Adequacy of Informed Consent for Lumbar Puncture in a Pediatric Emergency Department

Patel, Parul B.; Gilchrist, Amber; Cronan, Kathleen; Selbst, Steven M.

doi:10.1097/pec.0b013e3181f3961d

Cited by 12 publications

(10 citation statements)

References 6 publications

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“…Our overall compliance for documenting the various aspects of informed consent (purpose, risk, benefits, and alternatives) was found to be similar to prior studies performed in different settings: purpose (our study 74%; other studies 92% to 94%); risks (our study 79%; other studies 59% to 88%), benefits (our study 65%; other studies 36% to 59%); alternatives (our study 68%; other studies 13% to 62%) 30,31. In a study reviewing 1,057 audiotaped patient encounters, purpose was noted in 84%, risks/benefits (pros and cons) were noted in 26%, and alternatives were noted in 30% 32.…”

Section: Discussionsupporting

confidence: 83%

“…In a Chicago Children's Memorial Hospital Pediatric ED study, informed consent documentation for an LP was deemed to be inadequate 30. Comparing their findings with our study data for pediatric patients, they had higher rates of documentation of purpose (94% vs. 74%), risks (88% vs. 81%), and use of a consent form (88% vs. 61%), but a lower rate of documentation of benefits (36% vs. 65%) and alternatives (13% vs. 69%).…”

Section: Discussionmentioning

confidence: 99%

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Informed Consent Documentation for Lumbar Puncture in the Emergency Department

Patel¹,

Anderson²,

Keenly³

et al. 2014

WestJEM

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Introduction: Informed consent is a required process for procedures performed in the emergency department (ED), though it is not clear how often or adequately it is obtained by emergency physicians. Incomplete performance and documentation of informed consent can lead to patient complaints, medico-legal risk, and inadequate education for the patient/guardian about the procedure. We undertook this study to quantify the incidence of informed consent documentation in the ED setting for lumbar puncture (LP) and to compare rates between pediatric (<18 years) and adult patients.Methods: In this retrospective cohort study, we reviewed the ED electronic health records (EHR) for all patients who underwent successful LPs in 3 EDs between April 2010 and June 2012. Specific elements of informed consent documentation were reviewed. These elements included the presence of general ED and LP-specific consent forms, signatures of patient/guardian, witness, and physician, documentation of purpose, risks, benefits, alternatives, and explanation of the LP. We also reviewed the use of educational material about the LP and LP-specific discharge information.Results: Our cohort included 937 patients; 179 (19.1%) were pediatric. A signed general ED consent form was present in the EHR for 809 (86%) patients. A consent form for the LP was present for 524 (56%) patients, with signatures from 519 (99%) patients/guardians, 327 (62%) witnesses, and 349 (67%) physicians. Documentation rates in the EHR were as follows: purpose (698; 74%), risks (742; 79%), benefits (605; 65%), alternatives (635; 68%), and explanation for the LP (57; 6%). Educational material about the LP was not documented as having been given to any of the patients and LP-specific discharge information was documented as given to 21 (2%) patients. No significant differences were observed in the documentation of informed consent elements between pediatric and adult patients.Conclusion: General ED consent was obtained in the vast majority of patients, but use of a specific LP consent form and documentation of the elements of informed consent for LP in the ED were suboptimal, though comparable between pediatric and adult patients. There is significant opportunity for improvement in many aspects of documenting informed consent for LP in the ED. [West J Emerg Med. 2014;15(3):318–324.]

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Informed Consent Documentation for Lumbar Puncture in the Emergency Department

Patel¹,

Anderson²,

Keenly³

et al. 2014

WestJEM

View full text Add to dashboard Cite

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“…A recent study suggests that a significant proportion of paediatric trainees do not feel comfortable discussing key components of informed consent . Furthermore, previous studies suggest that risks, benefits, alternatives and explanation of LP are not adequately documented on consent forms if one is actually completed …”

Section: Discussionmentioning

confidence: 99%

“…17 Furthermore, previous studies suggest that risks, benefits, alternatives and explanation of LP are not adequately documented on consent forms if one is actually completed. 18 In Australia, for children under 18 years, the law gives a parent or guardian the authority to agree to treatment in most cases. 19 Verbalrather than writtenconsent is often requested from parents and carers for routine procedures, such as i.v.…”

Section: Discussionmentioning

confidence: 99%

Paediatric lumbar punctures: How do paediatric and emergency doctors differ?

Yeong

Craig

Cheek

2017

Emerg Medicine Australasia

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“…A largely discussed question related to their recruitment into clinical research resides in how to adequately (ethically and efficiently) obtain consent from them. As a result, ethical issues related to the consent process have been discussed at length in the bioethics literature, stating that research participants should be informed about the benefits and risks of the research project before they give their consent, should understand what it is expected of them, and should have the competency and freedom to choose to participate to the research project -and be under no pressure to do so [1][2][3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

Influence of Demographic Characteristics of Participants on Consent to Genomic Research into Congenital Heart Disease

Dupras¹,

Andelfinger

Paré³

et al. 2014

J Clinic Res Bioeth

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Background: The enrollment of sick children and their families in genomics studies calls for a comprehensive view of the consent process. Few studies have searched for correlations between the demographic characteristics of participants (age, gender, parental lineage) or their level of participation (affected children, parents, or other relatives), on the one hand, and patterns of consent to specific pediatric research procedures, on the other (DNA banking, use of cardiac tissue, disclosure of a cardiac condition, creation of cell lines, recall of a participant). Objectives: This study sought to analyze the extent to which respondents' participation in genomic research into congenital heart disease, based on their consent to specific procedures, revealed patterns correlated with their demographic data. Methods and findings: Data were abstracted from consent forms obtained from 600 participants enrolled in a research project on the genomics of congenital heart disease. Results: Our analysis revealed significant patterns between demographic characteristics and willingness to consent to various aspects of genomic research into congenital heart disease. Conclusions: Participant heterogeneity needs to be considered by clinical researchers in order to identify specific subgroups of participants who may require more attention for improving the recruitment and retention in genomic research into congenital heart disease, as well as the consent process.

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Adequacy of Informed Consent for Lumbar Puncture in a Pediatric Emergency Department

Cited by 12 publications

References 6 publications

Informed Consent Documentation for Lumbar Puncture in the Emergency Department

Informed Consent Documentation for Lumbar Puncture in the Emergency Department

Paediatric lumbar punctures: How do paediatric and emergency doctors differ?

Influence of Demographic Characteristics of Participants on Consent to Genomic Research into Congenital Heart Disease

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