Patients Acceptance and Comprehension to Written and Verbal Consent (PAC-VC)

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Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. P atients A cceptance and C omprehension to Written and V erbal C onsent (PAC-VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs. Methods: PAC-VC recruited patients from 3 AMI trials using both verbal N=12 and written N=6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71-100) %, Partial understanding (41-70)% and Inadequate understanding (0-40)%. Results: Responses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent. Conclusion : Patients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials. Biomedical Engineering Informed consent Acute Myocardial Infarction Verbal Assent Written Consent Clinical Trials Figures Figure 1 Figure 2 Figure 3 Background The concept of informed consent has a legacy of going back to the 1767 when an English court prevented experimentation on patients without obtaining consent.(1) Since the inception of this concept, informed consent has gone through many adjustments to reach the current definition. The International Council of Harmonization (ICH) defines informed consent as a process by which subjects voluntarily confirm their willingness to participate in a study after having been informed of all aspects relevant to the subjects’ decision. Informed consent relies on three principles: disclosure of adequate information about the study, subjects understand the information provided, and voluntariness to give consent.(2) Randomized clinical trials (RCTs) are essential to develop new treatment strategies as well as to refine existing ones for acute and chronic medical conditions. Acute myocardial infarction (AMI) research presents a special challenge. It often requires enrollment of critically ill patients who are distressed and require urgent therapy to prevent morbidity and potential mortality. Evidence suggests that patients in this category are generally in a suboptimal state to understand or remember facts related to their condition and planned interventions.(3-5) It also suggests that many patients who consent to AMI trials remember the main information, however their degree of understanding and perceived comprehension was subjective and often questionable.(6) Patients in this category of AMI research found it irrational to be expected to read written material in an acute phase of a heart attack.(6) Instead, patients turn to oral information and explanations as a substitute.(4, 7, 8) Despite the current evidence, verbal assent has not been formally examined nor compared to the conventional written consents. Additionally, previous studies assessed patient comprehension by simply seeking their subjective opinions about their level of understanding or using the degree of information recollection as surrogate measure. P atients A cceptance and C omprehension to Written and V erbal C onsent (PAC-VC) is designed to compare patient’ perspectives and understanding to verbal and written consents in AMI trials. Methods Study Design This was a questionnaire-based study conducted at the Mazankowski Alberta Heart Institute from April 2014 to June 2015. During this time, PAC-VC recruited patients from 3 ongoing AMI RCTs: Remote ischemic conditioning in ST-Elevation myocardial infarction research (REMCON-STEMI), Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI (COMPLETE) and routine aspiration ThrOmbecTomy with PCI versus PCI ALone in patients with STEMI undergoing primary PCI (TOTAL). REMCON-STEMI trial consented patients using verbal script delivered by Emergency Medical services (EMS) personnel during enrollment to obtain a verbal assent. This was performed by only reading a script to study participants with no supplementary material to read at the initial enrollment process. Once the patients have received their treatment and stabilized, a second formal written consent is obtained by a research nurse within 72 hours when the written material is provided. TOTAL and COMPLETE trials used the traditional written consents process. The main difference between the two arms was the availability of the written material to patients in the traditional written consent arm, while on the verbal arm an initial verbal script and explanation was provided, followed by the written information for review at later time once their treatment is completed. Approval from our research ethics board was obtained prior to initiating recruitment. Written information readability grade level ranged from 10 to 13 at the Flesch-Kincaid Grade Level test. Recruitment Once patients were randomized to one of the determined 3 AMI trials, notification was sent to the research team to screen potential patients for eligibility. Of 21 patients initially approached, 18 consented to participate. PAC-VC enrolled patients into two parallel arms: verbal and written. The verbal arm recruited patients from the REMCON-STEMI trial in the acute phase who provided verbal assent and had not yet provided written consent. The written arm enrolled patients from the COMPLETE and TOTAL trials. Patients from all studies were approached within 72 hours from their randomization to the original AMI trials once deemed medically stable. Patients were approached to participate in PAC-VC and the assessment of their comprehension was done by administering a survey questionnaire as shown in Figure 1. Study Population All patients who consented to REM-CON, COMPLETE and/or TOTAL trials were screened for eligibility. Patients were excluded if they were unconscious, hemodynamically unstable, has dementia or mental illness or patients who gave consent through a proxy or a substitute decision maker. Assessment Tools and Data Collection PAC-VC used two sets of survey questionnaires to assess qualitative and quantitative responses of the subjects. The first set used open-ended questions with multiple choice answers. The questions tested patients’ understanding of the core components of informed consent. This part was designed to objectively test patients’ understanding. The second part used a Likert scale to measure perceived patients’ understanding about the trials in addition to the assessment of patients’ attitudes and perspectives towards the consent process. Both parts of the questionnaire were reviewed by the research team in addition to an external expert to assess relevance of the content. Scoring Patients’ responses for the objective assessment (Part 1) were assigned scores according to the answers. Correct answers were granted a complete score of 100%. Incorrect answers were scored 0%. “Do not know” responses were considered as partial awareness given the insight to lack of knowledge and granted a score of 50%. Average scores were calculated for the consent components assessed through the questionnaire. Overall scores were categorized into Adequate understanding (71-100%), Partial understanding (41-70%) and Inadequate understanding (0-40%). These cutoffs scores were chosen arbitrary as there was no previous consensus to the definition of adequacy of understanding. Statistical Package for the Social Sciences (SPSS) was used for all analysis. Nonparametric tests were used to assess for statistically significant differences among the two groups. Results are reported in actual numbers of patients and their percentages in addition to overall response mean scores. Results Patient Characteristics PAC-VC enrolled 18 AMI RCTs participants divided into two arms according to the initial informed consent used: 12 participants in the verbal assent arm and 6 participants in the written consent arm. Males were 83.3% of the total participants. Median age was 54 years of age. English was the first language for 72.2% of participants and fifty percent had college education. Previous history of MI was observed in only one patient. Previous enrollment into research was reported by 4 (24%) patients. Previous ambulance transport and hospital admissions were reported by 52.9% and 70.6% of participants respectively. Attention, stress, pain and anxiety rated by the participants on a scale from 1-10 during the consent process is shown in Table 1. Patients’ Degree of Understanding and Comprehension Responses showed that patients had adequate understanding of most core components of the verbal assent and was comparable to the understanding of written consents as shown in figure 2. Participants from both arms had adequate comprehension to the purpose of consent with scores 91.7% vs 100% in the verbal and written consent groups respectively, however they had a partial understanding to the details when asked about the purpose of the study with average scores 41.67% and 66.7% in verbal and written consents respectively. This was consistent with the overall perspective of patients in both groups as demonstrated by the responses in the second questionnaire. (Tables 2 and 4) The concept of randomization was challenging to participants in both groups where