium-chain Acyl-CoA dehydrogenase (MCAD) deficiency in children: study protocol for systematic reviews and Delphi surveys.

Beth K Potter, Brian Hutton, Tammy J Clifford, Nicole Pallone, Maureen Smith, Sylvia Stockler, Pranesh Chakraborty, Pauline Barbeau, Chantelle M Garritty, Michael Pugliese, Alvi Rahman, Becky Skidmore, Laure Tessier, Kylie Tingley, Doug Coyle, Cheryl R Greenberg, Lawrence Korngut, Alex MacKenzie, John J Mitchell, Stuart Nicholls, Martin Offringa, Andreas Schulze, Monica Taljaard, ,

BACKGROUND:Inherited metabolic diseases (IMD) are a large group of rare single-gene disorders that are typically diagnosed early in life. There are important evidence gaps related to the comparative effectiveness of therapies for IMD, which are in part due to challenges in conducting randomized controlled trials (RCTs) for rare diseases. Registry-based ... Read more >>

Trials (Trials)
[2017, 18(1):603]

Cited: 1 time

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