Stuart Nicholls
Canadian Institutes of Health (CIHR) Postdoctral Fellow, Department of Epidemiology & Community Medicine, University of Ottawa.
My work is at the intersection of public health ethics, medical sociology, and knowledge translation (KT) although I have a special interest in genetics (and genomics) and personalized medicine.
I am an advocate of mixed methods approaches and interdisciplinary research. Methodologically I have a keen interest in latent variable methods such as structural equation modelling.
Supervisors: Brenda Wilson and Jamie Brehaut
Phone: Tel: 613 562 5800 ext 8288
Address: Dept. Epidemiology and Community Medicine,
University of Ottawa,
451 Smyth Rd,
Ottawa,
ON
K1H 8M5
My work is at the intersection of public health ethics, medical sociology, and knowledge translation (KT) although I have a special interest in genetics (and genomics) and personalized medicine.
I am an advocate of mixed methods approaches and interdisciplinary research. Methodologically I have a keen interest in latent variable methods such as structural equation modelling.
Supervisors: Brenda Wilson and Jamie Brehaut
Phone: Tel: 613 562 5800 ext 8288
Address: Dept. Epidemiology and Community Medicine,
University of Ottawa,
451 Smyth Rd,
Ottawa,
ON
K1H 8M5
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-- Empirical uncertainty : some difficulties in placing obesity centerstage
-- Normative uncertainty : what do we want from policies to address childhood obesity
-- Childhood obesity and parental responsibility
-- Childhood obesity interventions, equity and social justice
-- Stigma and weight bias : implications for childhood obesity interventions
-- Childhood obesity and the "obesogenic environment"
-- Price policies as strategies for obesity prevention
-- Responding to food marketing targeted at children : regulation, social marketing and media literacy
-- Schools and childhood obesity
-- Childhood obesity : some practical implications.
Reporting of consent rates in published articles is important in order to determine potential sources of bias, and validity and generalizability of results. Our objective was to determine the percentage of critical care studies for which the consent rate was reported.
Study Design and Setting
We reviewed all articles published in eight medical journals in 2013. Studies meeting the following inclusion criteria were selected: 1) randomized controlled trial (RCT) or observational clinical study, 2) study population involving critically ill patients, and 3) part of the study occurring in an intensive care unit.
Results
1871 articles were screened of which 156 were included. The consent rate was discernable in 30.8 % of articles (48/156, 95% CI: 24.1, 38.4) with a median consent rate of 86.9% (IQR 71.6, 94.1). A statement on Research Ethics Board (REB) approval was included in 96.8% of studies. There was a significant difference in reporting of consent rates between RCTs and non RCTs (58.70% versus 19.09%, P < 0.0001).
Conclusion
Consent rates are reported in less than one third of critical care studies. We encourage journals to require reporting of consent rates in order to improve interpretation, validity and generalizability of critical care study results.
Methods: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.
Results: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.
Discussion: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.
each of these disorders.
Objective: This eDelphi exercise was conducted in order to generate a list of translational dermatology research questions which are regarded as a priority for further investigations.
Results: During the first phase of the eDelphi, 228 research questions were generated by an expert panel which included clinical academic dermatologists, clinical dermatologists, non-clinical scientists, dermatology trainees and representatives from patient support groups. Following completion of the second and third phases, 40 questions on inflammatory skin disease, 20 questions on structural skin disorders /
genodermatoses, 37 questions on skin cancer and 8 miscellaneous questions were designated as priority translational dermatology research questions (PRQs). In addition to PRQs on a variety of disease areas (including multiple PRQs on psoriasis, eczema, squamous cell carcinoma (SCC) and melanoma), there were a number of cross-cutting
themes which identified a need to investigate mechanisms / pathogenesis of disease and the necessity to improve treatments for patients with skin disease. Conclusion: It is
predicted that this list of PRQs will help to provide a strategic direction for translational dermatology research in the UK and that addressing this list of questions will ultimately
provide clinical benefit for substantial numbers of subjects with skin disorders.
Methods: Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.
Results: The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.
Conclusions: The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.
