Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials.

This paper presents an examination of the process of recruitment in cancer clinical trials. This research was undertaken as part of a larger study which sought to assess the psychosocial impact of participation in phases I and II anti-cancer drug trials from the patient's perspective. Through a combination of in-depth interviews with 55 patients who were offered participation in a clinical trial, and reading ease assessments of the written information they were given, patients' experiences of recruitment to the trial and their perceptions of the informed consent process were obtained. The results indicate that patients decisions may be influenced by the way information was presented to them verbally and that the written information was difficult for them to understand. This aspect of the research identified the powerful influence of the verbal consultation when seeking consent for trial involvement, the lack of understanding patients had of what they were taking part in and the need to address the readability of the written information with which they are provided.     

Impact of risk information in a patient education leaflet

Informed consent requires the communication of information about possible adverse effects of treatment. Health professionals have expressed concern that increased provision of risk information may make patients unduly anxious and change their decisions about treatment. This study compared two patient leaflets about laparoscopy, one containing detailed information about potential side effects. Forty one consenting participants attending an outpatient gynaecology clinic and scheduled for an elective laparoscopic procedure were studied. They were randomly assigned to receive one of two leaflets after their consultation. Knowledge about laparoscopy, satisfaction with information provided, and anxiety were tested 2 days later, between the original consultation and their operation. Results showed that the leaflet containing detailed risk information was associated with greater knowledge about laparoscopy, higher satisfaction with information provision and no increase in anxiety. Provision of detailed information about possible adverse consequences of treatment can improve patients' understanding and satisfaction without inducing increased anxiety.     

Perceived organizational affiliation and its effects on patient trust: Role modeling with embodied conversational agents

ObjectiveVerbal and non-verbal behaviors, which are known as “relational contextualization cues”, relay information about relationships and how they are structured. We developed a computer-simulated provider conducting an informed consent process for clinical research to investigate the effects of a provider’s alignment of interests with a patient, the research team, or a neutral party on patient trust in the provider.MethodsParticipants (N = 43) interacted with a simulated provider for a research informed consent process in a three-arm, counterbalanced, within-subjects experiment. Participants reported their trust in the simulated provider after each treatment.ResultsParticipants successfully recognized the alignment manipulation, and perceived the patient-aligned provider as more trustworthy than the other providers. Participants were also more satisfied with the patient-aligned provider, liked this provider more, expressed more desire to continue working with this provider, and stated that they were significantly more likely to sign the consent form after interacting with this provider compared to the other two.ConclusionRelational contextualization that aligns with the patient increases trust, satisfaction, and willingness to enroll in the context of research informed consent.Practice implicationsHealth providers should align themselves with patients’ interests.     

The impact of a preoperative information leaflet on expectation management,satisfaction and patient outcomes in patients undergoing knee arthroscopy

BackgroundThis study examined the effects of a patient information leaflet on outcomes related to patient satisfaction following knee arthroscopy.MethodsCohort study of patients listed for knee arthroscopy under the care of a single surgeon over a nine-month period (May 2017–January 2018) following the introduction of an information leaflet as an adjunct to the consent process. Outcome data was collected postoperatively through telephone follow-up. Outcome measures included feelings of involvement with decision-making, expectations being met, satisfaction, postoperative pain numerical rating scales and the Forgotten Joint Score-12.ResultsFifty-five patients were consented by the operating surgeon, of which 28 (50.9%) received a leaflet and 27 (49.1%) did not. Patients who received the information leaflet felt more involved in and informed about the decision to have an operation than patients who did not (p = 0.016), however there were no differences in any other outcomes between patients who did and did not receive a leaflet (p > 0.05).ConclusionsThe use of an information leaflet as an adjunct to the preoperative consultation is an effective way of helping patients feel more involved in the surgical decision-making process, however this does not influence overall outcome or satisfaction metrics.     

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient,Caregiver, and Provider Perspectives

One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a “reasonable person.” However, research is limited on what types of information patients, caregivers, and providers consider “key information.” Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences.     

Informed consent and patient videotaping.

PURPOSE: To determine whether videotaping consent forms used in family medicine residencies meet the criteria for informed consent, adhere to published guidelines for videotaping patients, and are written at a suitable reading level. METHOD: Three reviewers independently evaluated videotaping consent forms obtained from 20 family practice residencies to determine whether they included the elements of informed consent and conformed to published guidelines for ethical videotaping. The reading level of each consent form was also determined using a standardized assessment. RESULTS: Depending on the reviewer, only one to three of the 20 consent forms were judged adequate in providing a patient with enough information to make an informed choice. Specific aspects of voluntariness were absent from most of the forms. In addition, the reading level was, on average, well above recommended levels for patient comprehension. CONCLUSION: Most of the videotaping consent forms analyzed in this study did not provide adequate information to assist patients in making a voluntary, informed choice to be videotaped. The absence of this information raises the potential for violations of patient privacy and confidentiality.     

