scholarly journals 254 An Audit to Assess the Completion of Consent Forms in the Department of Trauma and Orthopaedics

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
E Sultana
Keyword(s):  
Operative Procedure ◽  
Consent Form ◽  
Junior Doctors ◽  
Cross Sectional ◽  
Nice Guidelines ◽  
Consent Forms ◽  
Adequate Information ◽  
Orthopaedic Ward ◽  
Essential Prerequisite ◽  
Legal Consequences

Abstract Aim The objective was to audit how well the consent forms were being completed by junior doctors and registrars in the orthopaedic ward. This helped to assess whether the consent forms before orthopaedic procedures were being filled out according to the standards stated in the RCS and NICE guidelines. Method The initial audit was carried out in January 2020 in the three orthopaedic surgery wards at the Queen’s Medical Centre in Nottingham. Cross sectional data was collected by checking the consent forms to assess whether the important headings and sub-headings were filled out legibly with adequate information. Results All consent forms filled up in the study sample had the patient details and the name of the surgery written completely and accurately. 75.6% of the forms had the name of the Responsible Health Professional written, while the remaining had left the space blank or wrote an incorrect name. More than 90% of the forms had the intended benefit, and the possible risks of the orthopaedic operation written in the most suitable format. The likelihood of a blood transfusion being required was filled out in 78.6% of the forms. All consent forms were signed by a doctor, however, only 53% of the doctors provided both their name in print and contact number in the consent form. Conclusions Consent is an essential prerequisite for any operative procedure. By detecting the parts of the consent form that were frequently filled out inadequately, awareness was raised about the possible legal consequences of it.

scholarly journals Consenting Operative Orthopaedic Trauma Patients: Challenges and Solutions

ISRN Surgery ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
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.

scholarly journals An audit cycle of consent form completion: A useful tool to improve junior doctor training

2016 ◽  
Vol 49 (01) ◽  
pp. 72-75 ◽  
Author(s):  
Catherine Leng ◽  
Kavita Sharma
Keyword(s):  
Junior Doctor ◽  
General Medical Council ◽  
Consent Form ◽  
Junior Doctors ◽  
Medical Council ◽  
Emergency Setting ◽  
Consent Forms ◽  
Surgical Practice ◽  
Audit Cycle ◽  
Practice Methods

ABSTRACT Background: Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. Methods: An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Results: Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91–100%) and additional procedures (0–7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. Conclusion: The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

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.

scholarly journals Effectiveness of endoscopic intranasal incision reduction for nasal fractures

2021 ◽  
Author(s):  
Shu Yan ◽  
Yan Jiang ◽  
Yan Wang ◽  
Kaixuan Chen ◽  
Xudong Yan ◽  
...  
Keyword(s):  
Intraoperative Complications ◽  
Three Dimensional ◽  
Junior Doctors ◽  
3D Ct ◽  
Nasal Airflow ◽  
Temporal Window ◽  
Cross Sectional ◽  
Frontal Process ◽  
Bone Fragments ◽  
Nasal Fractures

Abstract Purpose To report our experience using endoscopic intranasal incision reduction (EIIR) for nasal fractures and to assess effectiveness of the method. Methods 30 patients who underwent EIIR were retrospectively analysed. All the patients were examined by three-dimensional computed tomography (3D CT), acoustic rhinometry and rhinomanometry, preoperatively and postoperatively at 1 month. The visual analogue scale (VAS) was used to assess the preoperative aesthetics and nasal airflow satisfaction and at 1, 3 and 6 months postoperatively. VAS aesthetic satisfaction was also scored by two junior doctors. Results 3D CT showed that the fracture fragments fitted well in 30 patients postoperatively at 1 month. VAS aesthetics and nasal airflow scores were significantly improved postoperatively at 1, 3 and 6 months compared with preoperative scores (P < 0.01). The VAS aesthetic scores from the two surgeons were also significantly improved (P < 0.01). The minimal cross-sectional area increased from 0.39 ± 0.13 to 0.64 ± 0.13 (P < 0.001), the nasal volume increased from 4.65 ± 0.86 to 6.37 ± 0.94 (P < 0.001) and the total inspiratory airway resistance of the bilateral nasal cavity median decreased from 0.467 Pa/mL/s to 0.193 Pa/mL/s (P < 0.001). There were no technique-related intraoperative complications. Conclusion EIIR was a practical choice, and the aesthetics and nasal airflow were significantly improved in patients with overlapped and displaced bone fragments, patients with fractures of the frontal process of the maxilla (FFPM), patients who underwent failed CR and patients beyond the optimal temporal window.

