A comprehensive analysis of the readability of consent forms for blood transfusion in Spain

A comprehensive analysis of the readability of consent forms for blood transfusion in Spain
Morales-Valdivia E, Brady AM, Mariscal-Crespo MI, Camacho-Bejarano R
Blood Transfusion, 22 December 2022
This study aimed to evaluate the readability of consent forms for blood transfusion in public hospitals in Spain.
Materials and methods
This was a cross-sectional, national study conducted within the Spanish healthcare system. Data were collected through the online retrieval of consent documents and direct consultation with 223 public hospitals. Consent forms were subjected to readability assessment including typographical, grammatical and lexical dimensions. The INFLESZ scale, a well-validated instrument adapted to the reading habits of Spaniards, was applied to determine the grammatical readability of the documents. The Spanish Mosby’s Dictionary and the Dictionary of Spanish were used together to systematically identify the number of medical terms contained in the text. Data were analyzed using descriptive and inferential statistics.
Forty-five written consent forms for blood transfusion, in use in 126 general public hospitals were evaluated for various parameters, including font size (=10.41), abbreviations (=10.58), word count (=595, 209 min-1,499 max) and length (1 to 7 pages). The overall readability score (=50.66) was indicative that consent forms are somewhat difficult to read. A heterogeneity of 116 different healthcare terminology words was identified. Word count was statistically and moderately positively related to the number of medical terms identified in the text (rho=0.496, p=0.001) and the INFLESZ score (rho=0.34, p=0.023).
In this first national study to assess the ease of reading written information on blood transfusion given to patients, deficiencies were found in the three dimensions of readability (typographical, grammatical and lexical) and a lack of uniformity among the written consent forms is pronounced. Further research is needed to develop more person-centered tools to support patients in the process of consenting for blood transfusion.

Attitude of perinatal pathologists to seeking consent for autopsies from parents: a web-based survey

Attitude of perinatal pathologists to seeking consent for autopsies from parents: a web-based survey
Kim, T.Y. Khong
Pathology, February 2023
Perinatal pathologists who know the value and process of autopsy rarely see parents, and there is argument among perinatal pathologists whether or not they should see parents regarding the autopsy. Consent rates for perinatal autopsies have dropped significantly. Poor communication between professionals and parents about autopsies and uncertainty about the value of autopsies from the professionals are two of many reasons for reduced perinatal autopsy rate.
Members of the Australian and New Zealand Paediatric Pathology Group were invited to participate in a web-based survey exploring their experiences in obtaining consent for perinatal autopsies and their views on being involved in discussion with parents.
Of 14 of 69 pathologists who responded, 10 have seen parents for obtaining consent for autopsies with three still seeing parents. Fifty-seven percent of the participants (8/14) did not want to speak with parents and six of them did not change their mind even with additional funding. More than half (8/14, 57%) believe pathologists should speak with parents regarding autopsies.
Promoting perinatal pathologists, who have positive views on being involved in discussion with parents, to participate in the process of obtaining consent and educating treating clinicians, may increase the perinatal autopsy rate.

Informed Consent and Shared Decision Making in the Perioperative Environment

Informed Consent and Shared Decision Making in the Perioperative Environment
Review Article
Elizabeth D. Krebs, Sook C. Hoang
Clinical Colon Rectal Surgery, 28 January 2023
Informed consent and shared decision making (SDM) are crucial portions of preoperative patient management. Informed consent is a standard for surgery from both a legal and ethical standpoint, involving disclosure of potential risks of a procedure and ensuring patient understanding of these risks. SDM is a process in which a clinician and patients decide between two or more treatment plans, taking into account the patient’s goals and values. SDM is a particularly important aspect of patient-centered care when two or more treatment options exist or in situations where an indicated treatment may not align with the patient’s long-term goals. This article details aspects of and issues surrounding informed consent and SDM.

Regulation, data management, informed consent, and legal issues for ART

Regulation, data management, informed consent, and legal issues for ART
Ilaria Soave, Roberto Marci
Management of Infertility, 19 January 2023
The number of assisted reproduction treatments undertaken worldwide has risen steadily since 1990. However when it comes to regulation, due to political, ethical, and social reasons related to assisted reproduction practice, each country has a different perspective. Several factors contribute to these differences, including financial issues (affordability, treatment costs), customary law, cultural and belief dimensions. In addition, individual and professional options may play different roles in different societies. The different restrictions across different countries, highlight a very complex reality, whose legislation represents a constant topic of debate and undergoes continuous evolution. In the daily practice, patient counseling and informed consent have both legal and ethical dimensions. The aim of this chapter is to provide an overview of assisted reproductive technology regulation, presenting its major legal issues and to underline the specific aspects of quality or data management and informed consent in assisted reproductive technology treatments.

Editor’s note: In this article ART stands for assisted reproduction treatment.

Legally Sound, Evidence-Based Informed Consent Form for Total Hip Arthroplasty

Legally Sound, Evidence-Based Informed Consent Form for Total Hip Arthroplasty
Original Article
Satvik N. Pai, Bishnu Prasad Patro, Naveen Jeyaraman, Arulkumar Nallakumarasamy & Madhan Jeyaraman
Indian Journal of Orthopaedics, 18 January 2023
Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure for obtaining informed consent for total hip arthroplasty (THA). We aimed to develop a solution for this need for a pre-designed, evidence-based informed consent form for THA cases.
Materials and Methods
We extensively reviewed the literature on the medico-legal aspects of THA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in THA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had previously undergone THA in the previous year. Based on all of the above, we developed an informed consent form that was evidence-based. We then had the form reviewed by a legal expert. The final form was utilised for THA cases at our institution for 1 year.
Legally sound, evidence-based Informed Consent Form for Total Hip Arthroplasty is given in Form A.
The use of legally sound, evidence-based informed consent for total hip arthroplasty cases would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, and promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.

