“I don’t like that, it’s tricking people too much…”: acute informed consent to participation in a trial of thrombolysis for stroke Informed consent: how much information is enough? Improving Informed Consent of Surgical Patients Using a Multimedia-Based Program?: Results of a Prospective Randomized Multicenter Study of Patients Before Cholecystectomy Patients' evaluation of informed consent to postponed information: cohort study Impact of risk information in a patient education leaflet. Predictors of comprehension during surgical informed consent. Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods. Patient-physician communication: informed consent for imaging-guided spinal injections. Seeking informed consent to cancer clinical trials: describing current practice. Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial The validity of informed consent in a clinical study Informed Consent: The Rate-Limiting Step in Acute Stroke Trials Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage Patients' perceptions of written consent: questionnaire study Modified informed consent procedure: consent to postponed information Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials.
Background : Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure , underst and ing , voluntariness and consent . The validity of informed consent for critically ill patients has been question ed . Little is known about how these patients experience the process of consent . Objective : The aim of this study was to explore critically ill patients ’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent . Design : 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews .  Results : None of the patients had any clear underst and ing of the purpose of the trial . Neither did they underst and the principles of r and omisation and voluntariness . Reasons for giving or not giving consent were trust , conceptions of benefits and risks and altruism . Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors ’ responsibility . Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity . A majority of the patients found the consent process vague and ambiguous . Conclusions : The results indicate that the principle of informed consent from critically ill patients can not be seen as a contract between equal and autonomous parties . Further studies are needed to explore critically ill patients ’ experiences with the process of informed consent BACKGROUND Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent . The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and /or written information improved their underst and ing . It was further determined whether the provision of more extensive information altered patients ' anxiety levels . METHODS Patients undergoing femoral popliteal bypass or carotid surgery were r and omized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent . Patients undertook a pre-operative risk and complication question naire , a pre- and postoperative anxiety and depression evaluation and a follow-up question naire 6 weeks after discharge . RESULTS Thirty-two patients were included in the trial . The comprehension question naire result ed in a correct percentage response of 48 % for the routine information only , 59 % with added verbal information , 59 % with added written information and 55 % with added written and verbal information . Twenty-five per cent of patients stated that they had a poor underst and ing of the risks and complications of the procedure . CONCLUSIONS Additional written or verbal information did not improve a patient 's underst and ing of risks and complications of the procedure . It also did not improve patients ' perceived underst and ing of the operation or its complications . Patients ' anxiety levels were unaltered by the increase in the information they were given . The information provided to patients should be simple , easy to underst and and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P < 0.001 ) . Patients with less formal education profited particularly from the MM-IP .  Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process Fundamental bias can be introduced in r and omised trials if patients can not be masked for the allocated strategy and assess subjective outcomes . In such a trial , on the effectiveness of outreach stroke care in addition to st and ard care , we masked patients by modifying the informed consent procedure . Before discharge home we informed patients that we were study ing their needs six months after discharge ; we could not inform about an additional research question because that would affect the results ; this question entailed no risk and would be clarified after follow up ; and the ethics committee approved this study .1 After we got consent we r and omised patients . We informed patients in the intervention group about the outreach care programme and asked them to participate , but we kept them ignorant that we were study ing the programme for effectiveness . Controls received no further information . After follow up , we sent all participants a Informed consent requires the communication of information about possible adverse effects of treatment . Health professionals have expressed concern that increased provision of risk information may make patients unduly anxious and change their decisions about treatment . This study compared two patient leaflets about laparoscopy , one containing detailed information about potential side effects . Forty one consenting participants attending an outpatient gynaecology clinic and scheduled for an elective laparoscopic procedure were studied . They were r and omly assigned to receive one of two leaflets after their consultation . Knowledge about laparoscopy , satisfaction with information provided , and anxiety were tested 2 days later , between the original consultation and their operation . Results showed that the leaflet containing detailed risk information was associated with greater knowledge about laparoscopy , higher satisfaction with information