Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Procedure-specific consent: the informed approach
- Umar S Shariff, Neeraj Bhala (Specialist Registrar in Gastroenterology), and Mark E McAlindon (Consultant Gastroenterologist) (5 September 2006)
-
Patients' perceptions of written consent: questionnaire study
- Tony S Zigmond (10 September 2006)
-
Informed consent information
- Jeevan P Marasinghe (12 September 2006)
-
Patient Perceptions of Consent Forms
- Sarah Chaudhary (12 September 2006)
-
One way forward: Review and update DOH’s Consent Key Documents.
- Babatunde A. Gbolade (12 September 2006)
-
"Informed " or "basic" consent: Are doctors seeking the latter one?
- Tatiana Izotova, Dr Faouzi Dib Alam (13 September 2006)
-
Health literacy is an often ignored underlying issue
- Andrew F. Pleasant (14 September 2006)
-
Is written "informed consent" simply a judicial act?
- Giuseppe Vetrugno, Fabio De Giorgio, Pia Andreotta, Gennaro Capalbo, Domenico De Mercurio, and Antonio Abbate (15 September 2006)
-
Re: Is written "informed consent" simply a judicial act?
- Nazar R DESSOUKI (16 September 2006)
-
Informed consent
- Fiona Woollard (21 September 2006)
-
impact of patient’s written consent on the understanding of their diagnosis
- Frédéric Lapostolle, Lydia Ameur, Jean Catineau, Frédéric Adnet (21 September 2006)
|
|
|||
|
Umar S Shariff, Senior House Officer Department of General Surgery, Northern General Hospital, Sheffield, UK, Neeraj Bhala (Specialist Registrar in Gastroenterology), and Mark E McAlindon (Consultant Gastroenterologist)
Send response to journal:
|
Akkad et al. raise a number of pertinent points in their study of consent in obstretic surgical patients.(1) Nearly half the patients felt the main function of consent was to primarily safeguard the hospital from litigation matters. Two-thirds felt consent gave doctor control, thus making patients feel disempowered about their potential treatment. Certainly this highlights that doctors and patients have very different perceptions of the consent process. We feel that it is important to highlight that the information patients require is variable, and also procedure-specific. In gastrointestinal endoscopy, for example, risks vary according to site and diagnostic or therapeutic intent. In a study of 300 patients undergoing gastroscopy and colonoscopy, patients in both groups were more likely to want to know about major than minor complications (p <0.001) but colonoscopy patients required more information about any complication compared to gastroscopy patients (p < 0.001).(2) The consent process could be improved by providing procedure-based information leaflets that provide information on common and serious complications, thus allowing patients to be more informed prior to signing written consent. Previous work has highlighted how this can benefit certain high risk groups such as the elderly.(3) Use of non-English language leaflets can also reduce anxiety and facilitate communication with ethnic minority groups.(4) Information leaflets sent to patients describing the firstly the role and function of consent together with information about the specific procedure would be a simple method of enabling patients to understand both. This would provide an informed approach to consent, letting patients feel more in control of their treatment. 1. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients’ perceptions of written consent: questionnaire study. BMJ, doi:10.1136/bmj.38922.516204.55 (31/7/06) 2. Brooks AJ, Hurlstone DP, Fotheringham J, Gane J, Sanders DS, McAlindon ME. Information required to provide informed consent for endoscopy: an observational study of patients' expectations. Endoscopy. 2005 Nov;37(11):1136-9. 3. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 May 8;306(6887):1273. 4. Conroy SP, Mayberry JF. Patient information booklets for Asian patients with ulcerative colitis. Public Health. 2001 Nov;115(6):418-20. Competing interests: None declared |
|||
|
|
|||
|
Tony S Zigmond, Consultant Psychiatrist Newsam Centre, Seacroft Hospital, Leeds LS14 6WB
Send response to journal:
|
The word 'consent' may be part of the problem. It is defined as 'to agree to' or 'to give permission for'. I wonder if 'Request for treatment' forms would be viewed differently, by both parties. Competing interests: None declared |
|||
|
|
|||
|
Jeevan P Marasinghe, Registrar in Obstetrics and Gynecology Professorial Obstetrics and Gynecology Unit,Faculty of Medicine,University of Peradeniya,Sri Lanka.
