Publications by authors named "Monica Taljaard"

Background: There are numerous approaches available to analyse data from cluster randomised trials. These include cluster-level summary methods and individual-level methods accounting for clustering, such as generalised estimating equations and generalised linear mixed models. There has been much methodological work showing that estimates of treatment effects can vary depending on the choice of approach, particularly when estimating odds ratios, essentially because the different approaches target different estimands.

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The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible.

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Background: This systematic review evaluates the effect of audit and feedback (A&F) interventions targeting antibiotic prescribing in primary care and examines factors that may explain the variation in effectiveness.

Methods: Randomized controlled trials (RCTs) involving A&F interventions targeting antibiotic prescribing in primary care were included in the systematic review. Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and ClinicalTrials.

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Background: Depression is a common nonmotor complication in Parkinson's disease (PD). However, few studies have evaluated the efficacy of first-line psychological therapies for depression in this patient population.

Objectives: This randomized controlled trial evaluated the efficacy of interpersonal psychotherapy (IPT), an empirically validated intervention for depression that focuses on the bidirectional relationship between mood disturbance and interpersonal and social stressors.

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Background: Evaluating the clinical status of concussions using virtual platforms has become increasingly common. While virtual approaches to care are useful, there is limited information regarding the barriers and facilitators associated with a virtual concussion assessment.

Objective: This study aims to identify the barriers and facilitators associated with engaging in virtual concussion assessments from the perspective of people living with workplace concussions; identify the barriers and facilitators to completing virtual concussion assessments from the perspectives of clinicians; and identify the clinical measures related to 4 clinical domains that would be most appropriate in virtual practice: general neurological examination and vestibular, oculomotor, and cervical spine assessment.

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Introduction: Home-based, virtually-supported care models may represent the most efficient and scalable approach to delivering prehabilitation services. However, virtual approaches to prehabilitation are understudied. This manuscript describes the protocol for an internal pilot randomised controlled trial of a virtually-delivered, multimodal prehabilitation intervention.

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Background: Cluster randomized trials (CRTs) are increasingly important for evaluating interventions embedded in health care systems. An essential parameter in sample size calculation to detect both overall and heterogeneous treatment effects for CRTs is the intra-cluster correlation coefficient (ICC) of both outcome and covariates of interest. However, obtaining advance estimates for the ICC can be challenging.

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Background: Dichotomisation of statistical significance, rather than interpretation of effect sizes supported by confidence intervals, is a long-standing problem.

Methods: We distributed an online survey to clinical trial statisticians across the UK, Australia and Canada asking about their experiences, perspectives and practices with respect to interpretation of statistical findings from randomised trials. We report a descriptive analysis of the closed-ended questions and a thematic analysis of the open-ended questions.

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Background: As the prevalence of chemotherapy-related cognitive impairment rises, investigation into treatment options is critical. The objectives of this study were to test the effects of an aerobic exercise intervention initiated during chemotherapy compared to usual care (wait list control condition) on (1) objectively measured cognitive function and self-reported cognitive function, as well as on (2) the impact of cognitive impairment on quality of life (QOL) postintervention (commensurate with chemotherapy completion).

Methods: The Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial was a two-arm, two-center randomized controlled trial conducted in Ottawa and Vancouver (Canada).

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Article Synopsis
  • Opioids, while commonly prescribed for pain management, pose safety risks; the study explores whether strategies like audit and feedback can improve prescription practices among primary care physicians in Ontario.
  • The research used a matched-cohort design to compare the effects of audit and feedback, with or without academic detailing, on opioid prescribing rates over a 30-month period, focusing on family physicians.
  • Results indicated a general decline in opioid prescriptions pre-intervention across all groups, with significant reductions in high-prescribing physicians in the audit and feedback group, but no notable difference post-intervention between the groups, suggesting future efforts should target high-volume prescribers.
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Background: Randomized controlled trials with pragmatic intent aim to generate evidence that directly informs clinical decisions. Some have argued that the ethical protection of informed consent can be in tension with the goals of pragmatism. But the impact of other ethical protections on trial pragmatism has yet to be explored.

