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

Wouter Kg Leclercq, Bram J Keulers, Saskia Houterman, Margot Veerman, Johan Legemaate, Marc R Scheltinga, Wouter Kg Leclercq, Bram J Keulers, Saskia Houterman, Margot Veerman, Johan Legemaate, Marc R Scheltinga

Abstract

Additional non-English language abstract (in Dutch)

Background: A properly conducted surgical informed consent process (SIC) allows patients to authorize an invasive procedure with full comprehension of relevant information including involved risks. Current practice of SIC may differ from the ideal situation. The aim of this study is to evaluate whether SIC practiced by Dutch general surgeons and residents is adequate with involvement of all required elements.

Methods: All members of the Dutch Society of Surgery received an online multiple choice questionnaire evaluating various aspects of SIC.

Results: A total of 453 questionnaires obtained from surgeons and residents representing >95% of all Dutch hospitals were eligible for analysis (response rate 30%). Knowledge on SIC was limited as only 55% was familiar with all three basic elements ('assessment of preconditions', 'provision of information' and 'stage of consent'). Residents performance was inferior compared to surgeons regarding most aspects of daily practice of SIC. One in 6 surgeons (17%) had faced a SIC-related complaint in the previous five years possibly illustrating suboptimal SIC implementation in daily surgical practice.

Conclusions: The quality of the current SIC process is far from optimal 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.

Achtergrond: Het doel van het preoperatieve informed consent proces (surgical informed consent, SIC) is om patiënten een weloverwogen en welgeïnformeerde keuze te laten maken over hun operatieve ingreep. De hedendaagse praktijk betreffende SIC staat mogelijk ver van de ideale situatie af. Doel van deze studie is om de dagelijkse praktijk van chirurgen en chirurgen in opleiding betreffende SIC te evalueren en te zien of deze voldoet aan de daarvoor gestelde eisen. METHODE: Alle chirurgen en andere leden van de Nederlandse Vereniging voor Heelkunde ontvingen een online multiple-choice vragenlijst betreffende de belangrijkste aspecten van SIC. RESULTATEN: In totaal waren er 453 bruikbare reacties uit meer dan 95% van alle Nederlandse ziekenhuizen (respons 30%). De kennis over SIC blijkt zeer beperkt. Slechts 55% van de chirurgen bleek bekend met de drie basiselementen van SIC ('beoordelen van de competentie van een patiënt', 'verstrekken van informatie' and 'adequaat vastleggen van de toestemming van de patiënt'). De dagelijkse praktijk liet behoorlijke verschillen tussen alle respondenten zien, maar chirurgen in opleiding scoorden significant slechter vergeleken met chirurgen. 17% van alle chirurgen kreeg de afgelopen vijf jaar te maken met een klacht betreffende SIC, wat zou kunnen wijzen op een suboptimale implementatie van SIC in de dagelijkse praktijk.

Conclusie: De kwaliteit van het preoperatieve informed consent proces is in Nederland verre van goed. Chirurgen in opleiding scoorden minder goed dan chirurgen en dienen beter geschoold te worden. Het hele SIC proces zou geformaliseerd moeten worden in protocollen. Moderne hulpmiddelen zoals interactieve softwareprogramma's kunnen hierbij mogelijk helpen. Door het verbeteren van het SIC proces kan de patiëntentevredenheid verhoogd worden terwijl het aantal klachten mogelijk wordt verminderd.

Figures

Figure 1
Figure 1
Three elements of informed consent.
Figure 2
Figure 2
Response to surgical informed consent questionnaire.

