The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment

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The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment
D S Wald, J P Bestwick, P Kelly
QJM, 19 March 2020
Abstract
Background
A landmark legal judgment in March 2015 (Montgomery) changed the test for determining negligence due to failing to inform patients before consent, by moving away from asking what a reasonable doctor should disclose and asking instead what a reasonable patient would expect to know.
Aim
We sought to determine the effect Montgomery has had on settled claims due to failure to inform compared with claims for other reasons and whether legal firms are adding contributory claims of failure to inform to other principal allegations of negligence.
Methods
A Freedom of Information request to NHS Resolution provided data on the number of settled claims against the NHS (2005–19) for any cause and where failure to inform before consent was the principal or contributory cause. Time-series regression was used to compare trends before and after 31 March 2015.
Results
The trend in claims/year increased 4-fold for failure to inform (an increase of 9.8/year before 2015 vs. 39.5/year after 2015, P < 0.01), 2.7-fold when failure to inform was the principal cause (7.9/year vs. 21.2/year, P = 0.02) and 9.9-fold as a contributory cause (1.9/year vs. 18.3/year, P < 0.01). There was no material difference in claims due to other causes (334/year vs. 318/year, P = 0.84).
Conclusions
Montgomery has led to a substantial increase in settled claims of failure to inform before consent, with no coincident change in claims for other causes. The increase in contributory compared with principal causes suggests that lawyers are using the judgment to increase the chances of a successful claim against the NHS.

Editor’s note: QJM is a general medical journal affiliated with the Association of Physicians of Great Britain & Ireland. It focuses on internal medicine and publishes peer-reviewed articles which promote medical science and practice.

Rules on informed consent and advance directives at the end of-life: the new Italian law

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Rules on informed consent and advance directives at the end of-life: the new Italian law
Commentary
R V Viola, N Di Fazio, Z Del Fante, V Fazio, G Volonnino, S Romano, A Quattrocchi, M Arcangeli
La Clinica terapeutica, March-April 2020; 171(2) e94-96
Open Access
Abstract
End-of-life decisions are an emergent issue for bioethical debates and practical concerns among health professionals. On December 2017, Italy enacted a new law named “Rules about informed consent and advance directives”, which promotes the relationship of care in a fiduciary sense through the implementation of a correct and exhaustive information. It is also prescribed to record in writing all the patients’ decisions about consent or refusal. Furthermore, the law explicitly forbids unreasonable therapeutic obstinacy for terminal patient, legitimizing deep palliative sedation. Finally, the law establishes the use of “advance directives” as a written document by which adults and capable people can express their wishes regarding health treatments and diagnostic tests in anticipation of a possible future incapacity. The law provides that doctors must comply with these directives, unless they appear clearly incongruous or not corresponding to the patient’s current clinical condition.

Editor’s note: We take note of the phrase “unreasonable therapeutic obstinacy” in the abstract.

Dissenting voices in a consenting village: lessons from implementation of free, prior and informed consent at a REDD+ pilot in Tanzania

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Dissenting voices in a consenting village: lessons from implementation of free, prior and informed consent at a REDD+ pilot in Tanzania
K Mukisa, D M Tumusiime, C Webersik, E T Liwenga, J R S Tabuti
International Forestry Review, March 2020; 22(1) pp 120-131
Abstract
Free, prior and informed consent (FPIC) is a key institutional tool in meeting social safeguards. Its implementation ensures respect of the local people’s rights in an intervention. This paper presents a case of FPIC implementation at a REDD+ pilot site. Data were obtained through key informant interviews and focus group discussions with proponents and village members of the Lindi REDD+ project. Findings indicate that the inclusive approach to FPIC by taking the consultations to the hamlet level did not deliver a flawless process. The consent decision was reached by a majority vote, not consensus. There was some dissent, prompting the early establishment of project implementation committees. Consent was obtained, though it was not absolutely free, prior and informed. Future REDD+ projects should consider having FPIC as an independent and earlier process, separate from the main implementation of the project in order to uphold local peoples’ rights in a less anxious process.