they showed inadequate to partial comprehension with an average score of 37.5% and 50% in the verbal and written consents respectively. The difference in scores did not reach statistical significance. Participants’ comprehension to the risks was adequate in the verbal group while inadequate in the written group 70.8% vs 33.3%. On the other hand, both groups showed adequate comprehension to the benefits with average scores 70% and 100% in the verbal and written consent arms respectively. Study participants showed adequate comprehension to the concept of autonomy and treatment alternatives in both arms with an average score of 83.3% vs 91.7% and 75% vs 83.3 % in the verbal and written groups respectively. Participants in both groups equally showed an adequate comprehension to confidentiality with an average score of 83.3% in both groups. Patients Perspectives and Attitudes Only 33.3% of patients read the written information. Most patients, 75% of the verbal arm and 100% of the written arm did not think written information was very important in making the final decision to choose to participate or not. However, participants from the verbal assent (75%) still wanted to have written information to be part of the consent process and only 25% of verbal and 16.7% of written arms wanted the written information to be presented during the initial consent process. Majority of patients in the written consent group (83.3%) and 50% of the verbal assent group felt pressured during the consent process. Also, 75% of patients in the verbal assent arm, and 100% of the written consent arm felt that the consent process was not satisfactory. (Table 3) Post-Verbal/Post-Written Consent Interviews REMCON-STEMI patients in the verbal arm were asked to take part of the questionnaire for a second time once completed the formal written consent. Among 12 patients, only 2 agreed to answer the questionnaire for the 2 nd time. Overall responses showed knowledge improvement in some areas as displayed in Figure 3. Interestingly, patients’ attitudes and opinions did not change after exposure to the written consent. Discussion The role of AMI clinical trials in developing and refining treatment guidelines is essential. However, the emergency nature of AMI as a disease poses extra challenges to obtain an ideal informed consent. To our knowledge, PAC-VC is the first study to utilize a questionnaire that objectively compares patients’ perspectives and comprehension of verbal assent to written consent. Our results show that patients understanding of verbal assent is comparable to written consents with an adequate understanding of most core components of the consent information. These include the purpose of consent, idea of autonomy, benefits, alternative treatments, choice to refuse participation and confidentiality. However, when attention to details was required, participants showed partial to inadequate understanding. Examples include the concept of randomization, blinding, alternative treatments and side effects. These results confirm previous findings demonstrating that patients who consent to clinical trials remember general information about studies, however often have sub-optimal understanding of the specific study details.(4, 7, 9-13) This was clearly illustrated in our cohort when participants performed poorly in understanding alternative treatments, randomization and side effects. Abstract thinking and complex processing is required to interpret these components and may not be possible and difficult to handle by severely ill patients in an acute phase of a disease. Additionally, it has also been previously suggested that poor understanding and recall to side effects may be influenced by patients inability to accept potentially unpleasant realities.(14) Interestingly, patients in the verbal arm of our cohort showed an adequate understanding of treatment side effects which may argue that verbal information is easier to understand and emphasize the importance of this tool of information delivery. Most patients in our cohort did not read the provided written information and reported that they did not believe it was very important in making their final decision in regards to participation. Patients did support the importance of having written information available, yet not necessarily to be presented during the acute phase of the consent process. These findings are consistent with the literature as was found that patients did not read the written material provided to them prior to making decisions.(4, 8, 11-13, 15) Instead, patients preferred a summary of verbal information and turned to oral explanations as a substitute. Interestingly, 75% of patients in the verbal assent arm, and 100% of the written consent arm felt that the consent process was not satisfactory. Such impressions require further exploration. Delay in treatment of AMI increases the rate of adverse outcomes and risk of death.(16-19) Hence, the consent process required for participation in AMI trials might unduly pressure potential participants and influence patients willingness to consent. The majority of patients (83.3%) in the written consent arm felt pressured during the consent process. It has been previously shown that participants felt pressured at the time of consent process and rushed into making a prompt decision, which put participants under stress. (11, 15) These findings were less observed in the verbal assent arm (50% of participants). This can be interpreted as reading needs more time and special attention to analyze the facts enlisted in a written format, on the other hand, patients may find oral information and explanations as an easier substitute to process the data and make a quicker decision without feeling pressured. Strengths And Limitations This study to our knowledge is the first to assess patients understanding of verbal assents in comparison to written consents in AMI research. PAC-VC used a multiple-choice questionnaire to objectively assess patients understanding in contrast to previous studies using self-reporting. Unfortunately, there are no standardized testing to quantify comprehension or define how much understanding is satisfactory. Since there are no grading systems, we opted to construct our own to simplify the interpretations of the results. This is certainly a point that can be debated, and may set a stage for further discussions to clarify the definitions of adequate and poor understanding. These are still subjective and one can argue that optimal understanding would require additional set of measures and standards. Study participants were recruited from different AMI trials addressing multiple research questions with diverse complexity and study protocols. Although the COMPLETE trial recruited patients with AMI, patients were in a stable condition in contrary to the acute patients recruited to REMCON and TOTAL. Finally, the study is small, non-randomized with heterogenous population characteristics (gender, age, education levels) that would plead to cautiously interpret the results to propose a question and an idea rather than claim conclusions. Conclusion PAC-VC is a small, non-randomized prospective study assessing patients’ comprehension to verbal assent and written consent in AMI research. Patients had adequate understanding to most components of verbal assent and comparable to those of written consent. Although patients still prefer written information to be part of the consent process, most do not read the written information nor feel that it should necessarily be presented during the acute phase of the consent process. The study results suggest that verbal assent may have a future role as acceptable alternative to the traditional written consent in similar AMI research. These results invite more research in this area with larger studies. Abbreviations PAC-VC: Patients Acceptance and Comprehension to Written and Verbal Consent; AMI: Acute myocardial infarction; RCT: Randomized clinical trials; ICH: The International Council of Harmonization; REMCON-STEMI: Remote ischemic conditioning in ST-Elevation myocardial infarction research; COMPLETE: Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI; TOTAL: routine aspiration ThrOmbecTomy with PCI versus PCI ALone in patients with STEMI undergoing primary PCI;EMS: Emergency Medical services (EMS). Declarations Ethics approval and consent to participate: The study received research ethics approval from the University of Alberta Research Ethics Board at the University of Alberta, study title PAC-VC, ID number Pro00046145. All participants provided written consent prior to participation. Consent for publication: Not applicable. Availability of data and material: The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: No funding was obtained for this study. Contributions: RW contributed to the conception and design of the study. RK contributed to data collection and data analysis. All authors were involved in data interpretation. The first draft of the manuscript was written by RK and RW and all authors commented on subsequent versions of the manuscript. All authors have read and approved the manuscript. Acknowledgements: Not applicable. References Ilfeld BM. Informed consent for medical research: an ethical imperative. Reg Anesth Pain Med. 2006;31(4):353-7. Faden RR, Beauchamp TL. A history and theory of informed consent: Oxford University Press; 1986. Smith HL. Myocardial infarction--Case studies of ethics in the consent situation. Soc Sci Med. 1974;8(7):399-404. Williams BF, French JK, White HD. