scholarly journals Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Jessica Hodson ◽  
Christiana Garros ◽  
Jodie Jensen ◽  
Jonathan P. Duff ◽  
Gonzalo Garcia Guerra ◽  
...  

Abstract Background The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information. Results Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”. Conclusion Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.

2021 ◽  
pp. medethics-2021-107311
Author(s):  
Amanda van Beinum ◽  
Nick Murphy ◽  
Charles Weijer ◽  
Vanessa Gruben ◽  
Aimee Sarti ◽  
...  

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient.We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological monitoring of dying patients prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care.Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval.Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed.


2009 ◽  
Vol 18 (5) ◽  
pp. 418-426 ◽  
Author(s):  
Ann K. Shelton ◽  
Anne F. Fish ◽  
J. Perren Cobb ◽  
Jean A. Bachman ◽  
Ruth L. Jenkins ◽  
...  

Surrogate decision makers may be poorly prepared to give informed consent for genomics research for their loved ones in intensive care. A review of the challenges and strategies associated with obtaining surrogates’ consent for genomics research in intensive care patients revealed that few well-controlled studies have been done on this topic. Yet, a major theme in the literature is the role of health care professionals in guiding surrogates through the informed consent process rather than simply witnessing a signature. Informed consent requires explicit strategies to approach potential surrogates effectively, educate them, and ensure that informed consent has been attained.


2021 ◽  
Author(s):  
Santiago Mencia ◽  
Raquel Cieza ◽  
Jimena Del Castillo ◽  
Jesús López-Herce ◽  
Sedation Group of Spanish Pediatric Critical Care SEDUCIP

Abstract Background Analgosedation (AS) assessment using clinical scales is crucial to follow the international recommendations about analgosedation. The Analgosedation workgroup of the Spanish Society of Pediatric Intensive Care (SECIP) carried out two surveys in 2008 and 2015, which verified the gap in analgosedation assessment in Spanish PICUs. The objective of the study was to analyze how analgosedation assessment by clinical scales changed after a multicenter intervention program. Methods multicenter pre-post study comparing the use of sedation, analgesia, withdrawal and delirium scales before and after the MONISEDA project. Results were also compared with a control group formed by non-participating units. A survey about analgosedation management and monitoring was filled out before (year 2015) and after (year 2020) the implementation of the Moniseda project in 2016. Results were compared between those periods of time, but also between participant and non-participants PICUs in the Moniseda project (M-group and non-M group, respectively). Data related to analgosedation of all patients admitted to a Moniseda-participant PICU were also collected for 2 months. Results 15 Spanish PICUs were enrolled in the Moniseda project and other 15 non-participant PICUs formed the control group. In the M-group, the number of PICUs with a written analgosedation protocol increased from 53 to 100% (p = 0.003) and withdrawal protocol from 53 to 100% (p = 0.003), whereas in non-M group the written AS protocol increased from 80 to 87% and withdrawal protocol stayed on 80%.


Author(s):  
Anna C. Sick-Samuels ◽  
Sara Cosgrove ◽  
Clare Rock ◽  
Alejandra Salinas ◽  
Opeyemi Oladapo-Shittu ◽  
...  

Abstract Background: Healthcare workers (HCWs) not adhering to physical distancing recommendations is a risk factor for acquisition of severe acute respiratory coronavirus virus 2 (SARS-CoV-2). The study objective was to assess the impact of interventions to improve HCW physical distancing on actual distance between HCWs in a real-life setting. Methods: HCWs voluntarily wore proximity beacons to measure the number and intensity of physical distancing interactions between each other in a pediatric intensive care unit. We compared interactions before and after implementing a bundle of interventions including changes to the layout of workstations, cognitive aids, and individual feedback from wearable proximity beacons. Results: Overall, we recorded 10,788 interactions within 6 feet (∼2 m) and lasting >5 seconds. The number of HCWs wearing beacons fluctuated daily and increased over the study period. On average, 13 beacons were worn daily (32% of possible staff; range, 2–32 per day). We recorded 3,218 interactions before the interventions and 7,570 interactions after the interventions began. Using regression analysis accounting for the maximum number of potential interactions if all staff had worn beacons on a given day, there was a 1% decline in the number of interactions per possible interactions in the postintervention period (incident rate ratio, 0.99; 95% confidence interval, 0.98–1.00; P = .02) with fewer interactions occurring at nursing stations, in workrooms and during morning rounds. Conclusions: Using quantitative data from wearable proximity beacons, we found an overall small decline in interactions within 6 feet between HCWs in a busy intensive care unit after a multifaceted bundle of interventions was implemented to improve physical distancing.


2020 ◽  
Vol 11 (02) ◽  
pp. 323-335 ◽  
Author(s):  
Moninne M. Howlett ◽  
Eileen Butler ◽  
Karen M. Lavelle ◽  
Brian J. Cleary ◽  
Cormac V. Breatnach

Abstract Background Increased use of health information technology (HIT) has been advocated as a medication error reduction strategy. Evidence of its benefits in the pediatric setting remains limited. In 2012, electronic prescribing (ICCA, Philips, United Kingdom) and standard concentration infusions (SCIs)—facilitated by smart-pump technology—were introduced into the pediatric intensive care unit (PICU) of an Irish tertiary-care pediatric hospital. Objective The aim of this study is to assess the impact of the new technology on the rate and severity of PICU prescribing errors and identify technology-generated errors. Methods A retrospective, before and after study design, was employed. Medication orders were reviewed over 24 weeks distributed across four time periods: preimplementation (Epoch 1); postimplementation of SCIs (Epoch 2); immediate postimplementation of electronic prescribing (Epoch 3); and 1 year postimplementation (Epoch 4). Only orders reviewed by a clinical pharmacist were included. Prespecified definitions, multidisciplinary consensus and validated grading methods were utilized. Results A total of 3,356 medication orders for 288 patients were included. Overall error rates were similar in Epoch 1 and 4 (10.2 vs. 9.8%; p = 0.8), but error types differed (p < 0.001). Incomplete and wrong unit errors were eradicated; duplicate orders increased. Dosing errors remained most common. A total of 27% of postimplementation errors were technology-generated. Implementation of SCIs alone was associated with significant reductions in infusion-related prescribing errors (29.0% [Epoch 1] to 14.6% [Epoch 2]; p < 0.001). Further reductions (8.4% [Epoch 4]) were identified after implementation of electronically generated infusion orders. Non-infusion error severity was unchanged (p = 0.13); fewer infusion errors reached the patient (p < 0.01). No errors causing harm were identified. Conclusion The limitations of electronic prescribing in reducing overall prescribing errors in PICU have been demonstrated. The replacement of weight-based infusions with SCIs was associated with significant reductions in infusion prescribing errors. Technology-generated errors were common, highlighting the need for on-going research on HIT implementation in pediatric settings.


2005 ◽  
Vol 29 (3) ◽  
pp. 176-185 ◽  
Author(s):  
Gisele Limongeli Gurgueira ◽  
Heitor Pons Leite ◽  
José Augusto de Aguiar Carrazedo Taddei ◽  
Werther Brunow de Carvalho

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