The Effect of the Consent Process on Patient Satisfaction With Pain Management: A Randomized Controlled Trial
Pain management and sedation/original research
Safire Valentine, James Majer, Nicole Grant, Antony Ugoni, David M. Taylor
Annals of Emergency Medicine, 15 May 2020
Abstract
Study objective
We aim to determine whether the timing and context of informed consent affects the subjective outcome of patient satisfaction with pain management.
Methods
We conducted a randomized controlled trial in a single emergency department (ED). Patients aged 18 years or older with a triage pain score of greater than or equal to 4 provided consent to participate in a pain management study. They were randomized to consent in the ED or at follow-up. All patients were followed up at 48 hours post–ED discharge. Patients who consented at follow-up were unaware of the study until cold called. The primary outcome was patient satisfaction with pain management. Secondary analyses examined effects on follow-up and participation rates. Variables associated with patients’ being very satisfied were determined with multivariate logistic regression.
Results
Outcome data were obtained on 655 of 825 patients enrolled (79.4%). Patients who provided consent at follow-up were less likely to be very satisfied compared with those who consented in the ED (difference in proportions 11.5%; 95% confidence interval 3.5 to 19.4). Follow-up and participation rates did not differ between the groups. Patients who received pain advice and adequate analgesia (both as defined in this study) were more likely to be very satisfied (odds ratio 5.18, 95% confidence interval 2.82 to 9.52; and odds ratio 1.54, 95% confidence interval 1.07 to 2.22, respectively).
Conclusion
The timing and context of informed consent significantly affect the subjective outcome of patient satisfaction, and this should be considered during study design. Clinicians should strive to provide pain advice and adequate analgesia to maximize their patients’ satisfaction.

Capacity to consent to medical procedures [BOOK CHAPTER]
Deborah Slater
Assessing Mental Capacity: A Handbook to Guide Professionals from Basic to Advanced Practice
Routledge, 4 May 2020; Chapter 13
Abstract Only Available
The law requires professionals to ensure that a person is able to give consent before any form of treatment, investigation or care is given. Consent must be valid and it should be given freely and voluntarily (Royal College of Nursing, 2017). This section will explore what you need to know and the process you need to follow to carry out an assessment of capacity to consent to treatment.

Bundled Consent in US Intensive Care Units
Maria L. Espinosa, Aaron M. Tannenbaum, Megha Kilaru, Jennifer Stevens, Mark Siegler, Michael D. Howell, William F. Parker
American Journal of Critical Care, 1 May 2020; 29(3) e44–e51
Open Access
Abstract
Background
Bundled consent, the practice of obtaining anticipatory consent for a predefined set of intensive care unit procedures, increases the rate of informed consent conversations and incorporation of patients’ wishes into medical decision-making without sacrificing patients’ or surrogates’ understanding. However, the adoption rate for this practice in academic and nonacademic centers in the United States is unknown.
Objective
To determine the national prevalence of use of bundled consent in adult intensive care units and opinions related to bundled consent.
Methods
A random sample of US hospitals with medical/surgical intensive care units was selected from the AHA [American Hospital Association] Guide. One intensive care unit provider (bedside nurse, nurse manager, or physician) from each hospital was asked to self-report use of per-procedure consent versus bundled consent, consent rate for intensive care unit procedures, and opinions about bundled consent.
Results
Of the 238 hospitals contacted, respondents from 100 (42%) completed the survey; 94% of respondents were nurses. The prevalence of bundled consent use was 15% (95% CI, 9%–24%). Respondents using per-procedure consent were more likely than those using bundled consent to self-report performing invasive procedures without consent. Users of bundled consent unanimously recommended the practice, and 49% of respondents using per-procedure consent reported interest in implementing bundled consent.