scholarly journals 515 How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A M Hussein ◽  
C J Callaghan
Keyword(s):  
Gold Standard ◽  
Deceased Donor ◽  
Consent Form ◽  
Donor Kidney ◽  
Consent Forms ◽  
Legal Case ◽  
Deceased Donor Kidney ◽  
Single Kidney ◽  
Donor Kidney Transplantation ◽  
Deceased Donor Kidney Transplantation

Abstract Introduction The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake. Method Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used. Results Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form. Discussion This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.

Improving consent forms for first-in-human trials through participant feedback.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13563-e13563
Author(s):  
Hannah Claire Sibold ◽  
Gavin Paul Campbell ◽  
John Bourgeois ◽  
Margie D. Dixon ◽  
R Donald Harvey ◽  
...  
Keyword(s):  
Patient Preferences ◽  
Clinical Trial Design ◽  
Study Drug ◽  
Clinic Visit ◽  
Consent Form ◽  
Consent Forms ◽  
Investigational Agents ◽  
Study Participants ◽  
Background Risks ◽  
Published Research

e13563 Background: Risks and benefits of investigational agents that have not been tested in humans are, at best, incompletely characterized in nonclinical investigations. Despite the growing emphasis to include patient voices in clinical trial design, no published research has explored patient preferences on how best to convey the information that the agent has not been tested in humans. This study established that First in Human (FIH) consent forms present this information in different locations and queried participants for their input on the preferable FIH consent form structure. Methods: Consent forms for FIH oncology trials open to accrual at Winship Cancer Institute in 2019-2020 were analyzed for (1) the location of the mention that the study drug has not been used in humans before (FIH information), (2) the location of animal and other nonclinical data, and (3) placement of the risks section. Patients offered enrollment in a FIH trial were eligible for this study. Participants were interviewed during a clinic visit after consent was obtained. An ethics researcher asked questions about the participant’s opinions on the wording and placement of the FIH, nonclinical, and risk information in the specific trial consent form. All interviews were audio-recorded and double coded by two independent coders. The location of FIH and nonclinical data in the consent forms was compared to the patient’s suggested location for this information. Results: Saturation of themes was reached after interviewing 17 (17/19, 89% accrual) participants who were enrolled in 9 different FIH trials. Twenty FIH consents were qualitatively analyzed. Preferred placement compared to actual consent placement is listed in the table. 82% (14/17) of participants thought that nonclinical data on risks and efficacy was important to mention. 95% (19/20) of consents listed nonclinical data and most participants thought the placement in the consent was appropriate but 18% (3/17) of participants wanted the information earlier in the consent. No consent forms that were analyzed had the risks section before the study schedule; however, 47% (8/17) of participants wanted to move the risks sections before the study schedule. Conclusions: There is considerable variation in the layout of FIH consent forms that does not align with patient preferences. Standardization of FIH consent forms to better reflect patient input is essential in order to promote understandability of these important yet sometimes misunderstood clinical trials and to ensure ethical informed consent.[Table: see text]

EP.FRI.771 National audit on VTE prophylaxis for lower limb injuries treated in a plaster cast

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Georgios Karagiannidis ◽  
Omar Toma
Keyword(s):  
Risk Assessment ◽  
Venous Thromboembolism ◽  
Lower Limb ◽  
Plaster Cast ◽  
Junior Doctors ◽  
National Audit ◽  
Lower Limb Injuries ◽  
Nice Guidelines ◽  
Vte Prophylaxis ◽  
Limb Injuries

Abstract Aims Audit to assess Orthopaedic departments’ compliance with NICE guidelines on Venous thromboembolism (VTE) prophylaxis published in 2010, specifically looking at VTE practices for patients with lower limb injuries treated in a plaster cast. Methods A telephonic survey was carried out on junior doctors within orthopaedic departments of 66 hospitals across all regions of England. A questionnaire was completed regarding VTE risk assessment, prophylaxis and hospital guidelines etc. Data collected from August 2016 till February 2017. Results 83% (n = 55) of trusts routinely give VTE prophylaxis to these patients. 96% (n = 64) give Chemoprophylaxis of some sort. Formal VTE assessments are performed in 81% (n = 54) and 77% (n = 51) have a local VTE prophylaxis policy. Conclusions We conclude that Orthopaedic departments across England have increased compliance with NICE guidelines for VTE prophylaxis. However there is considerable variation in practice, especially in duration and chemoprophylaxis agent. We attribute this to the lack of specific NICE guidelines for this cohort of patients. We aim that this study can influence NICE to introduce added guidance that will standardise practice.

