420 Accuracy of Documenting Complications When Consenting Patients for Laparoscopic Appendectomy

Abstract Background Appropriately performed informed consent acts as a shield against false complaints or claims of malpractice against the doctors. Laparoscopic Appendectomy accounts for a significant portion of general surgical workload hence shows a difference in the patient consenting. Method A proforma was devised which included recognised complications of Laparoscopic Appendectomy and grade of the consenting medical professional. The proforma containing 10 standard complications was then cross-referenced with the consent forms of 38 patients and the documented risks in each form was noted. Result The result showed a wide variation in the documentation of complications based on the grades of the medical professional. Out of 38 consent forms, 32/38 ( 84.21 %) were completed by Junior Grade Doctors out of which 15/32 by FY2 and 17/32 by Core Surgical Trainees (CST) and 6/38 (15.78 %) by Specialist Registrars (SpR). Of the set standard 10 complications, FY2 documented an average of 4.2, CST documented 6.2 and SpR documented 8.16 complications. Conclusions The study showed a need of improvement in the documentation of complications especially among Junior Doctors. Procedure specific complication stickers was developed for a standardised list of complications which will act as a source of information for the patient and prompt doctors to discuss the risks.

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Consenting Operative Orthopaedic Trauma Patients: Challenges and Solutions

ISRN Surgery ◽

10.1155/2014/354239 ◽

2014 ◽

Vol 2014 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Amin Kheiran ◽

Purnajyoti Banerjee ◽

Philip Stott

Keyword(s):

Phase 1 ◽

Operative Procedure ◽

Trauma Surgery ◽

National Standards ◽

Junior Doctors ◽

Trauma Patients ◽

Orthopaedic Trauma ◽

Phase 2 ◽

Consent Forms ◽

Surgical Trainees

Guidelines exist to obtain informed consent before any operative procedure. We completed an audit cycle starting with retrospective review of 50 orthopaedic trauma procedures (Phase 1 over three months to determine the quality of consenting documentation). The results were conveyed and adequate training of the staff was arranged according to guidelines from BOA, DoH, and GMC. Compliance in filling consent forms was then prospectively assessed on 50 consecutive trauma surgeries over further three months (Phase 2). Use of abbreviations was significantly reduced (P=0.03) in Phase 2 (none) compared to 10 (20%) in Phase 1 with odds ratio of 0.04. Initially, allocation of patient’s copy was dispensed in three (6% in Phase 1) cases compared to 100% in Phase 2, when appropriate. Senior doctors (registrars or consultant) filled most consent forms. However, 7 (14%) consent forms in Phase 1 and eleven (22%) in Phase 2 were signed by Core Surgical Trainees year 2, which reflects the difference in seniority amongst junior doctors. The requirement for blood transfusion was addressed in 40% of cases where relevant and 100% cases in Phase 2. Consenting patients for trauma surgery improved in Phase 2. Regular audit is essential to maintain expected national standards.

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Experience at Informed Consent Forms (ICF) Procedures in an Endoscopic Unit in Greece

Endoscopy ◽

10.1055/s-2006-954743 ◽

2006 ◽

Vol 38 (10) ◽

Author(s):

V Koussoulas ◽

S Vassiliou ◽

G Tassias ◽

A Spyridaki ◽

V Karagianni ◽

...

Keyword(s):

Informed Consent ◽

Consent Forms

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Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

Proceedings of the Annual Conference of CAIS / Actes du congrès annuel de l'ACSI ◽

10.29173/cais945 ◽

2016 ◽

Author(s):

Miraida Morales ◽

Sarah Barriage

Keyword(s):

Informed Consent ◽

Pilot Study ◽

Informed Consent Process ◽

Consent Process ◽

Measurement Tool ◽

Low Literacy ◽

Consent Forms ◽

Early Readers ◽

Research With Children ◽

Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes, utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

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Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00843-x ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Alina Weise ◽

Julia Lühnen ◽

Stefanie Bühn ◽

Felicia Steffen ◽

Sandro Zacher ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Informed Consent ◽

Adverse Events ◽

Knee Arthroplasty ◽

Evidence Based ◽

Nocebo Effect ◽

Legal Requirements ◽

Consent Forms ◽

Link Type ◽

Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

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Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

Journal of Empirical Research on Human Research Ethics ◽

10.1177/15562646211020160 ◽

2021 ◽

pp. 155626462110201

Author(s):

Caitlin Geier ◽

Robyn B. Adams ◽

Katharine M. Mitchell ◽

Bree E. Holtz

Keyword(s):

Individual Differences ◽

Informed Consent ◽

Research Process ◽

The Other ◽

Consent Form ◽

Online Research ◽

Consent Forms ◽

Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

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Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.9296 ◽

2020 ◽

Vol 3 (7) ◽

pp. e209296

Author(s):

Stephanie A. Kraft ◽

Kathryn M. Porter ◽

Devan M. Duenas ◽

Erin Sullivan ◽

Maya Rowland ◽

...

Keyword(s):

Informed Consent ◽

Behavioral Health ◽

Intervention Study ◽

Health Intervention ◽

Child Participation ◽

Consent Forms ◽

Behavioral Health Intervention ◽

Parent Decisions

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Information Sheets and Informed Consent Forms for Clinical Study Participants: Towards Standardised Recommendations?

Therapies ◽

10.2515/therapie/2009035 ◽

2009 ◽

Vol 64 (3) ◽

pp. 179-186 ◽

Cited By ~ 1

Author(s):

Olivier Chassany ◽

Micheline Bernard-Harlaut ◽

Gilles Guy ◽

Nathalie Billon ◽

Bernard Alberola ◽

...

Keyword(s):

Clinical Study ◽

Informed Consent ◽

Consent Forms ◽

Study Participants

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Written Informed Consent—Translating into Plain Language. A Pilot Study

Healthcare ◽

10.3390/healthcare9020232 ◽

2021 ◽

Vol 9 (2) ◽

pp. 232

Author(s):

Agnieszka Zimmermann ◽

Anna Pilarska ◽

Aleksandra Gaworska-Krzemińska ◽

Jerzy Jankau ◽

Marsha N. Cohen

Keyword(s):

Informed Consent ◽

Plain Language ◽

Consent Forms ◽

Software Analysis ◽

Informed Consent Form ◽

Education Levels ◽

Polish Language ◽

University Degree ◽

Study Participants ◽

Written Informed Consent

Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

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