The oral communication principle and coming up to informed decision requirements in national screening programs

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The oral communication principle and coming up to informed decision requirements in national screening programs
Short Communication
Birkeland
Public Health, May 2020; 182 pp 51-52
Abstract
Objective
Informed consent (IC) principles are often overlooked aspects in debates about national screening programs. This short communication examines the Danish approach to IC in decision-making about screening participation.
Study design
A descriptive approach is adopted in linking present screening practices with Danish regulation about IC and international ethical principles.
Methods
To ascertain the extent to which screening procedures come up to IC requirements, the article adopts a review approach by examining relevant Danish national legislation including ministerial orders as well as international ethical codes.
Results
The article finds that, although Danish legislation as well as international IC principles generally stipulates a decision-making process requiring oral communication, current procedures largely rely on one-way communication through written information available from leaflets, web sites, etc. Screening programs seem to have established no general formula to qualify healthcare users’ understanding of data underlying their choice whether to be screened.
Conclusion
The deviance from common IC principles may reduce healthcare quality, pose a safety problem, and challenge healthcare users’ ability to exercise autonomy.

Racial differences in patient consent policy preferences for electronic health information exchange

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Racial differences in patient consent policy preferences for electronic health information exchange
Carolyn L Turvey, Dawn M Klein, Kim M Nazi, Susan T Haidary, Omar Bouhaddou, Nelson Hsing, Margaret Donahue
Journal of the American Medical Informatics Association, 9 March 2020
Abstract
Objective
This study aimed to explore the association between demographic variables, such as race and gender, and patient consent policy preferences for health information exchange as well as self-report by VHA enrollees of information continuity between Veterans Health Administration (VHA) and community non-VHA heath care providers.
Materials and Methods
Data were collected between March 25, 2016 and August 22, 2016 in an online survey of 19 567 veterans. Three questions from the 2016 Commonwealth Fund International Health Policy Survey, which addressed care continuity, were included. The survey also included questions about consent policy preference regarding opt-out, opt-in, and “break the glass” consent policies.
Results
VHA enrollees had comparable proportions of unnecessary laboratory testing and conflicting information from providers when compared with the United States sample in the Commonwealth Survey. However, they endorsed medical record information being unavailable between organizations more highly. Demographic variables were associated with gaps in care continuity as well as consent policy preferences, with 56.8% of Whites preferring an opt-out policy as compared with 40.3% of Blacks, 44.9% of Hispanic Latinos, 48.3% of Asian/Pacific Islanders, and 38.3% of Native Americans (P < .001).
Discussion
Observed large differences by race and ethnicity in privacy preferences for electronic health information exchange should inform implementation of these programs to ensure cultural sensitivity. Veterans experienced care continuity comparable to a general United States sample, except for less effective exchange of health records between heath care organizations. VHA followed an opt-in consent policy at the time of this survey which may underlie this gap.

Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

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Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam
Nguyen Thi Thanh Thuy, Le Nguyen Thanh Nhan, Nguyen Van Vinh Chau, Nguyen Thi Phuong Dung
BMC Medical Ethics, 2020; pp 1-12
Abstract
Background
Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam.
Methods
We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process.
Results
In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not.
Conclusion
Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

Reconsidering the Process of Informed Consent in Assisted Reproductive Technology: Experiences and Implications for Practice

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Reconsidering the Process of Informed Consent in Assisted Reproductive Technology: Experiences and Implications for Practice
Reflections
Fabiola Fedele, Barbara Cordella, Viviana Langher
Psychological Studies, 28 March 2020
Abstract
A patient’s conscious decision to voluntarily undergo a therapeutic treatment is called informed consent (IC). The aim of IC is to provide information about health and treatment options and increase patient’s participation in healthcare decision-making. IC therefore honors the ethical principles of human autonomy and self-determination. In the field of assisted reproductive technology (ART), the process of communication and mutual understanding between patient and doctor (the IC process) is a current and relevant issue due to its medical, ethical and psychological implications. This exploratory research aims to understand how couples with infertility problems relate to the ART IC, and it proposes the innovative experience of IC conversations with a psychologist. It also provides practical advice on a better use of IC process in ART centers.

