Pragmatic Trials — Guides to Better Patient Care?

Ware, James H.; Hamel, Mary Beth

doi:10.1056/nejmp1103502

Cited by 240 publications

(203 citation statements)

References 4 publications

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“…They compare $2 interventions that are directly relevant to clinical care or health care delivery and strive to assess those interventions' effectiveness in real-world practice. 22 Participants Three-year-old children and their parents were recruited at their 3-year health maintenance visit from a 3-physician (SJ, MP, CT), communitybased, primary care pediatric group practice located in Toronto, Canada. This practice is participating in TARGet Kids!…”

Section: Methodsmentioning

confidence: 99%

Office-Based Randomized Controlled Trial to Reduce Screen Time in Preschool Children

Birken¹,

Maguire

Mekky³

et al. 2012

Pediatrics

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WHAT'S KNOWN ON THIS SUBJECT: Interventions to reduce screen time in preschool-aged children are promising. WHAT THIS STUDY ADDS:A screen time intervention in 3-year-old children implemented in the primary care setting did not reduce screen time or BMI. abstract OBJECTIVE: To determine if an intervention for preschool-aged children in primary care is effective in reducing screen time, meals in front of the television, and BMI. METHODS:A randomized controlled trial was conducted at a primary care pediatric group practice in Toronto, Canada. Three-year-old children and their parents were randomly assigned to receive a short behavioral counseling intervention on strategies to decrease screen time. The primary outcome 1 year later was parent reported screen time. Secondary outcomes included television in the child' s bedroom, number of meals in front of the television, and BMI. RESULTS:In the intention-to-treat analysis at 1 year, there were no significant differences in mean total weekday minutes of screen time (60, interquartile range [IQR]: 35-120 vs 65, IQR: 35-120; P = .68) or mean total weekend day minutes of screen time (80, IQR: 45-130 vs 90, IQR: 60-120; P = .33) between the intervention and control group. Adjusting for baseline BMI, there was a reduction in the number of weekday meals in front of the television (1.6 6 1.0 vs 1.9 6 1.2; P = .03) but no differences in BMI or number of televisions in the bedroom.CONCLUSIONS: This pragmatic trial was not effective in reducing screen time or BMI but was effective in reducing meals in front of the screen. Short interventions focused solely on reducing screen time implemented in the primary care practice setting may not be effective in this age group.

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Section: Methodsmentioning

confidence: 99%

Office-Based Randomized Controlled Trial to Reduce Screen Time in Preschool Children

Birken¹,

Maguire

Mekky³

et al. 2012

Pediatrics

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“…Evidence generation involves a variety of methods including clinical trials, 28 practical trials, 29,30 and observational studies. 31,32 Some but not all of the engagement activities in this stage depends on complex conceptual or methodological expertise.…”

Section: What Roles and Responsibilities Can Stakeholders Have In Pcomentioning

confidence: 99%

A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes Research

Concannon

Meißner

Grunbaum³

et al. 2012

J GEN INTERN MED

363

334

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Despite widespread agreement that stakeholder engagement is needed in patient-centered outcomes research (PCOR), no taxonomy exists to guide researchers and policy makers on how to address this need. We followed an iterative process, including several stages of stakeholder review, to address three questions: (1) Who are the stakeholders in PCOR? (2) What roles and responsibilities can stakeholders have in PCOR? (3) How can researchers start engaging stakeholders? We introduce a flexible taxonomy called the 7Ps of Stakeholder Engagement and Six Stages of Research for identifying stakeholders and developing engagement strategies across the full spectrum of research activities. The path toward engagement will not be uniform across every research program, but this taxonomy offers a common starting point and a flexible approach.

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“…The reason behind such selective enrollment is to minimize the presence of confounding factors [7]. Thus, a "trial" population is selected and differs from the general population [30]. A Norwegian study recently evaluated the magnitude of this difference by assessing the actual population referred to an asthma clinic using the inclusion and exclusion criteria commonly adopted in RCTs in asthma (e.g.…”

Section: Rcts: Limitationsmentioning

confidence: 99%

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

188

152

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a b s t r a c tRandomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate.In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies.Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

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Pragmatic Trials — Guides to Better Patient Care?

Cited by 240 publications

References 4 publications

Office-Based Randomized Controlled Trial to Reduce Screen Time in Preschool Children

Office-Based Randomized Controlled Trial to Reduce Screen Time in Preschool Children

A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes Research

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

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