A survey of the current practice of the informed consent process in general surgery in the Netherlands

Please see Additional file 1 for the Dutch abstract.

It is common surgical practice to provide patients with the opportunity to consent to an operative procedure. Moreover, a surgical informed consent process (SIC) is considered a conditional element of standard surgical patient care. The basic elements presupposed by the Nuremberg and Helsinki code, the U.S. National Institute of Health and the World Health Organization are ‘assessment of preconditions’, ‘provision of information’ and the ‘stage of consent’ (Figure 1) [1‐4]. A properly conducted SIC process is an interactive and structured process resulting in fully informed patients who are truly able to make an informed decision on risks and benefits of a treatment, alternative treatment options or postponing surgery [1, 5‐7]. Past, present and future aspects of SIC were discussed in a previous contribution [1]. Conversely, an inadequate SIC compromises patient autonomy, creates potential risks, diminishes patient satisfaction and trust in their surgeon and thereby jeopardizes the patient-physician relationship. Moreover, SIC violation may lead to a disciplinary tribunal, assault or battery action [8, 9].

In the Netherlands, surgical patients are predominantly treated in 94 public hospitals around the country (8 university, 26 large teaching and 60 general hospitals). A limited number of private clinics (10%) provide a restricted volume of outpatient surgical care. All doctors including senior and junior staff are legally allowed to execute SIC. Specifics of SIC are anchored in the 1995 Dutch Medical Treatment Contract Act (Wet Geneeskundige Behandelings Overeenkomst, WGBO). More recently, the Royal Dutch Medical Association (Koninklijke Nederlandse Maatschappij ter bevordering van de Geneeskunst, KNMG) published a specific guideline in a ‘Handbook of Informed Consent’ [10]. In 2009 a guideline for ‘the preoperative route’ initiated by the Dutch Institute for Healthcare Improvement (Centraal Beleids Orgaan, CBO) was published with even more strict guidelines [11]. In 2010, the Dutch Society of Surgery (Nederlandse Vereniging voor Heelkunde, NVvH) and the Dutch Society of Anaesthesia (Nederlandse Vereniging voor Anesthesie, NVA) implemented this guideline as the gold standard [12]. Although written consent is strongly recommended, a signature of the patient or medical representative is not legally required [12].

Even though improvements in SIC were attained in recent years, other studies suggest that the implementation of SIC is still suboptimal in surgical practice [1, 3]. Surgical staff may overestimate patient’s competence to make well informed decisions whereas patients are often unaware or misinformed on the role of SIC [1, 3, 13, 14]. Surgeons may also underestimate the extent of information that is expected by their patients [15]. Some aspects of the information may not be understood. Moreover, patients understanding is not routinely checked [3, 5, 16‐20]. Organisation and recording of the SIC process is often poor [21‐23]. Training of residents may vary as considerable geographical differences in knowledge were found [14, 23]. Whether these shortcomings are also present in the Netherlands is unknown.

The aim of this study is to evaluate the reported daily practice of Dutch surgeons and residents regarding characteristics of the SIC process. We hypothesized that levels of knowledge and skills are suboptimal and may differ between Dutch surgeons and residents.

The aim of this study was to investigate the daily practice of the SIC process by general surgeons and residents in the Netherlands. It was assumed that level of knowledge and skills were suboptimal. Results of the present study indeed confirmed this hypothesis. Interestingly, considerable differences between knowledge levels of surgeons and residents regarding various elements of SIC were identified. It may be assumed that lack of knowledge, training and structure in the SIC process may result in a suboptimal implementation in daily practice. Conversely, an optimized SIC process may enhance patient compliance, safety, satisfaction and trust, leading to an improved physician-patient relationship.