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): A prospective observational study. Lancet. 2003;361(9361):918-22. Ockene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI--phase I) trial. Clin Res. 1991;39(1):13-7. Gammelgaard A, Rossel P, Mortensen OS. Patients' perceptions of informed consent in acute myocardial infarction research: A Danish study. Social Science and Medicine. 2004;58(11):2313-24. Yuval R, Halon DA, Flugelman MY, Lewis BS. Perceived patient comprehension in acute and chronic cardiovascular clinical trials. Cardiology. 2003;99(2):68-71. Dickert NW, Fehr AE, Llanos A, Scicluna VM, Samady H. Patients' views of consent for research enrollment during acute myocardial infarction. Acute Card Care. 2015;17(1):1-4. Kucia AM, Horowitz JD. Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? American Heart Journal. 2000;140(1):94-7. Yuval R, Halon DA, Merdler A, Khader N, Karkabi B, Uziel K, et al. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Archives of Internal Medicine. 2000;160(8):1142-6. Ågård A, Hermerén G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: Is it time to adjust the informed consent procedure to the patient's capacity? Heart. 2001;86(6):632-7. Gammelgaard A. Informed consent in acute myocardial infarction research. Journal of Medicine and Philosophy. 2004;29(4):417-34. Gammelgaard A, Mortensen OS, Rossel P. Patients' perceptions of informed consent in acute myocardial infarction research: A questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004;90(10):1124-8. Riecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA. 1982;248(3):344-8. Gammelgaard A, Rossel P, Mortensen OSOS, Investigators D-. Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study. Soc Sci Med. 2004;58(11):2313-24. Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients. Fibrinolytic Therapy Trialists' (FTT) Collaborative Group. Lancet. 1994;343(8893):311-22. Newby LK, Rutsch WR, Califf RM, Simoons ML, Aylward PE, Armstrong PW, et al. Time from symptom onset to treatment and outcomes after thrombolytic therapy. GUSTO-1 Investigators. J Am Coll Cardiol. 1996;27(7):1646-55. Zijlstra F, Patel A, Jones M, Grines CL, Ellis S, Garcia E, et al. Clinical characteristics and outcome of patients with early (4 h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. Eur Heart J. 2002;23(7):550-7. De Luca G, Suryapranata H, Ottervanger JP, Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation. 2004;109(10):1223-5. Tables Table 1 Baseline Characteristics (Consent Type) Verbal Written Total N (%) 12(66.7) 6(33.3) 18 Males 11 (91.7) 4(66.7) 15(83.3) Age 60.83 (Median 57.5) 48.83 (Median 51.5) 56.83(M=54) 1 st language is English 7(58.3) 6(100) 13(72.2) College education 6(50) 3(50) 9(50) PREVIOUS HISTORY MI 1(9) 0 1(6) Research 3(27.3) 1(16.7) 4(24) Hosp. Admission 9(81.8) 3(50) 12(70.6) Ambulance transport 6(54.5) 3(50) 9(52.9) PHYSCAL SYMPTOMS (Mean out of 10) Attention 5.73 6.17 5.88 Stress 7.18 6.67 7 Pain 5.27 5 5.18 Anxiety 6.91 6.83 6.88 Table 2 Objective Questionnaire Scores Described in Means Out of 100 Consent component Consent type Verbal Assent Written Consent Purpose of consent 91.67 100.00 Purpose of study 41.67 66.67 Duration of study 45.83 25.00 Nature of study intervention 50.00 66.67 Number of study groups 50.00 75.00 Understanding of alternative treatments 33.33 33.33 Randomization 37.50 50.00 Blindness 25.00 25.00 Side effects 70.83 33.33 Contacts in case of side effects 62.50 25.00 ‎Compensation in case of harm 58.33 75.00 Voluntariness of withdraw 83.33 91.67 Treatment options if refused to participate 75.00 83.33 Benefits of participation 70.00 100.00 Financial benefits of participation 83.33 91.67 Confidentiality 83.33 83.33 Whom to contact for any complaints 83.33 75.00 Total Score 61.47 64.71 Table 3 Patients Perspectives Consent type Verbal Assent Written consent N % N % I would prefer only verbal information presented during the consent process Agree 2(16.7%) 2(33.3%) Cannot decide 1(8.3%) 2(33.3%) Disagree 9(75.0%) 2(33.3%) I would prefer written information presented during the consent process Agree 3(25.0%) 1(16.7%) Cannot decide 3(25.0%) 3(50.0%) Disagree 6(50.0%) 2(33.3%) I read the written information about the research study before making my decision Agree 2(16.7%) 2(33.3%) Cannot decide 2(16.7%) 0(0.0%) Disagree 8(66.7%) 4(66.7%) I believe written information is very important in making my final decision to participate Agree 2(16.7%) 0(0.0%) Cannot decide 1(8.3%) 0(0.0%) Disagree 9(75.0%) 6(100.0%) I feel satisfied and comfortable with the consent process Agree 0(0.0%) 0(0.0%) Cannot decide 3(25.0%) 0(0.0%) Disagree 9(75.0%) 6(100.0%) I felt pressured by time when I made my decision during the consent process Agree 6(50.0%) 5(83.3%) Cannot decide 3(25.0%) 1(16.7%) Disagree 3(25.0%) 0(0.0%) Table 4 Patients Subjective Understanding Items examined Consent type Verbal Assent Written Consent Count Column N % Count Column N % You understand the purpose of study Agree 1 8.3% 0 0.0% Cannot decide 2 16.7% 0 0.0% Disagree 9 75.0% 6 100.0% You know how long you will be enrolled in this study. Agree 3 25.0% 3 50.0% Cannot decide 4 33.3% 0 0.0% Disagree 5 41.7% 3 50.0% You understand what will be done in this study and what you are being asked to do Agree 1 8.3% 1 20.0% Cannot decide 3 25.0% 0 0.0% Disagree 8 66.7% 4 80.0% You recognize the experimental part that may be used in your treatment. (Study intervention) Agree 1 8.3% 0 0.0% Cannot decide 2 16.7% 0 0.0% Disagree 9 75.0% 6 100.0% You recognize the possible risks or discomforts that may result due to participation in this study Agree 0 0.0% 0 0.0% Cannot decide 2 16.7% 1 16.7% Disagree 10 83.3% 5 83.3% You recognize the possible benefits you may gain from participation Agree 0 0.0% 0 0.0% Cannot decide 2 16.7% 0 0.0% Disagree 10 83.3% 6 100.0% You recognize the possible benefits that may help future patients. Agree 0 0.0% 0 0.0% Cannot decide 0 0.0% 0 0.0% Disagree 12 100.0% 6 100.0% You know alternative options/treatments you may have if you had chosen to NOT participate. Agree 2 16.7% 1 16.7% Cannot decide 1 8.3% 1 16.7% Disagree 9 75.0% 4 66.7% You understand that your information is being kept confidential and disclosed only to authorized personnel Agree 0 0.0% 0 0.0% Cannot decide 0 0.0% 0 0.0% Disagree 12 100.0% 6 100.0% You know whom you should contact in case of side effects or injuries that may result due to participation in the study Agree 1 8.3% 2 33.3% Cannot decide 2 16.7% 0 0.0% Disagree 9 75.0% 4 66.7% You know what compensation or treatment is available for you in case of side effects or injury Agree 3 25.0% 3 50.0% Cannot decide 3 25.0% 0 0.0% Disagree 6 50.0% 3 50.0% You understand that your participation is completely voluntary and it is not going to affect your treatment if you choose to withdraw Agree 0 0.0% 0 0.0% Cannot decide 0 0.0% 0 0.0% Disagree 12 100.0% 6 100.0% You understand that you can withdraw from this study at any time you wish to do so Agree 0 0.0% 0 0.0% Cannot decide 0 0.0% 0 0.0% Disagree 12 100.0% 6 100.0% You know whom you should contact in case you have questions, comments, concerns or complaints about the study Agree 2 16.7% 2 33.3% Cannot decide 2 16.7% 0 0.0% Disagree 8 66.7% 4 66.7% Cite Share Download PDF Status: Published Journal Publication published 23 Feb, 2023 Read the published version in BMC Medical Ethics → Version 1 posted Reviewers agreed at journal 17 Jun, 2022 Reviews received at journal 23 Feb, 2022 Reviewer # 1 agreed at journal 15 Dec, 2021 Reviewers invited by journal 31 May, 2021 Submission checks completed at journal 21 Feb, 2021 Editor invited by journal 18 Feb, 2021 Editor assigned by journal 17 Feb, 2021 First submitted to journal 16 Feb, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-264330","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research article","associatedPublications":[],"authors":[{"id":12961943,"identity":"5ab15310-ddcf-4b1c-94b5-7a329dc3a3b4","order_by":0,"name":"Rabia Kashur","email":"","orcid":"","institution":"University of Alberta","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Rabia","middleName":"","lastName":"Kashur","suffix":""},{"id":12961944,"identity":"853e63fd-6b9c-44d3-aaf7-7e7eb16d9c9f","order_by":1,"name":"Justin Ezekowitz","email":"","orcid":"","institution":"University of Alberta","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Justin","middleName":"","lastName":"Ezekowitz","suffix":""},{"id":12961945,"identity":"9a06d07f-ffee-41b0-82d0-2a4b5f72298b","order_by":2,"name":"Shane