Pseudomonas aeruginosa

2015 ◽  
Vol 105 (2) ◽  
pp. 125-129 ◽  
Author(s):  
Heather Young ◽  
Bryan Knepper ◽  
Whitney Hernandez ◽  
Asaf Shor ◽  
Merribeth Bruntz ◽  
...  
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Glycosylated Hemoglobin ◽  
Operative Procedure ◽  
Empiric Therapy ◽  
Median Number ◽  
Diabetic Patients ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Antibiotic Drugs ◽  
Tobacco Abuse

Background Pseudomonas aeruginosa has traditionally been considered a common pathogen in diabetic foot infection (DFI), yet the 2012 Infectious Diseases Society of America guideline for DFI states that “empiric therapy directed at P aeruginosa is usually unnecessary.” The objective of this study was to evaluate the frequency of P aeruginosa isolated from bone or tissue cultures from patients with DFI. Methods This study is a cross-sectional survey of diabetic patients presenting with a foot infection to an urban county hospital between July 1, 2012, and December 31, 2013. All of the patients had at least one debridement procedure during which tissue or bone cultures from operative or bedside debridements were obtained. The χ2 test and the t test of means were used to determine relationships between variables and the frequency of P aeruginosa in culture. Results The median number of bacteria isolated from DFI was two. Streptococcus spp and Staphylococcus aureus were the most commonly isolated organisms; P aeruginosa was isolated in only five of 112 patients (4.5%). The presence of P aeruginosa was not associated with the patient's age, glycosylated hemoglobin level, tobacco abuse, the presence of osteomyelitis, a prescription for antibiotic drugs in the preceding 3 months, or the type of operative procedure. Conclusions Pseudomonas aeruginosa was an infrequent isolate from DFI in this urban, underserved diabetic population. The presence of P aeruginosa was not associated with any measured risk factors. By introducing a clinical practice guideline, we hope to discourage frontline providers from using routine antipseudomonal antibiotic drugs for DFI.

scholarly journals Profile of Osteomyelitis Patients Visiting the Orthopedic Clinic of Dr. Hasan Sadikin General Hospital, Indonesia, in 2017–2018

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Aditya Nugraha ◽  
Hermawan Nagar Rasyid ◽  
Hadyana Sukandar
Keyword(s):  
Staphylococcus Aureus ◽  
General Hospital ◽  
Sampling Method ◽  
Operative Procedure ◽  
Bone Destruction ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Male Patients ◽  
The Common ◽  
Age Range

Background: Osteomyelitis is an inflammatory process caused by microorganism infection that leads to bone destruction. Osteomyelitis may affect all bones, particularly long bones, and infects all ages. This disease is hard to diagnose and the treatment is complex due to the disease’s heterogenicity, pathophysiology, clinical presentation, and management. This study aimed to determine the profile of osteomyelitis inpatients and outpatients presented to the Orthopedic Clinic of Dr. Hasan Sadikin General Hospital Bandung, IndonesiaMethods: This was a descriptive cross-sectional study conducted from July to October 2019 using the total sampling method. Data were collected from the medical records of osteomyelitis inpatients and outpatients presented to the Orthopedic Clinic of Dr. Hasan Sadikin General Hospital Bandung, Indonesia from 2017–2018. Data were then analyzed descriptively and the results were presented in frequencies.Result: In total, 90 data were retrieved. Most of data presented male patients (n= 69, 76.7%) with the age range of 20–29 years old (24.4%). The majority of these patients experienced chronic onset of disease (94.4%) located on the tibia (51.1%), which was caused by a post-operative procedure (61.1%). The most common treatment was operative procedure without antibiotic beads (51.1%). Staphylococcus aureus was the common pathogens identified in these patients (22.2%).Conclusion: The majority of osteomyelitis patients are males in productive age with chronic onset of disease located on the tibia caused by a post-operative procedure. Staphylococcus aureus is the common pathogen involved and the most common treatment is an operative procedure without antibiotic beads.

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