Send response to journal:
|
The work by Akkad A et al(1)raises certain ethical issues and highlights certain ground clearance work on patient perception of written consent to surgery. The fact that only 41% of patients thought that the consent forms made their wishes known and nearly half (46%) of the respondents thought that the main function of it was to protect the hospital from litigation, depicts the thinking pattern of current patients in relation to medico legal procedures .Sixty eight percent of patients thought that it gave doctors control over what happened! These results denote the emerging conflicts and poor mutual understandings between the patients and the health care providers ( 2), ( 3).The chosen study population being patients in obstetrics and gynecology wards might have an effect on the findings, since these patients ,especially patients in obstetrics wards have high expectations. Certain measures can be suggested to ease the tension. Pregnant mothers can be more made knowledgeable during antenatal clinic visits regarding consent process in obstetric procedures and the implications. Leaflets, health talks, and group discussions could be well utilized for these purposes .A friendlier approach and a tension free environment might do wonders to improve doctor patient relationship. Midwives and other health care providers in local antenatal clinics can participate in educating the pregnant mothers. Patients awaiting gynecological surgeries can be allowed to be moved with post operatives, thereby providing opportunities for appropriate dialogues between peers to get an idea of it and to have a measure of it before hand. The recall bias and the number of non-responders could have been well minimized if the questionnaire had been delivered when the patients were in the recovery process from the surgery or when they were about to be discharged .There seems to be no rationale for mailing the questionnaire and to get the feed back within one month after the surgery. Moreover the study sample and the settings seem not to be uniform. The fact that the non responders were significantly younger than the respondents raises an interesting question ’Is this standard consent form for future adults?’ References. (1)Akkad A,Jackson C,Kenyon S,Dixon-Woods M,Taub N,Habiba M.Patients’ perception of written consent :questionnaire study.BMJ 2006 Jul 31;[Epub ahead of print] (2)Rachaqan SS,Sharon K.The patient’s view. Med J Malaysia.2003 Mar; 58 Suppl A: 86-101. (3)Teutsch C.Patient-doctor communication. Med Clin North Am.2003 Sep; 87(5):1115-45. Competing interests: None declared |
|||
|
|
|||
|
Sarah Chaudhary, Research Assistant Stanford University School of Medicine, Palo Alto CA, USA 94304
Send response to journal:
|
Thank you to the authors of this piece for highlighting an important but often overlooked bioethical aspect of patient care. The inclusion of some demographic data for non-participants is an excellent step in acknowledging the potential role of selection bias. Stratification by race and ethnicity may also be valuable to the analysis of these results. An underlying cause of the varying perceptions of consent forms may be related to varying degrees of trust amongst patients, which may be subsequently dictated by varying cultural norms and attitudes. Mistrust of the healthcare system is often present amongst minority groups, and there is data to support physician bias against minorities. Under such circumstances, levels of trust may profoundly impact patients’ beliefs regarding the purpose and intent of consent forms. Sarah Chaudhary sarah1c@stanford.edu Competing interests: None declared |
|||
|
|
|||
|
Babatunde A. Gbolade, Consultant Gynaecologist & Director of Fertility Control Unit The Leeds Teaching Hospitals NHS Trust, St James's University Hospital. Leeds LS9 7TF
Send response to journal:
|
The results of the study by Akkad et al.(1) point to what information about the written consent process is important and should be available to patients before being requested to give consent to undergo medical intervention. In particular, the paper highlights the importance of involving patients in the design and content of patient information documents and leaflets. The Department of Health’s (DOH) Website contains Consent key Documents(2) which are used by virtually all NHS Trusts. While answers to some of the questions asked in the questionnaire are present in the DOH’s consent documents for mentally capable adults (3,4) it seems that the contents in their present form do not fully address what patients need to know to help facilitate their understanding of the status, function, and remit of written consent to medical intervention. Most trusts print these documents and leaflets in one form or another and give them to patients to read before the written consent process. Whether patients actually do read them before the process does not appear to have been studied. Even where patients do manage to read them before the process, their needs for specific information may not be fully met. One way forward would be to undertake a review of the DOH’s Consent Key Documents pertaining to mentally capable adults, in partnership with patients and their representatives, taking into consideration the findings of this study. This approach may go some way towards producing appropriate documents and leaflets that should help facilitate patients’ understanding of the status, function, and remit of written consent to any medical intervention. References: 1.Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients perceptions of written consent: questionnaire study. BMJ 2006; 333:528-9. 2. Department of Health. Consent Key Documents. http://www.dh.gov.uk/PolicyAndGuidance/ HealthAndSocialCareTopics/ Consent/ ConsentGeneralInformation/fs/en (accessed 11 September 2006). 3. Department of Health. Consent – What you have a right to expect. A guide for adults. 2001 http://www.dh.gov.uk/assetRoot/04/06/69/93/04066993.pdf (accessed 11 September 2006). 4. Department of Health. About the consent form http://www.dh.gov.uk/assetRoot/04/01/90/97/04019097.pdf (accessed 11 September 2006) Competing interests: None declared |
|||
|
|
|||
|
Tatiana Izotova, F2 Aintree Hospital, Longmoor Lane, Liverpool, L9 7AL, Dr Faouzi Dib Alam
Send response to journal:
|
Akkad et al (1) wrote on patients’ perception of written consent. The findings of the survey are hardly surprising, in particular the high percentage (68%) of patients who thought consent forms allowed doctors to assume control. This survey shows that patients are giving “basic consent” rather than “informed” one. What is “informed consent”? “Informed consent” is the process by which a fully informed patient can participate in CHOICES about his/her health care. That means the patient should be informed about the nature of the decision/procedure, the reasonable alternatives to the proposed intervention, as well as the risk, benefits and uncertainties related to each alternative, after which comes the assessment of the patient’s understanding of the discussion and his/her acceptance of the proposed intervention. What is “basic consent”? “Basic consent” means letting the patients know what you want to do and asking them if they are all right with it. The problem with informed consent and complexity of consent forms is not new. In 1980, Garry Morrow spoke about the complexity of the informed consent forms and that substantial number of patients may not understand them (2) In 1995 Hopper et al wrote that consent forms used in radiology are too complex for the average patient to understand (3) The question which begs itself to be asked: Do health professionals use “informed consent” forms to get “basic consent”? And if not why is it that 68 % of patients think that they are allowing doctor to assume control when signing informed consent forms? 1. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients’ perceptions of written consent: questionnaire study. BMJ, doi:10.1136/bmj.38922.516204.55 (31/7/06) 2. Morrow GR. How readable are subject consent forms? JAMA. 1980; 244:56-8. 3. Hopper KD, Ten Have TR, Hartzel J,consent forms for clinical and research. imaging. procedures:. how. muLch. do. patients understand? Am. J. Roentgenol. 1995; 164: 493-96. Competing interests: None declared |
|||
|
|
|||
|
Andrew F. Pleasant, Assistant Professor Rutgers University, New Brunswick, NJ 08901 U.S.
Send response to journal:
|
Akkad et al. (1) point out one of the many serious issues that emerge from a vast disconnect between the communication materials often used by physicians, hospitals, and public health departments and the abilities of the public to find, understand, and use that information. Unfortunately, Akkad et al. do not directly label the issue they investigate as part of the emerging field of studying health literacy.(2) Studies have shown, for instance, that individuals with low health literacy can face poor adherence to medical regimes, poor understanding of the complex nature of their own health, lack of knowledge about medical care and conditions, poor understanding of medical information, low understanding and use of preventive services, lower self-reported health, increased hospitalization, increased health care costs, and poorer health status.(2- 5) Health literacy is defined as “the wide range of skills and competencies that people develop to seek out, comprehend, evaluate, and use health information and concepts to make informed choices, reduce health risks, and increase quality of life.” (2; pg. 6) Most importantly, responsibility and blame for these disconnects must not be placed solely on patients and the public as, is demonstrated by Akkad et al., health information providers often create and provide information that is too vague, complex, or undecipherable as they are responding to their own practical, cultural, civic, and scientific contexts rather than attempting to understand and meet their patients’ abilities and needs. Health literacy is a key tool of individual and community empowerment (2,6), and should be placed at the forefront of concerns in order to allow people to participate as full partners in their health care. Andrew Pleasant