References

    1. Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010;34:1406–1415. doi: 10.1007/s00268-010-0542-0.
    1. Legemate DA, Legemaate J. [The preoperative informed consent procedure] Ned Tijdschr Geneeskd. 2010;154:A2492.
    1. Schenker Y, Meisel A. Informed consent in clinical care: practical considerations in the effort to achieve ethical goals. JAMA. 2011;305:1130–1131. doi: 10.1001/jama.2011.333.
    1. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9:485–493. doi: 10.1016/S1470-2045(08)70128-1.
    1. Abed H, Rogers R, Helitzer D, Warner TD. Informed consent in gynecologic surgery. Am J Obstet Gynecol. 2007;197:674–675.
    1. Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007;197:654–656.
    1. McKneally MF, Martin DK, Ignagni E, D'Cruz J. Responding to trust: surgeons' perspective on informed consent. World J Surg. 2009;33:1341–1347. doi: 10.1007/s00268-009-0021-7.
    1. Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011;31:151–173. doi: 10.1177/0272989X10364247.
    1. Chassin MR, Becher EC. The wrong patient. Ann Intern Med. 2002;136:826–833. doi: 10.7326/0003-4819-136-11-200206040-00012.
    1. Royal Dutch Medical Association (KNMG) [Guidebook Informed Consent] 2001. .
    1. Dutch Institute for Healthcare Improvement (Centraal Beleids Orgaan C. [Guideline the preoperative route] 2009. .
    1. Dutch Institute for Healthcare Improvement (Centraal Beleids Orgaan C. [Guideline the peroperative route] 2010. .
    1. Jukic M, Kozina S, Kardum G, Hogg R, Kvolik S. Physicians overestimate patient's knowledge of the process of informed consent: a cross-sectional study. Med Glas Ljek komore Zenicko -doboj kantona. 2011;8:39–45.
    1. Jukic M, Kvolik S, Kardum G, Kozina S, Tomic JA. Knowledge and practices of obtaining informed consent for medical procedures among specialist physicians: questionnaire study in 6 Croatian hospitals. Croat Med J. 2009;50:567–574. doi: 10.3325/cmj.2009.50.567.
    1. Timmermans D, Molewijk B, Stiggelbout A, Kievit J. Different formats for communicating surgical risks to patients and the effect on choice of treatment. Patient Educ Couns. 2004;54:255–263. doi: 10.1016/S0738-3991(03)00238-6.
    1. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J. et al.Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010;252:27–36. doi: 10.1097/SLA.0b013e3181e3ec61.
    1. Falagas ME, Akrivos PD, Alexiou VG, Saridakis V, Moutos T, Peppas G, Kondilis BK. Patients' perception of quality of pre-operative informed consent in athens Greece: a pilot study. PLoS One. 2009;4:e8073. doi: 10.1371/journal.pone.0008073.
    1. Knops AM, Ubbink DT, Legemate DA, de Haes JC, Goossens A. Information communicated with patients in decision making about their abdominal aortic aneurysm. Eur J Vasc Endovasc Surg. 2010;39:708–713. doi: 10.1016/j.ejvs.2010.02.012.
    1. Berman L, Dardik A, Bradley EH, Gusberg RJ, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: assessing variations in surgeon opinion through a national survey. J Vasc Surg. 2008;47:287–295. doi: 10.1016/j.jvs.2007.10.050.
    1. Rajab TK, Wallwiener M, Talukdar S, Kraemer B. Adhesion-related complications are common, but rarely discussed in preoperative consent: a multicenter study. World J Surg. 2009;33:748–750. doi: 10.1007/s00268-008-9917-x.
    1. Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg. 2000;135:26–33. doi: 10.1001/archsurg.135.1.26.
    1. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721–726. doi: 10.1056/NEJMsa021212.
    1. Chen AM, Leff DR, Simpson J, Chadwick SJ, McDonald PJ. Variations in consenting practice for laparoscopic cholecystectomy. Ann R Coll Surg Engl. 2006;88:482–485. doi: 10.1308/003588406X114857.
