Improving the Consent Process in Foot and Ankle Surgery With the Use of Personalized Patient Literature.

A patient-specific letter was introduced to the consent process to observe the effect, if any, on information recall and satisfaction for patients undergoing elective foot and ankle surgery. The patients attending the clinic were written a personalized letter-this was a simple personalized letter that outlined their treatment options, the proposed management plan, likely treatment course, and the benefits, risks, and likely period required for recovery. The personalized letter system was compared with the 2 existing methods of consent process: signing for consent at their outpatient encounter at which they were scheduled for surgery and a separate consent clinic without the personalized letter. A total of 111 patients (87 females, 24 males) undergoing elective foot and ankle surgery were assessed on the day of surgery for recall of the procedure, risks, postoperative course, and satisfaction with the consent process. Patients receiving a personalized letter recalled more than those who had attended a routine preoperative consent clinic visit and significantly more than those who had provided consent at their last clinic visit. Patient satisfaction with the consent process was also greater in the personalized group. Our results suggest that the consent process is improved using routine preoperative consent clinics and, most notably, with patient-specific information to improve patient recall and satisfaction.

Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms.

INTRODUCTION: Completion of hand-written consent forms for surgical procedures may suffer from missing or inaccurate information, poor legibility and high variability. We audited the completion of hand-written consent forms and trialled a web-based application to generate modifiable, procedure-specific consent forms. METHODS: The investigation comprised two phases at separate UK hospitals. In phase one, the completion of individual responses in hand-written consent forms for a variety of procedures were prospectively audited. Responses were categorised into three domains (patient details, procedure details and patient sign-off) that were considered "failed" if a contained element was not correct and legible. Phase two was confined to a breast surgical unit where hand-written consent forms were assessed as for phase one and interrogated for missing complications by two independent experts. An electronic consent platform was introduced and electronically-produced consent forms assessed. RESULTS: In phase one, 99 hand-written consent forms were assessed and the domain failure rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparoscopic cholecystectomy was the most common procedure (7/99) but there was significant variability in the documentation of complications: 12 in total, a median of 6 and a range of 2-9. In phase two, 44% (27/61) of hand-written forms were missing essential complications. There were no domain failures amongst 29 electronically-produced consent forms and no variability in the documentation of potential complications. CONCLUSION: Completion of hand-written consent forms suffers from wide variation and is frequently suboptimal. Electronically-produced, procedure-specific consent forms can improve the quality and consistency of consent documentation.

[Living will, durable power of attorney and legal guardianship in the trauma surgery routine : Data from a geriatric trauma center]. / Patientenverfügung, Vorsorgevollmacht und gesetzliche Betreuung im unfallchirurgischen Alltag : Zahlen aus einem alterstraumatologischen Zentrum.

BACKGROUND: Due to the increasing number of elderly patients, trauma surgeons are often confronted with end-of-life treatment decisions. Advance directives can help reduce the lack of clarity in those situations. OBJECTIVES: The aim of this study was to identify the presence of living wills, durable power of attorney, legal guardianship and appointment of guardianship in the geriatric trauma center of a university hospital. MATERIALS AND METHODS: The data of all patients treated in our geriatric trauma center from 01/01/2013 to 03/31/2014 were analyzed regarding the presence of a living will, durable power of attorney, legal guardianship and appointment of guardianship as well as the procedure of documenting those items. RESULTS: Out of 181 patients, 63 % (n = 114) had one or more of these documents. Most frequently used was the durable power of attorney in 33 % (n = 59), followed by a living will in 27 % (n = 48), legal guardianship in 20 % (n = 37) and appointment of guardianship in 7 % (n = 12). The existence of those documents was recorded in 88 % (n = 100) of patients within 24 h after admission; documentation in the medical records was found in 58 % (n = 66). CONCLUSION: A large proportion of patients had one or more of the documents named above. In this respect, standardized documentation of advance directives in the medical record is an important issue for all persons involved.

Do surgeons and patients discuss what they document on consent forms?

BACKGROUND: Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. METHODS: We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. RESULTS: Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. CONCLUSIONS: The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need.

Opting out: confidentiality and availability of an 'alibi' for potential living kidney donors in the USA.