Information and informed consent in a longitudinal screening involving children: a questionnaire survey

This empirical study explores participants' perceptions of information and understanding of their children's and their own involvement in a longitudinal screening, the ABIS Study. ABIS (All Babies In Southeast Sweden) is a multicentre, longitudinal research screening for Type 1 diabetes and multifactorial diseases involving 17 005 children and their families. For this study, a random selection of mothers was made, using perinatal questionnaire serial numbers from the ABIS study. In total, 293 of these mothers completed an anonymous questionnaire (response rate 73.3%). Our findings from the questionnaire indicate a marked difference between the reported satisfaction with and understanding of the information provided on the one hand and the significant lack of knowledge of some of the aims and methods of the ABIS screening on the other, namely concerning high-risk identification of involved children, potential prevention and future questionnaires. Two questions evoked by our results are: (1) what information is required for participants in longitudinal studies involving children? and (2) how do we ensure and sustain understanding, and thus in a prolonging, informed consent in these studies? This study underlines the importance of an increased understanding of the ethical issues that longitudinal research on children raise and the need to discuss how information and informed consent strategies should be analysed and designed in longitudinal studies.     

Information booklets about cancer:: factors influencing patient satisfaction and utilisation

Providing patients with adequate information is an important component of care. This exploratory study investigated factors influencing patient satisfaction with and utilisation of information booklets. The research was conducted in two stages. In stage 1, five commonly used cancer information booklets were reviewed by 36 Australian patients who were either receiving chemotherapy or had just completed treatment. Data were collected on patient satisfaction with, preference for and utilisation of information booklets. In addition data were collected on variables identified in the literature as potentially influencing patient satisfaction, including patient characteristics, presentation and readability of booklets, and the timing of provision. A high level of satisfaction was found for all five information booklets, although a clear preference for one particular booklet emerged. The most notable feature of this booklet was its readability level (grade 8); in contrast the other booklets were written at levels equivalent to grades 11–12. Stage 2 focused on the effects of patient information preference style on their satisfaction and recall of information presented in two booklets in the course of their treatment. No differences were found between patients who seek information and those who avoid it. The findings of this study suggest that patients' information needs may be better met if information booklets are written in plain English, and presented to patients prior to treatment. Future studies incorporating a larger sample of patients and greater selection and variety of information booklets are required to further determine if patient characteristics and features of booklet presentation influence patient satisfaction and preference.     

How do consent forms for diagnostic high‐throughput sequencing address unsolicited and secondary findings? A content analysis

Whole exome and whole genome sequencing are increasingly being offered to patients in the clinical setting. Yet, the question of whether, and to what extent, unsolicited findings (UF) and/or secondary findings (SF) should be returned to patients remains open and little is known about how diagnostic consent forms address this issue. We systematically identified consent forms for diagnostic genomic sequencing online and used inductive content analysis to determine if and how they discuss reporting of UF and SF, and whether patients are given options regarding the return of these results. Fifty‐four forms representing 38 laboratories/clinics were analyzed. A quarter of the forms did not mention UF or SF. Forms used a variety of terms to discuss UF and SF, sometimes using these interchangeably or incorrectly. Reporting policies for UF varied: 5 forms stated that UF will not be returned, 15 indicated UF may be returned, and 28 did not specify their policy. One‐third indicated their laboratory returns SF. Addressing inconsistent terminology and providing sufficient information about UF/SF in consent forms will increase patient understanding and help ensure adequate informed consent.     

Patients' perceptions on informed consent and the quality of information disclosure in clinical trials

In a survey on 26 clinical trials we studied how patients experience and evaluate the information disclosure on the clinical trial they are enrolled in and which factors influence patients' perceptions of information disclosure. Our objective was to obtain more insight thereby in how informed consent is applied in the daily practice of clinical trials. Interviews were held with 198 adult patients and 32 trial-clinicians. Instead of focusing on patient comprehension of the information disclosed we analyzed patient perceptions of informed consent. Patients proved to be quite satisfied with the oral and written information disclosure. Patients' perceptions of the manner and content of information disclosure are influenced by more general attitudes towards medical care, research and institutions. Patients' trust in medical experiments, belief in the integrity of physicians and interest in medical affairs have an impact on the way patients perceive information disclosure. To improve the quality of the informed consent procedure, we propose a patient motivation classification (PMC) to enable trial-clinicians to gain more insight into patient motivation. Relevant factors found in our data have been used as criteria for classification. An informed decision making checklist (IDC) is suggested for patients as a general outline for patient education, covering relevant socio-psychological factors of enrolment.     

