consent form, and were more likely to report feeling frightened by signing it (OR 2.52). They were ..... some patients sign unread documents based solely on.
BJOG: an International Journal of Obstetrics and Gynaecology October 2004, Vol. 111, pp. 1133 –1138
DOI: 10 .1111/ j.1 471-0528.2 004.002 40.x
Informed consent for elective and emergency surgery: questionnaire study Andrea Akkad,a Clare Jackson,a Sara Kenyon,a Mary Dixon-Woods,b Nick Taub,b Marwan Habibaa Objectives To evaluate women’s experience of giving consent to obstetric and gynaecological surgery and to examine differences between those undergoing elective and emergency procedures. Design A prospective questionnaire study. Setting A large teaching hospital. Population 1006 consecutive patients undergoing elective or emergency surgery in obstetrics and gynaecology. Methods Questionnaires were administered to women who had given consent to surgery following the introduction of national guidelines and consent form. Differences in responses between elective and emergency patients were assessed using frequencies, single and multivariable analyses. Main outcome measures Patients’ experience and recall of the consent process, their overall satisfaction and their views on what is important for adequate consent. Results There were significant differences between patients undergoing elective or emergency surgery. Patients undergoing emergency surgery were less likely to have read (OR 0.22) or understood (OR 0.40) the consent form, and were more likely to report feeling frightened by signing it (OR 2.52). They were more likely to report they felt they had no choice about signing the consent form (OR 2.11), and that they would have signed regardless of its content (OR 3.14). Overall, significantly more patients undergoing elective (80%) or emergency (63%) surgery reported satisfaction with the consent process. Patients were more likely to report satisfaction if they read (OR 1.80) and agreed with (OR 3.49) the consent form, and if someone checked that they understood (OR 3.09). Conclusion Patients’ needs may not be adequately addressed by current guidelines for consent to treatment, particularly in emergency circumstances. The introduction of more complex forms and procedures appears to conflict with patients’ need for personal communication and advocacy. The implications on the ethical and legal standing of consent are considerable.
INTRODUCTION Consent to treatment has recently become subject to heightened public interest. The ongoing debate in medicolegal circles has led to growing emphasis on the provision of more information, and has resulted in the introduction of longer and more complex forms and procedures. In the UK, the Department of Health (DoH) has published national guidelines for obtaining valid consent to treatment,1 to ensure that specific information about
a
Division of Obstetrics and Gynaecology, University of Leicester, UK b Department of Health Sciences, University of Leicester, UK Correspondence: Mr M. Habiba, Division of Obstetrics and Gynaecology, Department of Cancer and Molecular Medicine, University of Leicester, Robert Kilpatrick Building, Leicester LE2 7LX, UK. D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology
procedures, their benefits and complications as well as alternative treatment is imparted to the patient.2 Whether these processes truly address patients’ needs is unknown, partly because the research field is dominated by measurements of information and recall, rather than addressing issues of patient-defined priorities and values.3,4 There is little published evidence about patients’ experience of the consent process, and in particular, there is little evidence that distinguishes between the experiences of patients who have undergone elective compared with emergency surgery. A new consent form for competent adults was among four recently introduced by the Department of Health. In this article, we report a questionnaire survey of patients’ experiences of and views on giving consent to elective and emergency surgery, focussing on competent adults. This builds on an earlier qualitative study of women’s views on consent to surgery, in which we found that patients’ accounts suggest that current procedures of obtaining informed consent neither adequately reflected their own views and values, nor addressed their needs in www.blackwellpublishing.com/bjog
1134
A. AKKAD ET AL.
situations of increased vulnerability. These issues appeared to be particularly prominent in accounts of patients who had undergone emergency surgery.
METHODS The content of the questionnaire was developed using themes which had emerged from semi-structured interviews conducted with patients from the same unit in the preceding 12 months. A panel of eight patients, who had recently given consent to surgery, participated in the questionnaire development. The role of the panel was to ensure patient-centredness of the questionnaire, to give a patient’s perspective on its readability and userfriendliness, and to identify any ambiguities or lack of clarity within the questions. The questionnaire was piloted with 17 patients prior to being finalised. The investigators and the patient panel reviewed feedback from the pilots, and, where appropriate, questions were modified accordingly. In this article, we report on two themes covered by the questionnaire: 1. Patients’ own experience and recall of the consent process, and their overall satisfaction with the experience (Tables 1 –4). 2. Patients’ views on what is important for adequate consent, whether it was achieved, and how this influenced patient satisfaction with the process (Tables 5 and 6). With the approval of the local Ethics Committee, 1040 consecutive women who had undergone elective or emergency surgery in obstetrics and gynaecology at a large teaching hospital in the East Midlands between 1 November 2002 and 30 April 2003 were contacted by letter within two to four weeks of surgery. They were invited to participate in the study, and an opt-out card was provided for those who did not wish to participate. The questionnaire was sent to participants who did not opt out. Non-responders received two reminders. All surveyed patients had recent experience of giving consent to surgery using the newly introduced DoH consent form 1 (consent form for adults with capacity to give consent, who will not or may not retain consciousness throughout the procedure).2 All questionnaires were anonymised and entered into a Microsoft Access database. We analysed the data using frequency tables, single-variable and multivariable analyses to assess differences between patients undergoing elective and emergency surgery. We used C 2 test and Mann – Whitney U test to compare categorical and continuous variables, respectively. Odds ratios (OR) for differences between the emergency and elective groups were calculated using logistic regression. For all odds ratios, elective patients form the reference group.
To determine which items were linked to patients’ satisfaction, the following demographic and procedural variables were analysed: age, Townsend social deprivation score,5 elective/emergency status, gynaecology/maternity patient and timing of consent. We also included the patients’ statements on a range of processes surrounding consent. These variables were entered into a multivariable binary regression analysis. We finally produced a multivariable model using backward deletion of variables until all remaining were significant at the 5% level. A Hosmer – Lemeshow goodness-of-fit statistic was performed on the final regression model. All analyses were undertaken in SPSS version 11.5. Statistical significance was defined at the 5% level throughout.
RESULTS Of the 1040 patients approached, 34 opted out. Questionnaires were sent to 1006 patients. A total of 734 questionnaires were returned, giving a response rate of 71%. Non-responders were likely to be younger (mean age 36.9 vs 39.8, P < 0.0001), living in areas associated with material deprivation — measured by Townsend score6
Table 1. Responses to factual and procedural questions by patients undergoing elective or emergency surgery. Responses are given in n (%). Question
Elective (n ¼ 499)
Emergency (n ¼ 233)
Overall satisfaction with the process of giving consent Very satisfied/satisfied 394 (80) 144 (63) Neither satisfied nor dissatisfied 80 (16) 71 (30) Dissatisfied/very dissatisfied 21 (4) 15 (7) Missing 4 3
P
24 hours before operation 281 (56)
