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Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study

Por: Deja · E. · Weeks · A. · Van Netten · C. · Gamble · C. · Meher · S. · Gyte · G. · Lavender · T. · Woolfall · K.
Objective

Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapartum randomised clinical trial.

Design

Embedded, mixed-methods study within a trial, involving questionnaires, recorded recruitment discussions, interviews and focus groups in the first 13 months of trial recruitment (December 2020–January 2022).

Setting

COPE is a double-blind randomised controlled trial, comparing the effectiveness of carboprost or oxytocin as first-line treatment of postpartum haemorrhage.

Participants

Two hundred and eighty-six people (190 women/96 birth partners), linked to 198/380 (52%) COPE recruits participated in the embedded study. Of these, 272 completed a questionnaire (178 women/94 birth partners), 22 were interviewed (19 women/3 birth partners) and 16 consent discussions with 12 women were recorded. Twenty-seven staff took part in three focus groups and nine staff were interviewed.

Results

Participants recommended that information about the study should be more accessible antenatally for those who wish to be informed. Most women and staff did not think it would be appropriate to seek consent during pregnancy or early labour as it may cause ‘unnecessary panic’ and lead to research waste, as most women would not become eligible. There was support for the use of RWPC as COPE interventions are used in standard clinical practice and viewed as low risk. Women who were approached about the trial while having a postpartum haemorrhage also supported RWPC as they could not recall research discussions.

Conclusions

Findings support the use of RWPC for time-critical interventions, and raise questions about the appropriateness of other commonly used consent pathways, including antenatal consent and verbal assent.

Best practices for communication while wearing facemasks: A scoping review

Abstract

Introduction

Facemasks are an important piece of personal protective equipment (PPE) to mitigate the spread of respiratory illnesses, but they can impede communication between patients and healthcare providers. The purpose of this scoping review is to identify effective communication practices while wearing facemasks.

Design

Scoping review using a systematic search of articles from the PubMed, CINAHL, and Embase databases.

Methods

The PEO (population, exposure, outcome) methodology was selected for this systematic scoping review. The population of interest (P) includes humans of all ages (children, adults, and older adults); the exposure of interest (E) is PPE that covers the mouth (i.e., facemasks); and the outcome of interest (O) is successful or unsuccessful communication practices. The Johns Hopkins Evidence-Based Practice for Nurses and Healthcare Professionals appraisal guidelines were used to determine the level and quality of the research.

Results

Thirty-nine articles met the inclusion criteria. Seventeen of these were high- or good-quality research studies, and the remaining 22 were non-research articles included with separate analysis as part of the scoping review. The 17 articles encompassed 2656 participants. The highest quality evidence indicated that standard surgical masks have the least impact on speech perception compared to other non-transparent mask types, and that recognizing emotions is less accurate with facemasks, necessitating compensatory actions (i.e., reducing extraneous noise, using a microphone to amplify voice, and employing clear speech). Evidence was contradictory regarding the use of transparent masks. Evidence was of limited quality for other non-verbal and verbal communication strategies.

Conclusion

Awareness of communication challenges is crucial when wearing facemasks. More high-quality studies are needed to evaluate communication techniques when speakers are wearing facemasks. Basic strategies such as selecting an appropriate mask type, reducing extraneous noise, using microphones, verbalizing emotions, and employing clear speech appear to be beneficial.

Clinical Relevance

The findings of this scoping review highlight the importance of considering communication challenges while wearing facemasks in the healthcare settings. The review suggests that selecting an appropriate mask type, reducing extraneous noise, verbalizing emotions, and employing clear speech are some strategies that may be effective in mitigating the impact of facemasks on communication between patients and healthcare providers.

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