1. Akkad A,Jackson C,Kenyon S,Dixon-Woods M,Taub N,Habiba M.Patients’ perception of written consent :questionnaire study.BMJ 2006 Jul 31;[Epub ahead of print] 2. Zarcadoolas, C., Pleasant, A., Greer, D.S. Advancing health literacy: A framework for understanding and action. San Francisco, CA, Jossey-Bass. 2006. 3. Zarcadoolas, C., Pleasant, A., Greer, D.S. Understanding health literacy: An expanded model. Health Promotion International, 20, 195-203. 2005. 4. Nielsen-Bohlman, L., Panzer, A.M., Kindig, D.A. Health literacy: A prescription to end confusion, Washington, D.C., Institute of Medicine of the National Academies. 2004. 5. Schwartzberg, J., VanGeest, J. & Wang, C. (Eds.) Understanding health literacy: Implications for medicine and public health, Chicago, IL, AMA Press. 2005. 6. Freire, P. Education for critical consciousness, New York, NY, Continuum. 1980. Competing interests: None declared |
|||
|
|
|||
|
Giuseppe Vetrugno, M.D. Medical Directorate, Catholic University of the Sacred Heart, School of Medicine - Rome, Fabio De Giorgio, Pia Andreotta, Gennaro Capalbo, Domenico De Mercurio, and Antonio Abbate
Send response to journal:
|
Dear Editor: The study by Dr. Akkad et al.(1) on patients’ perceptions of written consent seems to have succeeded in unmasking what other authors had already ventured to call the “legal fiction” or “myth” of informed consent(2). Nevertheless, we would like to recall that the phrase “informed consent” was coined by a United States Court in 1957. In the case of Salgo vs. Leland Stanford Jr. University Board of Trustees, the Court ruled that a physician violates his duty to his patient and subjects himself to liability if he withholds any fact that is necessary to form the basis of an intelligent consent by the patient to the proposed treatment. It is even symptomatic that this expression was born in a courtroom and therefore it should not come as a surprise that the perception patients have of these forms is that of an instrument of defense employed by hospitals to protect themselves from the risk of possible litigation. In Italy, we experience this debate very commonly. A number of famous criminal cases that resulted in the conviction of a doctor for manslaughter have further fueled this debate. In one case, a surgeon had decided to perform an elective surgical procedure on a patient and, without obtaining prior consent from the patient, he had changed the surgical approach from endoscopic to laparotomy. The case resulted in the death of the woman from a post- operative complication that is commonly associated with the second procedure(3). Similarly, a recent ruling by the Court of Cassation(4) concerned the conduct of a surgeon who, in the absence of prior consent, had decided to convert a cholecystectomy into a more demolitive surgery, a duodeno- cephalo-pancreasectomy.The patient subsequently died and, in this case, the physician was acquitted of manslaughter. In both cases, the Court, while stressing the value of informed consent as a stronghold for the free self-determination of patients, also took the opportunity to stigmatize the ravenous chase for informed consent forms. The operative part of the judgment reads as follows: “…. the widespread, growing juridical emphasis that has been placed on written consent has transformed it from an instrument of therapeutic alliance into an element of conflictuality that results from the ever-growing distrust of health care structures by citizens, which is countered by the alarming phenomena of defensive medicine, commonly expressed by the anxious quest carried out in every hospital, public or private, for written acceptance forms signed by patients in the erroneous assumption that such forms have the intrinsic aptitude for fully releasing the hospital from liability …..”. In this ongoing debate, we would like to thank Dr. Akkad and coll. to report on such a delicate issue and to remind us all that if we really wish to restore dignity to “informed consent”, we cannot ignore the fact that, for information to be understood, it must first and foremost be verbal, direct and simple, the result of a conversation that has the sole purpose of allowing the patient to understand and therefore be able to make an informed decision. Erudite forms and booklets, either detailed (an example, hideously comic, can be found in the form proposed by P.J. Burnham in 1966)(5) or summarized, that are full of juridical language clearly serve a different purpose that cannot go undetected by the recipient and, in fact, as the study by Dr. Akkad et al. actually seems to demonstrate, it does not go undetected. References 1. Akkad A., Jackson C., Kenyon S., et al. Patients’ perceptions of written consent: questionnaire study. BMJ, 333: 528 (2006); 2. Meisel A., Kuczewski M. Legal and ethical myths about informed consent. Arch. Intern. Med. 156: 2521 (1996); 3. Crim. Cass. April 21, 1992 vs. “Massimo”; 4. Crim. Cass. 07.11.2002 n. 26446 vs. “Volterrani”; 5. Burnham P.J. Medical experimentations on humans. Science 152: 448 (1966). Competing interests: None declared |
|||
|
|
|||
|