Ethicists and guidelines have suggested that potential living kidney donors who withdraw from evaluation be offered an 'alibi.' We sought to determine what potential living kidney donors are told about their ability to opt out, alibi availability and postwithdrawal confidentiality. We reviewed 148 consent forms for living kidney donor evaluation from US transplant centres that performed >5 living kidney transplants in 2010-2011 (response rate 87%). We found that while 98% of centres used evaluation consent forms that indicated that the donor could withdraw, only 21% of these documents offered an alibi. Another 23% of centres' consent forms indicated that the transplant team would be willing to inform the intended recipient that an individual was not a potential donor. Relatively few consent documents explicitly addressed the confidentiality of the donor's health information (31%), candidacy status (18%), decision (24%) or reasons (23%) following withdrawal. To preserve potential donors' autonomy and relationships, we advocate that all transplant centres offer general alibis in their evaluation consent forms. We conclude by offering recommendations for evaluation consent discussions of opting out, alibis and postwithdrawal confidentiality.

Assessment of Breast Cancer Patients' Knowledge and Decisional Conflict Regarding Tamoxifen Use.

Breast cancer is the most common type of female cancer. Tamoxifen, a selective estrogen receptor modulator, is widely used to decrease breast cancer recurrence and mortality among patients. However, it also increases the risk of endometrial cancer. This study aimed to assess knowledge and decisional conflict regarding tamoxifen use. Between June and October 2014, breast cancer patients using tamoxifen were consecutively screened and requested to complete a survey including the EQ-5D, Satisfaction with Decision Scale (SWD), Decisional Conflict Scale (DCS), and a self-developed, 15-item questionnaire measuring tamoxifen-related knowledge. The study sample comprised 299 patients. The mean total knowledge score was 63.4 of a possible 100.0 (range, 13.3-93.3). While 73.9% of the participants knew that tamoxifen reduces the risk of breast cancer recurrence, only 57.9% knew that the drug increases endometrial cancer risk. A higher education level (≥ college) was associated with a higher, total knowledge score (ß = 4.291; P = 0.017). A higher knowledge score was associated with a decreased DCS score (ß = -0.366; P < 0.001). A higher SWD score was also associated with decreased decisional conflict (ß = -0.178; P < 0.001). In conclusion, the breast cancer patients with higher levels of tamoxifen-related knowledge showed lower levels of decisional conflict regarding tamoxifen use. Clinicians should provide the exact information about tamoxifen treatment to patients, based on knowledge assessment results, so as to aid patients' decision-making with minimal conflict.

[Informative Texts for Rehabilitation Patients are Difficult to Understand]. / Informationstexte für Rehabilitanden sind schwer verständlich.

OBJECTIVE: To check the intelligibility of informational texts written for rehabilitation patients. METHOD: Most investigated texts came from rehabilitation providers, patient organizations and health portals (8 texts), and from 50 rehabilitation facilities for musculoskeletal conditions (145 texts). We added a self-written booklet in plain language. All texts dealt with the goals and substance of rehabilitation. Readability formulas were computed for each text, and the Hamburg approach to intelligibility was applied. RESULTS: Only highly educated people will find the documents easily to understand, except for our self-written booklet, which is also comprehensible to lower secondary school leavers. CONCLUSION: The informational texts are of little help for people who are undecided whether or not to participate in rehabilitative measures and for rehab patients in preparatory stages. Issuing organizations are overburdened with the task of wording in a comprehensible manner, and should consider seeking assistance by professional writers or providing training for their staff.

US public cord blood banking practices: recruitment, donation, and the timing of consent.

BACKGROUND: Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. STUDY DESIGN AND METHODS: Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. RESULTS: Thirteen of 16 participants reported a variably high percentage of women who consented to public cord blood donation. Fifteen banks offered donor registration at the time of hospital admission for labor and delivery. Seven obtained full informed consent and medical history during early labor and eight conducted some form of phased consent and/or phased medical screening and history. Nine participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. CONCLUSION: Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That and the targeted location of cord blood collection sites are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking.

School-based survey participation: oral health and BMI survey of Ohio third graders.

