scholarly journals Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy

2021 ◽  
Vol 64 (4) ◽  
pp. E435-E441
Author(s):  
Erin Williams ◽  
Raj Selvam ◽  
Wilma Hopman ◽  
Sulaiman Nanji
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Informed Consent ◽  
Operating Room ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Consent Form ◽  
Consent Forms ◽  
Future Studies ◽  
Attending Physicians ◽  
Better Than

Background: Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined. Methods: A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests. Results: A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes. Conclusion: Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation.

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

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.

Cholecystectomy for Biliary Hyperkinesia

2019 ◽  
Vol 85 (2) ◽  
pp. 219-222 ◽  
Author(s):  
Joshua Gazzetta ◽  
Betty Fan ◽  
Paul Bonner ◽  
John Galante
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Chart Review ◽  
Gallbladder Disease ◽  
Retrospective Chart Review ◽  
Biliary Colic ◽  
Study Cohort ◽  
Final Pathology ◽  
Pathology Reports ◽  
Histologic Changes

Patients with classic biliary colic symptoms and documented gallbladder ejection fractions on the higher end of the spectrum on hepatobiliary iminoacetic acid scans with cholecystokinin stimulation are presently understudied and the benefits of cholecystectomy are unclear. To determine whether patients with biliary-type pain and biliary hyperkinesia (defined as a gallbladder ejection fractions of 80% or greater) benefit from laparoscopic cholecystectomy, a retrospective chart review encompassing five community hospitals was performed. Patients 16 years and older with diagnosed biliary hyperkinesia who underwent laparoscopic cholecystectomy between January 1, 2010 and May 31, 2015 were included. Pathology reports were reviewed for histologic changes indicating cholecystitis. Resolution of biliary colic symptoms was reviewed one to three weeks after surgery in their postoperative follow-up documentation. Within our study cohort, we found 97 patients who underwent laparoscopic cholecystectomy for biliary hyperkinesia. Within this population, 84.5 per cent of patients undergoing laparoscopic cholecystectomy for biliary hyper-kinesia had positive findings for gallbladder disease on final pathology. Of the 77 patients with data available from their first postoperative visit, 70 (90.9%) reported improvement or resolution of symptoms. Our findings suggest that symptomatic biliary hyperkinesia may be treated successfully with surgery.

Personality, Sex of Participant, and Face-to-Face Interaction Affect Reading of Informed Consent Forms

2014 ◽  
Vol 114 (1) ◽  
pp. 297-313 ◽  
Author(s):  
Michael M. Knepp
Keyword(s):  
Informed Consent ◽  
Information Seeking ◽  
Consent Form ◽  
Research Support ◽  
Consent Forms ◽  
Face To Face ◽  
Informed Consent Form

Students ( N = 183) participated in a study designed to determine if each student read the informed consent form. Approximately 12% of students in the online condition followed the procedure compared with 38% in the laboratory phase. Participants with higher trait worry and those with lower emotion reappraisal were more likely to follow the procedure, while women were more likely to read the form than men. Across conditions, most students do not read informed consent documents, particularly in online formats. These findings of this research support the idea that women tend to be more information-seeking than men in health and research settings and those with higher trait worry tend to read the consent forms to alleviate uncertainty and trust concerns.

Outcomes After the Use of Silicone Oil in Complex Retinal Detachment Repair

2020 ◽  
Vol 4 (2) ◽  
pp. 96-102
Author(s):  
Omar A. Saleh ◽  
Efrat Fleissig ◽  
Charles C. Barr
Keyword(s):  
Visual Acuity ◽  
Retinal Detachment ◽  
Chart Review ◽  
Silicone Oil ◽  
Retrospective Chart Review ◽  
Final Visit ◽  
Complication Rates ◽  
Minimum Angle ◽  
The Mean ◽  
Better Than

Purpose: This study compares visual acuity (VA), anatomic outcomes, and complications in eyes that underwent complex retinal detachment (RD) repair in which silicone oil (SO) was retained vs removed. Methods: A retrospective chart review of patients undergoing vitrectomy with SO tamponade. The eyes were divided into 2 groups based upon SO removal or retention. Main outcome measures were corrected VA, anatomic outcomes, and the presence of SO-related complications. Results: Fifty-seven eyes with removed SO and 53 eyes with retained SO were identified. In both groups, the mean best-corrected VA (BCVA) at the final visit was significantly better than at baseline. In the retained-SO group, vision improved from 1.79 ± 0.6 to 1.2 ± 0.7 logarithm of the minimum angle of resolution (logMAR) (Snellen, 20/1200 to 20/350) at the final visit ( P < .001). In the removed-SO group, mean BCVA improved from 1.84 ± 0.5 at baseline to 1.55 ± 0.6 logMAR units (Snellen, 20/1400 to 20/700) at the visit preceding SO removal ( P < .002) and to 1.43 ± 0.6 logMAR units (Snellen, 20/500) at the final visit ( P < .001). Complication rates were similar in both groups, apart from RD, which occurred more frequently in the removed-SO group ( P = .03). Conclusions: There was similarity in VA and complications among patients with removed or retained SO. Removal of SO may benefit eyes with SO-related complications, but SO retention may decrease the chance of RD and may be indicated in selected cases.