Nazar R DESSOUKI, Consultant Surgeon St. BERNARDS HOSPITAL GIBRALTAR
Send response to journal:
|
INFORMED CONSENT....FACTS. The informed consent provides an ongoing explanation to patients in order to make educated decisions about whether to accept the doctor’s advice or to participate in a clinical trial. Informed consent is an ongoing, interactive process, rather than a one-time information session. The informed consent process is designed to help patients to weigh all of the information and make the right choice. Even after they sign the form, the patient is free to change his/her mind and decide not to accept the advice. They also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment. Competing interests: None declared |
|||
|
|
|||
|
Fiona Woollard, BA (Hons) Med Sec Dip YO24 1EP
Send response to journal:
|
Informed consent should also include written consent on taking genetic tests. The gene deletion that is to be tested explained to the patient, the risks and complications within it explained along with the information supplied to them on the condition prior to any testing. It is simply not good enough to take blood from the patient and then give the diagnosis, which, incidentally the patient might not have any idea what they are being tested for and the right for privacy and the right to choose. The process should be no different to that of other procedures and HIV/AIDS testing. At the point of a positive diagnosis found in auto-dominant conditions, the investigations and care to be given at the point of the diagnosis not years later as there are no such things as 'carriers' in certain genetic conditions which can cause confusion between doctors. Taking a proper medical history also applies to genetic specialists. Taking genetic tests is not simply about future risks of pregnancy but there are social, ethical, medical, psychological, employment and insurance problems to be considered when taking genetic tests to bear in mind for the future because if you aren't going to investigate and treat there is simply no point in giving a diagnosis. There is a duty of care to the patient to be considered when these complex problems are being discussed. Competing interests: None declared |
|||
|
|
|||
|
Frédéric Lapostolle, MD 93009, Lydia Ameur, Jean Catineau, Frédéric Adnet
Send response to journal:
|
Dear sir, We read with great interest the article from Akkad and al. on patient’s written consent 1. We recently studied the impact of patient’s written consent on the understanding of their diagnosis. To answer this question, patients initially managed in prehospital settings for ST elevation acute myocardial infarction treated by fibrinolysis or primary percutaneous angioplasty were contacted by telephone. All these patients were prospectively included in registers, from January 1998 to July 2004 and phoned back during 2005 2. 976 patients were included. With a mean follow up period of 33 (14-53) months, 111 (11 %) were lost to follow up, 161 (19%) had died and 120 failed to answer because of language problems or medical reasons. Finally 584 patients were contacted by telephone including 143 (24%) patients enrolled in prospective studies requiring a written consent during initial management 3-5. No written consent was obtained in the remaining cases (76%). The patients were questioned on their initial diagnosis and whether they had signed a written consent. 229 patients (52 %) who were enrolled without a written consent in comparison with 75 patients among 143 (52%) (p=0.9) who were enrolled with a written consent were able to say that they had had an “infarction” or a similar answer like a heart attack. 43 patients (10%) enrolled without a written consent erroneously remembered to have signed one in comparison with 53 patients (38%) enrolled with a written consent who remembered to have signed one (p<0.00001). We believe that this lack of impact of patient’s written consent on the understanding of their diagnosis strongly reinforces Akkad et al’s conclusions. Patients do not understand the aim of the written consent which, furthermore, doesn’t improve their understanding of the diagnosis. References 1. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients' perceptions of written consent: questionnaire study. BMJ 2006;333: 528 (9 September), doi:10.1136/bmj.38922.516204.55 2. Lapandry C, Laperche T, Lambert Y, Sauval P, Zurek M, Fosse S. Prise en charge préhospitalière des syndromes coronaires aigus ST + en Ile-de- France. Le registre E-must. Arch Mal Cœur 2005;98:1137-42 3. Bonnefoy E, Lapostolle F, Leizorovicz A, Steg G, McFadden EP, Dubien PY, et al. Comparison of Angioplasty and Prehospital Thromboysis in Acute Myocardial Infarction study group. Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study. Lancet 2002; 360:825-9 4. Wallentin L, Goldstein P, Armstrong PW, Granger CB, Adgey AA, Arntz HR, et al. Efficacy and safety of tenecteplase in combination with the low- molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction. Circulation 2003;108:135-42 5. Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 2005;352: 1179-89 Competing interests: None declared |
|||