Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal

Research output: Contribution to journalArticleResearchpeer-review

1 Citation (Scopus)

Abstract

Evidence translation in wound care relies on the need for evidence generation. Clinical practice may become evidence-generating only if evidence generating research projects, such as randomized controlled trials, became routinized in clinical settings. The aim of this study was to identify optimal trial-related practices to routinize trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted secondary analysis of the available data on how to routinize RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data was obtained from a qualitative observational study nested within a randomized double-blinded placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven step Routinization of Trials in Clinical Care Framework. These steps include: (a) pre-trial clinical site assessment; (b) optimizing pre-recruitment arrangements; (c) developing and updating trial-related skills; (d) embedding RCT recruitment as part of routine clinical care; (e) promoting teamwork and trial-related collaboration; (f) addressing trial-related financial issues; (g) communicating trial results to clinicians.
Original languageEnglish
Pages (from-to)442-458
Number of pages17
JournalInternational Wound Journal
Volume16
Issue number2
DOIs
Publication statusPublished - Apr 2019

Keywords

  • evidence-based practice
  • evidence-generating practice
  • routinisation of RCTs
  • venous leg ulcers
  • wound care

Cite this

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title = "Randomised controlled trials as part of clinical care:: A seven-step routinisation framework proposal",
abstract = "Evidence translation in wound care relies on the need for evidence generation. Clinical practice may become evidence-generating only if evidence generating research projects, such as randomized controlled trials, became routinized in clinical settings. The aim of this study was to identify optimal trial-related practices to routinize trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted secondary analysis of the available data on how to routinize RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data was obtained from a qualitative observational study nested within a randomized double-blinded placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven step Routinization of Trials in Clinical Care Framework. These steps include: (a) pre-trial clinical site assessment; (b) optimizing pre-recruitment arrangements; (c) developing and updating trial-related skills; (d) embedding RCT recruitment as part of routine clinical care; (e) promoting teamwork and trial-related collaboration; (f) addressing trial-related financial issues; (g) communicating trial results to clinicians.",
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Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal. / Team, Victoria; Weller, Carolina D.

In: International Wound Journal, Vol. 16, No. 2, 04.2019, p. 442-458.

Research output: Contribution to journalArticleResearchpeer-review

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