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Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

ABSTRACT: INTRODUCTION:Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. METHODS AND ANALYSIS:The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. DESIGN:Qualitative research study involving individual interviews and grounded theory methodology. PARTICIPANTS:SDMs for children enrolled into the SQUEEZE pilot trial. SAMPLE SIZE:Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. ANALYSIS:Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. ETHICS AND DISSEMINATION:This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines.

SUBMITTER: Parker MJ

PROVIDER: S-EPMC5030536 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

Parker Melissa J MJ de Laat Sonya S Schwartz Lisa L

BMJ open 20160913 9

<h4>Introduction</h4>Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known ...[more]

PMID: 27625066

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Project description:PurposeAn emergency rescue situation is an inevitable challenge in medical work, requiring collaborative efforts from healthcare professionals. Due to a lack of practical experience, novice nurses may encounter difficulties in successfully managing emergency resuscitation events. This study aimed to analyse the authentic psychological experiences of novice nurses participating in emergency resuscitation events by exploring applicable coping methods and management strategies.MethodsThis study utilized a hermeneutic phenomenological qualitative research method. We employed purposive sampling to select 27 Novice nurses from West China Hospital of Sichuan University for face-to-face semistructured interviews. Data collection for this study was conducted from November 2023 to January 2024. The interviews were fully audio-recorded and transcribed verbatim. The data were coded, categorized and summarized with the help of Nvivo 20.0 software based on the interpretation of phenomenological research methods. Thematic analysis was performed to deeply analyse and extract corresponding themes. The COREQ criteria were used to guide the reporting of this study.ResultsThe authentic psychological experiences of novice nurses participating in emergency rescue events mainly include six aspects: lack of rescue knowledge reserves and related abilities, psychological and emotional changes, psychological stress after the rescue, rational arrangement of manpower, team cooperation, and postevent reflection and learning. Their authentic psychological experiences directly affect whether novice nurses can effectively respond to emergency rescue events.ConclusionsThis study suggested enhancing novice nurses' knowledge, improving their resuscitation skills, and improving their psychological well-being during resuscitation events. It advocates for organized staffing, effective teamwork, and robust support systems to empower novice nurses and improve their overall capabilities in emergencies. These findings offer valuable insights for future research in this area.

Project description:ObjectiveThe aim of this study was to examine parents' and healthcare professionals' experiences and perceptions of parental readiness for resuscitation of their child in a paediatric hospital.DesignThis exploratory descriptive qualitative study used content analysis. Participants shared their experiences and perceptions about parental readiness for cardiopulmonary resuscitation through semi-structured and in-depth interviews. MAXQDA 2020 software was also used for data analysis.SettingThe setting was two large teaching paediatric hospitals in Iran (Este Azerbaijan and Mashhad).ParticipantsParticipants were 10 parents and 13 paediatric healthcare professionals (8 nurses and 5 physicians). Selection criteria were: (a) parents who experienced their child's resuscitation crisis at least 3 months prior and (b) nurses and physicians who were working in emergency rooms or intensive care wards with at least 2 years of experience on the resuscitation team.ResultsParticipants shared their experiences about parental readiness for resuscitation of their child in four categories: awareness (acceptance of resuscitation and its consequences; providing information about the child's current condition and prognosis), chaos in providing information (defect of responsibility in informing; provide selective protection of information; hardness in obtaining information), providing situational information (honest information on the border of hope and hopeless; providing information with apathy; providing information as individual; dualism in blaming; assurance to parents; presence of parents to better understand the child's situation) and psychological and spiritual requirements (reliance on supernatural power; need for access to a psychologist; sharing emotions; collecting mementos).ConclusionThe results of this study provide insight on the needs of parents and strategies to use to prepare them for their child's resuscitation crisis, which can be used to enhance family centred care practices in paediatric acute care settings.

Project description:BackgroundAchieving significant female representation in government at decision-making levels has been identified as a key step towards achieving gender equality. In 2015, women held 39.6% of parliamentary seats in Mozambique, which is above the benchmark of 30% that has been suggested as the turning point for minority representation to move from token status to having a sizable impact. We undertook a study to identify gender-related barriers and facilitators to improving women-centered policies in the health sector.MethodsWe conducted in-depth interviews with 39 individuals (32 women, 7 men) involved at a senior level in policy making or implementation of woman-centric policies within the Mozambique Ministry of Health and affiliated institutions. We used a semi-structured interview guide that included questions on difficulties and facilitating factors encountered in the policy making process, and the perceived role of gender in this process. We used both deductive and inductive analysis approaches, starting with a set of pre-identified themes and expanding this to include themes that emerged during coding.ResultsOur data suggest two main findings: (1) the women who participated in our study generally do not report feeling discrimination in the workplace and (2) senior health sector perceive women to be more personally attuned to women-centric issues than men. Within our specific sample, we found little to suggest that gender discrimination is a problem professionally for female decision-makers in Mozambique. However, these findings should be contextualized using an intersectional lens with recognition of the important difference between descriptive versus substantive female representation, and whether "percentage of women" is truly the best metric for gaging commitment to gender equality at the policy making level.ConclusionsMozambique's longstanding significant representation of women may have led to creating an environment that leads to positive experiences for female decision-makers in the government. However, while the current level of female representation should be celebrated, it does not negate the need for continued focus on female representation in decision-making positions.

Dataset Information

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

Publications

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

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