Knowledge about and attitudes toward medical informed consent

Knowledge about and attitudes toward medical informed consent
Mary Deeb, Dana Alameddine, Rasha Abi Radi Abou Jaoudeh, Widian Laoun, Julian Maamari, Rawan Honeini, Alain Khouri, Fadi Abou-Mrad, Nassib Elia, Aniella Abi-Gerges
Ethics & Behavior, 11 January 2023
As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults with an average age of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC.

Informed consent in dermatology: a narrative review

Informed consent in dermatology: a narrative review
Meredith Hengy, Marlee Hewitt, Victoria Dekany, Nastassja Bedford-Lyon, Steven Daveluy
International Journal of Dermatology, 11 January 2023
Informed consent is a legal and ethical obligation of healthcare providers, and there are several steps that must be followed for informed consent to be obtained. Numerous challenges exist to obtaining informed consent including gaps in health literacy, language barriers, impaired decision-making capacity, and inadequacy of informed consent forms. Dermatologists must understand the importance and process for obtaining informed consent to protect patients as well as avoid litigation. This narrative review provides an overview of the process of obtaining informed consent, insight into the top challenges that clinicians may face with suggested recommendations, and a brief review of litigation from improper consent among dermatologists.

Two Practices to Improve Informed Consent for Intraoperative Brain Research

Two Practices to Improve Informed Consent for Intraoperative Brain Research
A Peabody Smith, N Pouratian, A Feinsinger
Neurosurgery, 4 January 2023
As the clinical applications of neurologically implanted devices increase, so do opportunities for intracranial investigations in human patients. In some of these studies, patients participate in research during their awake brain surgery, performing additional tasks without the prospect of personal therapeutic benefit. These intraoperative studies raise persistent ethical challenges because they are conducted during a clinical intervention, in a clinical space, and often by the treating clinician. Whether intraoperative research necessitates innovative informed consent methods has become a pressing conversation. Familiar worries about inadequate participant understanding and undue influence dominate these discussions, as do calls for increasing information retention (e.g., using methods such as “teach-back”) and minimizing enrollment pressures (e.g., preventing surgeons from consenting their own patients). However, efforts have yet to inspire widespread consent practices that mirror the scope of ethical concern. Focusing on awake, intraoperative intracranial research, we identify 2 underappreciated problems in approaches to informed consent. The first is epistemic: Many practices do not fully consider when and under which conditions participants are adequately informed. The second is relational: Many practices do not fully consider the effects of trust between patient-participants and surgeon-researchers. In exploring these concerns, we also raise questions about whether additional steps beyond preoperative consent may improve the process because decisions at this time are decoupled from both the experiences and vulnerability of awake brain surgery. Motivated by these considerations, we propose 2 practices: first, requiring a third-party patient advocate in initial consent and second, requiring verbal intraoperative reconsent before initiating research.

Establishing Legal Obligations and Guidelines for Consent in Organ Transplants

Establishing Legal Obligations and Guidelines for Consent in Organ Transplants
Malik Zia-ud-Din, Driss Ed.daran, Hamid Mukhtar
Al-Qantara, 4 January 2023; 9(1)
The process of obtaining consent in the medical field is layered with complexity. Risk assessment and informed consent are very important public health problems that have gotten even more attention as the COVID-19 outbreak has progressed. This article identifies pertinent elements that physicians should take into account while obtaining permission for solid organ transplantation. First, we determine the circumstances behind the patient’s permission. The implications of recent legal decisions are then discussed, along with the legal principles governing consent in medical practice as they apply in the UK. The third section focuses on particular consent challenges in organ transplantation and discusses important variables to consider when deciding consent for organ transplantation. Practical suggestions are provided in the fourth part. In order to get informed permission for transplantation, we suggest a unique “multi-factor approach” that takes into account risk awareness, strong communication, and thorough review procedures. In conclusion, our suggested strategy adds just a little bit to the ongoing discussion around consent in medicine. This research further suggests that many developing countries are conducting such processes but those countries have no effective regulations similar to the UK; hence, such developing countries can follow the same footprints as the UK has taken.

Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons

Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons
Research Article
Christian G. Fritz, Dominic J. Romeo, Anne S. Lowery, Karthik Rajasekaran
American Journal of Rhinology & Allergy, 2 January 2023
Informed consent requires preoperative discussion of surgical risks, complications, and alternative treatment options. Allegations of incomplete informed consent are common in the field of otolaryngology.
Analyze outcomes and case variables in cases of alleged informed consent failure involving otolaryngologists.
A legal research database containing state and federal case records from across the United States was retrospectively reviewed for malpractice claims involving informed consent and otolaryngology.
Among the 128 informed consent cases identified, 72.6% resulted in favorable verdicts for otolaryngologists. Functional endoscopic sinus surgery (FESS) was the most common source of informed consent litigation in the field of otolaryngology, with an incidence four-fold higher than the next most litigated procedure of uvulopalatopharyngoplasty (21.9% vs 5.4%). The top four factors cited in FESS-related cases were CSF leak (10), inadequate discussion of alternative therapies (4), diplopia (3), and meningitis (3). Cases resulting in a transient injury were significantly less likely to result in a payment from a plaintiff verdict or settlement (9.1%) as compared to payment-rates among cases involving permanent complications (34.6%) (p = 0.005).
Failure to obtain informed consent is an important factor in medical malpractice litigation. This report identifies specific, actionable recommendations aimed at protecting sinus surgeons from liability and ensuring that patients are better informed.