A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions.

BACKGROUND: Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process. METHODS: Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed. RESULTS: The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose. CONCLUSIONS: IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.

Can face-to-face patient education be replaced by computer-based patient education? A randomised trial.

OBJECTIVE: Computer-based patient education is an effective (therapeutic) tool. More and more studies prove that it can be an effective additive for face-to-face education, but it is still unclear if it is possible to educate patients by only using a computer. Our objective was to compare knowledge levels and satisfaction scores after computer-based patient education versus doctor-based patient education. METHODS: We started a randomised and stratified trial in a large plastic surgery clinic in the Netherlands. One hundred thirteen patients with carpal tunnel syndrome (CTS), scheduled for operation were included. One group received CTS education by a doctor using a checklist (group A). The other group received the same CTS education by specially designed interactive computer program (group B). After 2 weeks, knowledge levels and satisfaction scores were tested by using a questionnaire. RESULTS: One hundred thirteen patients were included, 96 patients finished the questionnaire. With respect to knowledge levels the doctor group (A) scored 20.2 points (max 40 points), and the computer group (B) scored 23.5 points. After correction the difference was 2.8 points (p=0.001). The total satisfaction score in group A was 7.6 and in group B 7.5; a difference of -0.16 (p=0.585). CONCLUSIONS: The results suggest that educating patients can result in a higher knowledge levels by using a computer than by using a doctor. Satisfaction seems equal after both methods of education. PRACTICE IMPLICATIONS: Knowing that you can educate patients without seeing a doctor or nurse seems promising. Patient can be educated by computer-based education programs leaving more time in a consultation for asking questions and discussing treatment options. The discussion will be at a more equal level of knowledge. Possibly it can save time and money resulting in a more efficient patient care, without dissatisfying our patients.

Challenging the knowledge base and skillset for providing surgical consent by orthopedic and plastic surgeons in the Netherlands: an identified area of improvement in patient safety.

BACKGROUND: Successfully completing a surgical informed consent process is an important element of the preoperative consult. A previous study of Dutch general surgeons demonstrated that the implementation of SIC did not meet acceptable standards. However, the quality of the SIC process in the orthopedic surgical or plastic surgical arena is unknown. METHODS: Following ethical approval, an online survey investigating specifics of surgical informed consent was performed among members of the Dutch Scientific Association of Orthopedic Surgeons and the Dutch Society for Plastic Surgery. RESULTS: A total of 335 responses from a majority of departments of orthopedic (86 %) and plastic surgery (78 %) were eligible for analysis. Scores on knowledge were poor as only 50 % recognized the three basic elements of surgical informed consent (competence, exchange of information and consent). The orthopedic group used more tools in the surgical informed consent process, such as instruction movies and websites or specialized nursing staff, compared to plastic surgery (orthopedic: 31-50 % vs. plastic: 6-30 %, p = 0.05- < 0.001). In contrast, surgical informed consent forms were used more frequently by the plastic surgical group (orthopedic 21 % vs. plastic:42 % p < 0.001). Control of the efficacy of the surgical informed consent process was low, 36 % in both groups. One in every seven orthopedic or plastic surgeons was faced with an official surgical informed consent-related complaint in the previous five years. CONCLUSIONS: Similar to general surgeons, Dutch orthopedic and plastic surgeons demonstrate poor knowledge and skills regarding surgical informed consent. Increased awareness, better training and use of modern tools including standard forms and online software programs will improve the SIC process and will optimize patient care.

[Preoperative medical record-keeping can be improved: new informed consent form assists both physicians and patients]. / Preoperatieve dossiervoering kan beter: nieuw informed-consentformulier helpt arts én patiënt.

Adequate record-keeping is an important part of the surgical informed consent (IC) process. Standardization can enhance the quality of this process but is incomplete and qualitatively insufficiently implemented in current surgical practice. The introduction of well-designed tools would improve daily practice. We inventoried preoperative reporting at all 91 Dutch departments of General Surgery. Thirty-nine of the 73 departments that provided information on their IC process used a standard form. Twenty-nine of these forms were sent for analysis using a checklist based on legislation, recent case law and specialist literature. The mean number of items per form was 37, but not a single form was complete. Based on these results in combination with relevant legislation, guidelines and expert opinions, an adequate, user-friendly and straightforward preoperative IC form was designed. This IC form can serve as a checklist and report for the physician and as an information leaflet for the patient.

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

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.

Conventional versus invaginated stripping of the great saphenous vein: a randomized, double-blind, controlled clinical trial.

BACKGROUND: An invaginated strip of the great saphenous vein (GSV) may be associated with diminished blood loss and less discomfort compared to conventional stripping in patients with unilateral primary GSV varicosis. METHODS: Ninety-two patients were randomized for conventional (CON) or invaginated (INVAG) stripping and were followed for 26 weeks postoperatively. RESULTS: Both groups (n = 46) were well balanced for age, gender distribution, and body mass index. The CON group lost twice as much blood compared to the INVAG group (CON: 28 +/- 4 g, INVAG: 15 +/- 2 g, p < 0.001). Infragenual incision length following a conventional strip was twice as long (CON: 16 +/- 1 mm, INVAG: 8 +/- 1 mm, p < 0.001). Pain as measured with a visual analog scale (minimal 0, max 10) decreased in both groups in a similar fashion from 3.2 +/- 0.3 preoperatively to 0.6 +/- 0.2 after 26 weeks (p < 0.001). Saphenous nerve damage after one month was observed in four CON patients compared to no patients following invagination. Return to work was not different (CON: 13 +/- 2 days, INVAG: 11 +/- 2 days). CONCLUSION: Invagination of the GSV in uncomplicated primary varicosis may be associated with less surgical trauma compared to a conventional stripping technique.