-- Empirical uncertainty : some difficulties in placing obesity centerstage
-- Normative uncertainty : what do we want from policies to address childhood obesity
-- Childhood obesity and parental responsibility
-- Childhood obesity interventions, equity and social justice
-- Stigma and weight bias : implications for childhood obesity interventions
-- Childhood obesity and the "obesogenic environment"
-- Price policies as strategies for obesity prevention
-- Responding to food marketing targeted at children : regulation, social marketing and media literacy
-- Schools and childhood obesity
-- Childhood obesity : some practical implications.
Reporting of consent rates in published articles is important in order to determine potential sources of bias, and validity and generalizability of results. Our objective was to determine the percentage of critical care studies for which the consent rate was reported.
Study Design and Setting
We reviewed all articles published in eight medical journals in 2013. Studies meeting the following inclusion criteria were selected: 1) randomized controlled trial (RCT) or observational clinical study, 2) study population involving critically ill patients, and 3) part of the study occurring in an intensive care unit.
Results
1871 articles were screened of which 156 were included. The consent rate was discernable in 30.8 % of articles (48/156, 95% CI: 24.1, 38.4) with a median consent rate of 86.9% (IQR 71.6, 94.1). A statement on Research Ethics Board (REB) approval was included in 96.8% of studies. There was a significant difference in reporting of consent rates between RCTs and non RCTs (58.70% versus 19.09%, P < 0.0001).
Conclusion
Consent rates are reported in less than one third of critical care studies. We encourage journals to require reporting of consent rates in order to improve interpretation, validity and generalizability of critical care study results.
Methods: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.
Results: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.
Discussion: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.
each of these disorders.
Objective: This eDelphi exercise was conducted in order to generate a list of translational dermatology research questions which are regarded as a priority for further investigations.
Results: During the first phase of the eDelphi, 228 research questions were generated by an expert panel which included clinical academic dermatologists, clinical dermatologists, non-clinical scientists, dermatology trainees and representatives from patient support groups. Following completion of the second and third phases, 40 questions on inflammatory skin disease, 20 questions on structural skin disorders /
genodermatoses, 37 questions on skin cancer and 8 miscellaneous questions were designated as priority translational dermatology research questions (PRQs). In addition to PRQs on a variety of disease areas (including multiple PRQs on psoriasis, eczema, squamous cell carcinoma (SCC) and melanoma), there were a number of cross-cutting
themes which identified a need to investigate mechanisms / pathogenesis of disease and the necessity to improve treatments for patients with skin disease. Conclusion: It is
predicted that this list of PRQs will help to provide a strategic direction for translational dermatology research in the UK and that addressing this list of questions will ultimately
provide clinical benefit for substantial numbers of subjects with skin disorders.
Methods: Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.
Results: The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.
Conclusions: The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.
Objective: To explore the attitudes of parents towards different consent approaches for newborn bloodspot screening.
Methods: Qualitative interviews with parents in Ontario and Newfoundland & Labrador, Canada.
Results & Conclusion: We will present the results of semi-structured interviews with parents regarding consent practices for newborn bloodspot screening. Specifically, we present results of thematic analyses focussing on parent interpretations of key terms such as informed consent and implied consent, together with evaluations of necessary requirements for different approaches within the newborn screening context. In particular we report perceived differences between these approaches, and practicalities required by the differing approaches to consent.
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.
Objectives: To understand the factors that affect these prescribing decisions.
Methods: Cross-sectional survey of Canadian Family Physicians (FP: n=500), Geriatricians (G: n=149), and Internal Medicine specialists (IMS: n=500). Of these,1032 physicians were contactable, and 335 completed and usable responses were received. Physicians were asked about the frequency with which they see patients with atrial fibrillation, prescribing practices, and barriers to the prescription of anticoagulants.
Results: Stated prescribing practices did not significantly differ between physician groups. Falls risk, bleeding risk and poor patient compliance were all highly cited reasons for non-prescription. Fewer geriatricians indicated that patient falls would be a reason for non-prescription (G:47%; FP: 71%; IMS: 72%), and significantly fewer changed reported practice in the presence of falls risk (χ2(6)= 45.446, P<0.001). Experience of a patient having a stroke whilst not on warfarin had a significant impact on vignette decisions; physicians who had had patients who experienced a stroke were more likely to prescribe warfarin (χ2(3)=10.7, P=0.013).