During the 2009-2010 school year, the Ohio Department of Health conducted a statewide oral health and body mass index (BMI) screening survey among 3rd grade children. This marked the fifth school-based survey regarding the oral health of Ohio children since 1987. At 50 %, the participation rate of the 2009-2010 oral health and BMI survey was at the lowest level ever experienced. This study aimed to identify the factors associated with participation rates in a school-based survey. A stratified, random sample of 377 schools was drawn from the list of 1,742 Ohio public elementary schools with third grade students. All third grade children in the sampled schools with parent or guardian consent received an oral health screening and height/weight measurement by trained health professionals. Participation rates at the school level were then combined with data on school characteristics and survey implementation. Predictors of school form return, participation, and refusal rates were assessed by generalized linear modeling (GLM). High student mobility and larger school size were associated with lower form return (p = 0.000 and p = 0.001, respectively) and lower participation rates (p = 0.000 and p = 0.005, respectively). Surveying in the fall or spring (as opposed to winter) significantly decreased form return (p = 0.001 and p = 0.016, respectively) and participation rates (p = 0.008 and p = 0.002, respectively), while being surveyed by internal staff (versus external screeners) significantly increased form return (p = 0.003) and participation rates (p = 0.001). Efforts to increase participation should focus more on schools with higher student mobility and larger size. Additionally, participation could be improved by using internal staff and surveying during winter.

Consenting for risk in common ENT operations: an evidence-based approach.

Pre-operative consent discussion and documentation is an essential process that should follow relevant guidance, and include all serious or frequently occurring risks. We assessed the appropriateness of consent for grommet insertion, tonsillectomy, septoplasty, and hemithyroidectomy, by comparing the risks listed in current consenting practice to published complication data for the relevant operation. 120 consent forms and associated clinic letters were analysed. A literature search identified published complication data for comparison. There was great variation in consent practice for each operation type, and poor correlation with published risk incidence. Only 'bleeding' post-tonsillectomy and 'recurrent laryngeal nerve injury' post hemithyroidectomy were listed in 100 % of relevant cases. Common and serious complications were frequently omitted from forms. The number and type of risks consented for a procedure significantly differed between consultant and non-consultant staff. The potential requirement for blood transfusion was discussed in only 20 % of tonsillectomy cases. Currently, the pre-operative consent for commonly performed ENT operations does not reflect operative risks. Consenting for surgical complications should be evidence based using published or personal data. A change in the consent process is required to protect patient autonomy and meet both legal and professional body requirements.

Higher organ donation consent rates by relatives of potential uncontrolled donors versus potential controlled donors after death.

BACKGROUND: Refusal to consent to organ donation is an important cause of the persisting gap between the number of potential organ donors and effectuated donors. In the Netherlands, organ donors include both uncontrolled donors: donors who die unexpectedly after cardiac death (DCD), after failed resuscitation and donors in whom death can be expected and donors after brain death, and controlled DCD donors: those who die after the withdrawal of treatment. Different donor type implies a different setting in which relatives are requested to consent to organ donation. It is unknown whether the setting influences the eventual decision for donation or not. Therefore, we compared the consent rate in potential donors who died unexpectedly (UD group) and in whom death was expected. METHODS: A total of 523 potential organ donors between 2003 and 2011 in the 715-bed Maastricht University Medical Centre, the Netherlands were included. Both the patients' registration in the national donor register (DR) and the relatives' refusal rate in the two groups were retrospectively assessed using data from the donation application database. RESULTS: There were 109 unexpected and 414 expected potential donors The potential donors in the UD group were younger (mean age 52 versus 55 years, P = 0.032) and more often male (68 versus 52%, P = 0.003). There were no significant differences in registration in the DR between the groups. The relatives' consent rate in non-registered potential donors, or those who mandated the relatives for that decision, was higher in the UD group (53 versus 29%, P < 0.001). CONCLUSIONS: Less than 50% of the potential donors were registered in the national DR. Therefore, the relatives have an important role in the choice for organ donation. The relatives of potential donors who died unexpectedly consented more often to donation than those in whom death was expected.

Analysis of informed consent document utilization in a minimal-risk genetic study.

BACKGROUND: The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. OBJECTIVE: To examine the use of online consent documents in a minimal-risk genetic study. DESIGN: Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. SETTING: University of Michigan Campus, Ann Arbor, Michigan. PARTICIPANTS: Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. MEASUREMENTS: Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. RESULTS: The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. LIMITATION: The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. CONCLUSION: Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. PRIMARY FUNDING SOURCE: National Institutes of Health.

Recognition of mental incapacity when consenting patients with intracranial tumours for surgery: how well are we doing?

