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Protecting study participants in emergency research: is community consultation before trial commencement enough?

ABSTRACT: Background:This article presents the results of a community consultation (CC) process completed in Toronto, Ontario, using a random digit dialling technique, on the attitudes and perceptions of the public toward the use of exception from informed consent when conducting emergency research involving the use of massive blood transfusions. Methods:In 2012, our hospital conducted a CC, using a random digit dialling technique, to elicit the attitudes and perceptions of the public toward the use of an exemption from informed consent for an upcoming clinical trial. A total of 500 participants from high violent crime areas were interviewed as part of this consultation. Results:The response rate for the telephone survey was 54%. Participants indicated a personal acceptance rate of 76%, acceptance of the justification for the exception to consent at 81%, thatthe study would meet the best interest of patients and the community at 81% and that youth (between 15 and 18 years) could be enrolled at 71%. When offered, no participant requested an opt-out wrist band to avoid being enrolled in this study. Discussion:The use of violent crime neighborhoods to locate at risk communities was not effective in identifying the appropriate community of interest for this study. Though only representing a small subpopulation from a large Canadian city, the attitudes noted here is suggestive that Canadians may have a similar level of acceptance as the US based on published studies. However, given the resources needed to undertake this process and that in the end it did not elicit any useful feedback or recommendations for enhancing the safety of participants, the future use of phone surveys as a means of engaging communities should be reconsidered. Level of evidence Level V:This is a retrospective subanalysis of a CC using a randomized phone dialling technique from a site prior to the start of the Pragmatic Randomized Optimal Platelet and Plasma Ratios Trial. The CC was not designed specifically for research purposes and as such reflect only a case study from a single center. Trial registration number:Pre-result, NCT01545232.

SUBMITTER: Henry B

PROVIDER: S-EPMC5877900 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Protecting study participants in emergency research: is community consultation before trial commencement enough?

Henry Blair B Perez Adic A Trpcic Sandy S Rizoli Sandro S Nascimento Barto B

Trauma surgery & acute care open 20170712 1

<h4>Background</h4>This article presents the results of a community consultation (CC) process completed in Toronto, Ontario, using a random digit dialling technique, on the attitudes and perceptions of the public toward the use of exception from informed consent when conducting emergency research involving the use of massive blood transfusions.<h4>Methods</h4>In 2012, our hospital conducted a CC, using a random digit dialling technique, to elicit the attitudes and perceptions of the public towar ...[more]

PMID: 29766088

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Project description:To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study.A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury.Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent.Adult participants in community consultation events.Community consultation efforts at participating sites.Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%).Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed consent acceptance among different interactive consultation events. These findings have important implications for institutional review board and investigators conducting exception from informed consent research and for community engagement efforts in research more generally.

Project description:Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families.Epidemiologic, level III.

Project description:BackgroundDelivering emergency care in rural areas can be challenging, but video consultation (VC) offers opportunities to make healthcare more accessible. The communication and relationship between professionals and patients have a significant impact on the patient's experience of safety and inclusion. Understanding the patient perspective is crucial to developing good quality healthcare, but little is known about patient experiences of emergency care via VC in a rural context. The aim of this study was to explore patient experiences of emergency care via VC in northern rural Sweden.MethodsUsing a qualitative approach, semi- structured interviews (n = 12) were conducted with individuals aged 18-89 who had received emergency care with a registered nurse (RN) on site and VC with a general practitioner (GP). The interviews were conducted between October 2021 and March 2023 at community hospitals (n = 7) in Västerbotten County, Sweden. Interviews were analysed with content analysis.ResultsThe analysis resulted in main categories (n = 2), categories (n = 5) and subcategories (n = 20). In the main category, "We were a team of three", patients described a sense of inclusion and ability to contribute. The patients perceived the interaction between the GP and RN to function well despite being geographically dispersed. Patients highly valued the opportunity to speak directly to the GP. In the main category, "VC was a two-sided coin", some experienced the emergency care through VC to be effective and smooth, while some felt that they received a lower quality of care and preferred face-to-face consultation with the GP. The quality of the VC was highly dependent on the RN's ability to function as the hub in the emergency room.ConclusionPatients in rural areas perceived being included in 'the team' during VC, however they experienced disadvantages with the system on individual basis. The nursing profession plays an important role, and a proper educational background is crucial to support RNs in their role as the hub of the visit. The GP's presence via VC was seen as important, but to fully enable them to fulfil their commitments as medical professionals, VC needs to be further improved with education and support from technical devices.

Project description:BackgroundEffective public health emergency preparedness and response systems are important in mitigating the impact of all-hazards emergencies on population health. The evidence base for public health emergency preparedness (PHEP) is weak, however, and previous reviews have noted a substantial proportion of anecdotal event reports. To investigate the body of research excluding the anecdotal reports and better understand primary and analytical research for PHEP, a scoping review was conducted with two objectives: first, to develop a thematic map focused on primary research; and second, to use this map to inform and guide an understanding of knowledge gaps relevant to research and practice in PHEP.MethodsA scoping review was conducted based on established methodology. Multiple databases of indexed and grey literature were searched based on concepts of public health, emergency, emergency management/preparedness and evaluation/evidence. Inclusion and exclusion criteria were applied iteratively. Primary research studies that were evidence-based or evaluative in nature were included in the final group of selected studies. Thematic analysis was conducted for this group. Stakeholder consultation was undertaken for the purpose of validating themes and identifying knowledge gaps. To accomplish this, a purposive sample of researchers and practicing professionals in PHEP or closely related fields was asked to complete an online survey and participate in an in-person meeting. Final themes and knowledge gaps were synthesized after stakeholder consultation.ResultsDatabase searching yielded 3015 citations and article selection resulted in a final group of 58 articles. A list of ten themes from this group of articles was disseminated to stakeholders with the survey questions. Survey findings resulted in four cross-cutting themes and twelve stand-alone themes. Several key knowledge gaps were identified in the following themes: attitudes and beliefs; collaboration and system integration; communication; quality improvement and performance standards; and resilience. Resilience emerged as both a gap and a cross-cutting theme. Additional cross-cutting themes included equity, gender considerations, and high risk or at-risk populations.ConclusionsIn this scoping review of the literature enhanced by stakeholder consultation, key themes and knowledge gaps in the PHEP evidence base were identified which can be used to inform future practice-oriented research in PHEP.

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Protecting study participants in emergency research: is community consultation before trial commencement enough?

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Protecting study participants in emergency research: is community consultation before trial commencement enough?

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