Preoperative Patient Education Class during an Orthopaedic Mission Trip: Effects on Knowledge, Anxiety, and Informed Consent
Mitchell A. Solano, Kaaleswar K. Ramcharran, Lynne C. Jones, Robert S. Sterling, David R. Samaroo, Harpal S. Khanuja
The Journal of Arthroplasty, 1 May 2020
Abstract
Background
Patient knowledge about arthritis and risks, benefits, and outcomes of joint replacement in developing countries is unknown. We evaluated the effectiveness of a preoperative class on improving knowledge and decreasing anxiety during a surgical mission trip offering total joint replacement surgery.
Methods
A team of U.S. healthcare providers taught a preoperative class to 41 patients selected for total joint replacement during a surgical mission trip to Guyana. Participants completed a 32-point survey about arthritis; indications, risks, and benefits of joint replacement; and postoperative, in-patient rehabilitation expectations. The State-Trait Anxiety Inventory was used to measure participant anxiety. Participants completed identical surveys before and after class. Matched-pairs Student’s t-tests were used to compare means between pre- and post-class surveys. Significance was accepted at P < .05.
Results
Seventy-eight percent of patients (31/41) scored less than 12 of 32 possible points (40%) on the pre-class knowledge questionnaire. Mean ± standard deviation knowledge scores improved from 14.0 ± 4.5 before the class to 16.5 ± 6.5 after the class (P = .008). Anxiety scores (n = 33) improved from 35 ± 13 before the class to 33 ± 12 after the class (P = .047).
Conclusion
On this surgical mission trip, underserved patients’ knowledge about total joint replacement increased only modestly after taking a preoperative class. Greater understanding of how to educate patients and reduce their anxiety on medical missions is needed.

Patient Preferences Regarding Informed Consent Models for Participation in a Learning Health Care System for Oncology
Rochelle D. Jones, Chris Krenz, Michele Gornick, Kent A. Griffith, Rebecca Spence, Angela R. Bradbury, Raymond De Vries, Sarah T. Hawley, Rodney A. Hayward, Robin Zon, Sage Bolte, Navid Sadeghi, Richard L. Schilsky, Reshma Jagsi
JCO Oncology Practice, 30 April 2020
Abstract
Purpose
The expansion of learning health care systems (LHSs) promises to bolster research and quality improvement endeavors. Stewards of patient data have a duty to respect the preferences of the patients from whom, and for whom, these data are being collected and consolidated.
Methods
We conducted democratic deliberations with a diverse sample of 217 patients treated at 4 sites to assess views about LHSs, using the example of CancerLinQ, a real-world LHS, to stimulate discussion. In small group discussions, participants deliberated about different policies for how to provide information and to seek consent regarding the inclusion of patient data. These discussions were recorded, transcribed, and de-identified for thematic analysis.
Results
Of participants, 67% were female, 61% were non-Hispanic Whites, and the mean age was 60 years. Patients’ opinions about sharing their data illuminated 2 spectra: trust/distrust and individualism/collectivism. Positions on these spectra influenced the weight placed on 3 priorities: promoting societal altruism, ensuring respect for persons, and protecting themselves. In turn, consideration of these priorities seemed to inform preferences regarding patient choices and system transparency. Most advocated for a policy whereby patients would receive notification and have the opportunity to opt out of including their medical records in the LHS. Participants reasoned that such a policy would balance personal protections and societal welfare.
Conclusion
System transparency and patient choice are vital if patients are to feel respected and to trust LHS endeavors. Those responsible for LHS implementation should ensure that all patients receive an explanation of their options, together with standardized, understandable, comprehensive materials.

Editor’s note: JCO Oncology Practice is an American Society of Clinical Oncology Journal.