Kimber","email":"","orcid":"","institution":"University of Alberta","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Shane","middleName":"","lastName":"Kimber","suffix":""},{"id":12961946,"identity":"6440f402-bad8-4d48-ad22-3df559132b0f","order_by":3,"name":"Robert Welsh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2klEQVRIiWNgGAWjYFACHijNzsDG8IHhALFaEoCYmYGNcQbJWph5iNFi3t578HHlD4bEfmb2Z49tau7YM7AffoBXi8yZc8mGZxIYEmc285gb5xx7ltjAk2aAV4uERI6ZZEMCQ+6Gwzxs0jlshxMYJBgIajH/CdKy/zD7M2mLf4ftGSTYPxC0hRFsCzODmTRj22HGBgkeArbwnEuWbEiTqJ9xmMdMsrfvcGIbT04Bfi3svQc/NtjYGPO3tz+T+PHtsD0/+/ENeLXAdCKYbMSoHwWjYBSMglGAHwAAIsE+7yVZFqYAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0003-2613-9142","institution":"University of Alberta","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Robert","middleName":"","lastName":"Welsh","suffix":""}],"badges":[],"createdAt":"2021-02-21 16:40:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-264330/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-264330/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12910-023-00893-1","type":"published","date":"2023-02-23T18:59:34+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":6496846,"identity":"c163d29f-b47c-483f-9994-4b2e11576d7c","added_by":"auto","created_at":"2021-03-01 23:35:46","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":39586,"visible":true,"origin":"","legend":"PAC-VC Methods Flow Chart ","description":"","filename":"Fig1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-264330/v1/c24156c4ae1e7f1723d15293.jpg"},{"id":6496400,"identity":"387aa6d2-1e43-4bac-9849-af24d4b74866","added_by":"auto","created_at":"2021-03-01 23:32:46","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":83635,"visible":true,"origin":"","legend":"Total Score of Patients' Understanding to the Components of Consent","description":"","filename":"Fig2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-264330/v1/411b7fcd208fe914e20a8b8e.jpg"},{"id":6496847,"identity":"51f41fd0-3507-48fd-b1a9-edb3da299c8d","added_by":"auto","created_at":"2021-03-01 23:35:46","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":86625,"visible":true,"origin":"","legend":"Post-Verbal/Post-Written Consent Interviews Responses","description":"","filename":"Fig3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-264330/v1/1180ba20d10f44c1d965caaa.jpg"},{"id":44720075,"identity":"a3aab7b5-b01a-434f-a906-0046df07160a","added_by":"auto","created_at":"2023-10-16 19:07:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":645026,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-264330/v1/801481c1-8d31-4efe-a959-ae829245aa75.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003ePatients Acceptance and Comprehension to Written and Verbal Consent (PAC-VC)\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eThe concept of informed consent has a legacy of going back to the 1767 when an English court prevented experimentation on patients without obtaining consent.(1) Since the inception of this concept, informed consent has gone through many adjustments to reach the current definition. The International Council of Harmonization (ICH) defines informed consent as a process by which subjects voluntarily confirm their willingness to participate in a study after having been informed of all aspects relevant to the subjects\u0026rsquo; decision. Informed consent relies on three principles: disclosure of adequate information about the study, subjects understand the information provided, and voluntariness to give consent.(2)\u003c/p\u003e\n\u003cp\u003eRandomized clinical trials (RCTs) are essential to develop new treatment strategies as well as to refine existing ones for acute and chronic medical conditions. Acute myocardial infarction (AMI) research presents a special challenge. It often requires enrollment of critically ill patients who are distressed and require urgent therapy to prevent morbidity and potential mortality. Evidence suggests that patients in this category are generally in a suboptimal state to understand or remember facts related to their condition and planned interventions.(3-5) It also suggests that many patients who consent to AMI trials remember the main information, however their degree of understanding and perceived comprehension was subjective and often questionable.(6) Patients in this category of AMI research found it irrational to be expected to read written material in an acute phase of a heart attack.(6) Instead, patients turn to oral information and explanations as a substitute.(4, 7, 8)\u003c/p\u003e\n\u003cp\u003eDespite the current evidence, verbal assent has not been formally examined nor compared to the conventional written consents. Additionally, previous studies assessed patient comprehension by simply seeking their subjective opinions about their level of understanding or using the degree of information recollection as surrogate measure. \u003cem\u003e\u003cu\u003eP\u003c/u\u003e\u003c/em\u003eatients \u003cem\u003e\u003cu\u003eA\u003c/u\u003e\u003c/em\u003ecceptance and \u003cem\u003e\u003cu\u003eC\u003c/u\u003e\u003c/em\u003eomprehension to Written and \u003cem\u003e\u003cu\u003eV\u003c/u\u003e\u003c/em\u003eerbal \u003cem\u003e\u003cu\u003eC\u003c/u\u003e\u003c/em\u003eonsent (PAC-VC) is designed to compare patient\u0026rsquo; perspectives and understanding to verbal and written consents in AMI trials.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis was a questionnaire-based study conducted at the Mazankowski Alberta Heart Institute from April 2014 to June 2015. During this time, PAC-VC recruited patients from 3 ongoing AMI RCTs: Remote ischemic conditioning in ST-Elevation myocardial infarction research (REMCON-STEMI), Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI (COMPLETE) and routine aspiration ThrOmbecTomy with PCI versus PCI ALone in patients with STEMI undergoing primary PCI (TOTAL). REMCON-STEMI trial consented patients using verbal script delivered by Emergency Medical services (EMS) personnel during enrollment to obtain a verbal assent. This was performed by only reading a script to study participants with no supplementary material to read at the initial enrollment process. Once the patients have received their treatment and stabilized, a second formal written consent is obtained by a research nurse within 72 hours when the written material is provided. TOTAL and COMPLETE trials used the traditional written consents process. The main difference between the two arms was the availability of the written material to patients in the traditional written consent arm, while on the verbal arm an initial verbal script and explanation was provided, followed by the written information for review at later time once their treatment is completed. Approval from our research ethics board was obtained prior to initiating recruitment. Written information readability grade level ranged from 10 to 13 at the Flesch-Kincaid Grade Level test.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOnce patients were randomized to one of the determined 3 AMI trials, notification was sent to the research team to screen potential patients for eligibility. Of 21 patients initially approached, 18 consented to participate. PAC-VC enrolled patients into two parallel arms: verbal and written. The verbal arm recruited patients from the REMCON-STEMI trial in the acute phase who provided verbal assent and had not yet provided written consent. The written arm enrolled patients from the COMPLETE and TOTAL trials. Patients from all studies were approached within 72 hours from their randomization to the original AMI trials once deemed medically stable. Patients were approached to participate in PAC-VC and the assessment of their comprehension was done by administering a survey questionnaire as shown in Figure 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll patients who consented to REM-CON, COMPLETE and/or TOTAL trials were screened for eligibility. Patients were excluded if they were unconscious, hemodynamically unstable, has dementia or mental illness or patients who gave consent through a proxy or a substitute decision maker.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssessment Tools and Data Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePAC-VC used two sets of survey questionnaires to assess qualitative and quantitative responses of the subjects. The first set used open-ended questions with multiple choice answers. The questions tested patients\u0026rsquo; understanding of the core components of informed consent. This part was designed to objectively test patients\u0026rsquo; understanding. The second part used a Likert scale to measure perceived patients\u0026rsquo; understanding about the trials in addition to the assessment of patients\u0026rsquo; attitudes and perspectives towards the consent process. Both parts of the questionnaire were reviewed by the research team in addition to an external expert to assess relevance of the content.