Conclusions: Barriers to warfarin prescription differentially affect differing physician specialties. Moreover, prior experience of a patient suffering a stroke when not prescribed warfarin is positively associated with intention to prescribe warfarin prescription, even in the presence of falls risk.
Results: Participants (N=170; 120 CRC and 50 NBS) varied in attitude; more participants in the CRC groups indicated that they were “enthusiastic” or “optimistic”, while participants in the NBS workshops were more “worried” or had “mixed feelings”. More NBS participants were concerned that a result indicating increased
risk would cause extra worry compared to those in the CRC workshops (91% vs 49% respectively; p<0.01). Other differences included the relevance of results for their family (89% CRC vs 61% NBS; p<0.01 ). In both contexts concern was expressed regarding who had access to test results and implications for insurance. Conclusion: Consistent with previous studies in genetic testing, public attitudes appeared to be contingent on the context in which the genomic risk profiling technology was applied. Public attitudes to genomic technologies must, therefore, be considered in a nuanced, context-specific manner and broad brush assessments avoided. A one-size generic policy is unlikely to be satisfactory. That being said, concerns over access to test results and implications on for insurance were common to both contexts.
parents use certain types of information materials nor the relative importance placed on these. The present study addresses this deficit.
Methods: An exploratory sequential mixed methods approach using semi-structured interviews and a self-completion postal questionnaire.
Results: Consistent with Wilson's (1999) model of information-seeking parents could be distinguished as active-seekers
or passive-receivers of information. In the UK the main contact is the midwife and survey results indicated that the midwife was the principal information source; only half of parents used official leaflets. Barriers to use included provision post-natally and the inclusion with other, non-medical, leaflets and booklets. Multinomial logistic regression confirms the significant effect of the most important source in explaining the number of
information sources used (Likelihood Ratio Chi-square = 19.322, df=6, p=0.004). Passive-receivers, tended to cite their primary healthcare contact (the midwife) as the most important source and were more likely to use only that one source. Active-seekers sought out information not only from different perspectives but from more sources.
Discussion: The main practitioner contact (here the midwife) is the principal source of information for parents, irrespective of information-seeking behaviour, although their perceived importance varied. This person is best placed to act as a gate-keeper for parents seeking information about NBS. Parents should be provided with information in the pre-natal period in order to maximise information uptake. This should be supported by additional written materials. These materials should be clearly referenced."
Methods: I explore this potential tension through an exploratory sequential mixed methods approach using an initial phase of qualitative interviews with parents (n=18) and a subsequent postal questionnaire (n=154). Qualitative data was coded using a thematic analysis approach with survey responses analysed using descriptive statistics and structural equation modelling (SEM).
Results: Interviews indicated that there may be discord between the stated aims of supporting informed choice and the practice of providing a population screening programme. In particular parents referred to aspects of proceduralisation and information presentation as diminishing the perceived availability of choice. Parents also noted aspects of timing that impacted on their ability to make considered informed decisions. Survey results suggested that ability to make a choice was of less concern than the availability of choice with 80% of parents agreeing to some degree that it had been expected that their child have the heel prick and over 30% indicating that they did not feel they had a choice to decline the screening. Perhaps most disconcerting was that over 10% of parents felt that they had not made an informed choice. SEM revealed the importance of this finding with perceived choice having a significant impact on the perceived quality of decision made and a standardised coefficient almost twice as large as the parents'
Empirical data shows disparities in childhood obesity incidence on the basis of income, gender and neighbourhood characteristics (Matheson et al., 2008; Harrington et al 2009). Do these findings identify a section of society that are morally culpable for the increase in childhood obesity, or do they point to structural inequities that serve to exacerbate existing inequalities?
The question of responsibility, and particularly parental responsibility, is central to discussions of interventions for childhood obesity. Responsibility may be considered in three distinct ways: causal responsibility, moral responsibility, and blameworthiness (Holm, 2009). Thus whilst parents may be causally responsible, together with others such as the advertising industry, food producers, and government, are they also morally responsible and/or blameworthy?