Systematic Review of Preoperative Risk Discussion in Practice

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Systematic Review of Preoperative Risk Discussion in Practice
Original Reports
Davis M. Aasen, Brett M. Wiesen, Abhinav B. Singh, Christi Piper, Ben Harnke, Allan V. Prochazka, Aaron S. Fink, Karl E. Hammermeister, Robert A. Meguid
Journal of Surgical Education, 16 March 2020
Abstract
Background
Informed consent is an ethical imperative of surgical practice. This requires effective communication of procedural risks to patients and is learned during residency. No systematic review has yet examined current risk disclosure. This systematic review aims to use existing published information to assess preoperative provision of risk information by surgeons.
Methods
Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses as a guide, a standardized search in Ovid MEDLINE, Embase, CINHAL, and PubMed was performed. Three reviewers performed the study screening, with 2-reviewer consensus required at each stage. Studies containing objective information concerning preoperative risk provision in adult surgical patients were selected for inclusion. Studies exclusively addressing interventions for pediatric patients or trauma were excluded, as were studies addressing risks of anesthesia.
Results
The initial search returned 12,988 papers after deduplication, 33 of which met inclusion criteria. These studies primarily evaluated consent through surveys of providers, record reviews and consent recordings. The most ubiquitous finding of all study types was high levels of intra-surgeon variation in what risk information is provided to patients preoperatively. Studies recording consents found the lowest rates of risk disclosure. Studies using multiple forms of investigation corroborated this, finding disparity between verbally provided information vs chart documentation.
Conclusions
The wide variance in what information is provided to patients preoperatively inhibits the realization of the ethical and practical components of informed consent. The findings of this review indicate that significant opportunities exist for practice improvement. Future development of surgical communication tools and techniques should emphasize standardizing what risks are shared with patients.

Attitudes About Informed Consent: An Exploratory Qualitative Analysis of UK Psychotherapy Trainees

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Attitudes About Informed Consent: An Exploratory Qualitative Analysis of UK Psychotherapy Trainees
Original Research Article
Charlotte R. Blease, Tim Arnott, John M. Kelley, Gillian Proctor, Tobias Kube, Jens Gaab, Cosima Locher
Frontiers in Psychiatry, 13 March 2020
Open Access
Abstract
Background
Ethical informed consent to psychotherapy has recently been the subject of in-depth analysis among healthcare ethicists.
Objective
This study aimed to explore counseling and psychotherapy students’ views and understanding about informed consent to psychological treatments.
Methods
Two focus groups were conducted with a total of 10 students enrolled in a Masters course in counseling and psychotherapy at a British university. Questions concerned participants’ understanding of informed consent including judgments about client capacity; the kinds of information that should be disclosed; how consent might be obtained; and their experiences of informed consent, both as a client and as a therapist. Focus groups were audio-recorded, transcribed, and analyzed using qualitative content analysis. Coding was conducted independently by three authors.
Results
Comments were classified into three main themes: (1) the reasons and justifications for informed consent; (2) informed consent processes; and (3) the hidden ethics curriculum. Some trainees expressed significant doubts about the importance of informed consent. However, participants also identified the need to establish the clients’ voluntariness and their right to be informed about confidentiality issues. In general, the format and processes pertaining to informed consent raised considerable questions and uncertainties. Participants were unsure about rules surrounding client capacity; expressed misgivings about describing treatment techniques; and strikingly, most trainees were skeptical about the clinical relevance of the evidence-base in psychotherapy. Finally, trainees’ experiences as clients within obligatory psychotherapy sessions were suggestive of a “hidden ethics curriculum”—referring to the unintended transmission of norms and practices within training that undermine the explicit guidance expressed in formal professional ethics codes. Some students felt coerced into therapy, and some reported not undergoing informed consent processes. Reflecting on work placements, trainees expressed mixed views, with some unclear about who was responsible for informed consent.
Conclusions
This qualitative study presents timely information on psychotherapy students’ views about informed consent to psychotherapy. Major gaps in students’ ethical, conceptual, and procedural knowledge were identified, and comments suggested the influence of a hidden curriculum in shaping norms of practice.
Implications
This exploratory study raises important questions about the preparedness of psychotherapy students to fulfill their ethical obligations.

On shared decision-making and informed consent

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On shared decision-making and informed consent
Editorial
James L. Bernat, Michael P. McQuillen
Neurology Clinical Practice, 11 March 2020
Excerpt
In the idealized concept of shared decision-making, the physician and patient comprise a collaborative clinical decision-making dyad. The physician contributes medical knowledge, training, experience, and judgment, whereas the patient contributes personal values and health care goals through which to evaluate how each treatment option could fulfill those goals. As partners, the patient and physician collaboratively achieve a mutually agreeable medical decision through an ongoing communication process that creates informed consent…