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Informed consent documentation for total hip and knee replacement using generic forms with blank spaces
Mohamed Altayeb Mussa1, Tamer Ahmed Sweed, Aazer Khan
1Southend Hospital NHS Trust, Westcliff-on-Sea, Essex, United Kingdom.
Insights
Generic informed consent forms inadequately document complications for total hip (THR) and knee (TKR) replacements. Procedure-specific forms are recommended to improve patient understanding of surgical risks.
Area of Science:
- Orthopedic Surgery
- Patient Safety
- Informed Consent Law
Background:
- Informed consent is crucial for patient autonomy and safety in surgical procedures.
- Generic consent forms may not adequately convey the specific risks associated with complex orthopedic surgeries like total hip and knee replacements.
Purpose of the Study:
- To analyze the completeness of informed consent documentation for patients undergoing elective primary total hip replacement (THR) or total knee replacement (TKR).
- To evaluate the effectiveness of generic consent forms with blank spaces in documenting surgical complications.
Main Methods:
- Analysis of informed consent documentation from 100 patients (57 male, 43 female; mean age 54) undergoing elective primary THR (n=50) or TKR (n=50).
- Data collected included patient demographics, planned procedure, benefits, risks, and surgeon's grade.
- Consent forms were explained by surgical staff, primarily on the morning of surgery.
Main Results:
- For THR, frequently documented complications included infection (98%), bleeding (96%), and deep vein thrombosis (94%). Less documented risks were prosthesis wear (76%) and dislocation (68%).
- For TKR, infection (96%), bleeding (92%), and deep vein thrombosis (90%) were most common. Less documented risks included prosthesis wear (54%) and knee stiffness (40%).
- Overall documentation of clinically significant complications was insufficient across both procedures using generic forms.
Conclusions:
- Generic informed consent forms with blank spaces are insufficient for documenting all significant complications associated with total hip and knee replacements.
- Standardized, procedure-specific consent forms are recommended to ensure comprehensive patient information and improve informed consent processes.
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.
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