Understanding consent for surgery and for treatment in orthopaedics
Vane Antolič, Marius M. Scarlat
International Orthopaedics, 30 September 2022; 46 pp 2459–2460
Consenting to treatment implies that a person gives permission before receiving any type of medical care, test or examination. The Consent protects the doctor from the accusation of an “unwanted touch”. Surgery is a complex medical act involving treatments, acts, and manoeuvres that could be harmful, although they are expected to be beneficial and amend positively the patient’s health. Prior to obtaining consent for the proposed succession of acts, the surgeon must provide the patient with information about the nature of the treatment, the expected benefits, material risks and adverse effects, alternate treatments, and the consequences of not having the surgery. Consent for surgery has become a critical component of surgical practice and is of increasing importance and must be updated with patient and legal expectations. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The principle of consent is an important part of medical ethics and international human rights law.
How do patients benefit from consent?
The Bulletin, 30 September 2022; 104(7) pp 364-365
Our legal contributor discusses how gaining consent for treatment, and the importance of discussing all alternatives available to a patient, is vital to maintaining good practice.
Editor’s note: The Bulletin is published by the Royal College of Surgeons of England.
Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales
Cynthia A Ochieng, Hollie Richards, Jesmond Zahra, Sian Cousins, Daisy Elliott, Nicholas Wilson, Sangeetha Paramasivan, Kerry N L Avery, Johnny Mathews, Barry G Main, Robert Hinchliffe, Natalie S Blencowe, Jane M Blazeby
BMJ Open, 1 September 2022
To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).
A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
NHS trusts in England and health boards in Wales, UK.
Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.
From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.
Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.
How readable are orthognathic surgery consent forms?
Maurice J.Meade, Craig W. Dreyer
International Orthodontics, 16 September 2022
The valid consent process for medical intervention requires the disclosure of information in a format that is easily understandable by the patient. The aim of this investigation was to assess the readability of orthognathic surgery informed consent forms (OSICFs).
An online search methodology was conducted to identify OSICFs for analysis. The forms that satisfied inclusion/exclusion criteria were evaluated according to a standardised protocol. The readability of the content was assessed using three validated tools: the Simple Measure of Gobbledegook (SMOG) score, Flesch-Kincaid Grade-Level (FKGL) score and Flesch Reading Ease (FRE) score.
Most of the 26 evaluated OSICFs were sourced from websites within the United States (69.2%) and from oral and maxillo-facial surgery practices (76.9%). Two of the assessed forms were template OSICFs available from oral and maxillo-facial professional societies to its members. The scores from the three tools found that the content of 84.6% to 92.3% of the forms were “difficult” to read. The mean (SD) SMOG score for all evaluated OSICFs was 12.31(2.22) [95% CI: 11.42 to 13.21]. The SMOG and FKGL scores were closely correlated (r = 0.99, P < 0.0001; 95% CI: 0.9864 to 0.9973). There was no association between SMOG scores and the number of words contained within each consent form (r = −0.047;95% CI: −0.44 to 0.36).
The OSICFs surveyed in this investigation failed to meet recommended readability levels. A significant number of patients are not likely to understand the information contained within the forms. Orthodontists are advised that poor literacy skills of their patients may preclude them from validly consenting to orthognathic surgery treatment procedures.
An evaluation of patient informed consent for dental extractions
Richa Arya, Sarah Jadun, Aneesha Shah
Primary Dental Surgery, 7 September 2022; 11(3)
Dental practitioners are well versed in informing patients of the risks and benefits associated with dental extractions. The purpose of this service evaluation was to determine whether patients understood and recalled information relevant to their planned oral surgery procedure, prior to second stage consent. A questionnaire was distributed to patients who were attending for their elective treatment appointment. This explored their ability to recall the planned intervention, the modality of treatment (local anaesthetic, intravenous sedation, or general anaesthetic), understanding of alternative treatment options and the risks associated with the procedure. Completed responses were received from 29 of the distributed questionnaires (response rate=58%). The majority of patients were not aware of the following risks with their procedure: pain, bleeding, bruising, swelling, infection, damage to adjacent structures. Despite a well-documented consent form and comprehensive discussion, we identified that patients may not comprehend or recollect the risks associated with their dental extraction. As dental professionals we have a duty to seek ways to facilitate patient understanding and maximise their autonomy.
Fertility clinic consent forms and the disposition of reproductive material upon a fertility patient’s death
D W Thaldar
South African Medical Journal, September 2022; 112(9) pp 744-746
South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death, the fertility clinic may be committing a civil wrong and a crime. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient’s death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics’ storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.
Patient experience and decisional satisfaction with the informed consent process for elective gynecologic surgeries: A cross-sectional study
Glaiza S.de Guzman, Melissa D.L. Amosco
Annals of Medicine and Surgery, September 2022; 81
The informed consent process is a vital component of daily medical practice. It involves providing patients with sufficient, accurate, and understandable information to decide on a contemplated therapy. The study aims to evaluate the patient experience and satisfaction with the preoperative informed consent process.
