Cited by 303Health Policy Implementation ScienceHealth Sciences Research and EducationClinical practice guidelines implementation

The DOI matches its Crossref record; 48 of the 49 references it cites were found in a registry or an index; 5 of the 43 sources its claims cite were checked for support.

The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework

Open access

Abstract

BACKGROUND: The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. METHODS: The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. RESULTS: A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. CONCLUSIONS: This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

This embedded process evaluation of a national implementation RCT found that robust evidence was necessary but not sufficient for practice change, with context, inter-professional issues, and individual caution mediating implementation. The authors propose extending PARIHS by making individuals an explicit element alongside evidence, context, and facilitation.

Key findings

  • The trial showed no significant effect of the interventions on the primary outcome of fluid fasting time; the process evaluation drew on 151 staff and patients across 19 participating hospitals.
  • The evidence base for shortening fasting times was robust and relatively uncontested, but it was mediated by practitioner and patient caution, perceived risk, and staff fear of adverse consequences; in most sites it was unclear whether the evidence reached potential users.
  • Implementation context was challenging across micro, meso, and macro levels, including emotional responses, inter-professional issues, unclear ownership and decision-making authority, communication problems, variable organizational buy-in, and different starting points; average fluid fasting times ranged from 12.9 hours to 5.8 hours, one standard dissemination site decreased from 12.5 to 7.7 hours, and another site started at 5.8 hours and continued lower at 4.2 hours but not statistically significantly lower.
  • Facilitators reported many activities, but their relative and direct impact on policy and practice changes was difficult to judge, and there appeared to be no distinguishing features between the activities, skills, and attributes of an opinion leader and a PDSA facilitator despite the interventions being conceptually different.

Methods

  • Design: PARIHS was prospectively applied to guide intervention design, data collection, and analysis within a process evaluation embedded in a pragmatic randomized controlled trial; three interventions were randomly allocated across 19 hospitals in England, Scotland, Wales, and Northern Ireland: standard dissemination, a web-based resource championed by opinion leader(s), and a Plan-Do-Study-Act (PDSA) intervention, each over six months.
  • Data: pre- and post-intervention data were collected between November 2006 and February 2009 from a purposive sample of 151 staff and patients, including key contact interviews (28 total), change agent interviews (21 total), patient interviews (70 total), and five focus groups with 32 participants.
  • Analysis: qualitative data were transcribed and managed in N*DIST 5 and NVIVO 7; inductive and deductive content analysis was undertaken informed by Ritchie and Spencer’s approach, first within data sets and then mapped across the core PARIHS elements of evidence, context, and facilitation, with cross-checking by three researchers.

Limitations

  • The paper states that the process evaluation was designed to capture data across intervention sites rather than conduct in-depth case studies or ethnographies in a few sites, and that in-depth data collection in purposively sampled sites may have provided more illuminating evidence about intervention implementation, particularly fidelity.
  • The paper states that the study had no capacity for observational work and therefore relied on self-reported data, that some voices were missing (surgeons who did not consent and senior operational managers not included in sampling), and that although the study design and interventions were prospectively designed based on PARIHS, the evaluation of the framework was retrospective; the addition of the concept of the individual needs further consideration, elaboration, and clarification.
  • Evident from the text: because there was no significant effect on the primary outcome, the relative and direct impact of facilitator activities on policy and practice changes was difficult to judge, and no distinguishing features were found between opinion leader and PDSA facilitator activities, skills, and attributes despite the interventions being conceptually different.

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Integrity signals

Registry

Crossref · 10.1186/1748-5908-8-28

Cites

48 of 48 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Figures

Figure 1 Study Evaluation Framework.
Figure 1 Study Evaluation Framework.CC BY · PubMed Central

Verification

Claims the paper makes

47 Own result · 38 Own interpretation · 22 Not checked yet · 16 No basis given · 4 Own method · 1 Supported so far · 1 Not supported · accuracy not yet measured

Verify all 38 references — free account

Show all 45 claims

  • It may state two separate claims as one. 39
  • Probably not a substantial claim. 59
  • The quote only partly states this claim. 1
84 of 84
  • The paper relies on this without support.

    The study was conducted during a period of major NHS changes that impacted staff turnover, workforce reviews, and reorganizations.

    “This study was conducted at a time of major NHS changes, including reconfigurations, changes to junior medical staff training grades, and a re-focus on financial deficits impacting on staff turnover, workforce reviews, and reorganizations.”
  • The paper relies on this without support.

    The PARIHS framework is a useful heuristic for guiding the development and evaluation of implementation processes.

    “PARIHS was embedded within our evaluation framework because it provided a potentially useful heuristic to guide the development of the study and evaluate the process of implementation.”
  • The paper relies on this without support.

    The process evaluation's self-reported data (interviews) provide a sufficient and accurate account of the implementation activities and their impact.

    “We also did not have the capacity to undertake any observational work, and therefore have been reliant on self-reported data to reach the conclusions reported in this paper.”
  • The paper relies on this without support.

    The lack of effect on duration of fasting in the PoISE trial is a valid indicator of implementation failure rather than of the ineffectiveness of the evidence or of the outcome measure.

    “Given the lack of effect on duration of fasting as a primary outcome, it is difficult to judge the relative impact of the activities of opinion leaders and PDSA facilitators.”
4 of 4

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Self-check

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2 of 2

Citations

Cites

Show all 49 references

Research works printed but not linked: 2

  1. Rycroft-Malone J, Bucknall T: Theory, models and frameworks. Models and Frameworks for Implementing Evidence-Based Practice. Edited by: Rycroft-Malone J, Bucknall T. 2010, Oxford: Wiley-Blackwell, 23-47.
  2. RCN/RCoA: Perioperative fasting in adults and children. Clinical Practice guidelines. 2005, London: Royal College of Nursing

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Metadata

Authors
Rycroft-Malone, J., Seers, K., Chandler, J., Hawkes, C. A., Crichton, N., Allen, C., Bullock, I., & Strunin, L.
Affiliations
  • University of Warwick (GB)
  • Cochrane (GB)
  • Bangor University (GB)
  • London South Bank University (GB)
  • Royal College of Physicians (GB)
  • Royal College of Anaesthetists (GB)
Venue
Implementation Science
Published
2013-03-09
Volume
8
Issue
1
Pages
28-28
ISSN
1748-5908 (ISSN-L)
OpenAlex
W2141566744
Cited by
303
References
49
Citations by year
2026: 3 · 2025: 10 · 2024: 13 · 2023: 18 · 2022: 25 · 2021: 35 · 2020: 26 · 2019: 27 · 2018: 30 · 2017: 29 · 2016: 31 · 2015: 31 · 2014: 20 · 2013: 5
FWCI
52.53
Type
journal article
Language
en
Open access
Locations
  • Implementation Science (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Lancaster EPrints (Lancaster University) (submittedVersion)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
PARIHS framework, implementation research, implementation process evaluation, evidence-informed practice, implementation context, facilitators, evidence base, practice change, acute care
MeSH terms
Attitude of Health Personnel, Data Collection, Decision Making, Diffusion of Innovation, Fasting, Health Services Research, Humans, Interprofessional Relations, Intraoperative Care, Professional Practice, Program Development, Focus Groups, Evidence-Based Practice, Translational Research, Biomedical

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