The present study is the first of its kind in the Netherlands. However, a lack of knowledge on most aspects of SIC is consistently found in various other studies investigating surgical staffs in Europe, USA and New Zealand [1, 5, 14, 25‐27]. Residents performed worse compared to surgeons in Ireland, Germany, UK and USA [23‐25, 28]. They do not feel confident due to a lack of training [5, 13, 23, 24, 26, 29], and up to 60% of residents in the USA claimed that they never received any feedback on these issues during their residency [29, 30]. In recent years, informed consent was topic of debate in the USA and the UK and improvements in care followed. However, this debate was not so intense in the Netherlands. Dutch surgeons judge the process of SIC important but they are faced with uncertainties in daily practice. Which aspects of SIC are obligatory and which are accessory? Residents were familiar with some elements of SIC but evidently lacked practical knowledge and practice on other aspects of SIC. The recently updated curriculum for Dutch surgical residents referred to SIC only twice and just in general terms [31]. Moreover, training for surgical residents is only starting to be implemented. It may well be that surgeons still improve their knowledge the hard way, that is through complaints and legal actions. Future surgical residents require optimized training in SIC using specific courses supported by supervision in daily practice. An option would be to incorporate an educational SIC programme in the early phase (year 1–2) of the surgical residency.

Structuring a SIC process will improve its quality, completeness and legal solidity. Moreover, it will improve patient satisfaction, safety and prevent high impact malpractice claims [1, 32‐35]. In recent years, preoperative safety programs (SURPASS) have structured and improved patient safety significant, but there was little interest in the aspects of SIC [33]. A standard SIC form was introduced and successfully implemented in daily practice in various countries including Australia and the UK [23]. According to the present study, the SIC process in the Netherlands is highly dependent on local and personal circumstances. Therefore this process requires standardization and implementation in preoperative safety programs. A substantial number of respondents would like to receive specific forms that are designed to guide doctors and patients through the steps of the SIC process [23].

Is proper introduction and implementation of SIC in daily practice considered a nuisance by surgical staffs? All steps of the process require substantial amounts of precious consultation time. Theoretically, modern tools including computer based techniques may be used to facilitate SIC. Computers provide structure, improve quality, diminish consultation time and stimulate patient commitment [1]. At present, surgeons and residents are not using these tools for SIC on a large scale but the majority claim an open mind regarding the use of interactive software in the future [23, 24]. Unfortunately, development of these programs in Europe nowadays is at the level of small pilot studies [1]. In the US however, the iMed program is fully implemented [16, 36]. Further studies are necessary to explore and introduce these web-based interactive programs on a larger scale in Europe [8].

The present study may suffer from several shortcomings, as it reports on the daily practice using multiple-choice questions. Reporting bias may therefore be of influence although completing the questionnaire was voluntary and results were made anonymous. Although a 30% response rate is comparable to results obtained from other studies, the topic of the present study and e-mailing rather than post mailing may have negatively influenced this response rate [5, 28, 37‐42]. Selection bias may have been of influence even though the response rate of surgeons and residents (65% vs. 35%) closely reflects the present Dutch surgical population (70% vs. 30%). Moreover, a response was received from 96% of all hospitals whereas the existing types of hospitals were equally distributed [41]. We therefore feel that this study is representative for the current practice of surgeons and surgical residents in the Netherlands. However, the lack of validated questionnaires and few comparable studies render interpretation of our results somewhat hazardous. It is obvious that more studies are needed to confirm these results. Strengths of this study include the voluntary setting of this survey with a response of a substantial amount (n > 450) of individuals and the support of the Dutch Society of Surgery. The comparison between surgeons and residents incidentally, showed large differences in knowledge and practice. Interestingly, several respondents declared that the questionnaire itself was very instructive and opened discussions within their departments potentially suggesting an improved awareness and a more solid role of SIC in future surgical practice.

In conclusion, the quality of the current SIC process is suboptimal in the Netherlands. Surgical residents require training aimed at improving awareness and skills. The SIC process is ideally supported using modern tools including web-based interactive programs. Improvement of the SIC process may enhance patient satisfaction and may possibly reduce the number of complaints.