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eScoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients\u0026rsquo; responses for the objective assessment (Part 1) were assigned scores according to the answers. Correct answers were granted a complete score of 100%. Incorrect answers were scored 0%. \u0026ldquo;Do not know\u0026rdquo; responses were considered as partial awareness given the insight to lack of knowledge and granted a score of 50%. Average scores were calculated for the consent components assessed through the questionnaire. Overall scores were categorized into Adequate understanding (71-100%), Partial understanding (41-70%) and Inadequate understanding (0-40%). These cutoffs scores were chosen arbitrary as there was no previous consensus to the definition of adequacy of understanding.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStatistical Package for the Social Sciences (SPSS) was used for all analysis. Nonparametric tests were used to assess for statistically significant differences among the two groups. Results are reported in actual numbers of patients and their percentages in addition to overall response mean scores.\u003c/p\u003e"},{"header":"Results","content":"\u003ch3\u003ePatient Characteristics\u003c/h3\u003e\n\u003cp\u003ePAC-VC enrolled 18 AMI RCTs participants divided into two arms according to the initial informed consent used: 12 participants in the verbal assent arm and 6 participants in the written consent arm. Males were 83.3% of the total participants. Median age was 54 years of age. English was the first language for 72.2% of participants and fifty percent had college education. Previous history of MI was observed in only one patient. Previous enrollment into research was reported by 4 (24%) patients. Previous ambulance transport and hospital admissions were reported by 52.9% and 70.6% of participants respectively. Attention, stress, pain and anxiety rated by the participants on a scale from 1-10 during the consent process is shown in Table 1.\u003c/p\u003e\n\u003ch3\u003ePatients\u0026rsquo; Degree of Understanding and Comprehension\u003c/h3\u003e\n\u003cp\u003eResponses showed that patients had adequate understanding of most core components of the verbal assent and was comparable to the understanding of written consents as shown in figure 2.\u003c/p\u003e\n\u003cp\u003eParticipants from both arms had adequate comprehension to the purpose of consent with scores 91.7% vs 100% in the verbal and written consent groups respectively, however they had a partial understanding to the details when asked about the purpose of the study with average scores 41.67% and 66.7% in verbal and written consents respectively. This was consistent with the overall perspective of patients in both groups as demonstrated by the responses in the second questionnaire. (Tables 2 and 4)\u003c/p\u003e\n\u003cp\u003eThe concept of randomization was challenging to participants in both groups where they showed inadequate to partial comprehension with an average score of 37.5% and 50% in the verbal and written consents respectively. The difference in scores did not reach statistical significance. Participants\u0026rsquo; comprehension to the risks was adequate in the verbal group while inadequate in the written group 70.8% vs 33.3%. On the other hand, both groups showed adequate comprehension to the benefits with average scores 70% and 100% in the verbal and written consent arms respectively.\u003c/p\u003e\n\u003cp\u003eStudy participants showed adequate comprehension to the concept of autonomy and treatment alternatives in both arms with an average score of 83.3% vs 91.7% and 75% vs 83.3 % in the verbal and written groups respectively.\u003c/p\u003e\n\u003cp\u003eParticipants in both groups equally showed an adequate comprehension to confidentiality with an average score of 83.3% in both groups.\u003c/p\u003e\n\u003ch3\u003ePatients Perspectives and Attitudes\u003c/h3\u003e\n\u003cp\u003eOnly 33.3% of patients read the written information. Most patients, 75% of the verbal arm and 100% of the written arm did not think written information was very important in making the final decision to choose to participate or not. However, participants from the verbal assent (75%) still wanted to have written information to be part of the consent process and only 25% of verbal and 16.7% of written arms wanted the written information to be presented during the initial consent process. Majority of patients in the written consent group (83.3%) and 50% of the verbal assent group felt pressured during the consent process. Also, 75% of patients in the verbal assent arm, and 100% of the written consent arm felt that the consent process was not satisfactory. (Table 3)\u003c/p\u003e\n\u003ch3\u003ePost-Verbal/Post-Written Consent Interviews\u003c/h3\u003e\n\u003cp\u003eREMCON-STEMI patients in the verbal arm were asked to take part of the questionnaire for a second time once completed the formal written consent. Among 12 patients, only 2 agreed to answer the questionnaire for the 2\u003csup\u003end\u003c/sup\u003e time. Overall responses showed knowledge improvement in some areas as displayed in Figure 3. Interestingly, patients\u0026rsquo; attitudes and opinions did not change after exposure to the written consent.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe role of AMI clinical trials in developing and refining treatment guidelines is essential. However, the emergency nature of AMI as a disease poses extra challenges to obtain an ideal informed consent.\u003c/p\u003e\n\u003cp\u003eTo our knowledge, PAC-VC is the first study to utilize a questionnaire that objectively compares patients\u0026rsquo; perspectives and comprehension of verbal assent to written consent. Our results show that patients understanding of verbal assent is comparable to written consents with an adequate understanding of most core components of the consent information. These include the purpose of consent, idea of autonomy, benefits, alternative treatments, choice to refuse participation and confidentiality. However, when attention to details was required, participants showed partial to inadequate understanding. Examples include the concept of randomization, blinding, alternative treatments and side effects. These results confirm previous findings demonstrating that patients who consent to clinical trials remember general information about studies, however often have sub-optimal understanding of the specific study details.(4, 7, 9-13) This was clearly illustrated in our cohort when participants performed poorly in understanding alternative treatments, randomization and side effects. Abstract thinking and complex processing is required to interpret these components and may not be possible and difficult to handle by severely ill patients in an acute phase of a disease. Additionally, it has also been previously suggested that poor understanding and recall to side effects may be influenced by patients inability to accept potentially unpleasant realities.(14) Interestingly, patients in the verbal arm of our cohort showed an adequate understanding of treatment side effects which may argue that verbal information is easier to understand and emphasize the importance of this tool of information delivery.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMost patients in our cohort did not read the provided written information and reported that they did not believe it was very important in making their final decision in regards to participation. Patients did support the importance of having written information available, yet not necessarily to be presented during the acute phase of the consent process. These findings are consistent with the literature as was found that patients did not read the written material provided to them prior to making decisions.(4, 8, 11-13, 15) Instead, patients preferred a summary of verbal information and turned to oral explanations as a substitute. Interestingly, 75% of patients in the verbal assent arm, and 100% of the written consent arm felt that the consent process was not satisfactory. Such impressions require further exploration.\u003c/p\u003e\n\u003cp\u003eDelay in treatment of AMI increases the rate of adverse outcomes and risk of death.(16-19) Hence, the consent process required for participation in AMI trials might unduly pressure potential participants and influence patients willingness to consent. The majority of patients (83.3%) in the written consent arm felt pressured during the consent process. It has been previously shown that participants felt pressured at the time of consent process and rushed into making a prompt decision, which put participants under stress. (11, 15) These findings were less observed in the verbal assent arm (50% of participants). This can be interpreted as reading needs more time and special attention to analyze the facts enlisted in a written format, on the other hand, patients may find oral information and explanations as an easier substitute to process the data and make a quicker decision without feeling pressured.