provision and no increase in anxiety . Provision of detailed information about possible adverse consequences of treatment can improve patients ' underst and ing and satisfaction without inducing increased anxiety BACKGROUND Patient comprehension during surgical informed consent  remains problematic . Using data from our r and omized trial of methods to improve informed consent comprehension , we performed an additional analysis to define independent factors associated with improved patient underst and ing . STUDY DESIGN Patients scheduled for 1 of 4 elective operations ( total hip arthroplasty [ n = 137 ] , carotid endarterectomy [ n = 178 ] , laparoscopic cholecystectomy [ n = 179 ] , or radical prostatectomy [ n = 81 ] ) at 7 Department of Veterans Affairs ( VA ) medical centers were enrolled . All informed consent discussion s were performed using iMedConsent ( Dialog Medical ) , the VA 's computerized informed consent platform . Using a unique module within iMedConsent , we r and omized patients to repeat back ( RB ) , requiring correct reiteration of procedure-specific facts , or st and ard ( STD ) iMedConsent . Patient comprehension was tested after the informed consent discussion using procedure-specific question naires . Time spent completing the informed consent process was measured using time stamps within iMedConsent . Multiple linear regression identified factors independently associated with improved comprehension . RESULTS We enrolled 575 patients ( 276 RB , 299 st and ard ) ; 93 % were male , 74 % were Caucasian , and 89 % had at least a high school education . Independent factors associated with improved comprehension included race ( p < 0.01 ) , ethnicity ( p < 0.05 ) , age ( p < 0.02 ) , operation type ( p < 0.01 ) , group assignment ( + /- RB ; p < 0.05 ) , and total consent time ( p < 0.0001 ) . Patient comprehension was maximized when informed consent took between 15 and 30 minutes . RB 's positive impact on patient comprehension was weaker in the analysis including consent time . CONCLUSIONS Comprehension during informed consent discussion s may be limited in individuals with potential language difficulty due to ethnicity or education . Total consent time was the strongest predictor of patient comprehension . Affording adequate time for informed consent discussion s and using informed consent adjuncts such as RB may enhance comprehension in such individuals BACKGROUND Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor underst and ing of their disease and of related therapeutic risks , benefits , and alternatives . This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients ' knowledge of st and ard consent elements . METHODS Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI  were r and omly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) . Preconsent and postconsent question naires were administered to evaluate changes in patients ' self-reported underst and ing of st and ard consent elements . RESULTS One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys ( group I=48 ; group II=54 ) . Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p=0.028 ) . Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p<0.05 ) ; 4 of 5 queried risks were correctly identified by greater than 90 % of respondents . However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infa rct ion were identified as PCI-related benefits by 83 % and 46 % of respondents , respectively . CONCLUSIONS Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures . Future research appears warranted to improve patient comprehension PURPOSE Historically , informed-consent forms have been developed for the purpose of educating patients . However , informed-consent forms can be very difficult to underst and . The hypothesis of this study was that a method using diagrams would improve patient-physician communication without increasing the time required to obtain informed consent over the teach-the-teacher method , as well as over current st and ard informed-consent protocol . METHODS Ninety-nine of 109 patients undergoing spinal injections agreed to participate and completed this prospect i ve , r and omized , controlled study . The patients were r and omly assigned to the control group ( informed consent obtained in the customary manner at the investigators ' institution , with 12 key points of consent and home care discussed conversationally ) , the teach-the-teacher group ( patients had to repeat the 12 key points to the physicians before informed consent was complete ) , and the diagram group ( patients viewed a set of diagrams illustrating the 12 key points before signing the informed-consent form ) . After the procedure , the patients completed a survey to test knowledge recall , anxiety , and pain during the procedure . RESULTS Statistically significant results included a lower survey score for the control group , longer time required for the teach-the-teacher group than the control group , and a negative correlation between age and survey score in the teach-the-teacher group . CONCLUSIONS The diagram method required less time than the teach-the-teacher method , had no negative correlation in survey score results with age , and had improved patient-physician communication over the control group Clinical trials have come to be regarded as the gold st and ard for treatment evaluation . However , many doctors and their patients experience difficulties when discussing trials , leading to poor accrual to trials and question able quality of informed consent . We have previously developed a typology for ethical communication about Phase II and III clinical trials within four domains : ( a ) shared decision making , ( b ) sequencing information , ( c ) type and clarity of information , and ( d ) disclosure/coercion . The aim of this study was to compare current clinical practice when seeking informed consent with this typology . Fifty-nine consultations in which 10 participating oncologists sought informed consent were audiotaped . Verbatim transcripts were analysed using a coding system to ( a ) identify the presence or absence of aspects of the four domains and ( b ) rate the quality of aspects of two domains : ( i ) shared decision-making and ( ii ) type and clarity of information .  