abstract: 'Objectives: Clinical research is a complex scientific and social

  enterprise. Our objective was to identify strategies that pediatric

  critical care trialists consider acceptable, feasible, and effective to

  improve the design and conduct randomized controlled trials in pediatric

  critical care.

  Design: Qualitative descriptive study using semistructured individual

  interviews.

  Subjects: We interviewed 26 pediatric critical care researchers from

  seven countries who have published a randomized controlled trial

  (2005-2015). We used purposive sampling to achieve diversity regarding

  researcher characteristics and randomized controlled trial

  characteristics.

  Interventions: None.

  Measurements and Main Results: Most participants (24 {[}92\%]) were from

  high-income countries, eight (31\%) had published more than one

  randomized controlled trial, 17 (65\%) had published a multicenter

  randomized controlled trial, and eight (31\%) had published a

  multinational randomized controlled trial. An important theme was

  building communitiesgroups of individuals with similar interests, shared

  experiences, and common values, bound by professional and personal

  relationships. Participants described a sense of community as a source

  of motivation and encouragement and as a means to larger, more rigorous

  trials, increasing researcher and clinician engagement and maintaining

  enthusiasm. Strategies to build communities stressed in-person

  interactions (both professional and social), capable leadership, and

  trust. Another important theme was getting started. Participants

  highlighted the importance of formal research training and high-quality

  experiential learning through collaboration on other''s projects, guided

  by effective mentorship. Also important was working within the

  systemensuring academic credit for a range of contributions, not only

  for the principal investigator role. The longitudinal notion of building

  on success was also underscored as a cross-cutting theme.

  Conclusions: Coordinated, deliberate actions to build community and

  ensure key training and practical experiences for new investigators may

  strengthen the research enterprise in pediatric critical care. These

  strategies, potentially in combination with other novel approaches, may

  vitalize clinical research in this field.'
affiliation: 'Duffett, M (Corresponding Author), McMaster Univ, Dept Pediat, Hamilton,
  ON, Canada.

  Duffett, Mark, McMaster Univ, Dept Pediat, Hamilton, ON, Canada.

  Swinton, Marilyn; Brouwers, Melissa; Meade, Maureen; Cook, Deborah J., McMaster
  Univ, Dept Hlth Res Methods Evidence \& Impact, Hamilton, ON, Canada.

  Brouwers, Melissa, McMaster Univ, Dept Oncol, Hamilton, ON, Canada.

  Meade, Maureen; Cook, Deborah J., McMaster Univ, Dept Med, Hamilton, ON, Canada.

  McMaster Univ, Hamilton, ON, Canada.'
author: Duffett, Mark and Swinton, Marilyn and Brouwers, Melissa and Meade, Maureen
  and Cook, Deborah J.
author-email: duffetmc@mcmaster.ca
author_list:
- family: Duffett
  given: Mark
- family: Swinton
  given: Marilyn
- family: Brouwers
  given: Melissa
- family: Meade
  given: Maureen
- family: Cook
  given: Deborah J.
da: '2023-09-28'
doi: 10.1097/PCC.0000000000001696
eissn: 1947-3893
files: []
issn: 1529-7535
journal: PEDIATRIC CRITICAL CARE MEDICINE
keywords: 'pediatric critical care; qualitative methods; randomized controlled

  trials; research methods'
keywords-plus: CLINICAL-TRIALS; PUBLICATION; BARRIERS; QUALITY
language: English
month: NOV
number: '11'
number-of-cited-references: '19'
orcid-numbers: 'Duffett, Mark/0000-0003-1705-5422

  Brouwers, Melissa/0000-0002-9699-0269'
pages: E595-E602
papis_id: 7b2eb50dc95fb5d3cdc078016fa47ebf
ref: Duffett2018advancingrandomized
researcherid-numbers: 'Duffett, Mark/B-7524-2019

  '
times-cited: '3'
title: 'Advancing Randomized Controlled Trials in Pediatric Critical Care: The Perspectives
  of Trialists'
type: article
unique-id: WOS:000448945200005
usage-count-last-180-days: '0'
usage-count-since-2013: '1'
volume: '19'
web-of-science-categories: Critical Care Medicine; Pediatrics
year: '2018'