\u003c/p\u003e"},{"header":"Strengths And Limitations","content":"\u003cp\u003eThis study to our knowledge is the first to assess patients understanding of verbal assents in comparison to written consents in AMI research. PAC-VC used a multiple-choice questionnaire to objectively assess patients understanding in contrast to previous studies using self-reporting. Unfortunately, there are no standardized testing to quantify comprehension or define how much understanding is satisfactory. Since there are no grading systems, we opted to construct our own to simplify the interpretations of the results. This is certainly a point that can be debated, and may set a stage for further discussions to clarify the definitions of adequate and poor understanding. These are still subjective and one can argue that optimal understanding would require additional set of measures and standards. Study participants were recruited from different AMI trials addressing multiple research questions with diverse complexity and study protocols. Although the COMPLETE trial recruited patients with AMI, patients were in a stable condition in contrary to the acute patients recruited to REMCON and TOTAL. Finally, the study is small, non-randomized with heterogenous population characteristics (gender, age, education levels) that would plead to cautiously interpret the results to propose a question and an idea rather than claim conclusions.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePAC-VC is a small, non-randomized prospective study assessing patients\u0026rsquo; comprehension to verbal assent and written consent in AMI research. Patients had adequate understanding to most components of verbal assent and comparable to those of written consent. Although patients still prefer written information to be part of the consent process, most do not read the written information nor feel that it should necessarily be presented during the acute phase of the consent process. The study results suggest that verbal assent may have a future role as acceptable alternative to the traditional written consent in similar AMI research. These results invite more research in this area with larger studies.\u0026nbsp;\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003ePAC-VC: Patients Acceptance and Comprehension to Written and Verbal Consent; AMI: Acute myocardial infarction; RCT: Randomized clinical trials; ICH: The International Council of Harmonization; REMCON-STEMI: Remote ischemic conditioning in ST-Elevation myocardial infarction research;\u003c/p\u003e\n\u003cp\u003eCOMPLETE: Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI; TOTAL: routine aspiration ThrOmbecTomy with PCI versus PCI ALone in patients with STEMI undergoing primary PCI;EMS: Emergency Medical services (EMS).\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate:\u003c/p\u003e\n\u003cp\u003eThe study received research ethics approval from the University of Alberta Research Ethics Board at the University of Alberta, study title PAC-VC, ID number Pro00046145.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll participants provided written consent prior to participation.\u003c/p\u003e\n\u003cp\u003eConsent for publication:\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cbr /\u003e Availability of data and material:\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003eCompeting interests:\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003eFunding:\u003c/p\u003e\n\u003cp\u003eNo funding was obtained for this study.\u003c/p\u003e\n\u003cp\u003eContributions:\u003c/p\u003e\n\u003cp\u003eRW contributed to the conception and design of the study. RK contributed to data collection and data analysis. All authors were involved in data interpretation. The first draft of the manuscript was written by RK and RW and all authors commented on subsequent versions of the manuscript. All authors have read and approved the manuscript.\u003c/p\u003e\n\u003cp\u003eAcknowledgements:\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eIlfeld BM. Informed consent for medical research: an ethical imperative. Reg Anesth Pain Med. 2006;31(4):353-7.\u003c/li\u003e\n\u003cli\u003eFaden RR, Beauchamp TL. A history and theory of informed consent: Oxford University Press; 1986.\u003c/li\u003e\n\u003cli\u003eSmith HL. Myocardial infarction--Case studies of ethics in the consent situation. Soc Sci Med. 1974;8(7):399-404.\u003c/li\u003e\n\u003cli\u003eWilliams BF, French JK, White HD. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): A prospective observational study. Lancet. 2003;361(9361):918-22.\u003c/li\u003e\n\u003cli\u003eOckene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI--phase I) trial. Clin Res. 1991;39(1):13-7.\u003c/li\u003e\n\u003cli\u003eGammelgaard A, Rossel P, Mortensen OS. Patients' perceptions of informed consent in acute myocardial infarction research: A Danish study. Social Science and Medicine. 2004;58(11):2313-24.\u003c/li\u003e\n\u003cli\u003eYuval R, Halon DA, Flugelman MY, Lewis BS. Perceived patient comprehension in acute and chronic cardiovascular clinical trials. Cardiology. 2003;99(2):68-71.\u003c/li\u003e\n\u003cli\u003eDickert NW, Fehr AE, Llanos A, Scicluna VM, Samady H. Patients' views of consent for research enrollment during acute myocardial infarction. Acute Card Care. 2015;17(1):1-4.\u003c/li\u003e\n\u003cli\u003eKucia AM, Horowitz JD. Is informed consent to clinical trials an \"upside selective\" process in acute coronary syndromes? American Heart Journal. 2000;140(1):94-7.\u003c/li\u003e\n\u003cli\u003eYuval R, Halon DA, Merdler A, Khader N, Karkabi B, Uziel K, et al. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Archives of Internal Medicine. 2000;160(8):1142-6.\u003c/li\u003e\n\u003cli\u003e\u0026Aring;g\u0026aring;rd A, Hermer\u0026eacute;n G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: Is it time to adjust the informed consent procedure to the patient's capacity? Heart. 2001;86(6):632-7.\u003c/li\u003e\n\u003cli\u003eGammelgaard A. Informed consent in acute myocardial infarction research. Journal of Medicine and Philosophy. 2004;29(4):417-34.\u003c/li\u003e\n\u003cli\u003eGammelgaard A, Mortensen OS, Rossel P. Patients' perceptions of informed consent in acute myocardial infarction research: A questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004;90(10):1124-8.\u003c/li\u003e\n\u003cli\u003eRiecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA. 1982;248(3):344-8.\u003c/li\u003e\n\u003cli\u003eGammelgaard A, Rossel P, Mortensen OSOS, Investigators D-. Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study. Soc Sci Med. 2004;58(11):2313-24.\u003c/li\u003e\n\u003cli\u003eIndications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients. Fibrinolytic Therapy Trialists' (FTT) Collaborative Group. Lancet. 1994;343(8893):311-22.\u003c/li\u003e\n\u003cli\u003eNewby LK, Rutsch WR, Califf RM, Simoons ML, Aylward PE, Armstrong PW, et al. Time from symptom onset to treatment and outcomes after thrombolytic therapy. GUSTO-1 Investigators. J Am Coll Cardiol. 1996;27(7):1646-55.\u003c/li\u003e\n\u003cli\u003eZijlstra F, Patel A, Jones M, Grines CL, Ellis S, Garcia E, et al. Clinical characteristics and outcome of patients with early (\u0026lt;2 h), intermediate (2-4 h) and late (\u0026gt;4 h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. Eur Heart J. 2002;23(7):550-7.\u003c/li\u003e\n\u003cli\u003eDe Luca G, Suryapranata H, Ottervanger JP, Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation. 2004;109(10):1223-5.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 Baseline Characteristics (Consent Type)\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003eVerbal\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003eWritten\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003eTotal\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eN (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e12(66.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e6(33.3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e18\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eMales\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e11 (91.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e4(66.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e15(83.3)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eAge\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e60.83 (Median 57.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e48.83 (Median 51.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e56.83(M=54)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003e1\u003csup\u003est\u003c/sup\u003e language is English\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e7(58.3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e6(100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e13(72.