Antenatal and intrapartum consent: Implications of the NSW Consent Manual 2020
Opinion
Hans Peter Dietz, Jessica Caudwell Hall, Natalie Weeg
ANZJOG, 7 June 2021
Abstract
The provision of informed consent for antenatal and intrapartum care remains a contentious issue among healthcare professionals and has been the topic of controversies in the pages of this journal. Recently, the New South Wales (NSW) Department of Health has fundamentally changed the ground rules for the provision of maternity care within the state. In this opinion piece, we try to provide guidance to clinicians to help them deal with the medicolegal environment created by this document which is likely to affect practitioners not just in NSW.
Month: July 2021
Anxiety is associated with unfulfilled information needs and pain at the informed consent consultation of spine surgery patients: a longitudinal study
Anxiety is associated with unfulfilled information needs and pain at the informed consent consultation of spine surgery patients: a longitudinal study
Original Article
Sabine Fischbeck, Katja Petrowski, Mirjam Renovanz, Rebecca Nesbigall, Julian Haaf, Florian Ringel
European Spine Journal, 5 June 2021
Open Access
Abstract
Purpose
Meeting the information needs of patients adequately is of high importance in informed consent consultations in surgery. However, information needs often remain unmet in the informed consent consultation. The aim of this study was to assess anxiety and pain in relation to the patients’ information needs fulfillment perioperatively.
Methods
We applied a question prompt list (QPL) for patients undergoing spine surgery (SN-QPL) before (t1) and a question answering list (SN-QAL) after (t2) the informed consent consultation. The patients additionally completed the “State-Trait Anxiety Operation Inventory” (STOA, cognitive and affective scale) at t1, as well as a pain numerical rating scale (NRS) at t2 and postoperative (t3). We analyzed (1) the association between anxiety, information needs and pain and (2) anxiety and pain scores regarding information needs fulfillment after the consent consultation.
Results
A total of n = 118 patients was included. Affective and cognitive state anxiety was only reduced postoperatively (affective p < .001, cognitive p < .05). The higher trait anxiety was, the more patients longed for information at t1–t3 (t1: r = .58/r = .74, each p < .001), (t2: r = .38/r = .49, each p < .001) and (t3: r = .29, p < .01/r = 34, p < .001). Higher grades of trait anxiety resulted in lower information needs fulfilment. Higher state anxiety levels were associated with higher pain levels. Information needs more often remained unfulfilled in high trait and state anxiety patients.
Conclusion
Patients’ anxiety was associated with (un)fulfilled information needs. Meeting information needs should be optimized in the process of surgeon–patient communication. Adapting the information to the patients’ anxiety levels seem to be an effective way to reduce anxiety.
Arthroscopic Surgery Is Not Minor Surgery: Shared Decision Requires Comprehensive Informed Consent
Arthroscopic Surgery Is Not Minor Surgery: Shared Decision Requires Comprehensive Informed Consent
Editorial Commentary
Arthroscopy, 1 June 2021; 37(6) pp 1755-1756
Kwadwo Adu Owusu-Akyaw
Open Access
Abstract
Arthroscopic surgery of the shoulder has revolutionized the way we address intra-articular and tendinous injuries about the joint. Nevertheless, despite the apparent minimally invasive nature of our trade, there remain potential long-term consequences to every operation. This is especially true if future arthroplasty is indicated, as the risk of prosthetic joint infection is increased in patients having a previous procedure. True partnership with our patients necessitates that they have a clear understanding of the full implications of any surgery, no matter how small it may seem. True informed consent necessitates that our patients understand not only the immediate implications of the current operation but the potential effects on a future operation. This can only be accomplished by effective and honest communication about the full scope of the risk undertaken when an arthroscopic surgery is performed.
[The “right” patient for implant surgery in urology : Why patient selection, informed consent, and communication are so important for patient satisfaction].
[The “right” patient for implant surgery in urology : Why patient selection, informed consent, and communication are so important for patient satisfaction].
Leiber C, Katzenwadel A, Schlager D
The Urologist, 1 June 2021, 60(6) pp 732-739
Abstract
In implant surgery for erectile dysfunction and urinary incontinence, adequate patient selection is essential for postoperative therapy success. Several scientific studies report patient satisfaction rates for penile implants and artificial urinary sphincter implantation of over 90%. Nevertheless, studies also report, that between 5 and 30% of the patients are not satisfied with the result of their operation. Sufficient patient information and consent prior surgical procedure in urological prosthetics are a key determinant for later patient satisfaction and therapy success. Diligent assessment of realistic expectations, possible complications, and risks must be made. Unrealistic and exaggerated expectations need to be met and discussed with the patient. Therefore adequate physician-patient communication is essential. Especially in the case of surgical revision or for patients with risk factors, the probability of complications is higher and may significantly increase later dissatisfaction. Also, the involvement of the partner plays a major role in later patient satisfaction in urological implant surgery. Finally, there is a group of patients for which the risk of later dissatisfaction is particularly high. These are patients with compulsive/obsessive behavior, unrealistic expectations, patients after revision surgery, self-entitled patients, as well as those patients who deny the extent of their illness, visit multiple surgeons (surgeon hopping) or have psychiatric illnesses. These patients are referred to with the acronym “CURSED” patients.
Editor’s note: This is a German language publication.
A Novel Blended Curriculum for Communication of Informed Consent With Surgical Interns
A Novel Blended Curriculum for Communication of Informed Consent With Surgical Interns
Tiffany N. Anderson, Aboubacar Kaba, Eniola Gros, Ingrid S. Schmiederer, Robert Shi, Lauren R. Aalami, Dana T. Lin, James N. Lau
Journal of Graduate Medical Education, June 2021; 13(3) pp 411–416
Abstract
Background
Interns often conduct procedural informed consent discussions (ICDs), identified as a core entrustable professional activity. Deficiencies in the training process for ICDs span across specialties.