A cross-sectional study was performed on adult women admitted for elective gynecologic surgery in a tertiary training hospital. Participants were recruited on their second postoperative day and were asked to answer a structured questionnaire assessing decisional satisfaction and experience with the informed consent process. Satisfaction was measured using a 6-item Satisfaction with Decision Scale. Knowledge of the surgery and experience with the informed consent were measured using an Informed Consent Questionnaire. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher exact test.
A total of 150 patients were enrolled in the study with a mean age of 44.5 years. The resident-in-charge provided the information and assisted in the documentation of the informed consent in 86.7% and 67.3% of patients, respectively. There was an overall high decisional satisfaction with a mean score of 27.4 and 52.7% of patients strongly agreeing to all statements of the Satisfaction with Decision Scale. The majority of the respondents were informed and acknowledged comprehension of the surgery including its risks, benefits, and alternative treatment options. Knowing the success rate and benefits of the procedure as well as being informed of the need for postoperative catheterization were significantly associated with high satisfaction.
Knowledge and understanding of the key components of informed consent influence patient satisfaction. The current study highlights the high decisional satisfaction rates of patients who underwent elective gynecologic surgery. Strategies to further improve this patient-physician encounter include the establishment of standard policies on personnel involved, timing, and quality of information given to patients. Patient satisfaction should serve as an indicator of the quality of healthcare rendered and guide for continuous improvement of services.
Patients’ Choice, Consent, and Ethics in Patient Blood Management
James P. Isbister, Bronwyn L. Pearse, Alana S. Delaforce, Shannon L. Farmer
Anesthesia & Analgesia, September 2022; 135(3) pp 489-500
…Patients must be informed of their diagnosis, the nature, severity and prognosis of the disease, and treatment options along with risks and benefits. They should be involved in decision-making regarding their management. However, as part of this process, there are multifaceted medical, legal, ethical, and economic issues, encompassing shared decision-making, patient choice, and informed consent. Furthermore, variability in patient circumstances and preferences, the complexity of medical science, and the workings of health care systems in which consent takes place can be bewildering, not only for the patient but also for clinicians obtaining consent…
How Informed Is Your Informed Consent: Evaluating Differences Between Resident and Attending Obtained Consents for Cholecystectomy
Kathleen E. Singer, Jennifer E. Baker, Nora C. Elson, Taylor E. Wallen, Ann Salvator, Ralph C. Quillin, Jeffrey J. Sussman, Amy T. Makley, Michael D. Goodman
Journal of Surgical Education, 24 August 2022
There is considerable variability in surgeons’ approach to write and obtain informed consent for surgery, particularly among resident trainees. We analyzed differences in procedures and complications described in documented surgical consents for cholecystectomy between residents and attendings. We hypothesized that attending consents would describe more comprehensive procedures and complications than those done by residents.
This is a retrospective analysis of 334 patients who underwent cholecystectomy. Charts were queried for demographics, surgical approach, whether the consent was completed electronically, and which provider completed the consent. Specifically, consents were evaluated for inclusion of possible conversion to open procedure, intraoperative cholangiogram, bile duct injury, injury to nearby structures, reoperation, bile leak, as well as if the consent matched the actual procedure performed.
This study was conducted at an accredited general surgery training program at an academic tertiary care center in the Midwest.
This was a review of 334 patients who underwent cholecystectomy over a 1 year period.
Of all documented consents analyzed, 153 (47%) specifically included possible intraoperative cholangiogram, 156 (47%) included bile duct injury, 76 (23%) included injury to nearby structures, 22 (7%) included reoperation, and 62 (19%) included bile leak. In comparing residents and attendings, residents were more likely to consent for bile duct injury (p = 0.002), possible intraoperative cholangiogram (p = 0.0007), injury to nearby structures (p < 0.0001), reoperation (p < 0.0001), and bile leak (p < 0.0001).
Significant variation exists between documentation between resident and attending cholecystectomy consents, with residents including more complications than attendings on their consent forms. These data suggest that experience alone does not predict content of written consents, particularly for common ambulatory procedures. Education regarding the purpose of informed consent and what should be included in one may lead to a reduction in variability between providers.
Shared Consent: Acknowledging the Subjectivity of Surgical Decision-making
Paul J.Kepper, Sean C. Wightman, Baddr A. Shakhsheer
Annals of Surgery, 22 August 2022
Surgeons aspire to make data-driven decisions to provide the highest level of patient care. Evidence-based medicine mandates utilization of the best available data to guide decision making. The decision to offer an operation, however, is more than an evaluation of clinical evidence. Clinical expertise applies evidence-based medicine to a specific patient and tailors the practice of medicine to individual patient situations and preferences. Clinicians fill the gaps in the evidence with expertise developed over years of experience and training. Bridging these gaps is often described as the “art of surgery”; it is inherently subjective. Shared consent is the process that acknowledges subjectivity in decision-making. Shared consent is the foundation for a cooperative cognitive model between patient and surgeon, interpreting the available data through the lens of patient preference while relying on surgeon expertise…