恶性肿瘤患者及家属信息需求现状的多中心研究

目的 探究恶性肿瘤患者及家属信息需求的现状和影响因素,及其对患者心理状况的影响。方法 本研究为多中心横断面调查研究,于2016年1月~2018年7月采用信息需求调查问卷、患者抑郁自评工具（PHQ-9）及广泛性焦虑量表（GAD-7）对恶性肿瘤患者及家属展开调查,并对结果进行统计分析。结果 多数患者及家属认为医务人员是主要信息来源,大部分患者及家属对于患者病情的知晓表示满意。对于“患者治愈可能性”“治疗方法”以及“治疗后复发转移的可能性”,大部分患者及家属认为自己从医务人员或家属处获得了有关的信息;对于“预期寿命”,61.38%的肿瘤患者认为自己未从医务人员以及家属处获得有关信息,53.47%的家属认为自己并未从医务人员处获得有关“患者预期寿命”的信息;对于“患者治愈可能性”“治疗后复发转移的可能性”及“预期寿命”,认为自己“未被告知”的家属比例低于患者;对于目前病情知晓表示满意的患者以及认为自己了解日常生活注意事项的患者更不容易发生焦虑或抑郁。结论 多数患者及家属并未从医务人员处获得关于患者的预期寿命的信息,患者对目前病情知晓的满意程度及对日常生活注意事项的了解程度可能会影响患者焦虑、抑郁的发生。     

Capacity to consent to research among patients with bipolar disorder

Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of ‘choice’, ‘understanding’, ‘appreciation’ and ‘rational reasoning’, as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences ‘understanding’ and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient’s understanding of the research protocol, but also alter the patient’s views, values and level of insight, thus impairing decision-making abilities at the ‘appreciation’ standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.     

Knowledge and Practices of Obtaining Informed Consent for Medical Procedures among Specialist Physicians: Questionnaire Study in 6 Croatian Hospitals

Aim

To assess physicians’ knowledge and practices for obtaining patients’ informed consent to medical procedures.

Methods

An anonymous and voluntary survey of knowledge and practices for obtaining informed consent was conducted among 470 physicians (63% response rate) working in 6 hospitals: 93 specialists in anesthesiology, 166 in internal medicine, and 211 in surgery.

Results

Only 54% physicians were acquainted with the fact that the procedure for obtaining consent was regulated by the law. Internists and surgeons were better informed than anesthesiologists (P = 0.024). More than a half of respondents (66%) were familiar with the fact that a law on patient rights was passed in Croatia; there were no differences among different specialties (P = 0.638). Only 38% of the physicians were fully informed about the procedure of obtaining consent. Internists and surgeons provided detailed information to the patient in 33% of the cases and anesthesiologists in 16% of the cases (P < 0.050). Internists reported spending more time on informing the patient than anesthesiologists and surgeons (P < 0.001). There were no differences in knowledge and practices for obtaining informed consent between physicians working in university and those working in community hospitals (P ≥ 0.05 for all questions).

Conclusion

Physicians in Croatia have no formal education on informed consent and implement the informed consent process in a rather formal manner, regardless of the type of hospital or medical specialty. Systemic approach at education and training at the national level is needed to improve the informed consent process.Informed consent is a professional ethics issue emanating from the fiduciary responsibility of the physician to the patient. It is an integral component of the physician’s fiduciary responsibility. In many countries informed consent for medical procedures is a standard procedure (1-9) for providing the patients with the information on diagnostic and treatment procedures, risks, complications, and alternative treatment options in non-emergency cases (5,9,10), thereby considerably improving the communication between physician and patient. A signed form is the evidence that their conversation led to a mutual understanding. However, the implementation of the informed consent process differs among countries because informing the patient and requiring the consent are still not regarded as a legal obligation of the physician (6).In the clinical setting, the term “informed consent” was developed in the USA in 1957. It was further developed in the Declaration of Helsinki in 1964, which established worldwide ethical principles for medical research involving human participants. In its current, 2008 version (11), the article 24 states: “In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject''s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.” (citation, paragraph 24). The Belmont Report from 1979 outlined the guidelines for the protection of human participants of research.In Croatia, the requirement to obtain treatment consent was first legally introduced in 1997 (12) and the Act on The Protection of Patent’s Rights was passed in 2004 (13). The regulations proscribe that patients are entitled to get full information on their health condition, including medical assessment of the results and outcomes of a certain diagnostic or therapeutic procedure and recommended examinations and procedures, and to know the dates when they are to get that information. The patients should be informed on the possible advantages of performing or not performing the procedures recommended and risks involved, and possible alternatives for the procedures. Thereafter, they have the right to make a decision to accept or reject the outlined treatment. The information should be clearly explained having in mind the patients’ age, education, and mental abilities. A signed form is just evidence that a conversation between physician and patient led to that mutual understanding.Physicians’ knowledge and attitudes toward informed consent considerably differ in various countries and among different medical specialists (14-17). We conducted this study to compare knowledge and practices for obtaining informed consent for medical procedures between 3 groups of specialists. We compared the specialists in anesthesiology, internal medicine and related medical specialties, and in surgery, who obtain informed consent for medical procedures on a daily basis.     