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Article Synopsis
  • Stepped-wedge cluster randomized trials are studies that change between two groups (control and intervention), which means they can use fewer groups, but there are no clear rules about the minimum number of groups needed.
  • The authors looked at 61 small trials done between 2016 and 2022 to find out how they're designed and analyzed, discovering that many used just two to six groups.
  • They found reasons for using fewer groups, like wanting to avoid mix-ups between them and having limited options, but many still did not explain the small number clearly.
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Objective: Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time.

Design: A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews.

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Background: Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback.

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Introduction: The pragmatic explanatory continuum indicator summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions, and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, which is PRECIS-3.

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Article Synopsis
  • The study focused on whether a home-based exercise program combined with nutritional guidance (prehabilitation) improves disease-free survival and return to treatment for older cancer patients with frailty compared to usual care.* -
  • Out of 204 participants, results showed that the prehabilitation group and control group had similar rates of death or cancer recurrence (11% each), and slightly more patients returned to treatment in the prehabilitation group (29% vs. 23%).* -
  • Ultimately, the research found no significant advantage of exercise prehabilitation on disease-free survival or treatment return, suggesting that future studies may need to be larger to detect meaningful effects.*
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Background: There is little guidance available, and no uniform assessment battery is used in either in-person or remote evaluations of people who are experiencing persistent physical symptoms post concussion. Selecting the most appropriate measures for both in-person and remote physical assessments is challenging because of the lack of expert consensus and guidance.

Objective: This study used expert consensus processes to identify clinical measures currently used to assess 5 physical domains affected by concussion (neurological examination, cervical spine, vestibular, oculomotor, or effort) and determine the feasibility of applying the identified measures virtually.

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Objectives: The population is aging and falls are a common reason for emergency department visits. Appropriate imaging in this population is important. The objectives of this study were to estimate the prevalence of cervical spine injury and identify factors associated with cervical spine injuries in adults ≥ 65 years after low-level falls.

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Objectives: Emergent vascular imaging identifies a subset of patients requiring immediate specialized care (i.e. carotid stenosis > 50%, dissection or free-floating thrombus).

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Background: Acute heart failure (AHF) is a common emergency department (ED) presentation that may have poor outcomes but often does not require hospital admission. There is little evidence to guide dispositional decisions.

Objectives: The authors sought to create a risk score for predicting short-term serious outcomes (SSO) in patients with AHF.

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Article Synopsis
  • Children with chronic conditions often have unique health care needs that may not be fully addressed through current treatment practices focused on family and patient preferences.
  • A scoping review was conducted to analyze interventions aimed at enhancing family-centered care for these children by examining relevant studies published between January 2019 and August 2020.
  • The review found 61 interventions, primarily using quasiexperimental and randomized controlled trial designs, with key focuses on improving communication, involving families in care decisions, and increasing access to health services.
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Background: For emergency department (ED) patients with syncope, cardiac troponin can identify acute coronary syndrome (ACS) and prognosticate for 30-day serious adverse events. However, it is unclear if serial testing improves diagnostic yield and prognostication.

Methods: This was a secondary analysis of data from two prospective studies conducted to develop the Canadian Syncope Risk Score.

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Article Synopsis
  • - Workplace mild traumatic brain injuries can lead to long-term symptoms and reduced productivity, making rehabilitation essential, especially with the shift to remote care during the COVID-19 pandemic.
  • - This study aims to evaluate the effectiveness of remote concussion assessments by comparing them to in-person evaluations, focusing on their sensitivity and reliability.
  • - Participants will undergo both in-person and virtual assessments at the Ottawa Hospital, using a set toolkit of tests, with all sessions recorded for later analysis to ensure consistent findings.
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