Objective
We provide evidence for a curriculum and assessment designed to standardize the training process and ensure ICD competency in surgical interns.
Methods
In March 2019, PowerPoint educational materials were emailed to one academic institution’s new surgical interns, who in June participated in an onsite 1-hour role-play “hot seat” group activity (GA) with an untrained simulated patient, and in October completed a single trained simulated patient (real-time raters) verification of proficiency (VOP) assessment. Curriculum evaluation was measured through intern pre-/post-confidence (5-point scale), and the VOP’s Cronbach’s alpha and test-retest were examined. Data were analyzed with descriptive statistics, paired t tests, and 2-way random effects models.
Results
Of 44 new interns, 40 (91%) participated in the remote teaching and live GA and were assessed by the VOP. Pre-/post-GA confidence increased a mean difference of 1.3 (SD = 0.63, P < .001). The VOP’s Cronbach’s alpha was 0.88 and test-retest was 0.84 (95% CI 0.67–0.93, P < .001), with a 95% pass rate. The 2 first-time fail students required remediation. Time commitment included 1 hour maximum for individual training and implementation and 30 minutes for assessment. The use of volunteers and donated space mitigated additional costs.
Conclusions
Remote asynchronous and group skills teaching for new general surgical interns improved their confidence in conducting procedural ICDs. A patient-simulation verification process appeared feasible with preliminary evidence of retest and internal consistency.
Lessons Learned for Identifying and Annotating Permissions in Clinical Consent Forms
Lessons Learned for Identifying and Annotating Permissions in Clinical Consent Forms
Elizabeth E. Umberfield, Yun Jiang, Susan H. Fenton, Cooper Stansbury, Kathleen Ford, Kaycee Crist, Sharon L. R. Kardia, Andrea K. Thomer, Marcelline R. Harris
Applied Clinical Information, 23 June 2021; 12(3) pp 429-435
Abstract
Background
The lack of machine-interpretable representations of consent permissions precludes development of tools that act upon permissions across information ecosystems, at scale.
Objectives
To report the process, results, and lessons learned while annotating permissions in clinical consent forms.
Methods
We conducted a retrospective analysis of clinical consent forms. We developed an annotation scheme following the MAMA (Model-Annotate-Model-Annotate) cycle and evaluated interannotator agreement (IAA) using observed agreement (A o), weighted kappa (κw ), and Krippendorff’s α.
Results
The final dataset included 6,399 sentences from 134 clinical consent forms. Complete agreement was achieved for 5,871 sentences, including 211 positively identified and 5,660 negatively identified as permission-sentences across all three annotators (A o = 0.944, Krippendorff’s α = 0.599). These values reflect moderate to substantial IAA. Although permission-sentences contain a set of common words and structure, disagreements between annotators are largely explained by lexical variability and ambiguity in sentence meaning.
Conclusion
Our findings point to the complexity of identifying permission-sentences within the clinical consent forms. We present our results in light of lessons learned, which may serve as a launching point for developing tools for automated permission extraction.
“No Consent, No Access” The Indigenous-Environmentalist Middle Ground in Protests against the Arctic Railway in Sápmi [DISSERTATION]
“No Consent, No Access” The Indigenous-Environmentalist Middle Ground in Protests against the Arctic Railway in Sápmi [DISSERTATION]
Eeva-Maija Kakko
University of Helsinki, Masters Thesis, 2021
Abstract
The Arctic is home to many Indigenous peoples, including the Sámi. It is also an economically attractive area for governments and companies. Arctic Railway has been planned by the Finnish government and private parties to span over Sápmi, the Sámi homeland. Sámi youth association Suoma Sámi Nuorat, Sámi art collective Suohpanterror, and environmental NGO Greenpeace Finland have collaborated to fight against the railway and organized demonstrations and other campaigning.
The goals of this thesis are to find out what kind of themes have been present in these Sámi organizations and Greenpeace’s protests and communication related to the Arctic Railway. Shared priorities and differences in their priorities are also determined. Moreover, this thesis explores how the Sámi are portrayed in the protests against the Arctic Railway. The data of this thesis is derived from public media sources, including news articles, social media content, and press releases. Case study is used as a research approach, and qualitative content analysis is used as a method. A middle ground concept functions as an analytical tool. It refers to a creative process where groups from different cultures find ways to work together. Indigenous peoples and environmentalists have often built strategic alliances, although also having differences in their priorities. In the middle ground, Indigenous peoples are recognized as active, creative agents, but also the use of stereotypes of Indigenous peoples have been present in these kinds of alliances.
The results of this thesis show that the Sámi organizations have discussed the railway´s impacts on the Sámi livelihoods, lands, and culture, affecting their future as a people. They have also brought up that the railway has been planned without their consent, and the project has violated both Finnish law and international Indigenous rights. Greenpeace has focused on protecting the northern forests while raising awareness of Sámi issues and appearing as a supporter of Sámi people. They have had their unique middle ground where both priority differences and convergences have been present. In the protests against the Arctic Railway, the Sámi are portrayed as active agents. They have taken action in different ways: through demonstrations, participation in international events, art, and social media activism. This research can raise awareness about the potential of Indigenous-environmental alliances in promoting Indigenous rights and environmental protection and help build better alliances in the future. Further research could look at how these kinds of alliances have been negotiated.
Center for Informed Consent Integrity 