Oncologists rarely addressed aspects of shared decision-making , other than offering to delay a treatment decision ( 78 % ) . Moreover , many of these discussion s scored poorly with respect to ideal content . The oncologists were rarely consistent with the sequence of information provision . A general rationale for r and omising was only described in 46 % of consultations . In almost one third of the consultations ( 28.8 % ) doctors made implicit statements favouring one option over another , either st and ard or clinical trial treatment . Doctors complied with some but not other aspects of a st and ard procedure for discussing clinical trials . This reflects the difficulty inherent in seeking ethical informed consent and the need for communication skills training for oncologists Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) .  Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 ) Patients , aged 36 to 78 years , who had participated in two studies that included the ventilatory effects of postoperative analgesia , returned a question naire canvassing their views of the procedure for obtaining consent and the conduct of the study . Fourteen of 18 patients from one study , and all 18 from the second , returned their question  naires . Thirty of the 32 patients were satisfied with the pre‐operative explanation . Eleven patients felt obliged to take part , not because of coercion , but from a sense of duty to others . The breathing tests caused discomfort to eight patients but only one of them found this more than expected from the pre‐operative explanation . Only two patients , both in the second study , said that they would not volunteer again for a similar study . There was no suggestion that the age of the patient or the fact that they were undergoing major surgery had any influence on their attitudes or comprehension . It may be prudent to use this type of question naire to evaluate the response of patients to some research projects Successful implementation of a r and omized clinical trial ( RCT ) for neuro-vascular emergencies such as cerebral infa rct ion , intracerebral hemorrhage , or subarachnoid hemorrhage is extraordinarily challenging . Besides establishing an accurate , hyper-expedited diagnosis among many mimics in a person with acute neurological deficits , informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes , grasp the gravity of their situation , or give a complete history or examination . We review the influences , barriers , and factors investigators encounter when providing established and putative stroke therapies , and focus on informed consent , the most important research protector of human subjects , as the rate-limiting step for enrollment into acute stroke RCTs . The informed consent process has received relatively little attention in the stroke literature , but is especially important for stroke victims with acute cognitive , aural , lingual , motor , or visual impairments .  Consent by a surrogate may not accurately reflect the patient ’s wishes . Further , confusion about trial methodology , negative opinions of placebo-controlled studies , and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study . Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs . Ultimately , advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy , beneficence ( non-malfeasance ) , and justice must also be carefully interwoven into any well- design ed RCT Background : In patients with acute life threatening diseases , and in their relatives , the ability to make a balanced decision on participation in a clinical trial may be impaired . Objectives : To assess what relevant information could be recalled by patients who were living independently after a subarachnoid haemorrhage , and by their relatives ; and to determine how these patients and relatives had reacted to the informed consent encounter . Methods : Twenty months ( range 7 to 31 ) after treatment for subarachnoid haemorrhage , 49 patients and 47 relatives who had participated in one of two r and omised trials on medical management were interviewed . The interview consisted of items on : spontaneous recall and knowledge of trial design ; underst and ing of the trial design and the informed consent procedure ; the amount and clarity of the information given ; and reasons for participating . Finally patients and relatives were asked whether they would participate again in similar circumstances . Results : One third of the patients recalled having participated in a clinical trial . Thirteen per cent of the patients and 20 % of the relatives felt that the information supplied had not been sufficient . Nine per cent of the patients and half the relatives had read the written information . None of the patients and one relative thought that participation had been obligatory . Twenty eight per cent of the patients and 94 % of the relatives felt in retrospect that they had been capable of making an adequate decision . Virtually all patients and relatives would participate again in similar circumstances . Conclusions : Many patients and their relatives have little recall of the informed consent procedure and the essentials of acute subarachnoid haemorrhage trials . However , most were satisfied with the overall procedure and would participate again Abstract Objective To examine patients ' underst and ing of the status , function , and remit of written consent to surgery . Design Prospect i ve question naire study . Question naires were sent to patients within one month of surgery . Responses were analysed with frequencies and single variable analyses . Setting Large teaching hospital . Participants 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period . Main outcome measures Patients ' awareness of the legal implication s of written consent and their views on the function and remit of the consent form .  