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eCollege education\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e6(50)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e3(50)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e9(50)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" width=\"484\"\u003e\n\u003cp\u003ePREVIOUS HISTORY\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eMI\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e1(9)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e1(6)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eResearch\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(27.3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e1(16.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e4(24)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eHosp. Admission\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e9(81.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e3(50)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e12(70.6)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eAmbulance transport\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e6(54.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e3(50)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e9(52.9)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" width=\"484\"\u003e\n\u003cp\u003ePHYSCAL SYMPTOMS (Mean out of 10)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eAttention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e5.73\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e6.17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e5.88\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eStress\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e7.18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e6.67\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003ePain\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e5.27\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e5.18\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"165\"\u003e\n\u003cp\u003eAnxiety\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e6.91\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"159\"\u003e\n\u003cp\u003e6.83\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"139\"\u003e\n\u003cp\u003e6.88\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2 Objective Questionnaire Scores Described in Means Out of 100\u003c/p\u003e\n\u003ctable border=\"1\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"2\" width=\"320\"\u003e\n\u003cp\u003eConsent component\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"271\"\u003e\n\u003cp\u003eConsent type\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003eVerbal Assent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003eWritten Consent\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003ePurpose of consent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e91.67\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e100.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003ePurpose of study\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e41.67\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e66.67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eDuration of study\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e45.83\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e25.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eNature of study intervention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e50.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e66.67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eNumber of study groups\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e50.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e75.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eUnderstanding of alternative treatments\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e33.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e33.33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eRandomization\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e37.50\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e50.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eBlindness\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e25.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e25.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eSide effects\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e70.83\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e33.33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eContacts in case of side effects\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e62.50\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e25.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003e\u0026lrm;Compensation in case of harm\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e58.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e75.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eVoluntariness of withdraw\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e91.67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eTreatment options if refused to participate\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e75.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eBenefits of participation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e70.00\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e100.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eFinancial benefits of participation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e91.67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eConfidentiality\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eWhom to contact for any complaints\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e83.33\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e75.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"320\"\u003e\n\u003cp\u003eTotal Score\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e61.47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"135\"\u003e\n\u003cp\u003e64.71\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 3 Patients Perspectives\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" rowspan=\"3\" width=\"312\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"340\"\u003e\n\u003cp\u003eConsent type\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003eVerbal Assent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003eWritten consent\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003eN %\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003eN %\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI would prefer only verbal information presented during the consent process\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e2(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e2(33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e1(8.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e2(33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e9(75.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e2(33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI would prefer written information presented during the consent process\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(25.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e1(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(25.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e3(50.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e6(50.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e2(33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI read the written information about the research study before making my decision\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e2(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e2(33.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e2(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e8(66.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e4(66.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI believe written information is very important in making my final decision to participate\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e2(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e1(8.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e9(75.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e6(100.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI feel satisfied and comfortable with the consent process\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(25.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e9(75.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e6(100.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"189\"\u003e\n\u003cp\u003eI felt pressured by time when I made my decision during the consent process\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e6(50.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e5(83.3%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(25.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e1(16.7%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"160\"\u003e\n\u003cp\u003e3(25.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"180\"\u003e\n\u003cp\u003e0(0.0%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 4 Patients Subjective Understanding\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" rowspan=\"3\" width=\"295\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eItems examined\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"4\" width=\"339\"\u003e\n\u003cp\u003eConsent type\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" width=\"161\"\u003e\n\u003cp\u003eVerbal Assent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" width=\"179\"\u003e\n\u003cp\u003eWritten Consent\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003eCount\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003eColumn N %\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003eCount\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003eColumn N %\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou understand the purpose of study\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e8.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e75.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou know how long you will be enrolled in this study.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e25.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e50.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e33.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e41.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e50.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou understand what will be done in this study and what you are being asked to do\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e8.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e20.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e25.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e66.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e80.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou recognize the experimental part that may be used in your treatment. (Study intervention)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e8.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e75.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou recognize the possible risks or discomforts that may result due to participation in this study\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e83.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e83.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou recognize the possible benefits you may gain from participation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e83.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou recognize the possible benefits that may help future patients.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou know alternative options/treatments you may have if you had chosen to \u003cstrong\u003e\u003cem\u003eNOT\u003c/em\u003e\u003c/strong\u003e participate.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e8.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e75.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e66.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou understand that your information is being kept confidential and disclosed only to authorized personnel\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" width=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou know whom you should contact in case of side effects or injuries that may result due to participation in the study\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e8.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e33.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e75.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e66.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou know what compensation or treatment is available for you in case of side effects or injury\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e25.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e50.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e25.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e50.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e50.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou understand that your participation is completely voluntary and it is not going to affect your treatment if you choose to withdraw\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou understand that you can withdraw from this study at any time you wish to do so\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e12\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e100.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"3\" width=\"171\"\u003e\n\u003cp\u003eYou know whom you should contact in case you have questions, comments, concerns or complaints about the study\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eAgree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e33.3%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eCannot decide\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e16.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e0.0%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"123\"\u003e\n\u003cp\u003eDisagree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"95\"\u003e\n\u003cp\u003e66.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"112\"\u003e\n\u003cp\u003e66.7%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-ethics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meth","sideBox":"Learn more about [BMC Medical Ethics](http://bmcmedethics.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meth/default.aspx","title":"BMC Medical Ethics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Informed consent, Acute Myocardial Infarction, Verbal Assent, Written Consent, Clinical Trials","lastPublishedDoi":"10.21203/rs.3.rs-264330/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-264330/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e:\u003c/p\u003e\u003cp\u003eAcute myocardial infarction (AMI) research is challenging as it requires enrollment of acutely ill patients. Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. \u003cem\u003e\u003cu\u003e\u0026nbsp;P\u003c/u\u003e\u003c/em\u003eatients \u003cem\u003e\u003cu\u003eA\u003c/u\u003e\u003c/em\u003ecceptance and \u003cem\u003e\u003cu\u003eC\u003c/u\u003e\u003c/em\u003eomprehension to Written and \u003cem\u003e\u003cu\u003eV\u003c/u\u003e\u003c/em\u003eerbal \u003cem\u003e\u003cu\u003eC\u003c/u\u003e\u003c/em\u003eonsent (PAC-VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003ePAC-VC recruited patients from 3 AMI trials using both verbal N=12 and written N=6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71-100) %, Partial understanding (41-70)% and Inadequate understanding (0-40)%. \u003c/strong\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResponses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent.\u003c/strong\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: \u003c/p\u003e\u003cp\u003ePatients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Patients Acceptance and Comprehension to Written and Verbal Consent (PAC-VC)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-03-01 23:32:44","doi":"10.21203/rs.3.rs-264330/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2022-06-17T09:09:20+00:00","index":0,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2022-02-23T18:09:47+00:00","index":0,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-12-16T00:00:00+00:00","index":1,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-06-01T00:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2021-02-21T16:40:32+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2021-02-19T00:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2021-02-18T00:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"","date":"2021-02-17T00:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-ethics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meth","sideBox":"Learn more about [BMC Medical Ethics](http://bmcmedethics.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meth/default.aspx","title":"BMC Medical Ethics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7c361e21-6f49-49d4-851f-90f9d47a759f","owner":[],"postedDate":"March 1st, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":2665947,"name":"Biomedical Engineering"}],"tags":[],"updatedAt":"2023-10-16T19:03:34+00:00","versionOfRecord":{"articleIdentity":"rs-264330","link":"https://doi.org/10.1186/s12910-023-00893-1","journal":{"identity":"bmc-medical-ethics","isVorOnly":false,"title":"BMC Medical Ethics"},"publishedOn":"2023-02-23 18:59:34","publishedOnDateReadable":"February 23rd, 2023"},"versionCreatedAt":"2021-03-01 23:32:44","video":"","vorDoi":"10.1186/s12910-023-00893-1","vorDoiUrl":"https://doi.org/10.1186/s12910-023-00893-1","workflowStages":[]},"version":"v1","identity":"rs-264330","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-264330","identity":"rs-264330","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}