Post-consent assessment of dental subjects' understanding of informed consent in oral health research in Nigeria

Background  

Research participants may not adequately understand the research in which they agree to enroll. This could be due to a myriad of factors. Such a missing link in the informed consent process contravenes the requirement for an "informed" consent prior to the commencement of research. This study assessed the post consent understanding of Nigerian study participants of the oral health research they were invited to join.     

Improving informed consent in cardiac surgery by enhancing preoperative education

Objective

To investigate the effect of enhancing preoperative education in improving recall and understanding of a surgical procedure and its application to the informed consent process in cardiac surgery.

Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial

ObjectiveThis study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience.MethodsPatients due to undergo first conscious surveillance bronchoscopy following lung transplantation were randomized to receive IC with (intervention group) or without (control group) a graphic narrative illustrating the procedure. The primary endpoint was overall patient satisfaction with the IC. Key secondary endpoints were change in state anxiety level, as measured by State Trait Anxiety Inventory, and a questionnaire assessing satisfaction with IC and adverse experience during bronchoscopy (judged by patient and examiners).ResultsSixty patients were randomized, and 59 patients were included in the analysis (30 intervention-group; 29 control-group). Overall patient satisfaction was higher in the intervention group 9.5 (²⁵Q–⁷⁵Q: 8.6–9.8) vs. 8.6 (²⁵Q–⁷⁵Q: 8.1–9.2), p = 0.028). Change in state anxiety level (before vs after informed consent) was similar between the groups. There were no significant differences in adverse experience during bronchoscopy.ConclusionAddition of a graphic narrative illustrating bronchoscopy improved patient satisfaction with IC but did not influence anxiety before and adverse experience during the procedure.Practice implicationsSupplementing the IC process with a procedure-specific graphic narrative may be a simple tool to improve patient satisfaction.     

Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda

Background

Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.

Methods

Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.

Results

Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.

Conclusion

Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

     

Effective communication in the era of precision medicine: A pilot intervention with low health literacy patients to improve genetic counseling communication

Effective communication, where all parties share a common understanding, is necessary to realize the promise of Genomic Medicine. It is especially salient given the imperative to increase the participation of diverse populations in genomics research and to expand the reach of clinical genomics. We have previously shown that cancer genetic counseling is suboptimal for patients with limited health literacy. To address this finding, we implemented a pilot study to improve verbal communication between genetic counselors and their patients of limited health literacy that consisted of: i) curriculum development and delivery of a Genetic Counselors (GC) communication workshop; ii) two-month post-workshop interviews with GC participants (n = 9); iii) observations/audio recordings of counseling sessions involving 24 patients and two GC workshop participants; iv) post-counseling interviews with patients (n = 9). The 4.5-h workshop presented evidenced-based principles and strategies for effective communication with limited health literacy patients (e.g. use of plain language and teach-back), and offered specific techniques and exercises to practice adoption of such practices in the genetic counseling context. GCs expressed appreciation for the opportunity to refine their skills; however, they reported that some strategies were challenging given their professional training and communication habits. For example, GCs were concerned that use of plain language could undermine efforts to obtain informed consent and provide scientifically accurate information. Observations and patient interviews after the workshop revealed that GCs were able to employ the communication strategies with positive effects, with patients indicating sufficient understanding of the genetic test and its implications as well as satisfaction with the counselors’ communication. While derived from research on communication with those of limited health literacy, the communication approaches taught in the GC workshop could benefit most patients, given the high rates of low health literacy in many countries, and the many factors beyond health literacy that can contribute to reduced comprehension in health care environments.     

Scientists' perspectives on consent in the context of biobanking research

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.     

Information overload?

The use of the Internet for acquiring information on HIV and AIDS and the resulting impact on patient understanding of the disease are examined. Vast amounts of information about HIV and AIDS can be found on the Internet and many patients may have difficulty absorbing information due to the complexities of the disease. The article cautions that problems understanding HIV resources and a patient's desire to know as much as possible about the disease may result in frustration and loss of self esteem. This situation can lead to regressive behavior in the patient and hinder the healing process. Because of information overload, some patients leave all their treatment decisions to their doctors and simply do as they are told.