Results Patients had limited underst and ing of the legal st and ing of written consent . Nearly half ( 46 % , 95 % confidence interval 43 % to 50 % ) of patients believed the primary function of consent forms  was to protect hospitals and 68 % ( 65 % to 71 % ) thought consent forms allowed doctors to assume control . Only 41 % ( 37 % to 44 % ) of patients believed consent forms made their wishes known . Conclusions Many patients seem to have limited awareness of the legal implication s of signing or not signing consent forms , and they do not recognise written consent as primarily serving their interests . Current consent procedures seem inadequate as a means for the expression of autonomous choice , and their ethical st and ing and credibility can be called into question How do you obtain a valid assessment of subjective outcomes in a trial in which the participants can not be blinded to the intervention ? Bias is inevitable from unblinded patients , but trials that have not told patients about treatment in all arms have been heavily criticised . Asking participants to consent to postponed information could be a solution The most powerful tool for study ing the effectiveness of a medical treatment is a r and omised controlled clinical trial with blinded assessment of outcomes . However , blinding is not always possible — for example , in a trial comparing a surgical intervention with non-surgical treatment or the effectiveness of supplemental care compared with conventional care . Blinding needs special attention in such studies in order to prevent bias . When outcomes are assessed by doctors , it is often easy for the assessment to be done by doctors other than those who performed the procedure . However , when studies measure patients ' assessment of outcomes , blinding is much more complicated or even impossible . ! [ ] [ 1 ] Credit : PETER GRAY Unblinded patients who assess outcomes after being informed about the different treatment options during recruitment might bias the results of a study . The likelihood of bias increases when patients have a preference for one of the treatment options . For example , patients may have been told during recruitment that the new or supplemental strategy has been developed because the current strategy has disadvantages . The best way to obtain valid assessment s in such studies remains unclear . Intense debate was generated when research ers tried to mask patients … [ 1 ] : OBJECTIVE To evaluate the effectiveness of oral communication about the risks of facial cosmetic procedures compared with oral and written communication . DESIGN A prospect i ve r and omized study conducted in an ambulatory surgery center . One hundred twenty consecutive patients were included ; they presented for consultation for rhinoplasty , rhytidectomy , or laser resurfacing . Patients were r and omly assigned to 1 of 2 groups : ( 1 ) those receiving oral discussion of the risks of the procedure and ( 2 ) those receiving oral and written communication about the risks . Two weeks after the initial consultation , patients were surveyed for recall of the risks . RESULTS The group that received a pamphlet had a better risk recall than the group that did not ( 2.5 vs1.5 of 5 risks ; P<.001 ) . The recall rate in the following groups that received a pamphlet was also better : ( 1 ) university-educated patients ( P = .02 ) , ( 2 ) patients who underwent rhinoplasty ( P<.001 ) , ( 3 ) patients who underwent laser resurfacing ( P = .02 ) , and ( 4 ) female patients ( P<.001 ) . CONCLUSIONS Written disclosure of the risks of cosmetic procedures enables patients to retain and underst and more clearly those potential risks . They are , therefore , able to give an informed consent to the proposed procedure . This study also identifies patient groups who may require more intensive presurgical teaching . The medicolegal implication s are apparent R and omised clinical trials have come to be regarded as the gold st and ard in treatment evaluation . However , many doctors see the discussion of a clinical trial as an intrusion into the doctor-patient relationship and find these discussion s difficult to initiate . Detailed informed consent is now a requirement of patient participation in trials ; however , it is known that patients commonly fail to underst and and recall the information conveyed . These difficulties for doctors and patients raise questions about the ethical integrity of the informed consent process . In this study , we have developed a set of communication strategies underpinned by ethical , linguistic and psychological theory , design ed to assist doctors in this difficult task . Initially , audiotape transcripts of 26 consultations in which 10 medical oncologists invited patients to participate in clinical trials were analysed by expert ethicists , linguists , oncologists and psychologists , using rigorous qualitative methodology . A subset of seven of these was subjected to detailed linguistic analysis . A strategies document was developed to address themes which emerged from these analyses . This document was presented to relevant expert stakeholders . Their feedback was incorporated into the final document . Four themes emerged from the analysis ; ( a ) shared decision-making , ( b ) the sequence of moves in the consultation , ( c ) the type and clarity of the information provided and ( d ) disclosure of controversial information and coercion . Detailed strategies were developed to assist doctors to communicate in these areas . We have developed a set of ethical strategies which may assist health professionals in this difficult area . A training package based on these strategies is currently being evaluated in a multi-centre r and omised controlled trial
We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
There is evidence that at present some patients undergo procedures without informed consent being achieved .
OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .