Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background

Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the ‘Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children’ (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.

Methods

Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner–parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials.

Results

We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.

Conclusion

This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.

Related collections

Most cited references 25

Record: found
Abstract: not found
Article: not found

Using thematic analysis in psychology

Virginia Braun, Victoria Clarke (2014)

0 comments Cited 17135 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

A Tong, P SAINSBURY, J. Craig (2007)

Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.

0 comments Cited 7800 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Saturation in qualitative research: exploring its conceptualization and operationalization

Benjamin Saunders, Julius Sim, Tom Kingstone … (2017)

Saturation has attained widespread acceptance as a methodological principle in qualitative research. It is commonly taken to indicate that, on the basis of the data that have been collected or analysed hitherto, further data collection and/or analysis are unnecessary. However, there appears to be uncertainty as to how saturation should be conceptualized, and inconsistencies in its use. In this paper, we look to clarify the nature, purposes and uses of saturation, and in doing so add to theoretical debate on the role of saturation across different methodologies. We identify four distinct approaches to saturation, which differ in terms of the extent to which an inductive or a deductive logic is adopted, and the relative emphasis on data collection, data analysis, and theorizing. We explore the purposes saturation might serve in relation to these different approaches, and the implications for how and when saturation will be sought. In examining these issues, we highlight the uncertain logic underlying saturation—as essentially a predictive statement about the unobserved based on the observed, a judgement that, we argue, results in equivocation, and may in part explain the confusion surrounding its use. We conclude that saturation should be operationalized in a way that is consistent with the research question(s), and the theoretical position and analytic framework adopted, but also that there should be some limit to its scope, so as not to risk saturation losing its coherence and potency if its conceptualization and uses are stretched too widely.

0 comments Cited 1783 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): Emerg Med J

Journal ID (iso-abbrev): Emerg Med J

Journal ID (hwp): emermed

Journal ID (publisher-id): emj

Title: Emergency Medicine Journal : EMJ

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Print): 1472-0205

ISSN (Electronic): 1472-0213

Publication date (Print): March 2021

Publication date (Electronic): 29 August 2020

Volume: 38

Issue: 3

Pages: 198-204

Affiliations

[1 ] departmentInstitute of Population Health , University of Liverpool , Liverpool, UK

[2 ] departmentEmergency Department , Bristol Royal Children's Hospital , Bristol, UK

[3 ] departmentFaculty of Health and Applied Sciences , University of the West of England , Bristol, UK

[4 ] departmentClinical Trials Research Centre (CTRC) , University of Liverpool , Liverpool, UK

[5 ] departmentEmergency Department , Alder Hey Children's NHS Foundation Trust , Liverpool, Merseyside, UK

[6 ] departmentDepartment of Neurology , Alder Hey Children's NHS Foundation Trust , Liverpool, Merseyside, UK

Author notes

[Correspondence to ] Dr Kerry Woolfall, University of Liverpool, Liverpool L69 3BX, UK; k.woolfall@ 123456liverpool.ac.uk

Author information

Kerry Woolfall http://orcid.org/0000-0002-5726-5304

Article

Publisher ID: emermed-2020-209488

DOI: 10.1136/emermed-2020-209488

PMC ID: 7907554

PubMed ID: 32862140

SO-VID: 8f44d243-2299-411c-93c0-8d92549806b4

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.