Empirical data, which shows disparities in childhood obesity incidence may point to a lack of moral responsibility or blameworthiness – at least in some parents.
This paper explores the issue of parental responsibility and suggests that the attribution of responsibility is far more complex than may at first appear and that whilst parents are causally responsible, in many cases the moral responsibility and attribution of blame must fall elsewhere. In particular I consider to what extent the state can be seen as morally responsible and the implications that these conclusions have for interventions in childhood obesity. (244 words)
We present data from the European IDEFICS study, which provides information on parents’ support for taxation/subsidy schemes. Across all countries studied, support for taxation/subsidy schemes was high and, in addition, significantly higher among low-income than higher-income groups.
Positive attitudes among lower-income groups towards taxation/subsidy schemes lend legitimacy to their use in addressing health inequalities despite concerns about regressivity. Further, they may indicate that individuals expect to respond to price changes by shifting consumption towards healthier foods (as predicted by Jensen & Smed, 2007). This would improve health outcomes while keeping food expenditure roughly equal, alleviating concerns about regressivity.
We conclude by noting several limitations of our argument. Firstly, parental attitudes may not reflect wider public opinion. Second, our data did not capture different ways of implementing such schemes (Waterlander 2010). Third, respondents may be overly optimistic about the ease of changing food consumption. Finally, taxation/subsidy schemes may worsen health outcomes indirectly (e.g. Yaniv et al., 2009).
Methods: This paper draws on attitude data towards taxation and subsidisation generated from the first phase of the Identification and Prevention of Dietary and Lifestyle-induced Health Effects in Children and Infants (IDEFICS) parental questionnaire.
Results: The results indicate that parents show a high degree of support for taxation and subsidisation of food products, but that there is significant variation in support between countries.
Conclusion: These findings are consistent with recent data suggesting that public(s) are increasingly supportive of taxation and subsidisation policies yet are in conflict with the attitudes of other key stakeholders who are less supportive of taxation-subsidy policies. The implications of these findings and potential for policy interventions are discussed.
The paper will provide an account of the current practice of newborn screening in the UK before discussing the initial qualitative phase of this research. This initial phase will provide not only the variables to be included in the later analysis, but also a theoretical mechanism through which the different influences interact. The analysis of this data will be considered and the process of linking this to quantitative analysis through SEM will be discussed. The paper will conclude by discussing how it is envisaged that SEM will be used, and a number of the issues that will need to be addressed.
Methods and Analysis: Semi-structured interviews were conducted with parents whose children had been offered screening (n=28), healthcare professionals (n=19), and policy decision-makers (n=17). The study was undertaken in parallel at within Ontario and Newfoundland & Labrador. These sites vary in terms of both screening program structure and content, which may be presumed to influence experiences. Interviews were audio-recorded and transcribed verbatim prior to analysis. The examination of the transcripts followed a thematic analysis approach, in which textual data are coded and labelled in an inductive manner.
Results: Terms such as informed consent, implied consent, and standard-of-care were found to have different meanings to individuals. Understandings varied in terms of the perceived level and type of information required, whether authorization by the parent was necessary, as well as documentary evidence required. While variation between individuals was found, no consistent differences were identified between the two sites. For policy decision makers, a lack of formal policy may serve to propagate uncertainty and varied meanings.
Discussion: These data indicate that meaning of terms such as ‘informed consent’ may not be universal, and as such attitudes toward different consent approaches cannot be assumed to be based on consistent conceptualisations of terms. Detailed investigations of meaning are required to unpack the relevant elements upon which stakeholder attitudes toward consent approaches are based.
informed consent for NBS and how these experiences might differ across provinces or between key stakeholders such as parents and healthcare professionals (HCP). This study will extend an emerging literature on the opinions and experiences of parents and HCPs regarding consent practices to newborn screening in Canada.
Parents' and Healthcare Professionals' Experiences of Consent for Newborn Bloodspot Screening. Available from: https://www.researchgate.net/publication/275520029_Parents%27_and_Healthcare_Professionals%27_Experiences_of_Consent_for_Newborn_Bloodspot_Screening [accessed Apr 27, 2015].