scholarly journals Role of the consent form in UK veterinary practice

2020 ◽  
Vol 187 (8) ◽  
pp. 318-318
Author(s):  
Carol Gray
Keyword(s):  
Informed Consent ◽  
Thematic Analysis ◽  
Potential Role ◽  
Consent Form ◽  
Consent Process ◽  
Consent Forms ◽  
The Status ◽  
The Uk ◽  
Sufficient Space

BackgroundInformed consent from the client is required before veterinary professionals may administer treatment or perform surgery on an animal patient, except in an emergency. This study investigates the potential role(s) of the consent form in the consent process in the UK.MethodsThematic analysis was carried out on the text contained in 39 blank consent forms sourced from veterinary practices in the UK. Analysis was conducted at the levels of topical survey and thematic summary.ResultsConsent forms were used to authorise procedures, to define proposed treatment, to offer or recommend additional procedures, to convey the risks of treatment and to document the client’s financial obligations. None of the forms analysed provided sufficient space to document the accompanying conversation. Notable omissions from the submitted forms included options for treatment and benefits of treatment.ConclusionsThe consent form acts as a record of the procedure to be performed, the associated costs and the status of the person giving consent. However, from this analysis, it often fails to record the detail of the consent discussion, an essential part of the consent process. A proposal for an improved version of a veterinary consent form is provided.

Evaluation of Patient Feedback following Laparoscopic Cholecystectomy based on Information Described in the Informed Consent form Developed by the Association of Polish Surgeons

2015 ◽  
Vol 87 (11) ◽  
Author(s):  
Piotr Misiak ◽  
Sławomir Jabłoński ◽  
Jerry Lazarek ◽  
Katarzyna Malinowska ◽  
Edyta Santorek-Strumiłło ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Informed Consent ◽  
Surgical Intervention ◽  
Small Sample Size ◽  
Laparoscopic Approach ◽  
Invasive Procedure ◽  
Small Sample ◽  
Consent Form ◽  
Patient Feedback ◽  
Informed Consent Form

AbstractThe cholecystectomy procedure is the most routinely performed intervention in general surgery. The current international gold standard is via the laparoscopic approach. It is a safe, minimally-invasive procedure; however, it is associated with complications in 1% of cases.was to analyze patient feedback, by means of a survey, to determine how much knowledge patients possessed about their disease state and proposed surgical intervention, based primarily on information contained within the informed consent form developed by the Association of Polish Surgeons.This study involved the participation of 51 patients who underwent laparoscopic cholecystectomy, indicated by a diagnosis of gallstones, in the years 2014 and 2015.Despite having signed the informed consent form, there was considerable variation among the responses given to the survey by the 51 patients in this study. Some patients’ responses were tangential to the questions asked; many patients did not respond to any of the sub points.Given that this study is based on a small sample size of patients, it must be presumed that the process by which the patient declares his or her informed consent requires further consideration with respect to the means by which it is obtained. The authors of this study thus recommend that multimedia resources be harnessed as part of the process of obtaining the informed consent of patients prior to surgical intervention.

Infection and Antimicrobial Use in Laparoscopic Cholecystectomy

1999 ◽  
Vol 20 (9) ◽  
pp. 624-626 ◽  
Author(s):  
Maryanne McGuckin ◽  
Judy A. Shea ◽  
J. Sanford Schwartz
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Surgical Site Infection ◽  
Infection Rate ◽  
Chart Review ◽  
Antimicrobial Prophylaxis ◽  
Retrospective Chart Review ◽  
Low Risk ◽  
Antimicrobial Use ◽  
Site Infection ◽  
Surgical Site Infection Rate

AbstractRetrospective chart review of 1,702 patients undergoing laparoscopic cholecystectomy (LC) revealed an overall infection rate of 2.3% and a surgical-site infection rate of 0.4%. Preoperative antimicrobial prophylaxis was received by 79% of patients, but only 33% of these received the agent within 1 hour or less prior to surgery. These facts suggest that antimicrobial prophylaxis may not be necessary for low-risk LC patients.

Effectiveness of consenting in Otorhinolaryngology

Open Medicine ◽  
2012 ◽  
Vol 7 (2) ◽  
pp. 198-202
Author(s):  
Nnaemeka Okpala ◽  
Amala Okpala ◽  
Gareth John ◽  
Hugh Cox
Keyword(s):  
Informed Consent ◽  
Therapeutic Alliance ◽  
Medical Practice ◽  
Consent Form ◽  
Consent Process ◽  
Pharyngeal Pouch ◽  
Consent Forms ◽  
Ethical Component ◽  
At Home

AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.

How well informed is the informed consent for cancer clinical trials?

2014 ◽  
Vol 11 (6) ◽  
pp. 686-688 ◽  
Author(s):  
Laeeq Malik ◽  
James Kuo ◽  
Desmond Yip ◽  
Alex Mejia
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Tertiary Care ◽  
Reading Level ◽  
Consent Form ◽  
Consent Forms ◽  
Investigational Agent ◽  
Informed Consent Form ◽  
Grade Reading Level

Aims: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Methods: Informed consent forms for Phase I–III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch–Kincaid and Gunning-Fog index readability tests. Results: All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8–28). A detailed estimation of the frequency or intensity of risks (range: 3–8 pages) was provided. The average reading level of the informed consent forms was high (Flesch–Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Conclusion: Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length.

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