INTRODUCTION: Many patients with intracranial tumours have cognitive deficits that might affect their mental capacity to give valid consent to neurosurgical treatment. The aim of this study was to determine the incidence of mental incapacity, as assessed by neurosurgeons, in patients with intracranial tumours undergoing neurosurgery. METHODS: The case notes of successive patients undergoing brain tumour surgery between 16 October 2008 and 16 October 2010 were reviewed. The frequency of use of standard consent forms and Certificates of Incapacity was recorded. In addition, the frequency and scores of pre-operative cognitive assessments were recorded. RESULTS: Case notes of 247 of 262 patients undergoing surgery for intracranial tumours were reviewed since there was no record of either a standard consent form or a Certificate of Incapacity in the case notes for 15 patients. Nine of 247 brain tumour patients were issued with a Certificate of Incapacity (3.6%, 95% CI 1.6-6.8%), while 238 (96.4%) signed a standard consent form. Seven of these nine had high-grade gliomas, for an incidence of incapacity of 5.9% (95% CI 2.8-11.8%), while the remaining two Certificates of Incapacity were issued for patients with meningiomas (incidence 3%; 95% CI 0.04-10.4%). Fifty of the 262 patients (19%) had some form of pre-operative cognitive assessment documented, but only three of these were issued with a Certificate of Incapacity. All three patients issued with a Certificate of Incapacity had Mini-Mental State Examination scores suggestive of cognitive impairment. CONCLUSIONS: Incapacity to consent to brain tumour surgery, as assessed by neurosurgeons, is uncommon. The incidence of incapacity is less than might be expected given the level of cognitive impairment known in this population. Decisions about capacity by neurosurgeons are often made in the absence of any documented assessment of cognition or other objective evidence that could support their decision in the event of dispute.

[Use of joint crisis plans in psychiatric hospitals in Germany: results of a nationwide survey]. / Anwendung psychiatrischer Behandlungsvereinbarungen in Deutschland : Ergebnisse einer bundesweiten Befragung.

OBJECTIVE: Joint crisis plans in psychiatry are consensus-oriented instruments for patients to state their will in case of a crisis. The aim of this survey is to determine the prevalence, practice and barriers for implementation of joint crisis plans in Germany. METHODS: In spring 2009, 366 psychiatric hospitals in Germany were asked to complete a questionnaire. RESULTS: The return rate was 46.4%; 68% of the participating hospitals offered joint crisis plans. The number of completed joint crisis plans was low (median 2.7/year per clinic). The demand did not increase according to a majority of the hospitals. The main reason for hospitals to abstain from joint crisis plans was low demand. Hospitals providing the option of joint crisis plans reported positive experiences. CONCLUSIONS: A theoretical offer of joint crisis plans is widespread in German psychiatric hospitals. Despite positive experiences, patients do not ask for them frequently.

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

OBJECTIVES: To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. METHODS: The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. RESULTS: The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. CONCLUSIONS: This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

Fragility of randomized trials supporting cancer drug approvals stratified by approval pathway and review designations.

BACKGROUND: It has been suggested that the results from fragile trials are less likely to translate into benefit in routine clinical practice. METHODS: We searched the Food and Drug Administration (FDA) archives to identify drug approvals for solid organ malignancies between 2010 and 2019. We calculated the Fragility Index (FI) supporting each approval, using methods to account for time-to-event. We compared FI and trial and approval characteristics using Mann-Whitney U and Kruskal-Wallis test. Using logistic regression, we examined study characteristics associated with withdrawal of consent or lost to follow-up (WCLFU) exceeding the calculated FI. RESULTS: The median FI among 125 included studies was 23 (range 1-322). The FI was ≤10 in 35 studies (28%), 11-20 in 21 (17%), and >20 in 69 (55%). The median FI/Nexp was 7.7% (range 0.1-51.7%). The median FI was significantly lower among approvals processed through the accelerated vs regular pathway (5.5 vs 25, p = 0.001), but there was no difference in median FI/Nexp. The WCLFU exceeded FI in 42% of studies. Overall survival endpoints were more likely to have a WCLFU exceeding FI (OR 3.16, p = 0.003). WCLFU exceeding FI was also associated with a lesser magnitude of effect (median HR 0.69 vs 0.55, p < 0.001). In a sensitivity analysis including only studies with 1:1 randomization, 51% of studies had WCLFU >FI. CONCLUSION: The median FI among all trials was 23, and WCLFU exceeded FI in 42%. Comparative trials in solid tumors supporting approval through the accelerated pathway are more fragile compared to trials approved through the regular pathway, an observation likely explained by a lower sample size in the experimental arm.