    1. Schildmann J, Cushing A, Doyal L, Vollmann J. Informed consent in clinical practice: pre-registration house officers' knowledge, difficulties and the need for postgraduate training. Med Teach. 2005;27:649–651. doi: 10.1080/01421590500138747.
    1. Wenger NS, Lieberman JR. An assessment of orthopaedic surgeons' knowledge of medical ethics. J Bone Joint Surg Am. 1998;80:198–206.
    1. Peters C. Consenting to medical treatment: legal requirements vs medical practice. Are healthcare providers exposing themselves to potential legal action? N Z Med J. 2009;122:50–59.
    1. Fisher-Jeffes L, Barton C, Finlay F. Clinicians' knowledge of informed consent. J Med Ethics. 2007;33:181–184. doi: 10.1136/jme.2006.016758.
    1. O'Dwyer HM, Lyon SM, Fotheringham T, Lee MJ. Informed consent for interventional radiology procedures: a survey detailing current European practice. Cardiovasc Intervent Radiol. 2003;26:428–433. doi: 10.1007/s00270-003-0058-1.
    1. Gaeta T, Torres R, Kotamraju R, Seidman C, Yarmush J. The need for emergency medicine resident training in informed consent for procedures. Acad Emerg Med. 2007;14:785–789.
    1. Hutul OA, Carpenter RO, Tarpley JL, Lomis KD. Missed opportunities: a descriptive assessment of teaching and attitudes regarding communication skills in a surgical residency. Curr Surg. 2006;63:401–409. doi: 10.1016/j.cursur.2006.06.016.
    1. Hamming J, Borel Rinkes I, Heineman E. Curriculum for surgical residents in the Netherlands (Scherp Structuur Curriculum Heelkunde voor Reflectieve Professionals. Opleidingsplan Heelkunde) 2008.
    1. Keulers BJ, Scheltinga MR, Houterman S, van der Wilt GJ, Spauwen PH. Surgeons underestimate their patients' desire for preoperative information. World J Surg. 2008;32:964–970. doi: 10.1007/s00268-008-9581-1.
    1. de Vries EN, Eikens-Jansen MP, Hamersma AM, Smorenburg SM, Gouma DJ, Boermeester MA. Prevention of surgical malpractice claims by use of a surgical safety checklist. Ann Surg. 2011;253:624–628. doi: 10.1097/SLA.0b013e3182068880.
    1. Krause HR, Bremerich A, Rustemeyer J. Reasons for patients' discontent and litigation. J Craniomaxillofac Surg. 2001;29:181–183. doi: 10.1054/jcms.2001.0212.
    1. Betti S, Sironi A, Saino G, Ricci C, Bonavina L. Effect of the informed consent process on anxiety and comprehension of patients undergoing esophageal and gastrointestinal surgery. J Gastrointest Surg. 2011;15:922–927. doi: 10.1007/s11605-011-1517-7.
    1. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J. et al.Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010;210:919–926. doi: 10.1016/j.jamcollsurg.2010.02.049.
    1. Wauben LS, van Veelen MA, Gossot D, Goossens RH. Application of ergonomic guidelines during minimally invasive surgery: a questionnaire survey of 284 surgeons. Surg Endosc. 2006;20:1268–1274. doi: 10.1007/s00464-005-0647-y.
    1. Manthous CA, DeGirolamo A, Haddad C, Moateng-Adjepong Y. Informed consent for medical procedures: local and national practices. Chest. 2003;124:1978–1984. doi: 10.1378/chest.124.5.1978.
    1. Pleat JM, Dunkin CS, Davies CE, Ripley RM, Tyler MP. Prospective survey of factors affecting risk discussion during consent in a surgical specialty. Br J Surg. 2004;91:1377–1380. doi: 10.1002/bjs.4590.
    1. Dawes PJ, Kitcher E. Informed consent: British otolaryngologists surveyed. Clin Otolaryngol Allied Sci. 1999;24:198–207. doi: 10.1046/j.1365-2273.1999.00244.x.
    1. Buddingh KT, Hofker HS, ten Cate Hoedemaker HO, van Dam GM, Ploeg RJ, Nieuwenhuijs VB. Safety measures during cholecystectomy: results of a nationwide survey. World J Surg. 2011;35(6):1235–41. doi: 10.1007/s00268-011-1061-3. PubMed PMID: 21445669; PubMed Central PMCID: PMC3092925. discussion 1242-3.
    1. Barton A, Williams D, Beveridge M. A survey of Canadian general surgery residents' interest in international surgery. Can J Surg. 2008;51:125–129.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit