Evidence map›Paper›PMID 35906683›Full record

ArticlePilot and feasibility studies2022

Developing a method to assess fidelity to a complex vocational rehabilitation intervention in the FRESH trial: a feasibility study.

Jain Anne Holmes, Joanna Clare Fletcher-Smith, Jose Antonio Merchán-Baeza, Julie Phillips, Kathryn Radford

Abstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jain Anne HolmesFaculty of Medicine and Health Sciences, Centre for Rehabilitation and Ageing Research, B Floor, Medical School, Queen's Medical Centre, The University of Nottingham, Nottingham, NG7 2UH, UK. jain.holmes@nottingham.ac.uk.ORCID http://orcid.org/0000-0003-2465-102X
Joanna Clare Fletcher-SmithFaculty of Medicine and Health Sciences, Centre for Rehabilitation and Ageing Research, B Floor, Medical School, Queen's Medical Centre, The University of Nottingham, Nottingham, NG7 2UH, UK.
Jose Antonio Merchán-BaezaFaculty of Health Science and Welfare, University of Vic-Central University of Catalonia (UVIC-UCC), 08500, Vic, Spain.
Julie PhillipsFaculty of Medicine and Health Sciences, Centre for Rehabilitation and Ageing Research, B Floor, Medical School, Queen's Medical Centre, The University of Nottingham, Nottingham, NG7 2UH, UK.
Kathryn RadfordFaculty of Medicine and Health Sciences, Centre for Rehabilitation and Ageing Research, B Floor, Medical School, Queen's Medical Centre, The University of Nottingham, Nottingham, NG7 2UH, UK.

Funding

Health Technology Assessment Programme 11/66/02
6 · The paper itself

Abstract

backgroundDetermining whether complex rehabilitation interventions are delivered with fidelity is important. Implementation fidelity can differ between sites, therapists delivering interventions and, over time, threatening trial outcomes and increasing the risk of type II and III errors. This study aimed to develop a method of assessing occupational therapists' fidelity to deliver a complex, individually tailored vocational rehabilitation (VR) intervention to people with traumatic brain injury (TBI) and assess the feasibility of its use in a randomised controlled trial.

methodsUsing mixed methods and drawing on the intervention logic model, we developed data collection tools to measure fidelity to early specialist TBI VR (ESTVR). Fidelity was measured quantitatively using intervention case report forms (CRF), fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with intervention therapists, participants with TBI, employers and NHS staff at trial sites explored moderators of implementation fidelity. The conceptual framework of implementation fidelity (CFIF) guided measurement and analysis of and factors affecting fidelity. Data were triangulated and benchmarked against an earlier cohort study.

resultsFidelity to a complex individually tailored VR intervention could be measured. Overall, OTs delivered ESTVR with fidelity. Different fidelity measures answered different questions, offering unique insights into fidelity. Fidelity was best assessed using a fidelity checklist, intervention CRFs and clinical notes. The OT clinical notes and mentoring records were best at identifying fidelity moderating factors. Interviews added little insight into fidelity moderating factors over and above mentoring or clinical records. Data triangulation offered a comprehensive assessment of fidelity, highlighting limitations of measurement methods and learning for future trials but was resource intensive. Interviews, fidelity visits and analysing clinical notes were also resource intense. Comparing fidelity data to a benchmark and using CFIF as a framework for organising the fidelity assessment helped.

conclusionsOTs delivered the VR intervention with fidelity. A fidelity checklist and benchmark plus mentoring may offer a practical and effective way of measuring fidelity and identifying fidelity moderating factors in trials of complex individually-tailored rehabilitation interventions. Mentoring provided real-time indicators of and reasons for fidelity deviations. These methods require further evaluation.

trial registrationISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014).

Indexed as

AdherenceBrain injuryComplex interventionFidelityImplementationMixed methodsModerating factorsVocational rehabilitation

Identifiers

PMID35906683
PMCPMC9335967

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.