PURPOSE: To analyse informed consent documentation of 100 patients undergoing elective primary total hip replacement (THR) or total knee replacement (TKR) using generic forms with blank spaces. METHODS: Informed consent documentation of 57 men and 43 women (mean age, 54 years) undergoing elective primary THR (n=50) or TKR (n=50) using generic forms with blank spaces were analysed. The consent forms were explained to the patients mostly on the morning of surgery by a consultant surgeon (n=21), specialist registrar (n=23), or senior house officer (n=56). Data on patient demographics, planned procedure, benefits and risks of surgery, and the grade of the surgeon were collected. RESULTS: In the consent forms for THR, the most frequently documented complications included infection (98%), bleeding (96%), deep vein thrombosis (94%), nerve damage (94%), blood vessel damage (94%), and pain (90%). Common complications (2-5% of occurrence) that were less frequently documented included prosthesis wear or loosening (76%), dislocation (68%), and leg length discrepancy (62%). In the consent forms for TKR, the most frequently documented complications included infection (96%), bleeding (92%), deep vein thrombosis (90%), nerve damage (90%), and blood vessel damage (90%). Common risks (2-5% of occurrence) that were less frequently documented included pain (84%), prosthesis wear or loosening (54%), and knee stiffness (40%). CONCLUSION: Documentation of all clinically significant complications was insufficient when generic informed consent forms with blank spaces were used. The use of standardised procedure-specific consent forms is recommended.
PURPOSE: To analyse informed consent documentation of 100 patients undergoing elective primary total hip replacement (THR) or total knee replacement (TKR) using generic forms with blank spaces. METHODS: Informed consent documentation of 57 men and 43 women (mean age, 54 years) undergoing elective primary THR (n=50) or TKR (n=50) using generic forms with blank spaces were analysed. The consent forms were explained to the patients mostly on the morning of surgery by a consultant surgeon (n=21), specialist registrar (n=23), or senior house officer (n=56). Data on patient demographics, planned procedure, benefits and risks of surgery, and the grade of the surgeon were collected. RESULTS: In the consent forms for THR, the most frequently documented complications included infection (98%), bleeding (96%), deep vein thrombosis (94%), nerve damage (94%), blood vessel damage (94%), and pain (90%). Common complications (2-5% of occurrence) that were less frequently documented included prosthesis wear or loosening (76%), dislocation (68%), and leg length discrepancy (62%). In the consent forms for TKR, the most frequently documented complications included infection (96%), bleeding (92%), deep vein thrombosis (90%), nerve damage (90%), and blood vessel damage (90%). Common risks (2-5% of occurrence) that were less frequently documented included pain (84%), prosthesis wear or loosening (54%), and knee stiffness (40%). CONCLUSION: Documentation of all clinically significant complications was insufficient when generic informed consent forms with blank spaces were used. The use of standardised procedure-specific consent forms is recommended.