764 Is Consent Valid in Common Orthopaedic Surgeries?

Abstract Aim Consent is at the heart of the doctor-patient relationship. Valid consent should be voluntary, informed and the patient must have the capacity to make the decision. It is the doctor’s responsibility to ensure the patient can make an informed decision. The aim of this audit is to assess the validity of consent within Salford Royal Foundation Trust Orthopaedic department. Method We retrospectively reviewed 225 consent forms for four common orthopaedic trauma procedures: 44 wrist ORIF, 48 ankle fixation, 71 hip hemiarthroplasty and 62 fixations with DHS. BOA-endorsed OrthoConsent and SRFT-produced leaflets were utilised as a standard for reported surgical risks and complications. Collated patient consents were compared against these standards. Exclusion criteria included consent four and polytrauma patients. Results 96 forms were excluded leaving 129 consent forms. In all four procedures, 86%-100% had documented infection, nerve injury and bleeding. Compartment syndrome was not documented for any wrist ORIF patients. CRPS was recorded in only 57% of wrist and 31% of ankle ORIF patients. Wound healing complications was documented in 17% of ankle ORIF. In 71% of DHS and 64% of hemiarthroplasty patients, risk of death was not recorded. Conclusions Targets for achieving satisfactory consent form documentation were not met and showed significant variation amongst clinicians. It suggests that patients are not being fully informed of benefits and risks of surgery. Recommendations include the introduction of posters and encouraging printing off patient information leaflets and improving education on valid consent for rotational doctors.

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1316 An Evaluation of The Consent Process in One of The Largest Spinal Surgery Units in Europe

British Journal of Surgery ◽

10.1093/bjs/znab259.143 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

E Daitey ◽

J Afolayan ◽

N Shah ◽

T Stringfellow ◽

R Shafafy ◽

...

Keyword(s):

Spinal Surgery ◽

Significant Variation ◽

Consent Process ◽

Supplementary Information ◽

High Morbidity ◽

Consent Forms ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Tertiary Centre ◽

The One

Abstract Complex spinal surgery has high morbidity and mortality making the process of consent central to patient care [1]. Our aim was to qualitatively assess our consent process with three set metrics; how far in advance patients were consented prior to the date of surgery, the inclusion of all relevant risks on the consent form and the provision of supplementary patient information leaflets or equivalent. We retrospectively reviewed 100 consecutive patients undergoing elective spinal surgery at our tertiary centre which is the one of the largest spinal units in Europe between December 2019 and March 2020. All patients had valid consent forms. 16% of patients were consented on the day of surgery, 22% were consented the day before. Of the remaining 62%, 22 patients (35%) were consented within 2 weeks of surgery, and 40 (65%) over 2 weeks prior to surgery. 94% were consented for all relevant risks as determined by the senior authors. 81% had no documentation of receiving supplementary information and 11% had documentation of consent discussion in clinic. In conclusion, this audit revealed a significant variation in the consent process within our unit. This may highlight a deficit in the consenting process which we aim to explore further.

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Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis

BMJ Open ◽

10.1136/bmjopen-2020-037994 ◽

2020 ◽

Vol 10 (9) ◽

pp. e037994

Author(s):

Lydia O'Sullivan ◽

Prasanth Sukumar ◽

Rachel Crowley ◽

Eilish McAuliffe ◽

Peter Doran

Keyword(s):

Quantitative Analysis ◽

Health Literacy ◽

Clinical Research ◽

Patient Information ◽

Best Practice ◽

Difficulty Level ◽

Consent Forms ◽

Patient Information Leaflets ◽

Information Leaflets ◽

The Uk

ObjectivesThe first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.DesignRetrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.SettingPILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.InterventionNot applicable.Main outcome measuresPILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.ResultsA total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.ConclusionsWhen assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.

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N14 The Effectiveness of patient information leaflets provided by a Clinical Nurse Specialist on disease related knowledge in Inflammatory Bowel Disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab074.828 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S614-S615

Author(s):

C Walsh

Keyword(s):

Patient Information ◽

Significant Variation ◽

Nurse Specialist ◽

Convenience Sample ◽

Clinical Nurse ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Duration Of Disease ◽

Moderate Effect ◽

Chi Square Analysis

Abstract Background Patient information leaflets are used as an educational tool and also to enhance the verbal information provided by the consulting practitioner. Disease specific knowledge is well recognized as an important factor to improve the knowledge of the condition, improve self care, aid compliance and provide information on therapies and treatments. It was observed that patient understanding and knowledge of their condition varies widely. Methods A quantitative cross sectional research methodology was implemented. The sampling is non probability with purposive convenience sample. The single site study sample size was 63. The instrument selected was the Crohn’s and Colitis Knowledge Score (CCKNOW) developed by Eaden et al, (1999).The self administered questionnaire consists of three sections, demographics, CCKNOW instrument and source of information. Data collection was recorded and analysed on SPSS (Version 24.0). Descriptive statistics and inferential statistics were implemented. Ethical approval was granted. Results Sixty three patients responded and the median age is 39. Analysis of CCKNOW scores by classification of age, gender, education and duration of disease reveals the significant variation is between age and knowledge (mean 41.14, SD 12.59) and disease duration and knowledge (2008.218, SD 9.784) The four areas of knowledge were calculated individually. The mean calculated for general knowledge 36.88 and the SD 6.26 demonstrating the greater degree of variation of knowledge scores. Less variation in the diet section was indicated. Significant variation demonstrated in medications and complications/pregnancy. Frequency of CCKNOW scores demonstrated the various ranges of scores. Only 2% of patients achieved a score of 20/24, no participant achieved a score of 24/24. Statistical significance of patient information leaflets and knowledge was assessed using Pearson-Chi Square analysis, Mann-Whitney U test and Spearman’s Rank Order Co-efficient which indicate that patient information leaflets have a moderate effect on knowledge needs. Conclusion Younger and older participants demonstrated poor knowledge scores. Duration of disease indicated knowledge scores have improved significantly over the past 8–10 years. Statistically patient information leaflets have only a moderate effect on knowledge needs. Patient information leaflets are used by 69% of participants. Knowledge base of IBD patients who are provided with a patient information leaflet is moderate and educational needs are not being met. High quality educational programmes are required and IBD Clinical Nurse Specialists are ideally placed to provide these.

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1222 Improving Consenting for Emergency General Surgery During The COVID-19 Pandemic

British Journal of Surgery ◽

10.1093/bjs/znab259.496 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

B Oyewole ◽

A Sandhya ◽

A Tawfik ◽

A Elzaafarany ◽

J Ma ◽

...

Keyword(s):

Perioperative Period ◽

Pulmonary Complications ◽

Surgical Patients ◽

Inclusion Criteria ◽

Emergency General Surgery ◽

Exclusion Criteria ◽

Incision And Drainage ◽

Consent Forms ◽

Risk Of Death ◽

Complications And Mortality

Abstract Aim Patients undergoing surgery during the Covid pandemic are exposed to increased risks of pulmonary complications and mortality. These novel risks need to be documented on the consent form. We carried out various interventions to ensure appropriate consenting and documentation following an initial audit that revealed poor compliance with published guidelines. Method The initial audit reviewed consent forms of patients undergoing emergency surgery over two-weeks in May 2020 while the re-audit was over a two-week period in June 2020 following implementation of interventions. Inclusion Criteria: Age >18-years, urgent or emergency laparoscopic surgery Exclusion criteria: Age <18-years, Open surgery, ‘Covid-light’ areas, NELA. Results 57 consent forms were assessed during the audit loop: 22 laparoscopic appendicectomies and diagnostic laparoscopies, 14 incision and drainage, 8 laparoscopic cholecystectomies, 4 hernia repairs, and 9 other procedures. Consenting for covid pneumonia increased from 70% to 89%, potential ITU admission 56% from 25% and the risk of death 63% from 21% Conclusions The covid pandemic changed our surgical practice. There are many unknowns regarding the risks to surgical patients, however, evidence shows increased risks of covid pneumonia, ITU admission and death in the perioperative period. Our consenting and the documentation of such conversations with patients must reflect our new reality.

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EP.WE.120Improving consenting for Emergency General Surgery during the COVID-19 pandemic

British Journal of Surgery ◽

10.1093/bjs/znab308.019 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Ahmed Elzaafarany ◽

Bankole Oyewole ◽

Ahmed Tawfik ◽

Jennifer Ma ◽

Anu Sandhya

Keyword(s):

Perioperative Period ◽

Pulmonary Complications ◽

Surgical Patients ◽

Inclusion Criteria ◽

Emergency General Surgery ◽

Exclusion Criteria ◽

Incision And Drainage ◽

Consent Forms ◽

Risk Of Death ◽

Complications And Mortality

Abstract Aims Patients undergoing surgery during the Covid pandemic are exposed to increased risks of pulmonary complications and mortality. These novel risks need to be documented on the consent form. We carried out various interventions to ensure appropriate consenting and documentation following an initial audit that revealed poor compliance with published guidelines. Methods The initial audit reviewed consent forms of patients undergoing emergency surgery over two-weeks in May 2020 while the re-audit was over a two-week period in June 2020 following implementation of interventions. Inclusion Criteria: Age >18-years, urgent or emergency laparoscopic surgery Exclusion criteria: Age <18-years, Open surgery, ‘Covid-light’ areas, NELA. Results 57 consent forms were assessed during the audit loop; 22 laparoscopic appendicectomies and diagnostic laparoscopies, 14 incision and drainage, 8 laparoscopic cholecystectomies, 4 hernia repairs, and 9 other procedures. Consenting for covid pneumonia increased from 70% to 89%, potential ITU admission 56% from 25% and the risk of death 63% from 21% Conclusions The covid pandemic changed our surgical practice. There are many unknowns regarding the risks to surgical patients, however, evidence shows increased risks of covid pneumonia, ITU admission and death in the perioperative period. Our consenting and the documentation of such conversations with patients must reflect our new reality.

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A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012

Communication & Medicine ◽

10.1558/cam.v11i3.20700 ◽

2014 ◽

Vol 11 (3) ◽

Cited By ~ 2

Author(s):

Inger Askehave ◽

Karen Korning Zethsen

Keyword(s):

Comparative Analysis ◽

Patient Information ◽

Patient Information Leaflet ◽

General Interest ◽

Information Leaflet ◽

Empirical Results ◽

Patient Information Leaflets ◽

Information Leaflets ◽

The Subject ◽

The Eu

Since becoming mandatory in the EU in 1992, the patient information leaflet (PIL) has been the subject of an on-going discussion regarding its ability to provide easily understandable information. This study examines whether the lay-friendliness of Danish PILs has improved from 2000 to 2012 according to the Danish consumers. A reproduction of a questionnaire study from 2000 was carried out. The responses of the 2012 survey were compared to those of the 2000 survey and the analysis showed that Danes are less inclined to read the PIL in 2012 compared to 2000 and that the general interest in PILs has decreased. The number of respondents who deem the PIL easy to read has gone down. According to Danish consumers, the lay-friendliness of PILs has not improved from 2000 to 2012 and a very likely explanation could be that the PIL as a genre has become far too regulated and complex to live up to its original intentions. On the basis of the empirical results the article furthermore offers suggestions for practice changes.

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