The effect on consent rates for deceased organ donation in Wales after the introduction of an opt-out system
Original Article
Madden, D. Collett, P. Walton, K. Empson, J. Forsythe, A. Ingham, K. Morgan, Murphy, J. Neuberger, D. Gardiner
Anaesthesia, 16 March 2020
Open Access
Summary
Organ transplantation saves and transforms lives. Failure to secure consent for organ retrieval is widely regarded as the single most important obstacle to transplantation. A soft opt-out system of consent for deceased organ donation was introduced into Wales in December 2015, whilst England maintained the existing opt-in system. Cumulative data on consent rates in Wales were compared with those in England, using a two-sided sequential procedure that was powered to detect an absolute difference in consent rates between England and Wales of 10%. Supplementary risk-adjusted logistic regression analysis examined whether any difference in consent rates between the two nations could be attributed to variations in factors known to influence UK consent rates. Between 1 January 2016 and 31 December 2018, 8192 families of eligible donors in England and 474 in Wales were approached regarding organ donation, with overall consent rates of 65% and 68%, respectively. There was a steady upward trend in the proportion of families consenting to donation after brain death in Wales as compared with England and after 33 months, this reached statistical significance. No evidence of any change in the donation after circulatory death consent rate was observed. Risk-adjusted logistic regression analysis revealed that by the end of the study period the probability of consent to organ donation in Wales was higher than in England (OR [95%CI] 2.1 [1.26–3.41]). The introduction of a soft opt-out system of consent in Wales significantly increased organ donation consent though the impact was not immediate.

Surgeon clinical practice variation and patient preferences during the informed consent discussion: a mixed-methods analysis in lumbar spine surgery
Ali Zahrai, Kunal Bhanot, Xin Y. Mei, Eric Crawford, Zachary Tan, Albert Yee, Valerie Palda
Canadian Journal of Surgery, 10 October 2019; 63(3)
Open Access
Abstract
Background
Patients with lumbar disc herniation may greatly benefit from microdiscectomy. Although spine surgeons performing microdiscectomy routinely obtain informed consent, the potential adverse events they disclose often vary. Moreover, little is known about what disclosures are deemed most valuable by patients. The aim of this mixed-methods study was to determine practice variations among spine surgeons in regard to the disclosure of potential adverse events during informed consent discussions
for lumbar microdiscectomy and to determine which topics patients perceived to be valuable in the consent discussion.
Methods
A survey evaluating the frequency with which spine surgeons disclose 15 potential adverse events related to lumbar microdiscectomy during informed consent discussions was distributed among Canadian Spine Society members. Additionally, semistructured interviews were conducted with preoperative patients, postoperative patients, attending spine surgeons, spine fellows and orthopedic residents. Interview transcripts were analyzed using thematic analysis with open coding.
Results
Fifty-one Canadian Spine Society members completed the survey. The number of potential adverse events not routinely discussed was greater among orthopedic surgeons than among neurosurgeons (relative risk 1.83; 95% confidence interval 1.22–2.73; p = 0.003). Three preoperative patients, 7 postoperative patients, 6 attending spine surgeons, 3 spine fellows and 5 orthopedic residents participated in the semistructured interviews. The interviews identified gaps in information provided to patients, particularly on topics relating to postoperative care such as expected recovery time, activity restrictions and need for a caregiver.
Conclusion
There is variation in the disclosure of potential adverse events during informed consent discussions for lumbar microdiscectomy among Canadian spine surgeons. Patients desire more information regarding their postoperative care. Further research should focus on developing guidelines to reduce practice variation and optimize the effectiveness of consent discussions.

Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Rohi Shah, Sharan Sambhwani, Awf Al-Shawani, Christos Plakogiannis
Annals of Medicine and Surgery, 8 April 2020
Open Access
Abstract
Background
The Montgomery case in 2015 resulted in a pivotal change in practice, leading to a patient-centric approach for informed consent. Neck of femur fractures are associated with a high rates perioperative morbidity and mortality. Using guidelines highlighted by the British Orthopaedic Association we performed a multi-loop audit within our department to assess the adequacy of informed consent for NOF fractures.
Methods
Two prior cycles had been performed utilising a similar framework. Prior interventions included ward posters, verbal dissemination of information at Doctor’s induction and amendments to the JD handbook. For the latest audit loop, a retrospective analysis of 100 patients was performed. Risk factors were classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation in the signed Consent Form-1s.
Results
Infection, bleeding risks, clots and anaesthetic risks were documented in all patients(100%). Areas of improvement included documentation of neurovascular injuries(98%), pain(75%) and altered wound healing(69%). There was no significant change in the documentation of failure of surgery(83%) neurovascular injuries(98%). Poorly documented risk factors included mortality(21%), prosthetic dislocation(14%) and limb length discrepancy(6%).
Conclusion
Following the latest cycle, the trust has now approved the use of 2 consent-specific stickers(arthroplasty/fixation), amendable on a patient-to-patient basis. As part of the multi-loop process, the cycle will be repeated every year-in line with Junior Doctor rotations. Medical professionals have an ethical, moral and legal obligation to ensure they provide all information regarding surgical interventions to aid patients in making an informed decision.

Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking
Brief Communication
C Tortorella, C Solaro, P Annovazzi, L Boffa, M C Buscarinu, F Buttari, M Calabrese, P Cavalla, E Cocco, C Cordioli, G De Luca, M Di Filippo, R Fantozzi, D Ferraro, A Gajofatto, A Gallo, R Lanzillo, A Laroni, S Lo Fermo, S Malucchi, G T Maniscalco, M Moccia, V Nociti, D Paolicelli, I Pesci, L Prosperini, P Ragonese, V Tomassini, V L A Torri Clerici, M Rodegher, M Gherardi, C Gasperini, RIReMS Group
Neurological sciences, 2 Apr 2020
Abstract
In the last years, change in multiple sclerosis (MS) therapeutic scenario has highlighted the need for an improved doctor-patient communication in advance of treatment initiation in order to allow patient’s empowerment in the decision-making process. AIMS: The aims of our project were to review the strategies used by Italian MS specialists to inform patients about treatment options and to design a multicentre shared document that homogenizes the information about disease-modifying treatment (DMTs) and the procedure of taking informed consent in clinical practice. RESULTS: The new resource, obtained by consensus among 31 neurologists from 27 MS Centres in Italy with the supervision of a medico-legal advisor, received the aegis of Italian Neurological Society (SIN) and constitutes a step toward a standardized decision process around DMTs in MS.

Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Review
Tahlia Scheinberg, Alison Young, Henry Woo, Annabel Goodwin, Kate L. Mahon, Lisa G. Horvath
Asia-Pacific Journal of Clinical Oncology, 29 February 2020; pp 1–15
Open Access
Abstract
As demand for germline genetic testing for cancer patients increases, novel methods of genetic counseling are required. One such method is the mainstream consent pathway, whereby a member of the oncology team (rather than a genetic specialist) is responsible for counseling, consenting, and arranging genetic testing for cancer patients. We systematically reviewed the literature for evidence evaluating mainstream pathways for patients with breast, ovarian, colorectal, and prostate cancer. Medline, EMBASE, and Cochrane Library were searched for studies that met inclusion and exclusion criteria. Article references were checked for additional studies. Trial databases were searched for ongoing studies. Of the 13 papers that met inclusion criteria, 11 individual study groups were identified (two study groups had two publications each). Ten of the 11 studies evaluated the acceptability, feasibility, and impact of BRCA testing for patients and/or clinicians in different clinical settings in breast and ovarian cancer, while the final study explored the attitudes of colorectal specialists toward genetic testing for colorectal cancer. None involved prostate cancer. Overall, mainstream pathways were acceptable and feasible. Medical oncologist and nurse-driven pathways were particularly successful, with both patients and clinicians satisfied with this process. Although the content of pretest counseling was less consistent compared with counseling via the traditional model, patients were largely satisfied with the education they received. Further research is required to evaluate the mainstream pathway for men with prostate cancer.